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

NCT05110521 | Completed

• 1 other identifier: IRB21-1013
• Study Type: interventional
• Target: 10,992
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Care

Keywords

maternal and newborn health; quality of care; mentorship; mHealth

Outcome Measures

Primary Outcomes (7)

• Quality of routine maternity care, measured by delivery observation

  A ratio based on a 20-item index that measures essential actions providers must perform during the course of labor and delivery (Tripathi et al., 2015). The total score is calculated as the fraction of 20 items weighted equally, yielding a range of 0 to 1, with higher scores indicating better quality of maternal care.

  assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation

• Provider knowledge on obstetric and newborn care, measured by provider survey

  A continuous variable based on the answers to 10 questions on normal labor, infection prevention and control, preeclampsia and eclampsia, newborn care, postpartum hemorrhage, and shoulder dystocia.

  assessed approximately 6 months after intervention initiation

• Patient knowledge on danger signs, measured by patient survey

  A ratio based on questions that ask whether a respondent would seek medical care immediately in response to serious prenatal, neonatal, and postpartum danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital/call a doctor or not in response to a serious health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately.

  assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)

• Care seeking in response to severe danger signs, measured by patient survey

  A binary variable based on a series of questions that measure whether a respondent sought any medical advice or treatment for a healthcare provider in response to severe prenatal, postnatal, and neonatal danger signs. The variable is coded to one if respondent sought advice or treatment for at least one danger sign.

  assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)

• Postnatal care for mom within six weeks postpartum, measured by patient survey

  a binary variable equal to 1 if there was at least 1 postnatal visit within six weeks postpartum AND mom's own health was discussed during the postnatal care visit

  assessed at 7 - 8 weeks postpartum

• Number of antenatal care visits, measured by patient survey

  a continuous variable for the total number of antenatal care visits during the entire pregnancy

  assessed between 7 - 8 weeks postpartum

• Quality of care for management of neonatal resuscitation, measured by simulation exercise

  A continuous variable based on providers' actions in a simulation exercise for neonatal resuscitation. Each question is scored according to whether a provider performs the correct step for neonatal resuscitation. The total score is calculated as the sum of all questions. Higher scores mean a better outcome.

  assessed approximately 6 months after intervention initiation

Secondary Outcomes (28)

• Quality of care for management of maternal and neonatal complications, measured by delivery observation

  assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation

• Quality of care for infection prevention, measured by delivery observation

  assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation

• Quality of care for partograph completion, measured by delivery observation

  assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation

• Provider motivation and satisfaction, measured by provider survey

  assessed approximately 6 months after intervention initiation

• Patient treatment during labor and delivery, measured by delivery observation

  assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation

Study Arms (2)

Intervention (PROMPTS and MENTORS offered)

EXPERIMENTAL

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.

Behavioral: PROMPTS; Behavioral: MENTORS

Control (Routine Care/No PROMPTS or MENTORS OFFERED)

NO INTERVENTION

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

Interventions

PROMPTS 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.

Intervention (PROMPTS and MENTORS offered)

MENTORS 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.

Intervention (PROMPTS and MENTORS offered)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Innovations for Poverty Action: collaborator
• Jacaranda Health: collaborator

Study Sites (1)

Innovations for Poverty Actions

Nairobi, Kenya

Location

Related Publications (4)

• Tripathi V, Stanton C, Strobino D, Bartlett L. Development and Validation of an Index to Measure the Quality of Facility-Based Labor and Delivery Care Processes in Sub-Saharan Africa. PLoS One. 2015 Jun 24;10(6):e0129491. doi: 10.1371/journal.pone.0129491. eCollection 2015.

  PMID: 26107655 BACKGROUND

• Mbindyo PM, Blaauw D, Gilson L, English M. Developing a tool to measure health worker motivation in district hospitals in Kenya. Hum Resour Health. 2009 May 20;7:40. doi: 10.1186/1478-4491-7-40.

  PMID: 19457237 BACKGROUND

• 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.

  PMID: 34362791 BACKGROUND

• 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.

  PMID: 39899612 DERIVED

Study Officials

• Jessica L Cohen, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Margaret A McConnell, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Global Health

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 8, 2021
• Study Start: November 5, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

KE (1)