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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

Hardy, Victoria; O'Connor, Yvonne; Heavin, Ciara; Mastellos, Nikolaos; Tran, Tammy; O'Donoghue, John; Fitzpatrick, Annette L.; Ide, Nicole; Wu, Tsung Shu Joseph and Chirambo, Griphin Baxter, et al. (2017) In Trials 18(1).
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... (More)

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.

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keywords
Child health, Community health workers, Infectious diseases, Integrated management for childhood illness (IMCI), Malawi, MHealth
in
Trials
volume
18
issue
1
publisher
BioMed Central
external identifiers
  • scopus:85030837292
  • wos:000412904300005
ISSN
1745-6215
DOI
10.1186/s13063-017-2213-z
language
English
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yes
id
4354b7fe-bb5c-4a82-87a4-5530d8b7207a
date added to LUP
2017-11-07 15:05:45
date last changed
2018-02-18 05:05:13
@article{4354b7fe-bb5c-4a82-87a4-5530d8b7207a,
  abstract     = {<p>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.</p>},
  articleno    = {475},
  author       = {Hardy, Victoria and O'Connor, Yvonne and Heavin, Ciara and Mastellos, Nikolaos and Tran, Tammy and O'Donoghue, John and Fitzpatrick, Annette L. and Ide, Nicole and Wu, Tsung Shu Joseph and Chirambo, Griphin Baxter and Muula, Adamson S. and Nyirenda, Moffat and Carlsson, Sven and Andersson, Bo and Thompson, Matthew},
  issn         = {1745-6215},
  keyword      = {Child health,Community health workers,Infectious diseases,Integrated management for childhood illness (IMCI),Malawi,MHealth},
  language     = {eng},
  month        = {10},
  number       = {1},
  publisher    = {BioMed Central},
  series       = {Trials},
  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},
  url          = {http://dx.doi.org/10.1186/s13063-017-2213-z},
  volume       = {18},
  year         = {2017},
}