Quality of CareNCT03589625
Electricity Access and Maternal Care in Rural Health Facilities in Uganda
A study testing Solar Suitcase in people with Quality of Care, run by Harvard School of Public Health (HSPH) at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Care
- What is being tested?
- Solar Suitcase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,268 participants
- Where
- 1 siteUganda
- Study dates
- 13 Jun 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women who are admitted for labor and delivery at participating facilities.
- Women aged 16 years or older.
- 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).
Who cannot join
- 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
Show all 9Show fewer
- Health worker objects to the observation.
- For eligibility of health facility:
- facility already has a Solar Suitcase
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Quality of Care
- Being tested
- Solar Suitcase
- Keywords
- electricity and health, maternal health, quality of care, solar power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solar SuitcaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Solar Suitcase Installation First Group | Experimental | Facilities will receive the installation of the Solar Suitcase shortly after baseline data collection. Receives: Other: Solar Suitcase |
| Solar Suitcase Installation Second Group | Experimental | 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. Receives: Other: Solar Suitcase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average brightness of room during labor and delivery as measured by observer recorded questionnaire
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
Measured: up to 6 months after installation
Satisfactory light source used for entire delivery as measured by observer recorded questionnaire
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.
Measured: up to 6 months after installation
Adequate Light as measured by observer recorded questionnaire
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.
Measured: up to 6 months after installation
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
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.
Measured: up to 6 months after installation
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
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.
Measured: up to 6 months after installation
6-item delays in care index as measured by observer recorded questionnaire
Index including:
- 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.
Measured: up to 6 months after installation
Health Worker Satisfaction with Electricity as measured by health worker survey
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 am satisfied with the availability and brightness of light in this facility. ii) I am satisfied with the availability of electricity in this facility
Measured: up to 6 months after installation
Overall job satisfaction index as measured by health worker survey
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:
- 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.
Measured: up to 6 months after installation
Secondary outcomes (72)
Mean level of brightness over 4 periods of labor and delivery on brightness scale as measured by observer recorded questionnaire
Scale is scored as 1: Very Bright; 2: Somewhat Bright; 3: Dim; 4: Pitch Black
Measured: up to 6 months after installation
Minutes of delivery observation without satisfactory light as measured by observer recorded questionnaire
Satisfactory light source defined in Primary Outcome 2.
Measured: up to 6 months after installation
Consistent satisfactory light source as measured by observer recorded questionnaire
Variable equal to 1 if no interruptions of > 2 hours in satisfactory light source during observed deliveries.
Measured: up to 6 months after installation
Fetal Doppler Use as measured by observer recorded questionnaire
Number of times the provider used a fetal doppler during labor and delivery
Measured: up to 6 months after installation
Phone availability as measured by observer recorded questionnaire
Phone is available and on for deliveries
Measured: up to 6 months after installation
APGAR Score Assigned as measured by observer recorded questionnaire
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.
Measured: up to 6 months after installation
Basic emergency obstetric care signal functions as measured by facility assessment
Facility reported performance of basic emergency obstetric care signal functions in the past three months. Measure includes the number of signal functions performed from:
- Removal of retained products of conception
- Parenteral oxytocin for maternal hemorrhage
- Parenteral magnesium sulfate for (pre-) eclampsia
- Manual removal of placenta
- Parenteral antibiotics for maternal infection
- Assisted vaginal delivery
Measured: up to 6 months after installation
Basic emergency newborn care signal functions as measured by facility assessment
Facility reported performance of basic emergency newborn care signal functions in the past three months. Measure includes the number of signal functions performed from:
- Antibiotics for preterm or prolonged PROM
- Corticosteroids in preterm labor
- Resuscitation with bag and mask for non-breathing baby
- Kangaroo Mother Care for premature/very small babies
- Alternative feeding if baby unable to breastfeed
- Injectable antibiotics for neonatal sepsis
- PMTCT if HIV-positive mother
Measured: up to 6 months after installation
Routine obstetric care signal functions as measured by facility assessment
Facility reported universal practice of routine obstetric care signal functions. Measure includes the number of signal functions performed from:
- Infection control (provider hand-washing before patient exam in labor, new sterile gloves before every vaginal examination)
- Use of partograph to monitor labor
- Routine practice of active management of the third stage of labor
Measured: up to 6 months after installation
Routine newborn care signal functions as measured by facility assessment
Facility reported universal practice of routine newborn care signal functions. Measure includes the number of signal functions performed from:
- Thermal protection (newborn dried immediately, skin-to-skin, no bath/delayed>6 hours)
- Exclusive breastfeeding initiated within 1 hour of birth
- Hygienic cord care (cord cut with sterile blade/scissors; chlorhexidine or nothing applied to stump)
Measured: up to 6 months after installation
Time between delivery and when suturing began (minutes) as measured by observer recorded questionnaire
Observed time between delivery and when provider began suturing lacerations, if needed.
