Final Report Summary - CEDAR (Clinical decision making and outcome in routine care for people with severe mental illness)
Objectives: Main objectives of this multi-centre prospective observational study were to develop a methodology to assess the scope and quality of clinical decisions in the care of people with severe mental illness (SMI) from both the patient and clinician perspective; and to examine how and to what degree clinical decision making (CDM) in routine care affects patient behaviour and short- and long-term treatment outcome.
Methods:
Firstly, three instruments with parallel patient and staff versions each were developed to assess key aspects of CDM in the routine care of people with SMI:
1. CDM style (CDMS): To assess nature and stability of CDMS (with the subscales 'Participation in decision making' and 'Information') at baseline and at one-year follow-up;
2. CDM involvement and satisfaction (CDIS): To assess at monthly intervals) involvement in ('active' versus 'shared' versus 'passive') and satisfaction with CDM;
3. CDM in routine care (CDRC): To measure at monthly intervals context and content of CDM.
Secondly, a comprehensive prospective study was carried out in six European countries, namely Germany (DE), United Kingdom (UK), Italy (IT), Hungary (HU), Denmark (DK) and Switzerland (CH) in order to examine the effect of CDM on outcome.
Results:
Instrument development followed state-of-the-art recommendations for the development, translation and cultural adaptation of measures and yielded feasible instruments in five languages showing adequate psychometric properties. Data collection and check for the main study was completed in July 2012 (N = 588 patients, N = 213 staff). Patients were in their early forties on average, half of them were female and mean duration of mental illness was more than 12 years. Both patients and staff indicated shared as their preferred style of participation in decision making. Desire for information was predominantly high in patient report and mostly moderate in the view of staff. Satisfaction with the way the last decision was met was predominantly high in patients and mostly moderate in staff, while involvement was mainly rated as shared by both. Number of unmet needs (outcome) significantly decreased over one year and change in unmet needs was affected by satisfaction with how the actual treatment decision was made, but not by CDM style.
Conclusions and recommendations:
Via the development of validated instruments to capture structure, process and outcome of CDM in people with SMI, CEDAR has contributed to a refined research methodology in this field. Through the use of those instruments in a large multi-centre prospective study, a comprehensive model of CDM in people with SMI receiving treatment in different European mental health service systems will be tested. First results showed that aspects of decision making during an actual treatment session are more important for outcome than decision making style. This suggests that future interventions should specifically target the daily practice of decision making rather than rather trait-like aspects such as decision making style. Further best practice recommendations for CDM in the care of people with SMI will be derived from the results and will be made available to stakeholders (patients, clinicians and health care funders). Thus, CEDAR will provide evidence directly contributing to optimising the delivery of mental health care to European citizens.
Project context and objectives:
CDM in chronic conditions such as SMI differs from decision making in acute care. The former has to take into account that treatment focus is on long-term disease management, a high number of decisions have to be made frequently, often together with more than one service provider and/or carers and patients in general are highly knowledgeable about their illness. Furthermore, research on CDM so far has been rather artificial and decontextualised. The following key research challenges for CDM in the care of people with SMI have been outlined:
1. descriptive research and instrument development focussing on how decisions are actually made in routine care and how the process of decision making relates to everyday behaviours and outcomes.
2. improvement of measures for characterising decision making processes that are matched to study populations, complexity and type of decision making, especially in people with severe and long-standing mental disorder who are obliged to make multiple and repetitive treatment decisions, often in cooperation with more than one treatment provider.
3. information about the psychological impact of patient participation in making complex and stressful decisions.
4. decision making styles of both patients and of providers and how these styles are enacted in a variety of CDM encounters.
5. how decision making results in congruent or conflicting outcomes and how all participants evaluate such outcomes.
There is a lack of knowledge on CDM and its outcome in the care for people with SMI. Since patient-key worker communication is the main vehicle of service delivery, this situation is unsatisfying. The most salient approach (i.e. both clinically relevant and crucial for clinical governance) would be a focus on what level of participation a patient wants in their care and whether a good match between desired and experienced level of participation has any impact on treatment satisfaction or outcome. Furthermore, quality of CDM in the care of people with SMI has yet to be studied from an international perspective which would yield insights into similarities and differences of CDM among different countries and mental health service systems.
The CEDAR study addresses those challenges. The main objective of this multi-centre prospective observational study is to develop a methodology to assess the scope and quality of clinical decisions in the care of people with SMI from both the patient and clinician perspective and to specify how and to what degree CDRC affects patient behaviour and short- and long-term treatment outcome.
Project results:
Introduction
Main tasks of the first reporting period (1 April 2009 to 30 September 2010) were preparation and start of the main study. Those of the second reporting period (1 October 2010 to 30 September 2012) were completing data collection, data check and dissemination of results.
This document will describe CEDAR's scientific and technological (S&T) results in relation to the specified work packages (WPs) and milestones for the entire duration of the project.
Management of the consortium (WP1)
The kick-off meeting took place from 27 to 29 May 2009 in Ulm with all principal investigators, advisory board members and additional study staff present. Main achievements of this conference were that:
1. an email and phone network was established to ensure regular communication and information flow between all partners and other personnel
2. a project steering group was set up involving all principal investigators and their representatives
3. the project's goals and procedures were presented, discussed and agreed upon
4. a schedule for telephone conferences among study staff was approved and
5. legal and financial issues were presented, discussed and consented upon.
From then on, led by the coordinating centre (CC), regular phone conferences (every two weeks until January 2011, from then on monthly) took place.
Subsequent study meetings were:
1. Zurich (15 to 17 September 2009)
2. Debrecen (31 May to 1 June 2010)
3. London (12 to 14 January 2011)
4. Aalborg (7 to 9 September 2011)
5. Hindelang near Ulm (21 to 23 March 2012)
6. Naples (10 to 14 September 2012).
Instrument development (WP2 and WP3)
Objectives
Rational of instrument development followed one of the main study hypotheses which stated that 'the quality of CDM can be adequately described by taking into account decision making styles, satisfaction with decision making and type of decision making ('paternalistic' versus 'shared' versus 'informed'). The three instruments to be developed and their scope were:
1. CDMS: This instrument comprehensively assesses nature and stability of patients' and clinicians' decision making style both at baseline and at one-year follow-up. Elements of CDMS include preferred and actual decision making relating to amount of time dedicated to CDM (little, medium, ample); involvement (clinician-/user-led, 'shared'); detail-driven versus generic; focus (target- versus relationship-oriented); and importance and expected consequences of clinical decisions.
2. CDRC: This instrument measures (at monthly intervals) key aspects of CDM from the patient and clinician perspectives as they unfold in routine care, namely specificity: Broad (e.g. admission to inpatient care) versus specific (e.g. change in medication); acuteness: Urgent versus in the future; choices: Number of available treatment options including affordability and accessibility; participants in decision making (also beyond the clinician-patient dyad) and their roles; treatment: Broad (e.g. medication versus psychosocial treatments) versus specific (e.g. kind of medication).
3. CDIS: This instrument assesses (at monthly intervals) CDM involvement ('shared') and satisfaction with decision making from the patient and clinician perspectives.
Development of all three CEDAR measures followed the ISPOR Framework of good practice for the translation and cultural adaptation of patient-reported outcome measures. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) framework identifies 10 sequential steps, i.e. preparation; forward translation; reconciliation; back translation; back translation review; harmonisation; cognitive debriefing; review of cognitive debriefing results and finalisation; proof-reading; and final report. We refer to these steps as ISPOR 1 to ISPOR 10 respectively.
Focus groups were held in ISPOR 1 and 7. Focus groups are widely used to examine people's experience with illness and health services. They especially aim at enabling vulnerable people to freely express their views in the format of a moderated group discussion. Patient participants of focus groups were convenient samples of native speaker adults aged 18 to 60 using local non-forensic mental health services. Staff participants were workers in these services. Focus groups were held in non-clinical settings moderated and co-facilitated by two CEDAR research workers who ensured that all responders had sufficient opportunity to air their views and that non-verbal group dynamics were noted. All focus groups were audiotaped and fully transcribed.
Development of the source language instrument versions
At the first CEDAR study meeting in May 2009, Ulm research workers presented results of an extensive literature search on the instruments with a special focus on identifying scales to be considered candidates for inclusion. Presentations were discussed by the study group including advisory board members which allowed drafting a topic guide for the first round of focus groups. Subsequently, six focus groups (four with 23 patients altogether and two with eight clinicians altogether) were held by researchers in Ulm to explore the conceptual understanding of clinical decision-making. Topics covered included the experience of making decisions as well as level of involvement and satisfaction with the process during the last treatment session. Procedures and results of these focus groups have been reported in detail elsewhere.
