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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 June 16, 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

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
June 16, 2018, 1:09 PM EDT

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

Locations

Region

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. June 16. https://doi.org/10.1257/rct.3078-1.0
Former 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. June 16. https://www.socialscienceregistry.org/trials/3078/history/30810
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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. 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.
Intervention (Hidden)
Intervention Start Date
2018-06-13
Intervention End Date
2019-08-31

Primary Outcomes

Primary Outcomes (end points)
I. Electricity Outcomes:
1) Brightness (i. binary variable for "perfectly bright" or "somewhat bright" throughout delivery and ii. average level of brightness on brightness scale during delivery)
2) Type of light source. Define: Satisfactory light source: 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. i) Satisfactory light source used for entire delivery. ii) Satisfactory light source – duration. Minutes of delivery
observation without satisfactory light. iii) Consistent satisfactory light source. Variable equal 1 if no interruptions of > 2 hours in satisfactory light source during observed deliveries.
3) Adequate Light. binary variable equal to 1 if light is from a satisfactory source and is “bright” (“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).
2. Comprehensive quality of care index: Tripathi plus 17 items based on USAID/MCHIP (2013).

III. Delays in Care Outcomes:
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)

IV. Health Worker Satisfaction and Morale
Satisfaction with light and electricity:
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:
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
1. Each quality of care item contributing to the quality indices
2. Each delays item contributing to the index
3. Number of times fetal Doppler is used per delivery
4. Phone is available and on for deliveries
5. Health worker assigns any APGAR score
6. Facility performance of basic emergency obstetric and newborn care signal functions (BEmOC and BEmNC) in the past three months
7. Facility performance of routine obstetric and newborn care signal functions in the past three months
8. Appropriate suturing index (for those who get sutures)
9. Patient treatment/inter-personal quality care index
10. Partograph completeness
11. Delays in facility arrival: Dilation at first exam (cm); Time between contractions (mins)
12. Postpartum hemorrhage quality of care index
13. Newborn resuscitation quality of care index
14. Monthly Delivery Volumes Overall
15. Monthly Delivery Volumes at Night
16. Monthly ANC Volume
17. Monthly referrals out of facility for mothers and newborns
18. Recorded brightness at sensor sight in the two hours around delivery of baby.
19. Facility usage of solar suitcase
• Enumerator recorded usage of suitcase during delivery
• Load voltage difference between evening and morning
• Time from morning to full charge
20. Health worker assessment of overhead and task light availability and brightness
21. Health worker assessment of impact of blackouts in facility on ability to conduct their job
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
Randomization Method
Facilities are stratified by facility level and electricity source and then randomized in an office computer into one of two groups. The randomization assignment that maximizes balance based on monthly delivery volumes will be used (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

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials