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

University of Washington

Status: Completed

Conditions: Infectious Diseases

Treatments: Other: Standard care; Other: Supporting LIFE electronic Community Case Management

Study type: Interventional

Funder types: Other

Identifiers

NCT02763345

51750

Details and patient eligibility

About

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.

Enrollment: 6,995 patients

Sex: All

Ages: 2 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6,995 participants in 2 patient groups

Paper-based CCM (Standard Care)

Active Comparator group

Description:

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.

Treatment:

Other: Standard care

SL eCCM App + paper CCM

Experimental group

Description:

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.

Treatment:

Other: Supporting LIFE electronic Community Case Management