Development of the target language instrument versions
First (ISPOR 2), the three measures were forward translated from English into the four other study languages (German, Italian, Hungarian and Danish; Switzerland used the German version). Forward translations in each centre were done by native speakers of the target language who were familiar with the concepts of the instrument. Assistance by professional translators was drawn upon as needed and where more than one forward translations was produced independently of one another at a study centre, these were compared and merged into one single forward translation (ISPOR 3). Subsequently, in each study centre one person fluent in the source language who had not been involved into the forward translation(s) carried out a blind (without seeing the source) back translation into the source language (ISPOR 4). Back translations were then compared to the original by CEDAR team members who were English native speakers (ISPOR 5) and potential discrepancies were discussed with the key in-country person and corrected as needed (ISPOR 6). Patient and staff versions of instrument drafts were then subjected to a total of 17 focus groups (nine with 33 patients altogether and eight with 31 key workers altogether) at all study sites in order to test alternative wording and to check understandability, interpretation, feasibility and cultural relevance of the translations (ISPOR 7). Review of cognitive debriefing results based upon reports of previous step to the Ulm study centre resulted in some final amendments including changes in text and omission of some items in order to arrive at short and understandable measures. Final versions were then carefully proofread by local CEDAR team members and checked for consistency in order of items and format by the Ulm study team (ISPOR 9). The three papers on the instruments comprise the final report of the entire process of instrument development (ISPOR 10). In addition, in these papers psychometric properties of the three CEDAR CDM instruments have been described.
Led by the CC, these and other already established instruments (to assess clinical characteristics, sociodemographic status and service use, illness severity, needs, quality of life, therapeutic relationship, symptomatic impairment, functioning and recovery) were translated from English into each centre's language using ISPOR guidelines.
Instrument training (WP4)
Research workers were continuously trained in the use of study instruments and data entry tools. Initial instrument training at the Ulm and Zurich study meetings included training sessions given by experts for certain instruments (Threshold Assessment Grid, Health of the Nation Outcome Scale, Structured Clinical Interview for DSM-IV on the basis of case notes). Booster training sessions were held at the subsequent study meetings in Debrecen and London. While personal instruction at the study meetings was the primary means of training, regular phone conferences served to clarify remaining issues and to continuously monitor quality of instrument use. In order to ensure high quality of study data, research workers were also thoroughly trained in the use of the CEDAR data entry tool via instruction at the study meetings and during conferences on the basis of comprehensive handbooks on all study software distributed by the CC.
Conducting the study (WP5)
After successful completion of the preparatory tasks, recruitment for the study started with one month delay on 1 November 2009. By that time, research workers at every centre had already carried out activities for promoting the study, i.e. providing clinicians at relevant local outpatient services with study information personally or via local practitioner journals. Good contacts to patients and key worker were established in every centre, resulting in satisfactory recruitment rates close to target with some variance among centres. By 15 December 2010, N = 588 participants (540 planned, i.e. monthly rate total = 45) had been recruited.
Data preparation and analysis (WP6)
Preparation
Using tools prepared by the CC for data entry, data were transferred to the CC after the completion of data collection at each measurement point. Data check led by the co-ordinating centre involved data validation and data verification. Data validation involved checking the case-level data were internally consistent and identifying outlier ratings, asking the originating site to manually check each identified outlier rating against paper and local electronic databases and correcting the central database where necessary. Data verification involved identifying remaining outliers and deciding whether to include them in the analysis on the basis of plausibility, i.e. whether they were reasonable ratings and whether they correlated with other contemporaneous ratings for the same participant. After completion of data check, cleaned data were aggregated into two data bases, long (complete original data) and short (data for most analysis with calculated total scores) which were transferred to partner sites for analysis. Some minor corrections were carried out after final comments from people working with the data sets.
Analysis
In order to ensure coherence, data analysis took place at the CC for central parts of the data, e.g. sample description. Centre differences were found for the majority of variables describing patient and staff characteristics. Furthermore, data analysis pertaining to specific research questions in certain papers was guided by the first author of the respective Paper.
Dissemination of results (WP7)
The results of the implemented dissemination strategy have been reported upon the completion of relevant activities.
Potential impact:
Dissemination activities and exploitation of results
Publications
Dissemination of results has been kicked off with the publication of the study protocol (paper number six below). Subsequent publications are well in line with the publication plan which aims at an adequate number of papers in thematic groups (no-data papers, papers on psychometric properties of developed instruments, papers analysing baseline data and papers using follow-up data and papers using the complete follow-up repeated measures assessment). Another qualitative paper has and a book chapter on concept, measurement, evidence and practice on shared decision making in mental health care are in print (papers four and five) and three papers on instrument papers on the psychometric properties of the CEDAR instruments are under review (papers one to three).
Published/in press/submitted
1. Konrad, J., Loos, S., Neumann, P., Mayer, B., Slade, M., Jordan, H., Giacco, D., De Rosa, C., Egerhazi, A., Nagy, M., Krogsgaard Bording, M., Østermark Sørensen, H., Kawohl, W., Rössler, W., Puschner, B., and CEDAR study group (submitted). A five-language multiperspective instrument to assess CDM in the routine care of people with SMI. Social Psychiatry and Psychiatric Epidemiology.
2. Slade, M., Jordan, H., Clarke, E., Williams, S., Kaliniecka, H., Arnold, K., Fiorillo, A., Giacco, D., Luciano, M., Egerhazi, A., Nagy, M., Krogsgaard Bording, M., Østermark Sørensen, H., Rössler, W., Kawohl, W., Puschner, B., and CEDAR study group (submitted). The development and evaluation of a five-language multi-perspective standardised measure: Clinical Decision-making Involvement and Satisfaction (CDIS). BMC Health Services Research.
3. Puschner, B., Loos, S., Neumann, P., Konrad, J., Slade, M., Maj, M., Giacco, D., Egerhazi, A., Ivanka, T., Krogsgaard Bording, M., Østermark Sørensen, H., Kawohl, W., Bär, A., and CEDAR study group (2013). Psychometric properties of a five-language multiperspective instruments to assess CDMS in the treatment of people with SMI. BMC Psychiatry 13,48.
4. Puschner, B., Konrad, J., and Loos, S. (2013). Shared decision making': Begrifflichkeiten, Messung, Evidenz, Praxis [Shared decision making: concept, measurement, evidence, practice]. In: W. Rössler und W. Kawohl (eds.): Handbuch der sozialen Psychiatrie. Stuttgart: Kohlhammer.
5. Loos, S., Neumann, P., Arnold, K., Slade, M., Fiorillo, A., Frøkjær Krogsgaard Bording, M., Ivanka, T., Kawohl, W., and Puschner, B. (in press). Gemeinsame Entscheidungsfindung in der Behandlung von Patienten mit schweren psychischen Erkrankungen: Eine Fokusgruppen-Untersuchung [Shared decision-making in the treatment of people with SMI: a focus group study]. Psychiatrische Praxis 40,23-29.
6. Puschner, B., Steffen, S., Slade, M., Kaliniecka, H., Maj, M., Fiorillo, A., Munk-Jorgensen, P., Larsen, J. I., Egerhazi, A., Nemes, Z., Rössler, W., Kawohl, W., and Becker, T. (2010). CDM and outcome in routine care for people with SMI (CEDAR): study protocol. BMC Psychiatry 10, 90.
In preparation
1. Egerhazi, Nagy, Ivanca, Sandor, Giacco, Maj, Arnold, Slade, Jordan, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Puschner: Comparison between centres with regard to identifying regional/local differences in clinical decision making, focussing on context.
2. Giacco, Sampgna, Cozzolino, Slade, Clarke, Glaub, Nagy, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Zentner, Puschner: Predictor of needs of information of patients.
3. Slade, Clarke, Jordan, Puschner, Luciano, De Rosa, Ivanka, Magyar, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Loos: Recovery and decision-making involvement in people with SMI from six countries: longitudinal observational study.
4. Jordan, Clarke, Puschner, Ay, Maj, Fiorillo, Ivanka, Nagy, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Slade: Service user ratings of needs and recovery.
