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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infectious Diseases

Intervention / Treatment
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* Device: Supporting LIFE electronic Community Case Management
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paper-based CCM (Standard Care)<br>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. | Other: Standard care<br> <br> |
| Experimental: SL eCCM App + paper CCM<br>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. | Device: Supporting LIFE electronic Community Case Management<br>* The SL eCCM App is smartphone application developed to run on Android operating systems 3.0 Honeycomb and above. The SL eCCM App represents an electronic format of the WHO and UNICEFs paper-based CCM clinical decision rule, currently adopted as national policy in Malawi for assessing children presenting to village clinics with acute illness.The App includes a tap-sensitive breath counter for measuring breathing rate.<br>* Other names: SL eCCM App;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers and facilitators to parent/caregiver compliance with referral recommendations |  | <2-weeks post-enrollment | 
| 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 |