Evaluation of the Impact of the 'Solar Suitcase' Installation in Healthcare Facilities in Uganda on Quality of Care During Labor and Delivery and Reliability of Electricity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,268
- 试验地点
- 1
- 主要终点
- Average brightness of room during labor and delivery as measured by observer recorded questionnaire
研究概览
简要总结
The investigators will conduct a stepped wedge cluster-randomized controlled trial in maternity care facilities in Uganda to evaluate the impact of the provision of a reliable light source on the quality of delivery care provided. The facility-level intervention is the installation of a "Solar Suitcase", a complete solar electric system providing essential lighting and power for charging phones and small medical devices and a fetal doppler. The intervention will be rolled-out sequentially to all facilities over two time periods, in a randomized order.
详细描述
Ensuring universal access to electricity is essential for global development. In the health sector, lack of reliable light and electricity is a major challenge for health workers when conducting deliveries at night. However, there is very little evidence of the impact of improving access to reliable electrification at maternity facilities on the quality of maternity care they provide.
This stepped wedge cluster-randomized trial will evaluate the impact of a reliable light and electricity source - the "Solar Suitcase" - on outcomes of availability and brightness of light, the quality of maternal care provided, and health worker satisfaction. The study will take place in rural health facilities conducting deliveries in Uganda. The eligible facilities have either no connection to electricity or a modern light source or have reported to have very unreliable light (blackouts occur frequently).
The intervention is a "Solar Suitcase", provided by the non-governmental organization "We Care Solar". The Solar Suitcases are complete solar electric systems that provide essential lighting and power for charging phones and small medical devices. Data collection will include direct observation of deliveries during daytime and nighttime hours, as well as interviews with facility staff. The intervention will be implemented in about 30 facilities in a step process, whereby at each 'step', half of the facilities (selected randomly) will receive the intervention.
Data will be collected at three time points: a baseline period in which no facilities have received the intervention, a midline period in which the first group of facilities has received the intervention but the other half has not, and an endline period in which all facilities have received the intervention.
In addition, facility-level data will be collected at three time points over a 9-month period after the completion of the endline. This data will be used to monitor delivery and ANC volumes at 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
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For women delivering at facility:
- •Inclusion Criteria:
- •Pregnant women who are admitted for labor and delivery at participating facilities.
- •Women aged 16 years or older.
排除标准
- •Pregnant women who present to participating facilities for abortion or abortion-related complications, miscarriage, ectopic pregnancy, antenatal or postnatal complications of pregnancy (not an observation of labor)
- •Women who are immediately transferred to another hospital, or are taken straight to surgical theatre (limited or no period of observation possible)
- •Women who deliver at home but are brought to the facility for any complication.
- •Women who deliver outside the maternity ward or delivery area
- •Women who deliver in ambulance while on the way to the facility (woman admitted in the facility for placenta removal)
- •Women who have not given consent
- •Health worker objects to the observation.
- •For eligibility of health facility:
- •Inclusion criteria:
- •government health facilities level 2, 3, or 4
- •are open 24 hours a day
- •conduct deliveries at night
- •have unreliable electricity (have either no source of electricity, or have only 1 functional source of electricity and experience blackouts at least several times a week and had power available only sometimes in the past week).
- •Exclusion criteria:
- •facility already has a Solar Suitcase
研究组 & 干预措施
Solar Suitcase Installation First Group
Facilities will receive the installation of the Solar Suitcase shortly after baseline data collection.
干预措施: Solar Suitcase (Other)
Solar Suitcase Installation Second Group
Facilities will act as a comparator for experimental group 1 and then will receive the installation of the Solar Suitcase shortly after midline data collection.
干预措施: Solar Suitcase (Other)
结局指标
主要结局
Average brightness of room during labor and delivery as measured by observer recorded questionnaire
时间窗: up to 6 months after installation
Scale is scored as 1: Very Bright; 2: Somewhat Bright; 3: Dim; 4: Pitch Black. Variable is binary indicator for "very bright" or "somewhat bright" throughout delivery
Satisfactory light source used for entire delivery as measured by observer recorded questionnaire
时间窗: up to 6 months after installation
Satisfactory light source is a variable equal to 1 if observation occurs without daylight and facility is using grid, solar or functional generator and zero if using kerosene, candle, torch, etc. Variable is always equal to 1 during daylight.
Adequate Light as measured by observer recorded questionnaire
时间窗: up to 6 months after installation
Binary variable equal to 1 if light is from a satisfactory source and is "bright" ("very bright" or "somewhat bright") for duration of delivery observation.