5. Bär, Kawohl, Konrad, Puschner, Clarke, Slade, De Rosa, Luciano, Egerhazi, Süveges, Krogsgaard Bording, Østermark Sørensen, Rössler: Desire for autonomy.
6. Krogsgaard Bording, Munk-Jørgensen, Østermark Sørensen, Puschner, Zentner, Slade, Jordan, Fiorillo, del Veccio V, Ivanka, Kovacs, Rössler, Kawohl, Östmann: Involvement in CDM and professional context.
7. Krogsgaard Bording, Munk-Jørgensen, Østermark Sørensen, Puschner, Becker, Maj, Del Veccio H, Slade, Clarke, Egerhazi, Sandor, Rössler, Kawohl, Östman: Patient outcome and health care professionals.
8. Puschner, Becker, Ay, Jordan, Maj, Fiorillo, Égerházi, Ivánka, Munk-Jorgensen, Krogsgaard Bording, Rössler, Kawohl, Slade: Testing the CEDAR model (CDM-needs-Qol).
9. Fiorillo, Maj, De Rosa, Loos, Slade, Clarke, Nagy, Kovacs, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Puschner: CDM style: differences among professionals and impact on social and clinical outcome and on patients' quality of life.
10. Krogsgaard Bording, Munk-Jorgensen, Østermark Sørensen, Loos, Slade, Clarke, Luciano, Sampogna, Egerhazi, Magyar, Rössler, Kawohl, Puschner: Diagnosis as predictors of involvement in CDM and recovery in patients with SMI in six European countries.
11. Clarke, Jordan, Puschner, Konrad, Cozolino, De Rosa, Nagy, Süveges, Krogsgaard Bording, Østermark Sørensen, Bär, Rössler, Kawohl, Slade: Preferred DM style and decision implementation.
12. Zentner, Ay, Loos, Slade, Clarke, Maj, Salzano, Berecz, Glaub, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Puschner: Does CDM affect service use?
13. Arnold, Loos, Clarke, Jordan, Fiorillo, Del Veccio V, Egerhazi, Ivanca, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Puschner: Therapeutic relationship and outcome.
14. Østermark Sørensen, Krogsgaard Bording, Neumann, Slade, Jordan, Maj, Luciano, Egerhazi, Ivanka, Rössler, Bär, Puschner, Munk-Jorgensen: What characterises the therapeutic relationship between patient and staff? (qualitative).
15. Nagy, Egerhazi, Ivanka, Zentner, Slade, Jordan, Maj, Del Veccio H, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Puschner: Understanding the predictors and process moderators on change in quality of life.
16. Bär, Rössler, Kawohl, Konrad, Slade, Clarke, De Rosa, Luciano, Egerhazi, Nagy, Krogsgaard Bording, Østermark Sørensen, Puschner: Preferences and actual participation in CDM in people with SMI (longitudinal)
17. Konrad, Zentner, Loos, Slade, Jordan, Fiorillo, Luciano, Berecz, Nagy, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Puschner: Nature of clinical decisions (qualitative) and subgroup differences (e.g. diagnosis).
18. Loos ,Arnold, Slade, Jordan, Giacco, De Rosa, Süveges, Nagy, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Puschner: Identifying subtypes of helping alliance among patients with SMI: A latent class analytic approach.
Conferences
The concept of the study and first results have been presented at a number of national and international conferences. Main results were planned to be presented in two symposia at two major conferences in 2013 which would replace a CEDAR closing conference. Further presentations at conferences were planned, e.g. at the upcoming 10th International Conference of the European Network for Mental Health Service Evaluation (ENMESH).
Completed
1. Puschner, B., Arnold, K., Slade, M., Fiorillo, A., Krogsgaard Bording, M., Égerházi, A., Kawohl, W., and the CEDAR study group (2012). The helping alliance and outcome in people receiving routine mental health care in 6 European countries: results from the CEDAR study. Paper in panel. Third Joint Meeting of the European and the United Kingdom Chapters of the Society for Psychotherapy Research. 10 to 13 October, 2012, Porto, Portugal.
2. Puschner, B., Arnold, K., Loos, S., Slade, M., Fiorillo, A., Krogsgaard Bording, M., Nagy, M., Bär, A., Becker, T., and the CEDAR study group (2012). Helping alliance and outcome in the routine care of people with SMI across Europe. Paper in panel. 43rd International Meeting of the Society for Psychotherapy Research. 20 to 23 June 2012, Virginia Beach, USA.
3. Clarke, E., Jordan, H., Puschner, B., Slade, M., and the CEDAR study group (2012). CEDAR study: Factors associated with decision implementation in SMI. POSTER. Refocus on Recovery 2012. 5 to 7 March 2012, London, UK.
4. Jordan, H., Clarke, E., Puschner, B., Slade, M., and the CEDAR study group (2012). Development and evaluation of the five-language Clinical Decision-making Involvement and Satisfaction (CDIS) Measure. Paper. Refocus on Recovery 2012. 5 to 7 March 2012, London, UK.
5. Ay, E.-S. Krogsgaard Bording, M., Ivánka, T., Giacco, D., Bär, A., Jordan, H., and Steffen, S. (2011). CDM and outcome in routine care for people with SMI (CEDAR): First results. POSTER. IXth ENMESH International Conference. 23 to 25 June 2011, Ulm, Germany.
6. Neumann, P., Steffen, S., Becker, T., and Puschner, B. (2011). Patient participation in the CDM process in psychiatric treatment - a review of the literature. POSTER. IXth ENMESH International Conference. 23 to 25 June 2011, Ulm, Germany.
7. Ivánka, T., Nagy, M., Ègerházi, A., Ay, E.-S. Slade, M., and Puschner, B. (2011). A szükségletfelmérés új eszközének bemutatása egy menzetközi kutatás keretein belü. [Introducing the new instrument of need assessment through an international research]. Paper. XLIIth Annual Hungarian Nurses Conference. 23 to 27 May 2011, Várgesztes, Hungary.
8. Nagy, M., Ègerházi, A., and Fecska, E. (2011). Klinikai döntéshozatal súlyos pszichiátriai betegek esetében. [CDM for people with SMI]. Paper. Hungarian Psychiatric Association's annual meeting. 27 January 2011, Sopron, Hungary.
9. Puschner, B., Slade, M., Maj, M., Munk-Jørgensen, P., Égerházi, A., Rössler, W., and Becker T. (2010). CDM and Outcome in Routine Care for People with SMI (CEDAR). POSTER. EU Thematic Conference on Promoting Social Inclusion and Combating Stigma. 8 and 9 November 2010, Lisbon, Portugal.
10. Giacco, D., De Rosa, C., Salzano, A., Arnold, K., Neumann, P., Jordan, H., Slade, M., Égerházi, A., Rössler, W., Puschner B., Maj, M., and Becker, T. (2010). Lo studio europeo 'CDM and outcome in routine care for SMI (CEDAR): aspetti clinici e metodologici. [The European study 'CDM and outcome in routine care for SMI (CEDAR): clinical and methodological aspects]. POSTER. Vth Conferenza Tematica SIP (Societa Italiana de Psychiatria). 13 to 16 October 2010, Riccione, Italy.
