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

NCT ID: NCT05110521

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10992 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2022-08-26

Brief 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.

Detailed 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.

Conditions

Quality of Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention (PROMPTS and MENTORS offered)

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.

Group Type: EXPERIMENTAL

PROMPTS

Intervention Type: BEHAVIORAL

PROMPTS is a two-way Short Message Service (SMS) digital health platform that connects mothers with information, advice and referrals to care during the prenatal and postnatal period. The platform also collects information from women on care experience that is reported back to maternity facilities.

MENTORS

Intervention Type: BEHAVIORAL

MENTORS is a program in which in facility nurse-mentors are trained and supported to offer training to nurses, midwives and other maternity facility staff on aspects of basic and emergency obstetric and newborn care.

Control (Routine Care/No PROMPTS or MENTORS OFFERED)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PROMPTS

PROMPTS is a two-way Short Message Service (SMS) digital health platform that connects mothers with information, advice and referrals to care during the prenatal and postnatal period. The platform also collects information from women on care experience that is reported back to maternity facilities.

Intervention Type: BEHAVIORAL

MENTORS

MENTORS is a program in which in facility nurse-mentors are trained and supported to offer training to nurses, midwives and other maternity facility staff on aspects of basic and emergency obstetric and newborn care.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

• 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).

• 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.

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Innovations for Poverty Action

OTHER

Sponsor Role: collaborator

Jacaranda Health

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: lead

Responsible Party

Jessica Cohen

Associate Professor of Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica L Cohen, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Margaret A McConnell, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Innovations for Poverty Actions

Nairobi, , Kenya

Countries

Kenya

References

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Reference Type: BACKGROUND

PMID: 26107655 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19457237 (View on PubMed)

Berger BO, Strobino DM, Mehrtash H, Bohren MA, Adu-Bonsaffoh K, Leslie HH, Irinyenikan TA, Maung TM, Balde MD, Tuncalp O. Development of measures for assessing mistreatment of women during facility-based childbirth based on labour observations. BMJ Glob Health. 2021 Aug;5(Suppl 2):e004080. doi: 10.1136/bmjgh-2020-004080.

Reference Type: BACKGROUND

PMID: 34362791 (View on PubMed)

Vatsa R, Chang W, Akinyi S, Little S, Gakii C, Mungai J, Kahumbura C, Wickramanayake A, Rajasekharan S, Cohen J, McConnell M. Impact evaluation of a digital health platform empowering Kenyan women across the pregnancy-postpartum care continuum: A cluster randomized controlled trial. PLoS Med. 2025 Feb 3;22(2):e1004527. doi: 10.1371/journal.pmed.1004527. eCollection 2025 Feb.

Reference Type: DERIVED

PMID: 39899612 (View on PubMed)

Other Identifiers

IRB21-1013

Identifier Type: -

Identifier Source: org_study_id