Periodic Reporting for period 2 - LIVE INCITE (Lifestyle intervention in the perioperative process through digital service)
Période du rapport: 2017-10-01 au 2021-09-30
It is well known that health care outcomes in the perioperative care process correlate with severity of disease, operational procedure and co-morbidity as well as reduced effects of rehabilitation. Only recently, it has been proved that also the lifestyle factors of the patient are independent risk factors for a poor outcome after surgery and that significant reductions in post-surgery complications and rehabilitation can be achieved by introducing individually targeted intensive lifestyle interventions programs; research showing a reduction of the risk for complications from >40% to <20% with a 6-8 week smoking cessation program. Similar effects are achieved with hazardous alcohol drinking, where a 4-week program reduces the number of complications with 50% after colorectal resection. Thus, methods to alter dysfunctional behaviors such as smoking will have a significant impact on patients’ health as well as societal costs related to health care.
Relating to the core use case of LIVE INCITE, overall 26% of Europeans smoked in 2014 and the European average alcohol intake (among persons above 15 years of age) is the highest world-wide, including up to 10-15% risky drinkers. In Europe there are some 14 million elective surgeries performed each year.
The core goal of LIVE INCITE is to facilitate the development of digital solutions to empower patients to change risk behaviors prior to and after surgery. The solution should allow for individualized analyses and interventions based on evidence based methods for behavior change and leverage the potential of technology to maximize the reach of the interventions compared to current face to face intensive intervention programs.
The core case in LIVE INCITE constitutes complete quitting of smoking and risky alcohol drinking in relation to knee and hip surgery. However, it is essential for success and long-term sustainability and value that the solution is sufficiently flexible to allow for other and co-existing risk factors, medical conditions and care contexts, allowing for scaling beyond the core case.
The overall objectives of the project is to drive the creation of a market of flexible, sustainable digital solutions to enable care providers to, increasingly effectively, continuously improve care by addressing the complex task of behavior change in relation to harmful life style risk factors.
Relating to the core use case of LIVE INCITE, overall 26% of Europeans smoked in 2014 and the European average alcohol intake (among persons above 15 years of age) is the highest world-wide, including up to 10-15% risky drinkers. In Europe there are some 14 million elective surgeries performed each year.
The core goal of LIVE INCITE is to facilitate the development of digital solutions to empower patients to change risk behaviors prior to and after surgery. The solution should allow for individualized analyses and interventions based on evidence based methods for behavior change and leverage the potential of technology to maximize the reach of the interventions compared to current face to face intensive intervention programs.
The core case in LIVE INCITE constitutes complete quitting of smoking and risky alcohol drinking in relation to knee and hip surgery. However, it is essential for success and long-term sustainability and value that the solution is sufficiently flexible to allow for other and co-existing risk factors, medical conditions and care contexts, allowing for scaling beyond the core case.
The overall objectives of the project is to drive the creation of a market of flexible, sustainable digital solutions to enable care providers to, increasingly effectively, continuously improve care by addressing the complex task of behavior change in relation to harmful life style risk factors.
The LIVE INCITE project started in November 2016 and ended in September 2021. The project’s aim was to prepare and complete a PCP, focusing on new and innovative eHealth solutions required to enable the patient to take necessary actions both prior to and after surgery, to impact his or her own health care outcome. The PCP was designed to, mainly, cover risk factors related to smoking and hazardous alcohol drinking, but would also incorporate support of other patient needs.
The challenge presented to the market, by the LIVE INCITE consortium (Karolinska University Hospital in Sweden, Bispebjerg-Frederiksberg Hospital in Denmark, Hospital Clinic de Barcelona in Spain and Karolinska Institutet in Sweden), was therefore to develop a digital solution, with continued possibility for development, which would support patients scheduled for planned surgery, to change risky lifestyle factors, such as smoking and alcohol intake. The aim was to reduce complications and mortality in the perioperative process. By providing an effective and feasible solution to empower patients to address such risk factors related to surgical complications, great improvements in clinical outcomes could be achieved.
During the first phase of the project, i.e the preparation period, the project engaged in a dialogue with the market to learn more about the state of the art solutions currently available and the possibilities for LIVE INCITE related to new technology and user experience concepts in general. The project published a market survey document to communicate the problem and overall concept of LIVE INCITE, performed two open information meetings (Stockholm and Barcelona), and engaged in one on one meetings with any interested stakeholder to gain further market input. A survey was also performed with some 1600 previous patients and workshops with some 40 patients as well as performed several workshops with clinicians.
The project then moved towards the PCP process, which involved 3 R&D phases - solution design (begun May 2018), prototype development (November 2018) and testing (September 2019). At the first phase; 16 companies responded to the request for tenders, and a careful selection process was initiated to finally select 4 of them that were invited to participate in the next phase of the development. However, one of the companies withdrew their tender, meaning that 3 companies participated in the end.
