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
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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