Combined Clinical Audits and Low-Dose, High-frequency, In-service Training of Health Care Providers and Community Health Workers to Improve Maternal and Newborn Health in Mali: Protocol for a Pragmatic Cluster Randomized Trial

David Zombre, Jean-Luc Kortenaar, Farhana Zareef, Moussa Doumbia, Sekou Doumbia, Fadima Haidara, Katie McLaughlin, Samba Sow, Zulfiqar A Bhutta, Diego G Bassani, David Zombre, Jean-Luc Kortenaar, Farhana Zareef, Moussa Doumbia, Sekou Doumbia, Fadima Haidara, Katie McLaughlin, Samba Sow, Zulfiqar A Bhutta, Diego G Bassani

Abstract

Background: Although most births in Mali occur in health facilities, a substantial number of newborns still die during delivery and within the first 7 days of life, mainly because of existing training deficiencies and the challenges of maintaining intrapartum and postpartum care skills.

Objective: This trial aims to assess the effectiveness and cost-effectiveness of an intervention combining clinical audits and low-dose, high-frequency (LDHF) in-service training of health care providers and community health workers to reduce perinatal mortality.

Methods: The study is a three-arm cluster randomized controlled trial in the Koulikoro region in Mali. The units of randomization are each of 84 primary care facilities. Each trial arm will include 28 facilities. The facilities in the first intervention arm will receive support in implementing mortality and morbidity audits, followed by one-day LDHF training biweekly, for 6 months. The health workers in the second intervention arm (28 facilities) will receive a refresher course in maternal neonatal and child health (MNCH) for 10 days in a classroom setting, in addition to mortality and morbidity audits and LDHF hands-on training for 6 months. The control arm, also with 28 facilities, will consist solely of the standard MNCH refresher training delivered in a classroom setting. The main outcomes are perinatal deaths in the intervention arms compared with those in the control arm. A final sample of approximately 600 deliveries per cluster was expected for a total of 30,000 newborns over 14 months. Data sources included both routine health records and follow-up household surveys of all women who recently gave birth in the study facility 7 days postdelivery. Data collection tools will capture perinatal deaths, complications, and adverse events, as well as the status of the newborn during the perinatal period. A full economic evaluation will be conducted to determine the incremental cost-effectiveness of each of the case-based focused LDHF hands-on training strategies in comparison to MNCH refresher training in a classroom setting.

Results: The trial is complete. The recruitment began on July 15, 2019, and data collection began on July 23, 2019, and was completed in November 2020. Data cleaning or analyses began at the time of submission of the protocol.

Conclusions: The results will provide policy makers and practitioners with crucial information on the impact of different health care provider training modalities on maternal and newborn health outcomes and how to successfully implement these strategies in resource-limited settings.

Trial registration: ClinicalTrials.gov NCT03656237; https://ichgcp.net/clinical-trials-registry/NCT03656237.

International registered report identifier (irrid): DERR1-10.2196/28644.

Keywords: Mali; low dose high frequency training; maternal and newborn health outcomes; perinatal mortality.

Conflict of interest statement

Conflicts of Interest: None declared.

©David Zombre, Jean-Luc Kortenaar, Farhana Zareef, Moussa Doumbia, Sekou Doumbia, Fadima Haidara, Katie McLaughlin, Samba Sow, Zulfiqar A Bhutta, Diego G Bassani. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.12.2021.

Figures

Figure 1
Figure 1
Geographical location of health districts and health facilities under study. LDHF: low-dose, high-frequency; MNCH: maternal neonatal and child health.
Figure 2
Figure 2
Flow chart of community health services clusters recruitment and follow-up. CSCOM: Centre de Santé Communautaire; LDHF: low-dose, high-frequency; MNCH: maternal neonatal and child health.
Figure 3
Figure 3
The intervention model. LDHF: low-dose, high-frequency.

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