In the 2nd phase, the 3 suppliers developed prototype versions that were then demonstrated in three sets of sprint demonstrations and the results were carefully evaluated according to a agreed on scale. The conclusion was that all 3 Contractors performed well but they each prioritized and excelled different parts, meaning that their development process looked slightly different from each other.
At the beginning of phase 3, two of the three developers were selected to proceed, with the aim to hold Pilot tests at the hospitals. However, the pandemic had a major impact on patient recruitment and the overall set up of the pilot demonstrations. Several mitigation measures were thus introduced, including an extension of the project time frame.
The final outcome was that, although the pilot and final study could not fully provide clinical evidence for the efficiency of the IT solutions, both were assessed in accordance with the agreed on evaluation parameters. With the outcome that the partners agreed that both innovations were promising enough. More data is thus to be collected to further evaluate the two solutions. In addition, the participating companies were satisfied with the PCP process and the feedback given, to the extent that they are both proceeding towards market entry for the developed IT solutions
The challenge presented to the market, by the LIVE INCITE consortium (Karolinska University Hospital in Sweden, Bispebjerg-Frederiksberg Hospital in Denmark, Hospital Clinic de Barcelona in Spain and Karolinska Institutet in Sweden), was therefore to develop a digital solution, with continued possibility for development, which would support patients scheduled for planned surgery, to change risky lifestyle factors, such as smoking and alcohol intake. The aim was to reduce complications and mortality in the perioperative process. By providing an effective and feasible solution to empower patients to address such risk factors related to surgical complications, great improvements in clinical outcomes could be achieved.
During the first phase of the project, i.e the preparation period, the project engaged in a dialogue with the market to learn more about the state of the art solutions currently available and the possibilities for LIVE INCITE related to new technology and user experience concepts in general. The project published a market survey document to communicate the problem and overall concept of LIVE INCITE, performed two open information meetings (Stockholm and Barcelona), and engaged in one on one meetings with any interested stakeholder to gain further market input. A survey was also performed with some 1600 previous patients and workshops with some 40 patients as well as performed several workshops with clinicians.
The project then moved towards the PCP process, which involved 3 R&D phases - solution design (begun May 2018), prototype development (November 2018) and testing (September 2019). At the first phase; 16 companies responded to the request for tenders, and a careful selection process was initiated to finally select 4 of them that were invited to participate in the next phase of the development. However, one of the companies withdrew their tender, meaning that 3 companies participated in the end.
In the 2nd phase, the 3 suppliers developed prototype versions that were then demonstrated in three sets of sprint demonstrations and the results were carefully evaluated according to a agreed on scale. The conclusion was that all 3 Contractors performed well but they each prioritized and excelled different parts, meaning that their development process looked slightly different from each other.
At the beginning of phase 3, two of the three developers were selected to proceed, with the aim to hold Pilot tests at the hospitals. However, the pandemic had a major impact on patient recruitment and the overall set up of the pilot demonstrations. Several mitigation measures were thus introduced, including an extension of the project time frame.
The final outcome was that, although the pilot and final study could not fully provide clinical evidence for the efficiency of the IT solutions, both were assessed in accordance with the agreed on evaluation parameters. With the outcome that the partners agreed that both innovations were promising enough. More data is thus to be collected to further evaluate the two solutions. In addition, the participating companies were satisfied with the PCP process and the feedback given, to the extent that they are both proceeding towards market entry for the developed IT solutions
The project expected to drive the development of solutions moving well beyond state of the art. As of today, only face to face programs are used for intensive intervention programs but they are expensive and non-realistic to scale widely. Further, the need for the system to be able to learn and adapt, meant that it was likely to bring state of the art machine learning/AI technology into the mix.
In the end the two final IT systems offered several key innovations and progress beyond current available technology. For example they both consider AI and gamification capabilities to engage the patient. In addition, data collection was made available on several different levels, offering important insights to different user groups.
Although the final pilot tests and study were impacted by the pandemic all centres involved confirmed the potential to reach a vastly larger patient number in a more extensive context, in time and place, than the solutions available today.
Furthermore, the private sector participants in the PCP all responded very positively to the process and the result is that they are proceeding towards market entry post project.
In the end the two final IT systems offered several key innovations and progress beyond current available technology. For example they both consider AI and gamification capabilities to engage the patient. In addition, data collection was made available on several different levels, offering important insights to different user groups.
Although the final pilot tests and study were impacted by the pandemic all centres involved confirmed the potential to reach a vastly larger patient number in a more extensive context, in time and place, than the solutions available today.
Furthermore, the private sector participants in the PCP all responded very positively to the process and the result is that they are proceeding towards market entry post project.