20-item quality of maternal care index of essential actions to be performed by provider during labor and delivery as measured by observer recorded questionnaire
时间窗: up to 6 months after installation
Quality of care index is based on essential actions providers must perform during the course of labor and delivery, as described in Tripathi et al. (2015). Score is the fraction of 20 items, yielding a range of 0 to 1, with higher scores indicating better quality of maternal care.
6-item delays in care index as measured by observer recorded questionnaire
时间窗: up to 6 months after installation
Index including: i) Time between facility arrival and first contact with health worker (mins) ii) Time between facility arrival and first assessment (mins) iii) Time between delivery and uterotonic (mins) iv) Time between delivery and assessment of perineal and vaginal lacerations (mins) v) Time between delivery and drying baby with towel (mins) vi) Time between delivery and initiation of breastfeeding (mins) Score is average of the 6 items measured in minutes, with lower values indicating reduced delays in quality of maternal care. Range from 0 to 120 minutes.
37-item quality of maternal care index of essential actions to be performed by provider during labor and delivery as measured by observer recorded questionnaire
时间窗: up to 6 months after installation
Quality of care index is based on the essential actions providers must perform during the course of labor and delivery, derived from the Maternal and Child Health Integrated Program (MCHIP). It includes the 20 items from Tripathi et al. (2015) plus an additional 17 quality of care items from MCHIP (2013). Score is fraction of the 37 items, yielding a range of 0 to 1, with higher scores indicating better quality of maternal care.
Health Worker Satisfaction with Electricity as measured by health worker survey
时间窗: up to 6 months after installation
Responses on a 1-5 scale with 1: Strongly Disagree, 2: Disagree, 3: Neutral (Neither Agree nor Disagree), 4: Agree, 5: Strongly Agree Worker Satisfaction with Electricity is a binary variable equal to 1 if strongly agree with both: i) I am satisfied with the availability and brightness of light in this facility. ii) I am satisfied with the availability of electricity in this facility
Overall job satisfaction index as measured by health worker survey
时间窗: up to 6 months after installation
Responses on a 1-5 scale with 1: Strongly Disagree, 2: Disagree, 3: Neutral (Neither Agree nor Disagree), 4: Agree, 5: Strongly Agree Overall job satisfaction index is the mean score (1-5) of the 4 below components: i) These days, I feel motivated to work as hard as I can. ii) Overall, I am satisfied with my job. iii) Overall, the morale level at my department is good iv) I plan on staying at this position for the next year.
次要结局
- Sensor Brightness as measured by sensor(up to 6 months after installation)
- Initial Exam: Hand Washing as measured by observer recorded questionnaire(up to 6 months after installation)
- Initial Exam: Vaginal Examination as measured by observer recorded questionnaire(up to 6 months after installation)
- Delay in Drying Newborn as measured by observer recorded questionnaire(up to 6 months after installation)
- Partograph Use as measured by observer recorded questionnaire(up to 6 months after installation)
- Initial Exam Fetal Heart Rate Assessment as measured by observer recorded questionnaire(up to 6 months after installation)
- Preparation for Delivery: Cord ties/clamps and sterile scissors/blade as measured by observer recorded questionnaire(up to 6 months after installation)
- Preparation of Uterotonic as measured by observer recorded questionnaire(up to 6 months after installation)
- Newborn Temperature as measured by observer recorded questionnaire(up to 6 months after installation)
- Assistance with Breastfeeding as measured by observer recorded questionnaire(up to 6 months after installation)
- Mean level of brightness over 4 periods of labor and delivery on brightness scale as measured by observer recorded questionnaire(up to 6 months after installation)
- Delay in First Exam as measured by observer recorded questionnaire(up to 6 months after installation)
- Delay in Uterotonic as measured by observer recorded questionnaire(up to 6 months after installation)
- Phone availability as measured by observer recorded questionnaire(up to 6 months after installation)
- Routine obstetric care signal functions as measured by facility assessment(up to 6 months after installation)
- Time between delivery and when suturing began (minutes) as measured by observer recorded questionnaire(up to 6 months after installation)
- Delay in Breastfeeding Initiation as measured by observer recorded questionnaire(up to 6 months after installation)
- Health Worker Assessment of Task Light Brightness as measured by health worker survey(up to 6 months after installation)
- Consistent satisfactory light source as measured by observer recorded questionnaire(up to 6 months after installation)
- Fetal Doppler Use as measured by observer recorded questionnaire(up to 6 months after installation)
- Basic emergency obstetric care signal functions as measured by facility assessment(up to 6 months after installation)
- 10-item patient treatment index as measured by observer recorded questionnaire(up to 6 months after installation)
- 14-item Partograph Completeness index as measured by observer recorded questionnaire(up to 6 months after installation)
