CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 291 enrolled
Drug / intervention
electronic IMCI +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04074083
NCT04074083N/ACompleted

A Study to Evaluate the Effectiveness of e-IMCI Implementation Compared to Standard of Care for Sick Children Aged Under Five Years in Primary Health Care Clinics in KwaZulu-Natal, South Africa.

University of KwaZulu·interventional·Posted Aug 29, 2019·Updated Nov 4, 2022

In Brief

A clinical study evaluating electronic IMCI and paper IMCI for Child Health and 2 related conditions. Completed, enrolled 291 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 29, 2019
Enrollment StartJan 22, 2021
Primary CompletionJun 18, 2021
Study CompletionNov 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.8 years ago

Interventions

electronic IMCIbehavioral

Participants will be trained to use an electronic version of the Integrated Management of Childhood Illness (IMCI) guidelines

paper IMCIbehavioral

Participants will be trained to use routine paper version of Integrated Management of Childhood Illness (IMCI) guidelines