Trials · 2017
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.
СтатьяМногоцентровое исследованиеPragmatic Clinical TrialРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Hardy Victoria, O'Connor Yvonne, Heavin Ciara, Mastellos Nikolaos, Tran Tammy, O'Donoghue John, Fitzpatrick Annette L, Ide Nicole, Wu Tsung-Shu Joseph, Chirambo Griphin Baxter, Muula Adamson S, Nyirenda Moffat, Carlsson Sven, Andersson Bo, Thompson Matthew
Аннотация
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.
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.
Предметные рубрики MeSH
Attitude of Health PersonnelCase ManagementChild Health ServicesChild, PreschoolClinical ProtocolsCommunity Health WorkersCost-Benefit AnalysisDelivery of Health Care, IntegratedFemaleHealth Care CostsHealth Knowledge, Attitudes, PracticeHealth ResourcesHospitalizationHumansInfantMalawiMaleMobile ApplicationsReferral and ConsultationResearch DesignTelemedicine