Innovations for Poverty Action
Kampala, Uganda
NCT Number: NCT03589625
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.
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Notify Me16 year and older
Female
Interventional
Not applicable
Kampala, Uganda
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
For women delivering at facility:
Inclusion criteria
Exclusion criteria
For eligibility of health facility:
Inclusion criteria
Exclusion criteria
The intervention is a "Solar Suitcase". The Solar Suitcase comes with: 2 LED lights, 1 battery, 1 aluminum glass 100 watt solar panel, 2 rechargeable LED headlamps, 1 universal cell phone charger, 1 USB adapter, 1 fetal Doppler, 1 AA/AAA battery charger and expansion box (provides 2 additional lights).
Installers will teach health workers how to use and maintain the Solar Suitcase on the day of installation. Within one week following installation, the contractor will contact the facility over the phone and/or in-person to check if there are any problems with the Suitcase. Additional checks will be made to ensure the solar suitcase is functioning and being used properly.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: up to 6 months after installation
Scale is scored as 1: Very Bright; 2: Somewhat Bright; 3: Dim; 4: Pitch Black
Time frame: up to 6 months after installation
Satisfactory light source defined in Primary Outcome 2.
Time frame: up to 6 months after installation
Variable equal to 1 if no interruptions of > 2 hours in satisfactory light source during observed deliveries.
Time frame: up to 6 months after installation
Number of times the provider used a fetal doppler during labor and delivery
Time frame: up to 6 months after installation
Phone is available and on for deliveries
Time frame: up to 6 months after installation
Provider assigns any APGAR score (binary variable equal to 1 if provider assigns an APGAR score (range of 0-10), and equal to 0 if no APGAR score is assigned.
Time frame: up to 6 months after installation
Facility reported performance of basic emergency obstetric care signal functions in the past three months. Measure includes the number of signal functions performed from:
Time frame: up to 6 months after installation
Facility reported performance of basic emergency newborn care signal functions in the past three months. Measure includes the number of signal functions performed from:
Time frame: up to 6 months after installation
Facility reported universal practice of routine obstetric care signal functions. Measure includes the number of signal functions performed from:
Time frame: up to 6 months after installation
Facility reported universal practice of routine newborn care signal functions. Measure includes the number of signal functions performed from:
Time frame: up to 6 months after installation
Observed time between delivery and when provider began suturing lacerations, if needed.
Time frame: up to 6 months after installation
Index constructed from the following variables:
Time frame: up to 6 months after installation
Patient treatment/inter-personal quality care index, based on Kruk et al. (2014) including whether health worker: shouted/scolded patient, threatened to withhold treatment, ignored/left patient, did not answer questions, was not present when delivery began, slapped/beat mother, stitched episiotomy without anesthesia, demanded payment inappropriately, requested bribe, did not provide privacy to mother. Fraction of items that were NOT performed, yielding a range of 0-1, with higher scores indicating better treatment of patients.
Time frame: up to 6 months after installation
Index of variables (from MCHIP (2013) tool capturing completeness of recording on partograph). Fraction of 14 items completed on partograph (all binary variables), yielding a range of 0-1, with higher values indicating more completeness.
Time frame: up to 6 months after installation
Time between contractions at first exam (mins)
Time frame: up to 6 months after installation
Degree of dilation at woman's first exam (cm)
Time frame: up to 6 months after installation
Average Number of Monthly Deliveries
Time frame: up to 6 months after installation
Average Number of Nighttime Deliveries per Month
Time frame: up to 6 months after installation
Average Number of Antenatal Clients per Month
Time frame: up to 6 months after installation
Average Number of Monthly Referrals Out of Facility for Mothers and Newborns
Time frame: up to 6 months after installation
Recorded brightness at sensor sight in the two hours around delivery of baby.
Time frame: up to 6 months after installation
Average difference between solar suitcase load voltage in evening and morning (based on sensor)
Time frame: up to 6 months after installation
Average time between morning and when the solar suitcase is fully charged, based on sensor
Time frame: up to 6 months after installation
Fraction of deliveries in which enumerator recorded usage of suitcase
Time frame: up to 6 months after installation
Health worker response (1-5) on the following scale: 1: No overhead light; 2: Very poor; 3: Poor; 4: Good; 5: Very Good to the question:
"In general, how would you rate the availability of overhead light for maternal and newborn care (deliveries) in this facility at night?"
Time frame: up to 6 months after installation
Health worker response (1-5) on the following scale: 1: No procedure/task light; 2: Very poor; 3: Poor; 4: Good; 5: Very Good to the question:
"In general, how would you rate the availability of procedure/task light for maternal and newborn care (deliveries) in this facility at night?"
Time frame: up to 6 months after installation
Health worker response (1-5) on the following scale: 1: No overhead light; 2: Very poor; 3: Poor; 4: Good; 5: Very Good to the question: "In general, when the overhead light is on, how would you rate the quality of light (brightness) for maternal and newborn care (deliveries) in this facility at night?"
Time frame: up to 6 months after installation
Health worker response (1-5) on the following scale: 1: No procedure/task light; 2: Very poor; 3: Poor; 4: Good; 5: Very Good to the question: "In general, when the procedure/task light is on, how would you rate the quality of light (brightness) for maternal and newborn care (deliveries) in this facility at night?"
