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
Last registered on September 04, 2018

Pre-Trial

Trial Information
General Information
Title
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
RCT ID
AEARCTR-0003078
Initial registration date
June 12, 2018
Last updated
September 04, 2018 9:57 AM EDT
Location(s)

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Primary Investigator
Affiliation
Harvard School of Public Health
Other Primary Investigator(s)
PI Affiliation
University College Dublin
Additional Trial Information
Status
In development
Start date
2018-06-13
End date
2019-08-31
Secondary IDs
IRB-18-0406
Abstract
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 that lack access to reliable light and electricity. Data collection will include direct observation of deliveries during daytime and nighttime hours, as well as interviews with facility staff.
External Link(s)
Registration Citation
Citation
Cohen, Jessica and Slawa Rokicki. 2018. "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." AEA RCT Registry. September 04. https://www.socialscienceregistry.org/trials/3078/history/33868
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
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 that lack reliable light and electricity.
The intervention is a "Solar Suitcase", provided by the non-governmental organization We Care Solar (more detail below). 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, information from facility registers and records, as well as interviews with facility staff.
The intervention will be implemented in 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.

Solar Suitcase
The intervention is a "Solar Suitcase", provided by the non-governmental organization We Care Solar. Each Solar Suitcase comes with: 2 bright, rugged LED lights, 1 Lithium Ferrous Phosphate 12 volt battery, 1 homerun cable for connection to solar panels, 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, expansion box (provides 2 additional lights), and hardware installation kit. The installation takes 3-6 hours. Installers will teach health workers at the facility how to use and maintain the Solar Suitcase and all accessories on the day of installation. The
training usually takes about an hour. Following installation, the contractor will contact the facility over the phone and 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.
Intervention Start Date
2018-06-13
Intervention End Date
2019-08-31
Primary Outcomes
Primary Outcomes (end points)
I. Electricity Outcomes:
1) Average brightness of room during labor and delivery as measured by observer recorded questionnaire [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

2) Satisfactory light source used for entire delivery as measured by observer recorded questionnaire [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.

3) Adequate Light as measured by observer recorded questionnaire [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.

II. Quality of Care Outcomes:
1. 20 item quality of care index based on Tripathi et al. (2015). [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.

2. Comprehensive quality of care index: Tripathi plus 17 items based on USAID/MCHIP (2013). [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.

III. Delays in Care Outcomes Index [Time Frame: up to 6 months after installation]
The delays index includes:
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.

IV. Health Worker Satisfaction and Morale [Time Frame: up to 6 months after installation]
1.Satisfaction with light and electricity
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

2. Overall job satisfaction index [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. [agreement], ii) Sometimes when I get up in the morning, I dread having to face another day at work. [disagreement], iii) Overall, I am satisfied with my job [agreement], iv) Overall, the morale level at my dept is good [agreement], v) I plan on staying at this position for the next year.[agreement]

Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes [All Time Frames: up to 6 months after installation]
1. Mean level of brightness over 4 periods of labor and delivery on brightness scale as measured by observer recorded questionnaire (range 1-4)

2. Minutes of delivery observation without satisfactory light as measured by observer recorded questionnaire (min)

3. Consistent satisfactory light source as measured by observer recorded questionnaire (binary)
Variable equal to 1 if no interruptions of > 2 hours in satisfactory light source during observed deliveries.

4. Number of times the provider used a fetal doppler during labor and delivery

5. Phone is available and on for deliveries (binary)

6. 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.

7. Facility reported performance of basic emergency obstetric care signal functions in the past three months. Measure includes the number of signal functions performed out of 6.

8.Facility reported performance of basic emergency newborn care signal functions in the past three months. Measure includes the number of signal functions performed out of 7.

9. Facility reported universal practice of routine obstetric care signal functions. Measure includes the number of signal functions performed out of 3.

10.Facility reported universal practice of routine newborn care signal functions. Measure includes the number of signal functions performed out of 3.

11. Observed time between delivery and when provider began suturing lacerations, if needed. (min)

12. 4-item quality of suturing index as measured by observer recorded questionnaire. Score is fraction of 4 items, yielding a range of 0-1, with higher score indicating better quality of suturing.

13. 10-item patient treatment index based on Kruk et al. (2014) as measured by observer recorded questionnaire. Fraction of items that were NOT performed, yielding a range of 0-1, with higher scores indicating better treatment of patients.

14. 14-item Partograph Completeness index (from MCHIP (2013)) as measured by observer recorded questionnaire
Fraction of 14 items completed on partograph (all binary variables), yielding a range of 0-1, with higher values indicating more completeness.

15.Time between contractions at first exam (mins)

16. Degree of dilation at woman's first exam (cm)

17.Average Number of Monthly Deliveries

18. Average Number of Nighttime Deliveries per Month

19.Average Number of Antenatal Clients per Month

20. Average Number of Monthly Referrals Out of Facility for Mothers and Newborns

21. Recorded brightness at sensor sight in the two hours around delivery of baby.

22.Average difference between solar suitcase load voltage in evening and morning (based on sensor)

23.Average time between morning and when the solar suitcase is fully charged, based on sensor (min)

24. Fraction of deliveries in which enumerator recorded usage of suitcase

25. Health Worker Assessment of Overhead Light Availability as measured by health worker survey
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?"