Accepted
1. Puschner, B. (2013). CDM in the Routine Care of People with SMI across Europe: a prospective study. Symposium. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
2. Loos, S., Neumann, P., Arnold, K., Slade, M., Fiorillo, A., Krogsgaard Bording, M., Ivánka, T., Kawohl, W., and Puschner, B. (2013). Shared decision making in the treatment of people with chronic mental illness: A qualitative study with focus groups. Paper in panel. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
3. Zentner, N., Loos, S., Slade, M., and Puschner, B. (2013). Does CDM affect service use? Paper in panel. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
4. Konrad, J., Loos, S., Zentner, N., Slade, M., Mayer, B., and Puschner, B. (2013). A five-language multiperspective instrument to assess CDM in the routine care of people with SMI (CDRC). Paper in panel. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
5. Puschner, B., Becker, T., Fiorillo, A., Égerházi, A., Krogsgaard Bording, M., Kawohl, W., and Slade, M. (2013). The effect of CDM on outcome over one year in people with SMI across Europe. Paper in panel. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
6. Puschner, B., and Fiorillo, A. (2013). CDM and Outcome in Routine Care for People with SMI (CEDAR): Results from a European multicentre study. Symposium. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
7. Fiorillo, A., Maj, M., De Rosa, C., and Puschner, B. (2013). CDM style: differences among professionals and impact on social and clinical outcome and on patients' quality of life. Paper in panel. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
8. Krogsgaard Bording, M., Sørensen, H., Munk-Jørgensen, P., and Puschner, B. (2013). Involvement, satisfaction and treatment adherence in people with SMI and differences by diagnostic group (affective versus psychotic disorders). Paper in panel. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
9. Nagy, M., Ivánka, T., Sandor, J., Égerházi, A., Ay, E.-S. and Puschner, B. (2013). How elements of context determine decision making and information flow in patient-clinician interviews. Paper in panel. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
10. Puschner, B., Becker, T. J. H., Maj, M., Fiorillo, A., Égerházi, A., Ivanka, T., Munk-Jørgensen, P., Krogsgaard Bording, M., Rössler, W., Kawohl, W., and Slade, M. (2013). CDM and outcome over one year in the routine treatment of people with SMI across Europe: main results. Paper in panel. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
11. Puschner, B. (2013). The role of CDM in mental health practice. Presentation in early career psychiatrists' programme: 'What works in mental health? The role of non-specific elements'. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
12. Nagy, M., Égerházi, A., Ivanka, T., Sandor, J., Frecska, E., and Puschner, B. (2013). Az életminoség befolyásoló tényezoi egy multicentrikus kutatás eredményei [CDM and quality of life their connections and main influencing factors in the severe mentally ill]. Paper. National Conference of the Hungarian Psychiatric Association. 23 to 26 January 2013, Gyor, Hungary.
13. Égerházi, A., Nagy, M., Ivanka, T., Sandor, J., Frecska, E., and Puschner, B. (2013). A klinikai döntéshozatalt befolyásoló tényezok összehasonlítása hat európai országban [Comparison between six european countries with regard to identifying regional differences in clinical decision making]. Paper. National Conference of the Hungarian Psychiatric Association. 23 to 26 January 2013, Gyor, Hungary.
Other dissemination activities
Other dissemination activities include Student papers. Furthermore, at all sites first results of the study were presented to participants (service users and staff) via written information (short plain language summaries) and/or workshops.
1. Giacco, D., and Fiorillo, A. (2011). Stili di CDM nei disturbi mentali gravi: risultati preliminary dallo studio europeo CEDAR. [Styles of CDM in SMI]. Student Paper. Department of Psychiatry, University of Naples SUN Social Psychiatry Unit. 28 July 2011, Naples, Italy.
2. Nagy, M., Ègerházi, A., and Frecska, E. (2011). Klinikai döntéshozatal súlyos pszichiátriai betegek esetében. [CDM for people with SMI]. Student Paper. National part of the Scientific Students' Conference. 8 April 2011, Debrecen, Hungary.
3. Nagy, M., Ègerházi, A., and Frecska, E. (2010). Klinikai döntéshozatal súlyos pszichiátriai betegek esetében. [CDM for people with SMI]. Student Paper. Sixth year Student Department of Psychiatry. 3 Decemner 2010, Debrecen, Hungary.
The potential impact (including the socio-economic impact and the wider societal implications of the project so far)
During the last decades, almost all European Union (EU) Member States have undergone substantial psychiatric reforms. In addition, mental health practice and research has provided a large number of pharmacological and psychosocial interventions with proven efficacy and also effectiveness for improving clinical outcome and quality of life among people with SMI. Still, as stated in the European Community's (EC's) green paper 'Mental health of the EU population can be considerably improved'. CEDAR represents an effort to improve the delivery of existing effective treatment and that these are being utilised via specifying best practices of CDM in the care of people with SMI.
Steps to bring about the impacts:
1. feasible instruments with good psychometric properties were developed to assess vital aspects of clinical decisions in the routine care of people with SMI, desired and actual patient involvement and satisfaction with CDM;
2. established outcome measures were used and adapted as needed to ascertain adherence and outcome;
3. CDM, outcome and related variables as outlined were repeatedly measured in order to gain insight into stability and change of CDM processes over time;
4. the quality of CDM was be determined by specifying aspects of clinical decisions which substantially contribute to good clinical outcome (taking into account/controlling for effects of other covariates);
5. good practice recommendations for CDM in the care for people with SMI will be extracted from the results of this prospective multi-centre study.
In the following, CEDAR's impacts will be outlined in relation to the topics of the call.
Develop and validate methodology to measure the quality of clinical decisions
Instruments to capture structure, process and outcome of decision making in the care of people with SMI were developed and empirically validated:
1. Structure: CDMS and key elements of clinical decisions;
2. Process: Contribution of patient and clinician to CDM, patient behaviour (immediate and long-term);
3. Outcome: Satisfaction with CDM and clinical outcome (immediate and long-term). These instruments' psychometric properties (feasibility, validity, reliability, sensitivity to change) were tested at all centres in the respective host country's language (German, English, Italian, Hungarian and Danish) and then used for the comprehensive assessment of CDM in a large multi-centre prospective study. Since there is no current gold standard for a clinical decision, CEDAR has contributed to an outcome-oriented conceptualisation of CDM quality: Clinical decisions of a 'good quality' are those with a strong association with good clinical outcome.
Apply methodology to explain variations of care in seemingly similar populations resulting from the CDM process in different health care settings to allow comparative analyses of quality of care
Through a multi-centre prospective observational study, a comprehensive model of CDM is tested in people with SMI in different countries with different mental health service systems. Since quality of CDM is just one of many factors impacting upon clinical outcome, possible moderators and mediators of the CDM-outcome relation (e.g. sociodemographic characteristics, clinical variables, therapeutic relationship, satisfaction with involvement) have been comprehensively included in the analysis.
The CEDAR conceptual model will be tested by the publications as listed above. Once a significant number of central papers have been published which will be the case by the end of 2013, a summary paper will be put together which will delineate good practice recommendations for CDM in the care for people with SMI. CEDAR main papers extract best practices of CDM in order to identify structure and process variables with a substantial relation to clinical outcome. People with SMI will serve as the population for the establishment of best CDM practices. In case differences related to diagnoses should emerge, these practices will be specified for different severe mental disorders (e.g. schizophrenia and depression) and can serve as a model to be transferred to other persistent illnesses.
Strengthen the clinical governance process for measurable improvements in clinical decision making
By specifying the relationship between CDM and outcome, best practices of CDM in the care for people with SMI will be made available to stakeholders (patients, clinician, health care funders) and clinical governance will be strengthened. This will include the question of whether and to what extent clinical evidence and guidelines are put into practice (in the CDM process) in routine care for people with SMI. This will also include a thorough analysis whether the patient/user perspective is actively integrated in the CDM process in routine care. Thus, the study will contribute to routine mental health care being based on an integration of professional and user perspectives.
The central target will be to provide a differentiated answer to the question, 'What amount of patient involvement is most beneficial (i.e. substantially related to patient satisfaction, patient behaviour and clinical outcome) in what kind of clinical decision?' This has been done on a general level, but also took into account variations in service provision between the participating centres in DE, UK, IT, HU and DK. This will lead to a set of good practice points which will give guidance on how to improve CDM in the service provision for people with SMI. Furthermore, evidence generated in this project will serve as a starting point for recommending specific interventions to improve CDM.
Optimising the delivery of health care to European citizens and translating the results of clinical research outcome into clinical practice
Communication between clinicians and patients builds the context for the delivery of mental health care in the form of specific treatments at the patient-level. While being affected by a wider background of system level variables (i.e. the extent to which local mental health policy and service provider organisations adequately support the provision of evidence-based interventions), CDM can be regarded the primary means for translating the results of clinical research into practice.
There is a lack of knowledge on the scope and quality of CDM in the care for people with chronic diseases such as SMI. In addition, a small number of studies investigating the effect of interventions to improve CDM in mental health have yielded mixed results and particularly hardly any on clinical outcome. A thorough examination of CDM and its outcome in this field via a multi-centre prospective study will help to fill this gap. By identifying elements of best practice CDM (i.e. aspects of CDM with a substantial relation to good treatment outcome), CEDAR will provide evidence directly contributing to optimising the delivery of health care to European citizens. Furthermore, CEDAR will pave the way for the development of targeted interventions to improve CDM in mental health.
