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

Last registered on April 29, 2022

Pre-Trial

Trial Information

General Information

Title
Impact of a Nurse Mentorship and Digital Health Package Intervention for Maternal and Newborn Health in Kenya: A Cluster Randomized Controlled Trial
RCT ID
AEARCTR-0008449
Initial registration date
October 28, 2021

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
November 01, 2021, 10:59 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
April 29, 2022, 1:02 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
Harvard School of Public Health

Other Primary Investigator(s)

PI Affiliation
Harvard School of Public Health
PI Affiliation
Harvard School of Public Health

Additional Trial Information

Status
On going
Start date
2021-11-05
End date
2022-07-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
The investigators will conduct a cluster randomized controledl 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 careseeking 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.
External Link(s)

Registration Citation

Citation
Chang, Wei, Jessica Cohen and Margaret McConnell. 2022. "Impact of a Nurse Mentorship and Digital Health Package Intervention for Maternal and Newborn Health in Kenya: A Cluster Randomized Controlled Trial." AEA RCT Registry. April 29. https://doi.org/10.1257/rct.8449
Experimental Details

Interventions

Intervention(s)
PROMPTS is a two-way 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 is a program in which in facility nursementors 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 Start Date
2021-11-08
Intervention End Date
2022-07-31

Primary Outcomes

Primary Outcomes (end points)
1. 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.
[Time Frame: ssessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation]
2. 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.
[Time Frame: assessed approximately 6 months after intervention initiation]
3. 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 espondent correctly identifies the need to seek medical care immediately.
[Time Frame: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)]
4. 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.
[Time Frame: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)]
5. 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
[Time Frame: assessed at 7 - 8 weeks postpartum]
6. Number of antenatal care visits, measured by patient survey
a continuous variable for the total number of antenatal care visits during the entire pregnancy
[Time Frame: assessed between 7 - 8 weeks postpartum]
7. 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.
[Time frame: assessed approximately 6 months after intervention initiation.]
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
8. Quality of care for management of maternal and neonatal complications, measured by delivery observation
A continuous variable based on essential actions providers should perform to manage maternal and neonatal complications, including postpartum hemorrhage, pre-eclampsia/eclampsia, neonatal resuscitation, and shoulder dystocia. Score is calculated as the fraction of total items applicable to each case, with higher scores indicating better quality of care.
[Time Frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation]
9. Quality of care for infection prevention, measured by delivery observation
A continuous variable based on a series of questions that measure whether infection prevention and control procedures are performed during labor and delivery. Individual item is assigned a score equal to 1 if an action is done.
[Time Frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation]
10. Quality of care for partograph completion, measured by delivery observation
A continuous variable based on a series of questions that measure whether progress of labor is plotted appropriately on the partograph. Individual item is assigned a score equal to 1 if an action is done.
[Time Frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation]
11. Provider motivation and satisfaction, measured by provider survey
A continuous variable based on 11 questions that measure health workers’ motivation adapted from a scale validated in Kenya (Mbindyo et al, 2009). Individual questions are scored using a 1-to-5 LIkert scale. The total score is calculated as the sum of all items (with a few items reverse coded).
[Time Frame: assessed approximately 6 months after intervention initiation]
12. Patient treatment during labor and delivery, measured by delivery observation
A continuous variable based on a series of questions that measure aspects of mistreatment during labor and delivery: interpersonal abuse scale, exams & procedures index, and unsupportive birth environment (Berger et al., 2021). Individual items are scored to 1 if observed.
[Time Frame: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation]
13. Respectful maternity care during last antenatal care visit, measured by patient survey
A binary variable equal to one if a patient felt she was treated with respect during her last antenatal care visit.
[Time Frame: assessed in the last month of pregnancy]
14. Disrespect in care during delivery, measured by patient survey
An ordinal variable based on to what extent a patient was abused or treated in a way that made her feel humiliated/disrespected during her delivery.
[Time Frame: assessed between 7 - 8 weeks postpartum]
15. Severe morbidity and mortality, measured by delivery observation and document review
A binary variable that measures whether a woman or her baby had any severe maternal complication (including severe postpartum hemorrhage, severe pre-eclampsia, eclampsia, severe systemic infection or sepsis, and uterine rupture), neonatal complication (including asphyxia), maternal mortality, and perinatal mortality (including stillbirth and newborn death)
[Time Frame: assessed at approximately 6 months after intervention initiation]
16. Medical advice/treatment seeking during pregnancy, measured by patient survey
A binary variable that measures whether a participant sought advice or treatment from a healthcare professional in the past month
[Time Frame: assessed during the last month of pregnancy]
17. Medical advice/treatment seeking for baby's health postpartum, measured by patient survey
