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

President and Fellows of Harvard College

Status: Completed

Conditions: Quality of Care

Treatments: Behavioral: MENTORS; Behavioral: PROMPTS

Study type: Interventional

Funder types: Other

Identifiers

NCT05110521

IRB21-1013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,992 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Health Facilities:

• have at least 50 normal vaginal deliveries per month on average
• have at most 400 normal vaginal deliveries per month on average
• are owned by the government or a faith-based organization
• have no potentially confounding ongoing research or quality-improvement programs at the time of selection (especially mentorship or mHealth programs).

Inclusion Criteria for Participants of Provider Surveys:

• nurses or midwives
• provide delivery care in the study facility
• have no plan to move to a different facility in the next 6 months (baseline only).

Inclusion Criteria for Participants of PROMPTS Surveys:

• at least 15 years old
• have access to a mobile phone
• are at least 16 weeks pregnant or in Month 5, 6, 7, 8, and 9 of pregnancy.

Inclusion Criteria for Participants of Delivery Observations:

• at least 15 years old
• are admitted for labor and delivery at the maternity ward

Exclusion Criteria for Participants of Delivery Observations:

• are presenting for conditions other than labor and delivery (e.g., patients admitted for prenatal observation or complications from abortion)
• are immediately transferred to another hospital.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,992 participants in 2 patient groups

Intervention (PROMPTS and MENTORS offered)

Experimental group

Description:

Health facilities randomized into the Intervention Arm will be offered the MENTORS program, which trains in-facility nurse-mentors to provide health workers with training and mentorship on aspects of basic and emergency obstetric and newborn care. At health facilities in the intervention arm, patients attending antenatal care clinics will be offered the PROMPTS program, which is a digital health platform that connects mothers with information, advice and referrals to care.

Treatment:

Behavioral: PROMPTS

Behavioral: MENTORS

Control (Routine Care/No PROMPTS or MENTORS OFFERED)

No Intervention group

Description:

In the control arm, neither the PROMPTS program nor the MENTORS program will be offered during the study period.