Project website: http://www.cedar-net.eu
Dr Bernd Puschner (coordinator)
Ulm University, Department of Psychiatry II
Section process-outcome-research
Ludwig-Heilmeyer-Str. 2
D-89312 Günzburg
Telephone +49-822-1962866
Fax +49-822-19628160
http://www.uni-ulm.de/psychiatrieII/en/research.htm
Methods:
Firstly, three instruments with parallel patient and staff versions each were developed to assess key aspects of CDM in the routine care of people with SMI:
1. CDM style (CDMS): To assess nature and stability of CDMS (with the subscales 'Participation in decision making' and 'Information') at baseline and at one-year follow-up;
2. CDM involvement and satisfaction (CDIS): To assess at monthly intervals) involvement in ('active' versus 'shared' versus 'passive') and satisfaction with CDM;
3. CDM in routine care (CDRC): To measure at monthly intervals context and content of CDM.
Secondly, a comprehensive prospective study was carried out in six European countries, namely Germany (DE), United Kingdom (UK), Italy (IT), Hungary (HU), Denmark (DK) and Switzerland (CH) in order to examine the effect of CDM on outcome.
Results:
Instrument development followed state-of-the-art recommendations for the development, translation and cultural adaptation of measures and yielded feasible instruments in five languages showing adequate psychometric properties. Data collection and check for the main study was completed in July 2012 (N = 588 patients, N = 213 staff). Patients were in their early forties on average, half of them were female and mean duration of mental illness was more than 12 years. Both patients and staff indicated shared as their preferred style of participation in decision making. Desire for information was predominantly high in patient report and mostly moderate in the view of staff. Satisfaction with the way the last decision was met was predominantly high in patients and mostly moderate in staff, while involvement was mainly rated as shared by both. Number of unmet needs (outcome) significantly decreased over one year and change in unmet needs was affected by satisfaction with how the actual treatment decision was made, but not by CDM style.
Conclusions and recommendations:
Via the development of validated instruments to capture structure, process and outcome of CDM in people with SMI, CEDAR has contributed to a refined research methodology in this field. Through the use of those instruments in a large multi-centre prospective study, a comprehensive model of CDM in people with SMI receiving treatment in different European mental health service systems will be tested. First results showed that aspects of decision making during an actual treatment session are more important for outcome than decision making style. This suggests that future interventions should specifically target the daily practice of decision making rather than rather trait-like aspects such as decision making style. Further best practice recommendations for CDM in the care of people with SMI will be derived from the results and will be made available to stakeholders (patients, clinicians and health care funders). Thus, CEDAR will provide evidence directly contributing to optimising the delivery of mental health care to European citizens.
Project context and objectives:
CDM in chronic conditions such as SMI differs from decision making in acute care. The former has to take into account that treatment focus is on long-term disease management, a high number of decisions have to be made frequently, often together with more than one service provider and/or carers and patients in general are highly knowledgeable about their illness. Furthermore, research on CDM so far has been rather artificial and decontextualised. The following key research challenges for CDM in the care of people with SMI have been outlined:
1. descriptive research and instrument development focussing on how decisions are actually made in routine care and how the process of decision making relates to everyday behaviours and outcomes.
2. improvement of measures for characterising decision making processes that are matched to study populations, complexity and type of decision making, especially in people with severe and long-standing mental disorder who are obliged to make multiple and repetitive treatment decisions, often in cooperation with more than one treatment provider.
3. information about the psychological impact of patient participation in making complex and stressful decisions.
4. decision making styles of both patients and of providers and how these styles are enacted in a variety of CDM encounters.
5. how decision making results in congruent or conflicting outcomes and how all participants evaluate such outcomes.
There is a lack of knowledge on CDM and its outcome in the care for people with SMI. Since patient-key worker communication is the main vehicle of service delivery, this situation is unsatisfying. The most salient approach (i.e. both clinically relevant and crucial for clinical governance) would be a focus on what level of participation a patient wants in their care and whether a good match between desired and experienced level of participation has any impact on treatment satisfaction or outcome. Furthermore, quality of CDM in the care of people with SMI has yet to be studied from an international perspective which would yield insights into similarities and differences of CDM among different countries and mental health service systems.
The CEDAR study addresses those challenges. The main objective of this multi-centre prospective observational study is to develop a methodology to assess the scope and quality of clinical decisions in the care of people with SMI from both the patient and clinician perspective and to specify how and to what degree CDRC affects patient behaviour and short- and long-term treatment outcome.
Project results:
Introduction
Main tasks of the first reporting period (1 April 2009 to 30 September 2010) were preparation and start of the main study. Those of the second reporting period (1 October 2010 to 30 September 2012) were completing data collection, data check and dissemination of results.
This document will describe CEDAR's scientific and technological (S&T) results in relation to the specified work packages (WPs) and milestones for the entire duration of the project.
Management of the consortium (WP1)
The kick-off meeting took place from 27 to 29 May 2009 in Ulm with all principal investigators, advisory board members and additional study staff present. Main achievements of this conference were that:
1. an email and phone network was established to ensure regular communication and information flow between all partners and other personnel
2. a project steering group was set up involving all principal investigators and their representatives
3. the project's goals and procedures were presented, discussed and agreed upon
4. a schedule for telephone conferences among study staff was approved and
5. legal and financial issues were presented, discussed and consented upon.
From then on, led by the coordinating centre (CC), regular phone conferences (every two weeks until January 2011, from then on monthly) took place.
Subsequent study meetings were:
1. Zurich (15 to 17 September 2009)
2. Debrecen (31 May to 1 June 2010)
3. London (12 to 14 January 2011)
4. Aalborg (7 to 9 September 2011)
5. Hindelang near Ulm (21 to 23 March 2012)
6. Naples (10 to 14 September 2012).
Instrument development (WP2 and WP3)
Objectives
Rational of instrument development followed one of the main study hypotheses which stated that 'the quality of CDM can be adequately described by taking into account decision making styles, satisfaction with decision making and type of decision making ('paternalistic' versus 'shared' versus 'informed'). The three instruments to be developed and their scope were:
1. CDMS: This instrument comprehensively assesses nature and stability of patients' and clinicians' decision making style both at baseline and at one-year follow-up. Elements of CDMS include preferred and actual decision making relating to amount of time dedicated to CDM (little, medium, ample); involvement (clinician-/user-led, 'shared'); detail-driven versus generic; focus (target- versus relationship-oriented); and importance and expected consequences of clinical decisions.
2. CDRC: This instrument measures (at monthly intervals) key aspects of CDM from the patient and clinician perspectives as they unfold in routine care, namely specificity: Broad (e.g. admission to inpatient care) versus specific (e.g. change in medication); acuteness: Urgent versus in the future; choices: Number of available treatment options including affordability and accessibility; participants in decision making (also beyond the clinician-patient dyad) and their roles; treatment: Broad (e.g. medication versus psychosocial treatments) versus specific (e.g. kind of medication).
3. CDIS: This instrument assesses (at monthly intervals) CDM involvement ('shared') and satisfaction with decision making from the patient and clinician perspectives.
Development of all three CEDAR measures followed the ISPOR Framework of good practice for the translation and cultural adaptation of patient-reported outcome measures. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) framework identifies 10 sequential steps, i.e. preparation; forward translation; reconciliation; back translation; back translation review; harmonisation; cognitive debriefing; review of cognitive debriefing results and finalisation; proof-reading; and final report. We refer to these steps as ISPOR 1 to ISPOR 10 respectively.
Focus groups were held in ISPOR 1 and 7. Focus groups are widely used to examine people's experience with illness and health services. They especially aim at enabling vulnerable people to freely express their views in the format of a moderated group discussion. Patient participants of focus groups were convenient samples of native speaker adults aged 18 to 60 using local non-forensic mental health services. Staff participants were workers in these services. Focus groups were held in non-clinical settings moderated and co-facilitated by two CEDAR research workers who ensured that all responders had sufficient opportunity to air their views and that non-verbal group dynamics were noted. All focus groups were audiotaped and fully transcribed.
Development of the source language instrument versions
At the first CEDAR study meeting in May 2009, Ulm research workers presented results of an extensive literature search on the instruments with a special focus on identifying scales to be considered candidates for inclusion. Presentations were discussed by the study group including advisory board members which allowed drafting a topic guide for the first round of focus groups. Subsequently, six focus groups (four with 23 patients altogether and two with eight clinicians altogether) were held by researchers in Ulm to explore the conceptual understanding of clinical decision-making. Topics covered included the experience of making decisions as well as level of involvement and satisfaction with the process during the last treatment session. Procedures and results of these focus groups have been reported in detail elsewhere.
