The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial

Abstract

BackgroundThere is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the added value of the Supporting LIFE electronic Community Case Management Application (SL eCCM App) compared to paper-based CCM on urgent referral, re-consultation and hospitalization rates, in two districts in Northern Malawi.Methods/designThis is a pragmatic, stepped-wedge cluster-randomized trial assessing the added value of the SL eCCM App on urgent referral, re-consultation and hospitalization rates of children aged 2 months and older to up to 5 years, within 7 days of the index visit. One hundred and two health surveillance assistants (HSAs) were stratified into six clusters based on geographical location, and clusters randomized to the timing of crossover to the intervention using simple, computer-generated randomization. Training workshops were conducted prior to the control (paper-CCM) and intervention (paper-CCM + SL eCCM App) in assigned clusters. Neither participants nor study personnel were blinded to allocation. Outcome measures were determined by abstraction of clinical data from patient records 2 weeks after recruitment. A nested qualitative study explored perceptions of adherence to urgent referral recommendations and a cost evaluation determined the financial and time-related costs to caregivers of subsequent health care utilization. The trial was conducted between July 2016 and February 2017.DiscussionThis is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5 years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle-income countries.Trial registrationClinicalTrials.gov, ID: NCT02763345. Registered on 3 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2213-z) contains supplementary material, which is available to authorized users.

People Welcomed This Innovation with Two Hands: A Qualitative Report of an mHealth Intervention for Community Case Management in Malawi

“…The trial was conducted from October 2016 to February 2017 in Rumphi and Nkhata Bay districts, Northern Malawi (methods described in full elsewhere) [17]. Qualitative interviews were conducted with participants between January–February 2017 at village clinics, participants’ homes, or a community facility convenient to participants.…”

“…However, the impact of interventions on CHWs’ referral patterns and caregivers’ subsequent health-seeking behavior, to our knowledge, has yet to be investigated. We sought to address this in a clinical trial [17]. We investigated the acceptability of delivering CCM via an mHealth solution among CHWs, known in Malawi as Health Surveillance Assistants (HSAs), and parents/caregivers (referred to as caregivers hereafter), with a particular emphasis on factors that might influence its impact on referrals from community clinics to higher-level health care facilities.…”

Development and Initial Validation of a Frontline Health Worker mHealth Assessment Platform (MEDSINC®) for Children 2–60 Months of Age

“…8 Implementation of these digital protocols on smartphones or tablets by FLW has shown the potential to increase the number of children being checked for important clinical danger signs, improved antibiotic use, and referrals for consultations and hospitalizations. 5,9,10 A clinician-based study in Tanzania demonstrated that digitalized modified IMCI-ALMANACH algorithms in conjunction with selective point-of-care tests achieved a reduction of 43% in the proportion of clinical failures, a 58% reduction in the proportion of severe adverse events, and a substantial decrease in the proportion of antibiotic prescriptions from 30% to 11% compared with the traditional IMCI-ALMANACH algorithms. 11 Despite these important improvements, current IMCI-iCCM–based and other mHealth platforms have not demonstrated consistency with implementation or a high agreement with expert clinical assessments of children with important clinical conditions such as pneumonia (26–41%).…”

Evaluating mobile solutions of integrated Community Case Management (iCCM): Making the final connection

“…Several programs of work (in Malawi 19 and Uganda 20 ) have either adopted double assessment and data entry approaches, or have utilized mobile iCCM to direct assessment and data entry into patient records. Whilst it is impossible to speculate on why these procedures were selected in these instances (interoperability may or may not have been the rate limiting step), the authors can identify that lack of interoperability was a crucial determinant of the decision to investigate the added value of a mobile version of iCCM in a feasibility study and clinical trial, as part of the Supporting LIFE program 21 . Whilst adding or integrating mobile iCCM with paper iCCM generates some insight into the potential benefits, we have limited understanding of relationships between mobile versions of iCCM and most clinical, process, patient-reported and cost-related outcome measures.…”