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Supporting Low-cost Intervention For disEase control

Final Report Summary - SUPPORTING LIFE (Supporting Low-cost Intervention For disEase control)

Executive Summary:
The vast majority of health care for children with acute illnesses in sub-Saharan African countries is provided by community health care workers who receive a limited level of training. In Malawi, these are known as Health Surveillance Assistants (HSAs). HSA’s, a group of outreach workers who serve as frontline health care staff in the battle against largely preventable childhood diseases. To support HSAs in this battle, the WHO and UNICEF developed the Community Case Management (CCM) strategy, now adopted as standard practice in many countries in sub-Saharan Africa, including Malawi. CCM is a paper-based clinical decision tool, utilizing a traffic light triage system, enabling first-level health workers, such as HSAs in Malawi. This enables them to promptly identify children from 2 months up to 5 years of age requiring urgent referral to higher level facilities, and direct the treatment and advice at the point-of-care for children who can be treated at home.
The Supporting Low-cost Intervention For disEase control (Supporting LIFE) project is designed to support HSAs at the patient point-of-care as well as larger epidemiological bodies to manage and control diseases through the utilization of cost-effective technologies. The overarching objective of the Supporting LIFE project is to assist HSAs in delivering an intervention to improve and manage disease control, targeting children aged ≥2 months up to 5 years. This project endeavored to utilize established technology to circumvent the absent or limited healthcare infrastructure by exploiting the cellular telecommunications network and point of care decision support systems. The expansion of information and communication technologies to low and middle-income countries (LMIC) such as Malawi has offered the potential for CCM to be delivered as a mobile health (mHealth) solution.
The Supporting LIFE consortium achieved the following key outputs:
• Developed a mobile digital decision support toolkit dedicated to support HSAs with the adherence to and implementation of CCM guidelines. This decision support toolkit, in the form of an Android-based smartphone application, known as Supporting LIFE electronic Community Case Management Application (SL eCCM App), leverages current CCM protocols for disease control.
• Conducted a technology/clinical feasibility study in July 2015 to assess the acceptability of the app to HSAs and the feasibility of following-up children in the community to collect clinical outcomes. HSAs reported that the SL eCCM App improved their adherence to the CCM protocol, in addition to being perceived better within the community by parents and caregivers.
• Conducted the first clinical trial to investigate the effectiveness of a mobile version of CCM. A pragmatic stepped-wedge randomized trial comparing referral rates, patient re-consultations at village clinics and attendances at referral facilities/hospitals was conducted from October 2016 to January 2017, with 101 HSAs from 2 districts in northern Malawi enrolling over 7,000 children. Preliminary results reveal that referral rates were similar in the intervention and control phases, but re-consultations at village clinics and presentations to higher-level facilities and hospital admissions were higher in the control phase.
• Designed disease surveillance guidelines for a national disease surveillance information system to address the challenges faced by the Malawian Ministry of Health. In order to achieve an integrated surveillance platform with complete, timely, valid and consistent data - a service corridor approach connecting silo systems is recommended.
• Presented progress and results to stakeholders at multiple meetings. The most notable was the Malawi mHealth sub-technical working group meeting, which included individuals from the Ministry of Health, other mHealth projects and donors in the week of 24th April 2017.
• Built research capacity within Malawi. Mzuzu University’s involvement as an active partner in the Supporting LIFE project has equipped university staff with experience of an international research collaboration.

Project Context and Objectives:
To support frontline workers, the WHO and UNICEF developed the Integrated Management of Childhood Illness (IMCI) in the mid 1990’s as a strategy to reduce morbidity and mortality from common and potentially serious childhood illnesses such as malaria, pneumonia, infantile diarrhoea with dehydration, meningitis and sepsis. The IMCI strategy involves a stepwise and structured approach to the assessment and management of children presenting with acute illness in developing countries. The strategy involves three foci: 1) improving the performance of health care workers through training with a set of clinical guidelines, 2) strengthening health care systems for delivery of child health, including availability of medications, supervisions, and health information system (HIS) data, and 3) developing and encouraging family and community interventions. The briefer version of IMCI, called Community Case Management (CCM), is aimed for use by health care workers with even lower levels of training in resource poor settings. As a result of this, the Supporting LIFE project focuses on CCM over IMCI guidelines as we wish to maintain the overall focus of the project (i.e. supporting HSAs in rural settings).
During the project conception period, the under-five mortality rate of children was 77 per 1,000 live births [1]. Internationally most of the 11 million deaths per year of children under the age of five occur in areas where adequate medical care is not available. First-level health facilities, the closest health care services available to most sick children in developing countries, are generally run by HSAs.
The current state of the art for the recognition and management of children with acute illness in sub-Saharan countries such as Malawi involves use of IMCI/CCM as the core strategy. Nearly all countries in the African region have implemented these guidelines [2], and effects on many health indicators have been impressive. However, there are several challenges that need to be addressed to improve the effectiveness and adherence of IMCI/CCM. These include difficulties in training and maintaining skills in IMCI/CCM, deficiencies in adherence to clinical protocols, and inadequate discriminatory value leading to misclassification of severe illness in children, resulting in over or under diagnosis. Poor clinical outcomes for children can affect the health system, compounding further the resource limitations in referral facilities by either referring children unnecessarily (hence ‘wasting’ resources), or failing to identify children who do need referral and contributing to excess morbidity and mortality.
The Supporting LIFE project aimed to address key limitations to the provision of health care for children in Malawi and contribute to progress beyond current health care in the following ways:
1) The SL eCCM App is underpinned by a clinical decision support system (CDSS), which classifies a child’s illness and recommends treatment to the HSA based on the data entered by the user at the point-of-care. Paper-based forms cannot ensure that HSAs are fully adhering to the clinical guidelines. The SL eCCM App has a turnkey form field validation feature which allows all data input fields in the app to be assessed (i.e. all validation rules can be turned on or off), as required. When field validation was turned on, it was found that HSAs were more likely to fully adhere to the clinical guidelines, which aims to promote safer and more effective care provision.

