Clinical trial NCT05110521: Evaluation of a Nurse Mentorship and Digital Health Package Intervention in Kenya
Official title: Impact of a Nurse Mentorship and Digital Health Package Intervention for Maternal and Newborn Health in Kenya: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Care
Keywords: maternal and newborn health
quality of care
mentorship
mHealth
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
name: Jacaranda Health
First posted: 2021-11-08
Enrollment: 10992
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Quality of routine maternity care, measured by delivery observation
timeFrame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
measure: Provider knowledge on obstetric and newborn care, measured by provider survey
timeFrame: assessed approximately 6 months after intervention initiation
measure: Patient knowledge on danger signs, measured by patient survey
timeFrame: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)
measure: Care seeking in response to severe danger signs, measured by patient survey
timeFrame: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)
measure: Postnatal care for mom within six weeks postpartum, measured by patient survey
timeFrame: assessed at 7 - 8 weeks postpartum
measure: Number of antenatal care visits, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Quality of care for management of neonatal resuscitation, measured by simulation exercise
timeFrame: assessed approximately 6 months after intervention initiation
Secondary outcomes:
measure: Quality of care for management of maternal and neonatal complications, measured by delivery observation
timeFrame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
measure: Quality of care for infection prevention, measured by delivery observation
timeFrame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
measure: Quality of care for partograph completion, measured by delivery observation
timeFrame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
measure: Provider motivation and satisfaction, measured by provider survey
timeFrame: assessed approximately 6 months after intervention initiation
measure: Patient treatment during labor and delivery, measured by delivery observation
timeFrame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
measure: Respectful maternity care during last antenatal care visit, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Disrespect in care during delivery, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Severe morbidity and mortality, measured by delivery observation and document review
timeFrame: assessed at approximately 6 months after intervention initiation
measure: Medical advice/treatment seeking during pregnancy, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Medical advice/treatment seeking for baby's health postpartum, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Medical advice/treatment seeking for mom's health postpartum, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Care seeking in response to severe antenatal danger signs, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Care seeking in response to severe postnatal danger signs, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Care seeking in response to severe neonatal danger signs, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Patient knowledge on prenatal danger signs, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Patient knowledge on postnatal danger signs, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Patient knowledge on neonatal danger signs, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Patient knowledge on signs of labor, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Patient knowledge on breastfeeding, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Use of prenatal supplements, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Birth preparation, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Institutional delivery, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Exclusive breastfeeding, measured by patient survey
timeFrame: assessed between 7 - 8 weeks postpartum
measure: Sleep safety, measured by patient survey
timeFrame: assessed between 7- to 8-week postpartum
measure: Interaction with newborn, measured by patient survey
timeFrame: assessed between 7- to 8-week postpartum
measure: Patient self-efficacy in care-seeking during last antenatal care visit, measured by patient survey
timeFrame: assessed between 36 - 42 weeks' gestation
measure: Patient self-efficacy in care-seeking during pregnancy and delivery, measured by patient survey
timeFrame: assessed between 7- to 8-week postpartum
measure: Timeliness of care, measured by delivery observation
timeFrame: assessed from patient arrival to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Innovations for Poverty Actions
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Jessica L Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Margaret A McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.