NCT04074083

An Evaluation of the Effectiveness of e-IMCI Implementation in Primary Health Care Clinics in South Africa.

Completed NA Last updated 4 November 2022

What this trial tests

NA trial testing electronic IMCI in Child Health in 291 participants. Completed in 1 November 2022.

Timeline

22 January 2021

Primary endpoint
18 June 2021

1 November 2022

Quick facts

Lead sponsor	University of KwaZulu
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	291
Start date	22 January 2021
Primary completion	18 June 2021
Estimated completion	1 November 2022
Sites	1 location across South Africa

Drugs / interventions tested

• electronic IMCI
• paper IMCI

Conditions studied

• Child Health — all drugs for Child Health →
• Clinical Practice Guidelines — all drugs for Clinical Practice Guidelines →
• Primary Health Care — all drugs for Primary Health Care →

Sponsor

University of KwaZulu

Who can join

Adults 2 Months to 59 Months, any sex, with Child Health or Clinical Practice Guidelines. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The research hypothesis is that sick children attending primary health care (PHC) clinics who are managed by IMCI-trained health workers (HWs) using electronic Integrated Management of Childhood Illness guidelines (e-IMCI) receive better quality of care compared to children managed by HWs using conventional paper-based IMCI (pIMCI). The aim of the study is to evaluate the effectiveness of e-IMCI to improve care for sick children under five years attending PHC clinics in one district in KwaZulu-Natal, South Africa.

Objectives:

1. To assess feasibility and acceptability of eIMCI implementation in PHC clinics
2. To compare clinic-based management of sick children using e-IMCI with a gold standard IMCI assessment, and those managed using p-IMCI to a gold standard IMCI assessment
3. To determine the cost effectiveness of e-IMCI compared to p-IMCI implementation in PHC clinics

Primary outcomes:

* Proportion of sick children receiving all medications indicated among children managed by HWs using eIMCI and HWs using pIMCI.
* Proportion of sick children with risk/high risk of Tuberculosis, HIV or HIV exposed, and/or malnutrition correctly identified among children assessed using eIMCI and children assessed using pIMCI, compared to a gold standard IMCI assessment.
* Incremental cost-effectiveness of eIMCI implementation vs standard of care (pIMCI).

The study will employ a prospective two-arm cluster randomized controlled trial. Sample size: a total of 30 clinics in one district will be randomly selected to participate and allocated to the intervention (eIMCI) group (n=15) and control (pIMCI) group (n=15). One IMCI trained HW will be randomly selected from each clinic to participate. Six observations will be conducted with each participating health worker Intervention HWs will receive an IMCI update and computer training based on eIMCI. Control HWs will receive a similar update using pIMCI. Both groups will receive support visits and intervention HWs will receive additional computer/IT support. Health worker knowledge will be assessed pre and post training using a self-administered questionnaire.

Quality of care will be assessed in both groups using exit interviews with mothers and review of child health records. In addition, gold standard IMCI assessments will be conducted by an IMCI expert to determine correct findings. Assessment and management of the child by the IMCI expert will be compared to that of the participating HW to determine quality of care provided.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.