Measured: up to 6 months after installation
4-item quality of suturing index as measured by observer recorded questionnaire
Index constructed from the following variables:
- Health worker explains to woman what is happening (binary)
- Health worker cleans area prior to suturing with antiseptic solution (binary)
- Health worker prepares instruments/sutures on a sterile surface (binary)
- Health worker sutures episiotomy or tears appropriately in layers. (binary) Score is fraction of 4 items, yielding a range of 0-1, with higher score indicating better quality of suturing.
Measured: up to 6 months after installation
10-item patient treatment index as measured by observer recorded questionnaire
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.
Measured: up to 6 months after installation
14-item Partograph Completeness index as measured by observer recorded questionnaire
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.
Measured: up to 6 months after installation
Time between contractions as measured by observer recorded questionnaire
Time between contractions at first exam (mins)
Measured: up to 6 months after installation
Dilation at first exam as measured by observer recorded questionnaire
Degree of dilation at woman's first exam (cm)
Measured: up to 6 months after installation
Monthly Delivery Volumes as measured by facility register
Average Number of Monthly Deliveries
Measured: up to 6 months after installation
Monthly Nighttime Delivery Volumes as measured by facility register
Average Number of Nighttime Deliveries per Month
Measured: up to 6 months after installation
Monthly ANC Volumes as measured by facility register
Average Number of Antenatal Clients per Month
Measured: up to 6 months after installation
Monthly Referral Volumes as measured by facility register
Average Number of Monthly Referrals Out of Facility for Mothers and Newborns
Measured: up to 6 months after installation
Sensor Brightness as measured by sensor
Recorded brightness at sensor sight in the two hours around delivery of baby.
Measured: up to 6 months after installation
Depletion of Solar Suitcase Battery Based on Voltage as measured by sensor
Average difference between solar suitcase load voltage in evening and morning (based on sensor)
Measured: up to 6 months after installation
Depletion of Solar Suitcase Battery Based on Charge Time as measured by sensor
Average time between morning and when the solar suitcase is fully charged, based on sensor
Measured: up to 6 months after installation
Solar Suitcase Use for Deliveries as measured by enumerator recorded questionnaire
Fraction of deliveries in which enumerator recorded usage of suitcase
Measured: up to 6 months after installation
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?"
Measured: up to 6 months after installation
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?"
Measured: up to 6 months after installation
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?"
Measured: up to 6 months after installation
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?"
Measured: 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
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.
