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

NCT04074083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2022-11-04

No results posted yet for this study

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.

Conditions

  • Child Health
  • Clinical Practice Guidelines
  • Primary Health Care

Interventions

BEHAVIORAL

electronic IMCI

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

BEHAVIORAL

paper IMCI

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

Sponsors & Collaborators

  • The ELMA Foundation

    collaborator OTHER
  • KwaZulu Natal Department of Health

    collaborator UNKNOWN
  • University of KwaZulu

    lead OTHER

Principal Investigators

  • Christiane Horwood, MB.BS., PhD · University of KwaZulu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2021-06-18
Completion
2022-11-01

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04074083 on ClinicalTrials.gov