26. Health Worker Assessment of Task Light Availability as measured by health worker survey
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?"

27. Health Worker Assessment of Overhead Light Brightness as measured by health worker survey
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?"

28. Health Worker Assessment of Task Light Brightness as measured by health worker survey
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?"

29. 14-item index of Health worker assessment of impact of blackouts on their ability to perform job functions as measured by health worker survey. 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.

30.Provider asks whether woman has experienced vaginal bleeding during current pregnancy (binary)

31. Provider asks whether woman has experienced headaches and/or blurred vision during current pregnancy (binary)

32. Provider offers woman an HIV test or checks her HIV status (binary)

33. Provider takes pulse of mother during initial exam (binary)

34. Provider takes both systolic and diastolic blood pressure measurements of mother during initial exam (binary)

35. Provider wears sterile gloves for initial vaginal exam (binary)

36. At least once, explains what will happen in labour to woman and/or her support person. (binary)

37. Provider starts partograph to monitor progress of labour. (binary)

38. Provider washes his/her hands with soap and water or uses alcohol hand rub prior to every examination of woman. (binary)

39. Uterotonic is prepared for Active Management of the Third Stage of Labor (AMTSL). (binary)

40. Prepares self-inflating ventilation bag and newborn face mask. (binary)

41. After delivery, provider administers 10 IU of IM oxytocin, OR:
5 IU slow push if IV in place, 600μg of misoprostol sublingually, or 600μg misoprostol rectally (binary)

42. Provider assesses completeness of the placenta and membranes. (binary)

43. Provider assesses lacerations (binary)

44. Provider places baby on mother's abdomen or chest skin-to-skin. (binary)

45.Provider immediately dries baby with towel. (binary)

46. Provider ties or clamps cord. (binary)

47. Provider takes mother's vital signs after delivery. (binary)

48. Provider palpates uterus after delivery of placenta. (binary)

49. Breastfeeding is initiated within one hour of delivery. (binary)

50.Provider asks about complications during previous pregnancies. (binary)

51. Provider washes his/her hands with soap and water or uses alcohol hand rub before initial examination. (binary)

52. Provider takes mother's temperature during initial exam. (binary)

53. Provider checks fundal height during initial exam. (binary)

54. Provider checks fetal presentation by palpation of abdomen. (binary)

55. Provider checks fetal heart rate with fetoscope/Doppler/ultrasound. (binary)

56.Provider performs vaginal examination at initial exam. (binary)

57.Provider wears sterile gloves for all vaginal examinations. (binary)

58.Prepares disposable cord ties/clamps AND sterile scissors/blade. (binary)

59.Provider supports perineum after baby's head is delivered. (binary)

60.Applies traction to the cord while applying suprapubic counter traction. (binary)

61.Provider performs uterine massage immediately following the delivery of the placenta. (binary)

62.Provider checks newborn's temperature. (binary)

63.Provider assists mother with breastfeeding. (binary)

64.Provider sterilizes or uses high-level disinfection for all reusable instruments. (binary)

65.Provider disposes of all contaminated waste in leak-proof containers. (binary)

66.Provider washes his/her hands with soap and water or uses alcohol hand rub after cleaning up. (binary)

67.Time between facility arrival and first contact with health worker (mins)

68.Time between facility arrival and first assessment (mins)

69.Time between delivery and uterotonic (mins)

70.Time between delivery and assessment of perineal and vaginal lacerations (mins)

71.Time between delivery and drying baby with towel (mins)

72.Time between delivery and initiation of breastfeeding (mins)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Eligibility criteria for study facilities include that the facility is open 24 hours, conducts deliveries 24 hours, is level 2-4, has either no source of modern electricity or experiences blackouts at least several times a week and conducts at least 10 deliveries per month.
30 eligible maternity facilities will be randomized with equal probability into one of two groups. Group 1 will receive the solar suitcase after baseline and Group 2 will receive the solar suitcase after midline (roughly 3 months later). At baseline, endline and midline, a team of researchers will observe deliveries for 4 weeks and record data on the quality of care provided (including the timeliness and adequacy of care based on validated quality of care checklists) and on the source and brightness of light. Data will also be collected through facility assessments and health care worker interviews.
Experimental Design Details
Not available
Randomization Method
Randomization will occur over three staggered waves of approximately 10 facilities. Each wave of 10 facilities will be stratified by a binary measure of average adequate light during baseline (above/below the median of the 10 facilities), and balanced on continuous baseline measures of facility volume and average quality score. Facilities will be randomized into one of two groups. The randomization will be conducted on an office computer (generated from the stata "randomize" command).
Randomization Unit
Maternity facility
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
30 maternity facilities
Sample size: planned number of observations
2000 deliveries
Sample size (or number of clusters) by treatment arms
15 facilities in group 1 (first to receive intervention), 15 facilities in group 2 (second to receive intervention)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Mildmay Uganda Research Ethics Committee
IRB Approval Date
2018-05-15
IRB Approval Number
#REC REF 0211-2017
IRB Name
Harvard T. H. Chan School of Public Health
IRB Approval Date
2018-05-14
IRB Approval Number
IRB18-0406