Measured: up to 6 months after installation
Initial exam Bleeding Assessment as measured by observer recorded questionnaire
Provider asks whether woman has experienced vaginal bleeding during current pregnancy (binary)
Measured: up to 6 months after installation
Initial exam Headaches/Blurred Vision Assessment as measured by observer recorded questionnaire
Provider asks whether woman has experienced headaches and/or blurred vision during current pregnancy (binary)
Measured: up to 6 months after installation
HIV testing as measured by observer recorded questionnaire
Provider offers woman an HIV test or checks her HIV status (binary)
Measured: up to 6 months after installation
Takes Pulse as measured by observer recorded questionnaire
Provider takes pulse of mother during initial exam (binary)
Measured: up to 6 months after installation
Takes Blood Pressure as measured by observer recorded questionnaire
Provider takes both systolic and diastolic blood pressure measurements of mother during initial exam (binary)
Measured: up to 6 months after installation
Wears Sterile Gloves as measured by observer recorded questionnaire
Provider wears sterile gloves for initial vaginal exam (binary)
Measured: up to 6 months after installation
Communication with Patient as measured by observer recorded questionnaire
At least once, explains what will happen in labour to woman and/or her support person. (binary)
Measured: up to 6 months after installation
Partograph Use as measured by observer recorded questionnaire
Provider starts partograph to monitor progress of labour. (binary)
Measured: up to 6 months after installation
Hand Washing as measured by observer recorded questionnaire
Provider washes his/her hands with soap and water or uses alcohol hand rub prior to every examination of woman. (binary)
Measured: up to 6 months after installation
Preparation of Uterotonic as measured by observer recorded questionnaire
Uterotonic is prepared for Active Management of the Third Stage of Labor (AMTSL). (binary)
Measured: up to 6 months after installation
Preparation of Bag and Mask as measured by observer recorded questionnaire
Prepares self-inflating ventilation bag and newborn face mask. (binary)
Measured: up to 6 months after installation
Administration of Oxytocin as measured by observer recorded questionnaire
After delivery, provider administers 10 IU of IM oxytocin, OR:
- 5 IU slow push if IV in place
- 600μg of misoprostol sublingually
- 600μg misoprostol rectally (binary)
Measured: up to 6 months after installation
Assessment of Completeness of Placenta as measured by observer recorded questionnaire
Provider assesses completeness of the placenta and membranes. (binary)
Measured: up to 6 months after installation
Assessment of Lacerations as measured by observer recorded questionnaire
Assesses completeness of the placenta and membranes. (binary)
Measured: up to 6 months after installation
Skin-to-Skin as measured by observer recorded questionnaire
Provider places baby on mother's abdomen or chest skin-to-skin. (binary)
Measured: up to 6 months after installation
Drying Newborn as measured by observer recorded questionnaire
Provider immediately dries baby with towel. (binary)
Measured: up to 6 months after installation
Cord Clamping as measured by observer recorded questionnaire
Provider ties or clamps cord. (binary)
Measured: up to 6 months after installation
Vital Signs Postpartum as measured by observer recorded questionnaire
Provider takes mother's vital signs after delivery. (binary)
Measured: up to 6 months after installation
Palpation of Uterus as measured by observer recorded questionnaire
Provider palpates uterus after delivery of placenta. (binary)
Measured: up to 6 months after installation
Breastfeeding within 1 Hour as measured by observer recorded questionnaire
Breastfeeding is initiated within one hour of delivery. (binary)
Measured: up to 6 months after installation
Initial Exam: Previous Pregnancy Inquiry as measured by observer recorded questionnaire
Provider asks about complications during previous pregnancies. (binary)
Measured: up to 6 months after installation
Initial Exam: Hand Washing as measured by observer recorded questionnaire
Provider washes his/her hands with soap and water or uses alcohol hand rub before initial examination. (binary)
Measured: up to 6 months after installation
Initial Exam Temperature Assessment as measured by observer recorded questionnaire
Provider takes mother's temperature during initial exam. (binary)
Measured: up to 6 months after installation
Initial Exam Fundal Height Assessment as measured by observer recorded questionnaire
Provider checks fundal height during initial exam. (binary)
Measured: up to 6 months after installation
Initial Exam Fetal Presentation Assessment as measured by observer recorded questionnaire
Provider checks fetal presentation by palpation of abdomen. (binary)
Measured: up to 6 months after installation