Development of the target language instrument versions
First (ISPOR 2), the three measures were forward translated from English into the four other study languages (German, Italian, Hungarian and Danish; Switzerland used the German version). Forward translations in each centre were done by native speakers of the target language who were familiar with the concepts of the instrument. Assistance by professional translators was drawn upon as needed and where more than one forward translations was produced independently of one another at a study centre, these were compared and merged into one single forward translation (ISPOR 3). Subsequently, in each study centre one person fluent in the source language who had not been involved into the forward translation(s) carried out a blind (without seeing the source) back translation into the source language (ISPOR 4). Back translations were then compared to the original by CEDAR team members who were English native speakers (ISPOR 5) and potential discrepancies were discussed with the key in-country person and corrected as needed (ISPOR 6). Patient and staff versions of instrument drafts were then subjected to a total of 17 focus groups (nine with 33 patients altogether and eight with 31 key workers altogether) at all study sites in order to test alternative wording and to check understandability, interpretation, feasibility and cultural relevance of the translations (ISPOR 7). Review of cognitive debriefing results based upon reports of previous step to the Ulm study centre resulted in some final amendments including changes in text and omission of some items in order to arrive at short and understandable measures. Final versions were then carefully proofread by local CEDAR team members and checked for consistency in order of items and format by the Ulm study team (ISPOR 9). The three papers on the instruments comprise the final report of the entire process of instrument development (ISPOR 10). In addition, in these papers psychometric properties of the three CEDAR CDM instruments have been described.
Led by the CC, these and other already established instruments (to assess clinical characteristics, sociodemographic status and service use, illness severity, needs, quality of life, therapeutic relationship, symptomatic impairment, functioning and recovery) were translated from English into each centre's language using ISPOR guidelines.
Instrument training (WP4)
Research workers were continuously trained in the use of study instruments and data entry tools. Initial instrument training at the Ulm and Zurich study meetings included training sessions given by experts for certain instruments (Threshold Assessment Grid, Health of the Nation Outcome Scale, Structured Clinical Interview for DSM-IV on the basis of case notes). Booster training sessions were held at the subsequent study meetings in Debrecen and London. While personal instruction at the study meetings was the primary means of training, regular phone conferences served to clarify remaining issues and to continuously monitor quality of instrument use. In order to ensure high quality of study data, research workers were also thoroughly trained in the use of the CEDAR data entry tool via instruction at the study meetings and during conferences on the basis of comprehensive handbooks on all study software distributed by the CC.
Conducting the study (WP5)
After successful completion of the preparatory tasks, recruitment for the study started with one month delay on 1 November 2009. By that time, research workers at every centre had already carried out activities for promoting the study, i.e. providing clinicians at relevant local outpatient services with study information personally or via local practitioner journals. Good contacts to patients and key worker were established in every centre, resulting in satisfactory recruitment rates close to target with some variance among centres. By 15 December 2010, N = 588 participants (540 planned, i.e. monthly rate total = 45) had been recruited.
Data preparation and analysis (WP6)
Preparation
Using tools prepared by the CC for data entry, data were transferred to the CC after the completion of data collection at each measurement point. Data check led by the co-ordinating centre involved data validation and data verification. Data validation involved checking the case-level data were internally consistent and identifying outlier ratings, asking the originating site to manually check each identified outlier rating against paper and local electronic databases and correcting the central database where necessary. Data verification involved identifying remaining outliers and deciding whether to include them in the analysis on the basis of plausibility, i.e. whether they were reasonable ratings and whether they correlated with other contemporaneous ratings for the same participant. After completion of data check, cleaned data were aggregated into two data bases, long (complete original data) and short (data for most analysis with calculated total scores) which were transferred to partner sites for analysis. Some minor corrections were carried out after final comments from people working with the data sets.
Analysis
In order to ensure coherence, data analysis took place at the CC for central parts of the data, e.g. sample description. Centre differences were found for the majority of variables describing patient and staff characteristics. Furthermore, data analysis pertaining to specific research questions in certain papers was guided by the first author of the respective Paper.
Dissemination of results (WP7)
The results of the implemented dissemination strategy have been reported upon the completion of relevant activities.
Potential impact:
Dissemination activities and exploitation of results
Publications
Dissemination of results has been kicked off with the publication of the study protocol (paper number six below). Subsequent publications are well in line with the publication plan which aims at an adequate number of papers in thematic groups (no-data papers, papers on psychometric properties of developed instruments, papers analysing baseline data and papers using follow-up data and papers using the complete follow-up repeated measures assessment). Another qualitative paper has and a book chapter on concept, measurement, evidence and practice on shared decision making in mental health care are in print (papers four and five) and three papers on instrument papers on the psychometric properties of the CEDAR instruments are under review (papers one to three).
Published/in press/submitted
1. Konrad, J., Loos, S., Neumann, P., Mayer, B., Slade, M., Jordan, H., Giacco, D., De Rosa, C., Egerhazi, A., Nagy, M., Krogsgaard Bording, M., Østermark Sørensen, H., Kawohl, W., Rössler, W., Puschner, B., and CEDAR study group (submitted). A five-language multiperspective instrument to assess CDM in the routine care of people with SMI. Social Psychiatry and Psychiatric Epidemiology.
2. Slade, M., Jordan, H., Clarke, E., Williams, S., Kaliniecka, H., Arnold, K., Fiorillo, A., Giacco, D., Luciano, M., Egerhazi, A., Nagy, M., Krogsgaard Bording, M., Østermark Sørensen, H., Rössler, W., Kawohl, W., Puschner, B., and CEDAR study group (submitted). The development and evaluation of a five-language multi-perspective standardised measure: Clinical Decision-making Involvement and Satisfaction (CDIS). BMC Health Services Research.
3. Puschner, B., Loos, S., Neumann, P., Konrad, J., Slade, M., Maj, M., Giacco, D., Egerhazi, A., Ivanka, T., Krogsgaard Bording, M., Østermark Sørensen, H., Kawohl, W., Bär, A., and CEDAR study group (2013). Psychometric properties of a five-language multiperspective instruments to assess CDMS in the treatment of people with SMI. BMC Psychiatry 13,48.
4. Puschner, B., Konrad, J., and Loos, S. (2013). Shared decision making': Begrifflichkeiten, Messung, Evidenz, Praxis [Shared decision making: concept, measurement, evidence, practice]. In: W. Rössler und W. Kawohl (eds.): Handbuch der sozialen Psychiatrie. Stuttgart: Kohlhammer.
5. Loos, S., Neumann, P., Arnold, K., Slade, M., Fiorillo, A., Frøkjær Krogsgaard Bording, M., Ivanka, T., Kawohl, W., and Puschner, B. (in press). Gemeinsame Entscheidungsfindung in der Behandlung von Patienten mit schweren psychischen Erkrankungen: Eine Fokusgruppen-Untersuchung [Shared decision-making in the treatment of people with SMI: a focus group study]. Psychiatrische Praxis 40,23-29.
6. Puschner, B., Steffen, S., Slade, M., Kaliniecka, H., Maj, M., Fiorillo, A., Munk-Jorgensen, P., Larsen, J. I., Egerhazi, A., Nemes, Z., Rössler, W., Kawohl, W., and Becker, T. (2010). CDM and outcome in routine care for people with SMI (CEDAR): study protocol. BMC Psychiatry 10, 90.
In preparation
1. Egerhazi, Nagy, Ivanca, Sandor, Giacco, Maj, Arnold, Slade, Jordan, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Puschner: Comparison between centres with regard to identifying regional/local differences in clinical decision making, focussing on context.
2. Giacco, Sampgna, Cozzolino, Slade, Clarke, Glaub, Nagy, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Zentner, Puschner: Predictor of needs of information of patients.
3. Slade, Clarke, Jordan, Puschner, Luciano, De Rosa, Ivanka, Magyar, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Loos: Recovery and decision-making involvement in people with SMI from six countries: longitudinal observational study.
4. Jordan, Clarke, Puschner, Ay, Maj, Fiorillo, Ivanka, Nagy, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Slade: Service user ratings of needs and recovery.
5. Bär, Kawohl, Konrad, Puschner, Clarke, Slade, De Rosa, Luciano, Egerhazi, Süveges, Krogsgaard Bording, Østermark Sørensen, Rössler: Desire for autonomy.
6. Krogsgaard Bording, Munk-Jørgensen, Østermark Sørensen, Puschner, Zentner, Slade, Jordan, Fiorillo, del Veccio V, Ivanka, Kovacs, Rössler, Kawohl, Östmann: Involvement in CDM and professional context.
