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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Victoria Hardy, Yvonne O’Connor, Ciara Heavin, Nikolaos Mastellos, Tammy Tran, John O’Donoghue, Annette L. Fitzpatrick, Nicole Ide, Tsung-Shu Joseph Wu, Griphin Baxter Chirambo, Adamson S. Muula, Moffat Nyirenda, Sven Carlsson, Bo Andersson, Matthew Thompson

Published in: Trials | Issue 1/2017

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Abstract

Background

There 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/design

This 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.

Discussion

This 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 registration

ClinicalTrials.gov, ID: NCT02763345. Registered on 3 May 2016.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Victoria Hardy
Yvonne O’Connor
Ciara Heavin
Nikolaos Mastellos
Tammy Tran
John O’Donoghue
Annette L. Fitzpatrick
Nicole Ide
Tsung-Shu Joseph Wu
Griphin Baxter Chirambo
Adamson S. Muula
Moffat Nyirenda
Sven Carlsson
Bo Andersson
Matthew Thompson
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2213-z

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