The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi

Not Applicable

Completed

• Conditions: Infectious Diseases
• Interventions: Other: Standard care; Other: Supporting LIFE electronic Community Case Management

• Registration Number: NCT02763345
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Study Start: 2016-10
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6995

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paper-based CCM (Standard Care)	Standard care	Children are assessed and treated according to the WHO and UNICEFs paper-based Community Case Management decision aid for Malawi for a minimum of 2 and a maximum of 7-weeks. Clinical assessment is guided by the paper-based 'Sick Child Form' presented in English, and clinical data is recorded by Health Surveillance Assistants manually in the Village Clinic Register.
SL eCCM App + paper CCM	Supporting LIFE electronic Community Case Management	Health Surveillance Assistants use the Supporting LIFE electronic Community Case Management App (SL eCCM App) deployed on a smartphone and replicating paper-based CCM guidelines to assess and treat children in conjunction with standard care, for a minimum of 2-weeks and maximum of 7-weeks. Clinical data is recorded in both the SL eCCM App and Village Clinic Register.

Primary Outcome Measures

Name	Time	Method
Health worker initiated referral of children to higher-level health facilities	at the index visit (study enrollment)
Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities	7-days post-enrollment

Secondary Outcome Measures

Name	Time	Method
Acceptability of the SL eCCM App to HSAs and parents/caregivers	<2-weeks post-enrollment
Household-level costs associated with healthcare seeking behavior	< 2-weeks post-enrollment
Barriers and facilitators to parent/caregiver compliance with referral recommendations	<2-weeks post-enrollment