Time frame: up to 6 months after installation
Index of items measuring health worker assessment of impact of blackouts in facility on ability to conduct their job, including how often health worker: conducted deliveries without overhead light; had to hold torch in hand to see patient; experienced lack of light that affected normal care provided; delayed care; feared to move around facility; was affected in ability to suture, find/use equipment, conduct examinations of mother, provide emergency care, provide newborn care, monitor fetal heartrate, administer medication, clean up after delivery, manage infection control. Response to items scored (1-5) on following scale: 1. Every delivery, 2. Most, 3. Some, 4. Few, or 5. Never. Overall score measured as average of 14 items, yielding a range of 1-5.
Time frame: up to 6 months after installation
Provider asks whether woman has experienced vaginal bleeding during current pregnancy (binary)
Time frame: up to 6 months after installation
Provider asks whether woman has experienced headaches and/or blurred vision during current pregnancy (binary)
Time frame: up to 6 months after installation
Provider offers woman an HIV test or checks her HIV status (binary)
Time frame: up to 6 months after installation
Provider takes pulse of mother during initial exam (binary)
Time frame: up to 6 months after installation
Provider takes both systolic and diastolic blood pressure measurements of mother during initial exam (binary)
Time frame: up to 6 months after installation
Provider wears sterile gloves for initial vaginal exam (binary)
Time frame: up to 6 months after installation
At least once, explains what will happen in labour to woman and/or her support person. (binary)
Time frame: up to 6 months after installation
Provider starts partograph to monitor progress of labour. (binary)
Time frame: up to 6 months after installation
Provider washes his/her hands with soap and water or uses alcohol hand rub prior to every examination of woman. (binary)
Time frame: up to 6 months after installation
Uterotonic is prepared for Active Management of the Third Stage of Labor (AMTSL). (binary)
Time frame: up to 6 months after installation
Prepares self-inflating ventilation bag and newborn face mask. (binary)
Time frame: up to 6 months after installation
After delivery, provider administers 10 IU of IM oxytocin, OR:
Time frame: up to 6 months after installation
Provider assesses completeness of the placenta and membranes. (binary)
Time frame: up to 6 months after installation
Assesses completeness of the placenta and membranes. (binary)
Time frame: up to 6 months after installation
Provider places baby on mother's abdomen or chest skin-to-skin. (binary)
Time frame: up to 6 months after installation
Provider immediately dries baby with towel. (binary)
Time frame: up to 6 months after installation
Provider ties or clamps cord. (binary)
Time frame: up to 6 months after installation
Provider takes mother's vital signs after delivery. (binary)
Time frame: up to 6 months after installation
Provider palpates uterus after delivery of placenta. (binary)
Time frame: up to 6 months after installation
Breastfeeding is initiated within one hour of delivery. (binary)
Time frame: up to 6 months after installation
Provider asks about complications during previous pregnancies. (binary)
Time frame: up to 6 months after installation
Provider washes his/her hands with soap and water or uses alcohol hand rub before initial examination. (binary)
Time frame: up to 6 months after installation
Provider takes mother's temperature during initial exam. (binary)
Time frame: up to 6 months after installation
Provider checks fundal height during initial exam. (binary)
Time frame: up to 6 months after installation
Provider checks fetal presentation by palpation of abdomen. (binary)
Time frame: up to 6 months after installation
Provider checks fetal heart rate with fetoscope/Doppler/ultrasound. (binary)
Time frame: up to 6 months after installation
Provider performs vaginal examination at initial exam. (binary)
Time frame: up to 6 months after installation
Provider wears sterile gloves for all vaginal examinations. (binary)
Time frame: up to 6 months after installation
Prepares disposable cord ties/clamps AND sterile scissors/blade. (binary)
Time frame: up to 6 months after installation
Provider supports perineum after baby's head is delivered. (binary)
Time frame: up to 6 months after installation
Applies traction to the cord while applying suprapubic counter traction. (binary)
Time frame: up to 6 months after installation
Provider performs uterine massage immediately following the delivery of the placenta. (binary)
Time frame: up to 6 months after installation
Provider checks newborn's temperature. (binary)
Time frame: up to 6 months after installation
Provider assists mother with breastfeeding. (binary)
Time frame: up to 6 months after installation
Provider sterilizes or uses high-level disinfection for all reusable instruments. (binary)
Time frame: up to 6 months after installation
Provider disposes of all contaminated waste in leak-proof containers. (binary)
Time frame: up to 6 months after installation
Provider washes his/her hands with soap and water or uses alcohol hand rub after cleaning up. (binary)
Time frame: up to 6 months after installation
Time between facility arrival and first contact with health worker (mins)
Time frame: up to 6 months after installation
Time between facility arrival and first assessment (mins)
Time frame: up to 6 months after installation
Time between delivery and uterotonic (mins)
Time frame: up to 6 months after installation
Time between delivery and assessment of perineal and vaginal lacerations (mins)
Time frame: up to 6 months after installation
Time between delivery and drying baby with towel (mins)
Time frame: up to 6 months after installation
Time between delivery and initiation of breastfeeding (mins)
Harvard School of Public Health (HSPH)
Other
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
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