Clinical trial NCT02763345: The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi
Official title: The Added Value of a Mobile Application of Community Case Management on Under-5 Referral, Re-consultation and Hospitalization Rates in Malawi: a Pragmatic Stepped-wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Diseases
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: University College Cork
name: Lund University
name: Mzuzu University
name: Luke International Norway
First posted: 2016-05-05
Enrollment: 6995
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Community Case Management (CCM) is a clinical decision aid used by frontline Health Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and malaria (amongst other conditions). Children identified has having complicated illness are urgently referred to larger health facilities better equipped to clinically manage these more complex presentations. There is evidence to suggest HSAs are missing opportunities to refer seriously ill children, and parents/caregivers are failing to comply with urgent referral recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of mobile technology for deploying CCM has been demonstrated in prior research as feasible to evaluate, acceptable to health workers and parents/caregivers and improving health worker fidelity to the guidelines, but it is unknown if this translates into increased referral and referral completion rates. This trial seeks to evaluate the added value of a purpose developed mobile solution for CCM, called Supporting LIFE electronic Community Case Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.


Eligibility criteria: Inclusion Criteria:

* Parents/caregivers aged ≥18 years with spoken fluency in Chichewa, Tonga and Tumbuka
* Children aged ≥2 months to \<5 years
* Able/willing to give voluntary verbal consent

Exclusion Criteria:

* Parents/caregivers aged \<18 years
* Children aged \<2 months or ≥5 years
* Children who are convulsing or unconscious/unresponsive at presentation
* Parents/caregivers unable/unwilling to give voluntary verbal consent

Primary outcomes:
measure: Health worker initiated referral of children to higher-level health facilities
timeFrame: at the index visit (study enrollment)
measure: Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities
timeFrame: 7-days post-enrollment
Secondary outcomes:
measure: Barriers and facilitators to parent/caregiver compliance with referral recommendations
timeFrame: <2-weeks post-enrollment
measure: Acceptability of the SL eCCM App to HSAs and parents/caregivers
timeFrame: <2-weeks post-enrollment
measure: Household-level costs associated with healthcare seeking behavior
timeFrame: < 2-weeks post-enrollment
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Matthew J Thompson, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chirambo GB, Thompson M, Hardy V, Ide N, Hwang PH, Dharmayat K, Mastellos N, Heavin C, O'Connor Y, Muula AS, Andersson B, Carlsson S, Tran T, Hsieh JC, Lee HY, Fitzpatrick A, Joseph Wu TS, O'Donoghue J. Effectiveness of Smartphone-Based Community Case Management on the Urgent Referral, Reconsultation, and Hospitalization of Children Aged Under 5 Years in Malawi: Cluster-Randomized, Stepped-Wedge Trial. J Med Internet Res. 2021 Oct 20;23(10):e25777. doi: 10.2196/25777.
citation: Hardy V, O'Connor Y, Heavin C, Mastellos N, Tran T, O'Donoghue J, Fitzpatrick AL, Ide N, Wu TJ, Chirambo GB, Muula AS, Nyirenda M, Carlsson S, Andersson B, Thompson M. 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. Trials. 2017 Oct 11;18(1):475. doi: 10.1186/s13063-017-2213-z.