2) The translation of the CCM protocols to a mobile phone platform (SL eCCM App) offers novel opportunity to train health care workers. Mobile technology has been cited as a solution to support and empower HSAs to provide care effectively and self-sufficiently [3]. Training modules were integrated into the SL eCCM App with the intention of providing supplementary support to HSAs in an electronic format. These are very much in line with current recommendations for training in the area, such as the WHO’s computer based format for CCM, yet utilises low cost mobile phone technology with all its associated advantages of coverage and cost, rather than more costly computers. Importantly, it also addresses the current difficulties in motivating and retaining health care worker levels of training in CCM, which is widely acknowledged as a current limitation in wider and more consistent implementation of CCM. Lack of sufficient CCM training does lead to a drop off in adherence to CCM thus resulting in a less effective patient care a management of disease control [4].

3) The Supporting LIFE project investigated the use of wireless vital sign devices to support the diagnostic value for correct classification of children with serious illness. Vital signs are considered as basic measures of overall physiological wellbeing in children, and CCM guidelines currently recommend measuring temperature and breathing rate. We know that currently even these vital signs are not measured consistently or accurately, which leads to failure to identify children with severe illness, and may contribute to morbidity and mortality. Therefore, a systematic review was conducted to evaluate existing evidence for the diagnostic value of vital signs for diagnosis of (and/or prediction of prognosis of) important child diseases relevant to the FP7 call e.g. malaria, infantile diarrhoea. Findings revealed that breathing rate demonstrates the most promising diagnostic value, and thus the Supporting LIFE project incorporated a breathing counter in the App to enable HSAs to capture respiration rates more accurately and efficiently.

The SL eCCM App integrated a vital sign sensor into the App to enable the reading of patient heart and respiratory rates. Improving access to diagnostics is one of the major limitations of health care in Malawi, and has been acknowledged as a key priority by the WHO for improving implementation of CCM. However, the utility of the vital sign sensors was not tested in the field due to its cost and unsuitability for children under 10kgs.

4) The Supporting LIFE project proposes design guidelines for improved disease control surveillance. Single disease approaches pose a challenge in low resource settings particularly for the management of timely and accurate response to communicable diseases. The move from a vertical, disease-orientated (or silo) approach to a horizontal, child centred approach was initially realised in the development of the CCM guidelines. The WHO also developed the Integrated Disease Surveillance and Response (IDSR) [5] approach for improving public health surveillance and response promotes the integration and streamlining of common surveillance activities. Upon evaluating the information flow within Malawi, it was determined that one of the main problems related to effective integrated disease surveillance is the vertical silos of information. Thus, in line with the IDSR approach, the Supporting LIFE project developed design guidelines for a national disease surveillance information system. This involves the development of a national service platform ‘service corridor’ where a web service is used to communicate between systems.

Other major barriers to effective integrated disease surveillance include delays and data quality. The use of mobile phone technology enables fast communication of data to district health offices and regional zones to assist Ministry of Health officials to react more quickly and be equipped with detailed disease surveillance information. Additionally, CDSS and form field validation minimizes human error during data entry, thus improving data quality at the source.

Overall, the Supporting LIFE project has demonstrated: the usefulness of the mobile phone based eCCM to support HSAs, the added value of the SL eCCM App on referral, re-consultation and higher-level facility attendance rates of children under-5, the further utilisation of this rich dataset to support regional and national Ministry of Health officials to monitor and control disease outbreaks of malaria and other serious infections, and the value of capacity building by creating a technological base of mobile phones in the hands of trained HSAs to enable further development of mHealth applications.

Project Results:
The Supporting LIFE project was divided into seven work packages (WP). WPs 1, 6-7 are sketched as background layers to the four core work packages: WP 2 Technical Feasibility, WP 3 Clinical Feasibility, WP 4 Adherence to eCCM, and WP 5 Disease Control Surveillance. The details are described in the attached document.
Potential Impact:
Since the overarching objective of Supporting LIFE was to assist HSAs in delivering health interventions to improve and manage disease control, dissemination and exploitation measures aimed to contribute to this very same goal. They did so by:
• Informing funding bodies, policymakers and the general public about the importance and impact of mHealth (Section 4.1.1).
• Sharing results on the effectiveness of the SL eCCM App among the scientific community (Section 4.1.2).
• Sharing results regarding the effectiveness of mHealth solutions and recommendations for effective and efficient Health Information Systems to those stakeholders who are most in need of such information: policymakers in Malawi (Section 4.2.1).
• Increasing the sustainability of Supporting LIFE by finding funding for follow-up research or implementation projects (Sections 4.2.2 4.2.3).
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