TY - JOUR
T1 - 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
T2 - Study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial
AU - Hardy, Victoria
AU - O'Connor, Yvonne
AU - Heavin, Ciara
AU - Mastellos, Nikolaos
AU - Tran, Tammy
AU - O'Donoghue, John
AU - Fitzpatrick, Annette L.
AU - Ide, Nicole
AU - Wu, Tsung Shu Joseph
AU - Chirambo, Griphin Baxter
AU - Muula, Adamson S.
AU - Nyirenda, Moffat
AU - Carlsson, Sven
AU - Andersson, Bo
AU - Thompson, Matthew
N1 - Publisher Copyright:
© 2017 The Author(s).
PY - 2017/10/11
Y1 - 2017/10/11
N2 - 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.
AB - 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.
KW - Child health
KW - Community health workers
KW - Infectious diseases
KW - Integrated management for childhood illness (IMCI)
KW - MHealth
KW - Malawi
UR - http://www.scopus.com/inward/record.url?scp=85030837292&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-2213-z
DO - 10.1186/s13063-017-2213-z
M3 - Article
C2 - 29020976
AN - SCOPUS:85030837292
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 475
ER -
