Impact of a Nurse Mentorship and Digital Health Package Intervention for Maternal and Newborn Health in Kenya: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,992
- 试验地点
- 1
- 主要终点
- Patient knowledge on danger signs, measured by patient survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Patient knowledge on danger signs, measured by patient survey
时间窗: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)
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.
Quality of care for management of neonatal resuscitation, measured by simulation exercise
时间窗: assessed approximately 6 months after intervention initiation
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.
Provider knowledge on obstetric and newborn care, measured by provider survey
时间窗: assessed approximately 6 months after intervention initiation
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.
Care seeking in response to severe danger signs, measured by patient survey
时间窗: assessed in the last month of pregnancy (prenatal danger signs) and between 7 - 8 weeks postpartum (neonatal and postpartum danger signs)
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.
Postnatal care for mom within six weeks postpartum, measured by patient survey
时间窗: assessed at 7 - 8 weeks postpartum
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
Number of antenatal care visits, measured by patient survey
时间窗: assessed between 7 - 8 weeks postpartum
a continuous variable for the total number of antenatal care visits during the entire pregnancy
Quality of routine maternity care, measured by delivery observation
时间窗: assessed from patient admission to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation
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.
次要结局
- 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)
- Medical advice/treatment seeking for baby's health postpartum, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- Care seeking in response to severe postnatal danger signs, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- Patient knowledge on signs of labor, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- Patient knowledge on breastfeeding, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- Birth preparation, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- 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)
- Care seeking in response to severe antenatal danger signs, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- Patient knowledge on prenatal danger signs, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- Exclusive breastfeeding, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- 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)
- Provider motivation and satisfaction, measured by provider survey(assessed approximately 6 months after intervention initiation)
- Respectful maternity care during last antenatal care visit, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- Medical advice/treatment seeking for mom's health postpartum, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- Care seeking in response to severe neonatal danger signs, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- Patient knowledge on neonatal danger signs, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- Disrespect in care during delivery, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- Severe morbidity and mortality, measured by delivery observation and document review(assessed at approximately 6 months after intervention initiation)
- Use of prenatal supplements, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- Institutional delivery, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- Medical advice/treatment seeking during pregnancy, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- Patient knowledge on postnatal danger signs, measured by patient survey(assessed between 7 - 8 weeks postpartum)
- Sleep safety, measured by patient survey(assessed between 7- to 8-week postpartum)
- Interaction with newborn, measured by patient survey(assessed between 7- to 8-week postpartum)
- Patient self-efficacy in care-seeking during pregnancy and delivery, measured by patient survey(assessed between 7- to 8-week postpartum)
- Patient self-efficacy in care-seeking during last antenatal care visit, measured by patient survey(assessed between 36 - 42 weeks' gestation)
- Timeliness of care, measured by delivery observation(assessed from patient arrival to up to 1 hour post the delivery of the placenta approximately 6 months after intervention initiation)
研究者
Jessica Cohen
Associate Professor of Global Health
Harvard School of Public Health (HSPH)