A binary variable that measures whether a participant sought advice or treatment from a healthcare professional since she left the hospital after delivery for her baby’s health
[Time Frame: assessed between 7 - 8 weeks postpartum]
18. Medical advice/treatment seeking for mom's health postpartum, measured by patient survey
A binary variable that measures whether a participant sought advice or treatment from a healthcare professional since she left the hospital after delivery for her own health
[Time Frame: assessed between 7 - 8 weeks postpartum]
19. Care seeking in response to severe antenatal 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 danger signs.The variable is coded to one if respondent sought advice or treatment for at least one danger sign.
[Time Frame: assessed in the last month of pregnancy]
20. Care seeking in response to severe postnatal 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 postnatal danger signs. The variable is coded to one if respondent sought advice or treatment for at least one danger sign.
[Time Frame: assessed between 7 - 8 weeks postpartum]
21. Care seeking in response to severe neonatal 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 neonatal danger signs. The variable is coded to one if respondent sought advice or treatment for at least one danger sign.
[Time Frame: assessed between 7 - 8 weeks postpartum]
22. Patient knowledge on prenatal 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 danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital or not in response to a health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately..
[Time Frame: assessed in the last month of pregnancy]
23. Patient knowledge on postnatal 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 postpartum danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital or not in response to a health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately.
[Time Frame: assessed between 7 - 8 weeks postpartum]
24. Patient knowledge on neonatal 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 neonatal danger signs. Each question is scored according to whether a participant chooses the correct response (i.e., whether to visit a hospital or not in response to a health condition). The total score is calculated as the share of the times the respondent correctly identifies the need to seek medical care immediately.
[Time Frame: assessed between 7 - 8 weeks postpartum]
25. Patient knowledge on signs of labor, measured by patient survey
A count variable that measures the number of signs of labor a woman lists without being prompted.
[Time Frame: assessed in the last month of pregnancy]
26. Patient knowledge on breastfeeding, measured by patient survey
A binary variable that measures whether a woman correctly identifies the best time to start breastfeeding after delivery
[Time Frame: assessed in the last month of pregnancy]
27. Use of prenatal supplements, measured by patient survey
a binary variable that measures whether a woman is taking IFAS tablets or prenatal supplement that contains iron and folic during her pregnancy
[Time Frame: assessed in the last month of pregnancy]
28. Birth preparation, measured by patient survey
a count variable that measures the total number of things a woman has done to prepare for her delivery
[Time Frame: assessed in the last month of pregnancy]
29. Institutional delivery, measured by patient survey
a binary variable that measures whether a woman delivered her baby in a hospital or health clinic/center
[Time Frame: assessed between 7 - 8 weeks postpartum]
30. Exclusive breastfeeding, measured by patient survey
a binary variable that measures whether a baby is exclusively fed with breast milk
[Time Frame: assessed between 7 - 8 weeks postpartum]
31. Sleep safety, measured by patient survey
A binary variable that measures weather a woman puts her baby to sleep in the safest position at night
[Time Frame: assessed between 7- to 8-week postpartum]
32. Interaction with newborn, measured by patient survey
A binary variable that measures weather a woman spoke or sang to the baby in the past 24 hours
[Time Frame: assessed between 7- to 8-week postpartum]
33. Patient self-efficacy in care-seeking during last antenatal care visit, measured by patient survey
a binary variable that measures whether a woman feels that she could ask healthcare workers at her last antenatal care visit any question she had about her pregnancy.
[Time Frame: assessed in the last month of pregnancy]
34. Patient self-efficacy in care-seeking during pregnancy and delivery, measured by patient survey
an ordinal variable that measures to what extent a woman feels she can get her questions about her health answered during pregnancy and delivery.
[Time Frame: assessed between 7- to 8-week postpartum]
35. Timeliness of care, measured by delivery observation
[Time Frame: assessed from patient arrival to up to 1 hour post the delivery of the placenta 6 months after intervention start]
Secondary Outcomes (explanation)
35. Timeliness of care, measured by delivery observation
A continuous variable indicating delays in essential actions providers should perform, including time between facility arrival and first contact with health care worker, time between delivery and provision of uterotonic, time between delivery and breastfeeding initiation, and time between delivery and first maternal exam after birth.


Experimental Design

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

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.
Experimental Design Details
Not available
Randomization Method
Randomization done in office by a computer
Randomization Unit
Health facilities
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
40 health facilities
Sample size: planned number of observations
10000 individuals, including patients and providers at maternity facilities
Sample size (or number of clusters) by treatment arms
20 facility control, 20 facility nurse mentorship and digital health package intervention
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Harvard T.H. Chan School of Pulic Health
IRB Approval Date
2021-08-05
IRB Approval Number
IRB21-1013
IRB Name
Amref Health Africa in Kenya
IRB Approval Date
2021-09-24
IRB Approval Number
ESRC P1047/2021