7. Krogsgaard Bording, Munk-Jørgensen, Østermark Sørensen, Puschner, Becker, Maj, Del Veccio H, Slade, Clarke, Egerhazi, Sandor, Rössler, Kawohl, Östman: Patient outcome and health care professionals.
8. Puschner, Becker, Ay, Jordan, Maj, Fiorillo, Égerházi, Ivánka, Munk-Jorgensen, Krogsgaard Bording, Rössler, Kawohl, Slade: Testing the CEDAR model (CDM-needs-Qol).
9. Fiorillo, Maj, De Rosa, Loos, Slade, Clarke, Nagy, Kovacs, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Puschner: CDM style: differences among professionals and impact on social and clinical outcome and on patients' quality of life.
10. Krogsgaard Bording, Munk-Jorgensen, Østermark Sørensen, Loos, Slade, Clarke, Luciano, Sampogna, Egerhazi, Magyar, Rössler, Kawohl, Puschner: Diagnosis as predictors of involvement in CDM and recovery in patients with SMI in six European countries.
11. Clarke, Jordan, Puschner, Konrad, Cozolino, De Rosa, Nagy, Süveges, Krogsgaard Bording, Østermark Sørensen, Bär, Rössler, Kawohl, Slade: Preferred DM style and decision implementation.
12. Zentner, Ay, Loos, Slade, Clarke, Maj, Salzano, Berecz, Glaub, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Puschner: Does CDM affect service use?
13. Arnold, Loos, Clarke, Jordan, Fiorillo, Del Veccio V, Egerhazi, Ivanca, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Puschner: Therapeutic relationship and outcome.
14. Østermark Sørensen, Krogsgaard Bording, Neumann, Slade, Jordan, Maj, Luciano, Egerhazi, Ivanka, Rössler, Bär, Puschner, Munk-Jorgensen: What characterises the therapeutic relationship between patient and staff? (qualitative).
15. Nagy, Egerhazi, Ivanka, Zentner, Slade, Jordan, Maj, Del Veccio H, Krogsgaard Bording, Østermark Sørensen, Kawohl, Rössler, Puschner: Understanding the predictors and process moderators on change in quality of life.
16. Bär, Rössler, Kawohl, Konrad, Slade, Clarke, De Rosa, Luciano, Egerhazi, Nagy, Krogsgaard Bording, Østermark Sørensen, Puschner: Preferences and actual participation in CDM in people with SMI (longitudinal)
17. Konrad, Zentner, Loos, Slade, Jordan, Fiorillo, Luciano, Berecz, Nagy, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Puschner: Nature of clinical decisions (qualitative) and subgroup differences (e.g. diagnosis).
18. Loos ,Arnold, Slade, Jordan, Giacco, De Rosa, Süveges, Nagy, Krogsgaard Bording, Østermark Sørensen, Rössler, Kawohl, Puschner: Identifying subtypes of helping alliance among patients with SMI: A latent class analytic approach.
Conferences
The concept of the study and first results have been presented at a number of national and international conferences. Main results were planned to be presented in two symposia at two major conferences in 2013 which would replace a CEDAR closing conference. Further presentations at conferences were planned, e.g. at the upcoming 10th International Conference of the European Network for Mental Health Service Evaluation (ENMESH).
Completed
1. Puschner, B., Arnold, K., Slade, M., Fiorillo, A., Krogsgaard Bording, M., Égerházi, A., Kawohl, W., and the CEDAR study group (2012). The helping alliance and outcome in people receiving routine mental health care in 6 European countries: results from the CEDAR study. Paper in panel. Third Joint Meeting of the European and the United Kingdom Chapters of the Society for Psychotherapy Research. 10 to 13 October, 2012, Porto, Portugal.
2. Puschner, B., Arnold, K., Loos, S., Slade, M., Fiorillo, A., Krogsgaard Bording, M., Nagy, M., Bär, A., Becker, T., and the CEDAR study group (2012). Helping alliance and outcome in the routine care of people with SMI across Europe. Paper in panel. 43rd International Meeting of the Society for Psychotherapy Research. 20 to 23 June 2012, Virginia Beach, USA.
3. Clarke, E., Jordan, H., Puschner, B., Slade, M., and the CEDAR study group (2012). CEDAR study: Factors associated with decision implementation in SMI. POSTER. Refocus on Recovery 2012. 5 to 7 March 2012, London, UK.
4. Jordan, H., Clarke, E., Puschner, B., Slade, M., and the CEDAR study group (2012). Development and evaluation of the five-language Clinical Decision-making Involvement and Satisfaction (CDIS) Measure. Paper. Refocus on Recovery 2012. 5 to 7 March 2012, London, UK.
5. Ay, E.-S. Krogsgaard Bording, M., Ivánka, T., Giacco, D., Bär, A., Jordan, H., and Steffen, S. (2011). CDM and outcome in routine care for people with SMI (CEDAR): First results. POSTER. IXth ENMESH International Conference. 23 to 25 June 2011, Ulm, Germany.
6. Neumann, P., Steffen, S., Becker, T., and Puschner, B. (2011). Patient participation in the CDM process in psychiatric treatment - a review of the literature. POSTER. IXth ENMESH International Conference. 23 to 25 June 2011, Ulm, Germany.
7. Ivánka, T., Nagy, M., Ègerházi, A., Ay, E.-S. Slade, M., and Puschner, B. (2011). A szükségletfelmérés új eszközének bemutatása egy menzetközi kutatás keretein belü. [Introducing the new instrument of need assessment through an international research]. Paper. XLIIth Annual Hungarian Nurses Conference. 23 to 27 May 2011, Várgesztes, Hungary.
8. Nagy, M., Ègerházi, A., and Fecska, E. (2011). Klinikai döntéshozatal súlyos pszichiátriai betegek esetében. [CDM for people with SMI]. Paper. Hungarian Psychiatric Association's annual meeting. 27 January 2011, Sopron, Hungary.
9. Puschner, B., Slade, M., Maj, M., Munk-Jørgensen, P., Égerházi, A., Rössler, W., and Becker T. (2010). CDM and Outcome in Routine Care for People with SMI (CEDAR). POSTER. EU Thematic Conference on Promoting Social Inclusion and Combating Stigma. 8 and 9 November 2010, Lisbon, Portugal.
10. Giacco, D., De Rosa, C., Salzano, A., Arnold, K., Neumann, P., Jordan, H., Slade, M., Égerházi, A., Rössler, W., Puschner B., Maj, M., and Becker, T. (2010). Lo studio europeo 'CDM and outcome in routine care for SMI (CEDAR): aspetti clinici e metodologici. [The European study 'CDM and outcome in routine care for SMI (CEDAR): clinical and methodological aspects]. POSTER. Vth Conferenza Tematica SIP (Societa Italiana de Psychiatria). 13 to 16 October 2010, Riccione, Italy.
Accepted
1. Puschner, B. (2013). CDM in the Routine Care of People with SMI across Europe: a prospective study. Symposium. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
2. Loos, S., Neumann, P., Arnold, K., Slade, M., Fiorillo, A., Krogsgaard Bording, M., Ivánka, T., Kawohl, W., and Puschner, B. (2013). Shared decision making in the treatment of people with chronic mental illness: A qualitative study with focus groups. Paper in panel. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
3. Zentner, N., Loos, S., Slade, M., and Puschner, B. (2013). Does CDM affect service use? Paper in panel. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
4. Konrad, J., Loos, S., Zentner, N., Slade, M., Mayer, B., and Puschner, B. (2013). A five-language multiperspective instrument to assess CDM in the routine care of people with SMI (CDRC). Paper in panel. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
5. Puschner, B., Becker, T., Fiorillo, A., Égerházi, A., Krogsgaard Bording, M., Kawohl, W., and Slade, M. (2013). The effect of CDM on outcome over one year in people with SMI across Europe. Paper in panel. 14th International Congress of the International Federation of Psychiatric Epidemiology (IFPE). 5 to 8 June 2013, Leipzig, Germany.