- Solar Suitcase Use for Deliveries as measured by enumerator recorded questionnaire(up to 6 months after installation)
- Minutes of delivery observation without satisfactory light as measured by observer recorded questionnaire(up to 6 months after installation)
- Routine newborn care signal functions as measured by facility assessment(up to 6 months after installation)
- Time between contractions as measured by observer recorded questionnaire(up to 6 months after installation)
- Monthly Nighttime Delivery Volumes as measured by facility register(up to 6 months after installation)
- Health Worker Assessment of Overhead Light Availability as measured by health worker survey(up to 6 months after installation)
- Health Worker Assessment of Task Light Availability as measured by health worker survey(up to 6 months after installation)
- Health Worker Assessment of Overhead Light Brightness as measured by health worker survey(up to 6 months after installation)
- Communication with Patient as measured by observer recorded questionnaire(up to 6 months after installation)
- Assessment of Completeness of Placenta as measured by observer recorded questionnaire(up to 6 months after installation)
- APGAR Score Assigned as measured by observer recorded questionnaire(up to 6 months after installation)
- 4-item quality of suturing index as measured by observer recorded questionnaire(up to 6 months after installation)
- Dilation at first exam as measured by observer recorded questionnaire(up to 6 months after installation)
- Monthly ANC Volumes as measured by facility register(up to 6 months after installation)
- Monthly Referral Volumes as measured by facility register(up to 6 months after installation)
- Depletion of Solar Suitcase Battery Based on Voltage as measured by sensor(up to 6 months after installation)
- Depletion of Solar Suitcase Battery Based on Charge Time as measured by sensor(up to 6 months after installation)
- Takes Blood Pressure as measured by observer recorded questionnaire(up to 6 months after installation)
- Cord Clamping as measured by observer recorded questionnaire(up to 6 months after installation)
- Breastfeeding within 1 Hour as measured by observer recorded questionnaire(up to 6 months after installation)
- Initial Exam: Previous Pregnancy Inquiry as measured by observer recorded questionnaire(up to 6 months after installation)
- Initial Exam Temperature Assessment as measured by observer recorded questionnaire(up to 6 months after installation)
- Basic emergency newborn care signal functions as measured by facility assessment(up to 6 months after installation)
- Monthly Delivery Volumes as measured by facility register(up to 6 months after installation)
- Hand Washing as measured by observer recorded questionnaire(up to 6 months after installation)
- 14-item index of Health worker assessment of impact of blackouts on their ability to perform job functions as measured by health worker survey(up to 6 months after installation)
- Initial exam Bleeding Assessment as measured by observer recorded questionnaire(up to 6 months after installation)
- Initial exam Headaches/Blurred Vision Assessment as measured by observer recorded questionnaire(up to 6 months after installation)
- HIV testing as measured by observer recorded questionnaire(up to 6 months after installation)
- Takes Pulse as measured by observer recorded questionnaire(up to 6 months after installation)
- Wears Sterile Gloves as measured by observer recorded questionnaire(up to 6 months after installation)
- Assessment of Lacerations as measured by observer recorded questionnaire(up to 6 months after installation)
- Palpation of Uterus as measured by observer recorded questionnaire(up to 6 months after installation)
- Initial Exam Fetal Presentation Assessment as measured by observer recorded questionnaire(up to 6 months after installation)
- Support of Perineum as measured by observer recorded questionnaire(up to 6 months after installation)
- Cord Traction as measured by observer recorded questionnaire(up to 6 months after installation)
- Hand Hygiene after Clean Up as measured by observer recorded questionnaire(up to 6 months after installation)
- Preparation of Bag and Mask as measured by observer recorded questionnaire(up to 6 months after installation)
- Administration of Oxytocin as measured by observer recorded questionnaire(up to 6 months after installation)
- Skin-to-Skin as measured by observer recorded questionnaire(up to 6 months after installation)
- Drying Newborn as measured by observer recorded questionnaire(up to 6 months after installation)
- Vital Signs Postpartum as measured by observer recorded questionnaire(up to 6 months after installation)
- Sterile Gloves for All Exams as measured by observer recorded questionnaire(up to 6 months after installation)
- Uterine Massage as measured by observer recorded questionnaire(up to 6 months after installation)
- Initial Exam Fundal Height Assessment as measured by observer recorded questionnaire(up to 6 months after installation)
- Sterilization of Equipment as measured by observer recorded questionnaire(up to 6 months after installation)
- Waste Disposal as measured by observer recorded questionnaire(up to 6 months after installation)
- Delay in Facility Arrival as measured by observer recorded questionnaire(up to 6 months after installation)
- Delay in Assessment for Lacerations as measured by observer recorded questionnaire(up to 6 months after installation)
研究者
Jessica Cohen
Associate Professor of Global Health
Harvard School of Public Health (HSPH)
