Evaluation of a Nurse Mentorship and Digital Health Package Intervention in Kenya

Quality of Care Clinical Trial

Official title: Impact of a Nurse Mentorship and Digital Health Package Intervention for Maternal and Newborn Health in Kenya: A Cluster Randomized Controlled Trial

Status Completed

Clinical Trial Summary

The investigators will conduct a cluster randomized controlled trial in maternity facilities in Kenya to evaluate the impact of a maternal and neonatal health package intervention on patient and provider outcomes. This package intervention includes two programs: PROMPTS, a digital health platform for mothers aimed to improve knowledge and health behaviors and increase care-seeking behavior at the right time and place, and MENTORS, a facility-based program aimed to increase and sustain providers' knowledge and skills in basic and emergency obstetric and newborn care. Facilities will be randomized into a treatment group that receives the package or a control group that receives usual care. Patient outcomes include health knowledge, health behaviors and health care utilization in the prenatal and postnatal period; provider outcomes include knowledge and quality of care.

Clinical Trial Description

This study is designed as a parallel arm cluster randomized controlled trial (RCT). Randomization of the intervention package will occur at the facility level. The investigators will randomize 40 facilities across 8 counties into either the intervention or control group.

Data will be collected at multiple points during the study period. Facility baseline data collection will occur over a one month period in each facility. Baseline data collection will include a facility assessment, maternity register data extraction and health worker interviews.

In order to evaluate the PROMPTS component of the intervention, the investigators will enroll a cohort of women during baseline facility data collection that will be followed through their pregnancy, delivery and postpartum period. The investigators will recruit pregnant women attending study clinics for antenatal care during the baseline data collection period. They will be surveyed by phone twice in the follow-up period: once in the last month of pregnancy and again at 7- to 8-weeks postpartum. Women enrolled from the intervention facilities will be offered the PROMPTS intervention immediately after the baseline survey.

The facility-based endline data collection will occur 4-5 months after the end of baseline and will last for 1-2 months in each facility. The facility-based endline data collection will include register data extraction, health worker interviews, and observations of quality of care during labor and delivery.

A process evaluation will be conducted using administrative program data collected by Jacaranda Health to monitor intervention implementation within the treatment facilities.

After the endline, facilities in the control group will also be offered the intervention. ;

Related Conditions & MeSH terms

• Quality of Care

• NCT number: NCT05110521
• Study type: Interventional
• Source: Harvard School of Public Health (HSPH)
• Status: Completed
• Phase: N/A
• Start date: November 5, 2021
• Completion date: August 26, 2022