6. Puschner, B., and Fiorillo, A. (2013). CDM and Outcome in Routine Care for People with SMI (CEDAR): Results from a European multicentre study. Symposium. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
7. Fiorillo, A., Maj, M., De Rosa, C., and Puschner, B. (2013). CDM style: differences among professionals and impact on social and clinical outcome and on patients' quality of life. Paper in panel. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
8. Krogsgaard Bording, M., Sørensen, H., Munk-Jørgensen, P., and Puschner, B. (2013). Involvement, satisfaction and treatment adherence in people with SMI and differences by diagnostic group (affective versus psychotic disorders). Paper in panel. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
9. Nagy, M., Ivánka, T., Sandor, J., Égerházi, A., Ay, E.-S. and Puschner, B. (2013). How elements of context determine decision making and information flow in patient-clinician interviews. Paper in panel. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
10. Puschner, B., Becker, T. J. H., Maj, M., Fiorillo, A., Égerházi, A., Ivanka, T., Munk-Jørgensen, P., Krogsgaard Bording, M., Rössler, W., Kawohl, W., and Slade, M. (2013). CDM and outcome over one year in the routine treatment of people with SMI across Europe: main results. Paper in panel. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
11. Puschner, B. (2013). The role of CDM in mental health practice. Presentation in early career psychiatrists' programme: 'What works in mental health? The role of non-specific elements'. 21st European Congress of Psychiatry EPA 2013. 6 to 9 April 2013, Nice, France.
12. Nagy, M., Égerházi, A., Ivanka, T., Sandor, J., Frecska, E., and Puschner, B. (2013). Az életminoség befolyásoló tényezoi egy multicentrikus kutatás eredményei [CDM and quality of life their connections and main influencing factors in the severe mentally ill]. Paper. National Conference of the Hungarian Psychiatric Association. 23 to 26 January 2013, Gyor, Hungary.
13. Égerházi, A., Nagy, M., Ivanka, T., Sandor, J., Frecska, E., and Puschner, B. (2013). A klinikai döntéshozatalt befolyásoló tényezok összehasonlítása hat európai országban [Comparison between six european countries with regard to identifying regional differences in clinical decision making]. Paper. National Conference of the Hungarian Psychiatric Association. 23 to 26 January 2013, Gyor, Hungary.
Other dissemination activities
Other dissemination activities include Student papers. Furthermore, at all sites first results of the study were presented to participants (service users and staff) via written information (short plain language summaries) and/or workshops.
1. Giacco, D., and Fiorillo, A. (2011). Stili di CDM nei disturbi mentali gravi: risultati preliminary dallo studio europeo CEDAR. [Styles of CDM in SMI]. Student Paper. Department of Psychiatry, University of Naples SUN Social Psychiatry Unit. 28 July 2011, Naples, Italy.
2. Nagy, M., Ègerházi, A., and Frecska, E. (2011). Klinikai döntéshozatal súlyos pszichiátriai betegek esetében. [CDM for people with SMI]. Student Paper. National part of the Scientific Students' Conference. 8 April 2011, Debrecen, Hungary.
3. Nagy, M., Ègerházi, A., and Frecska, E. (2010). Klinikai döntéshozatal súlyos pszichiátriai betegek esetében. [CDM for people with SMI]. Student Paper. Sixth year Student Department of Psychiatry. 3 Decemner 2010, Debrecen, Hungary.
The potential impact (including the socio-economic impact and the wider societal implications of the project so far)
During the last decades, almost all European Union (EU) Member States have undergone substantial psychiatric reforms. In addition, mental health practice and research has provided a large number of pharmacological and psychosocial interventions with proven efficacy and also effectiveness for improving clinical outcome and quality of life among people with SMI. Still, as stated in the European Community's (EC's) green paper 'Mental health of the EU population can be considerably improved'. CEDAR represents an effort to improve the delivery of existing effective treatment and that these are being utilised via specifying best practices of CDM in the care of people with SMI.
Steps to bring about the impacts:
1. feasible instruments with good psychometric properties were developed to assess vital aspects of clinical decisions in the routine care of people with SMI, desired and actual patient involvement and satisfaction with CDM;
2. established outcome measures were used and adapted as needed to ascertain adherence and outcome;
3. CDM, outcome and related variables as outlined were repeatedly measured in order to gain insight into stability and change of CDM processes over time;
4. the quality of CDM was be determined by specifying aspects of clinical decisions which substantially contribute to good clinical outcome (taking into account/controlling for effects of other covariates);
5. good practice recommendations for CDM in the care for people with SMI will be extracted from the results of this prospective multi-centre study.
In the following, CEDAR's impacts will be outlined in relation to the topics of the call.
Develop and validate methodology to measure the quality of clinical decisions
Instruments to capture structure, process and outcome of decision making in the care of people with SMI were developed and empirically validated:
1. Structure: CDMS and key elements of clinical decisions;
2. Process: Contribution of patient and clinician to CDM, patient behaviour (immediate and long-term);
3. Outcome: Satisfaction with CDM and clinical outcome (immediate and long-term). These instruments' psychometric properties (feasibility, validity, reliability, sensitivity to change) were tested at all centres in the respective host country's language (German, English, Italian, Hungarian and Danish) and then used for the comprehensive assessment of CDM in a large multi-centre prospective study. Since there is no current gold standard for a clinical decision, CEDAR has contributed to an outcome-oriented conceptualisation of CDM quality: Clinical decisions of a 'good quality' are those with a strong association with good clinical outcome.
Apply methodology to explain variations of care in seemingly similar populations resulting from the CDM process in different health care settings to allow comparative analyses of quality of care
Through a multi-centre prospective observational study, a comprehensive model of CDM is tested in people with SMI in different countries with different mental health service systems. Since quality of CDM is just one of many factors impacting upon clinical outcome, possible moderators and mediators of the CDM-outcome relation (e.g. sociodemographic characteristics, clinical variables, therapeutic relationship, satisfaction with involvement) have been comprehensively included in the analysis.
The CEDAR conceptual model will be tested by the publications as listed above. Once a significant number of central papers have been published which will be the case by the end of 2013, a summary paper will be put together which will delineate good practice recommendations for CDM in the care for people with SMI. CEDAR main papers extract best practices of CDM in order to identify structure and process variables with a substantial relation to clinical outcome. People with SMI will serve as the population for the establishment of best CDM practices. In case differences related to diagnoses should emerge, these practices will be specified for different severe mental disorders (e.g. schizophrenia and depression) and can serve as a model to be transferred to other persistent illnesses.
Strengthen the clinical governance process for measurable improvements in clinical decision making
By specifying the relationship between CDM and outcome, best practices of CDM in the care for people with SMI will be made available to stakeholders (patients, clinician, health care funders) and clinical governance will be strengthened. This will include the question of whether and to what extent clinical evidence and guidelines are put into practice (in the CDM process) in routine care for people with SMI. This will also include a thorough analysis whether the patient/user perspective is actively integrated in the CDM process in routine care. Thus, the study will contribute to routine mental health care being based on an integration of professional and user perspectives.
The central target will be to provide a differentiated answer to the question, 'What amount of patient involvement is most beneficial (i.e. substantially related to patient satisfaction, patient behaviour and clinical outcome) in what kind of clinical decision?' This has been done on a general level, but also took into account variations in service provision between the participating centres in DE, UK, IT, HU and DK. This will lead to a set of good practice points which will give guidance on how to improve CDM in the service provision for people with SMI. Furthermore, evidence generated in this project will serve as a starting point for recommending specific interventions to improve CDM.
Optimising the delivery of health care to European citizens and translating the results of clinical research outcome into clinical practice
Communication between clinicians and patients builds the context for the delivery of mental health care in the form of specific treatments at the patient-level. While being affected by a wider background of system level variables (i.e. the extent to which local mental health policy and service provider organisations adequately support the provision of evidence-based interventions), CDM can be regarded the primary means for translating the results of clinical research into practice.
There is a lack of knowledge on the scope and quality of CDM in the care for people with chronic diseases such as SMI. In addition, a small number of studies investigating the effect of interventions to improve CDM in mental health have yielded mixed results and particularly hardly any on clinical outcome. A thorough examination of CDM and its outcome in this field via a multi-centre prospective study will help to fill this gap. By identifying elements of best practice CDM (i.e. aspects of CDM with a substantial relation to good treatment outcome), CEDAR will provide evidence directly contributing to optimising the delivery of health care to European citizens. Furthermore, CEDAR will pave the way for the development of targeted interventions to improve CDM in mental health.
Project website: http://www.cedar-net.eu
Dr Bernd Puschner (coordinator)
Ulm University, Department of Psychiatry II
Section process-outcome-research
Ludwig-Heilmeyer-Str. 2
D-89312 Günzburg
Telephone +49-822-1962866
Fax +49-822-19628160
http://www.uni-ulm.de/psychiatrieII/en/research.htm