Initial Exam Fetal Heart Rate Assessment as measured by observer recorded questionnaire
Provider checks fetal heart rate with fetoscope/Doppler/ultrasound. (binary)
Measured: up to 6 months after installation
Initial Exam: Vaginal Examination as measured by observer recorded questionnaire
Provider performs vaginal examination at initial exam. (binary)
Measured: up to 6 months after installation
Sterile Gloves for All Exams as measured by observer recorded questionnaire
Provider wears sterile gloves for all vaginal examinations. (binary)
Measured: up to 6 months after installation
Preparation for Delivery: Cord ties/clamps and sterile scissors/blade as measured by observer recorded questionnaire
Prepares disposable cord ties/clamps AND sterile scissors/blade. (binary)
Measured: up to 6 months after installation
Support of Perineum as measured by observer recorded questionnaire
Provider supports perineum after baby's head is delivered. (binary)
Measured: up to 6 months after installation
Cord Traction as measured by observer recorded questionnaire
Applies traction to the cord while applying suprapubic counter traction. (binary)
Measured: up to 6 months after installation
Uterine Massage as measured by observer recorded questionnaire
Provider performs uterine massage immediately following the delivery of the placenta. (binary)
Measured: up to 6 months after installation
Newborn Temperature as measured by observer recorded questionnaire
Provider checks newborn's temperature. (binary)
Measured: up to 6 months after installation
Assistance with Breastfeeding as measured by observer recorded questionnaire
Provider assists mother with breastfeeding. (binary)
Measured: up to 6 months after installation
Sterilization of Equipment as measured by observer recorded questionnaire
Provider sterilizes or uses high-level disinfection for all reusable instruments. (binary)
Measured: up to 6 months after installation
Waste Disposal as measured by observer recorded questionnaire
Provider disposes of all contaminated waste in leak-proof containers. (binary)
Measured: up to 6 months after installation
Hand Hygiene after Clean Up as measured by observer recorded questionnaire
Provider washes his/her hands with soap and water or uses alcohol hand rub after cleaning up. (binary)
Measured: up to 6 months after installation
Delay in Facility Arrival as measured by observer recorded questionnaire
Time between facility arrival and first contact with health worker (mins)
Measured: up to 6 months after installation
Delay in First Exam as measured by observer recorded questionnaire
Time between facility arrival and first assessment (mins)
Measured: up to 6 months after installation
Delay in Uterotonic as measured by observer recorded questionnaire
Time between delivery and uterotonic (mins)
Measured: up to 6 months after installation
Delay in Assessment for Lacerations as measured by observer recorded questionnaire
Time between delivery and assessment of perineal and vaginal lacerations (mins)
Measured: up to 6 months after installation
Delay in Drying Newborn as measured by observer recorded questionnaire
Time between delivery and drying baby with towel (mins)
Measured: up to 6 months after installation
Delay in Breastfeeding Initiation as measured by observer recorded questionnaire
Time between delivery and initiation of breastfeeding (mins)
Measured: up to 6 months after installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start13 Jun 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Quality of CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge cluster-randomized trial
- Masking
- None (open label)
- Enrolment
- 1,268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin, Innovations for Poverty Action
- Responsible party
- Principal investigator, Jessica Cohen, Harvard School of Public Health (HSPH)
- Investigators
- Jessica Cohen, PhD, Principal investigator, Harvard School of Public Health (HSPH)Slawa Rokicki, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589625
- Sponsor's protocol ID
- IRB-18-0406
- Status last verified
- Jul 2020
- First submitted
- 7 Jun 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After manuscript publication, fully de-identified data may be shared with researchers upon request.
Publications
Tripathi V, Stanton C, Strobino D, Bartlett L. Development and Validation of an Index to Measure the Quality of Facility-Based Labor and Delivery Care Processes in Sub-Saharan Africa. PLoS One. 2015 Jun 24;10(6):e0129491. doi: 10.1371/journal.pone.0129491. eCollection 2015.
PubMed 26107655USAID. Maternal and Child Health Integrated Program (MCHIP), Washington DC: USAID/Jhpiego; 2013.
Chang W, Cohen J, Mwesigwa B, Waiswa P, Rokicki S. Impact of reliable light and electricity on job satisfaction among maternity health workers in Uganda: A cluster randomized trial. Hum Resour Health. 2022 Mar 29;20(1):30. doi: 10.1186/s12960-022-00722-3.
PubMed 35351147Rokicki S, Mwesigwa B, Schmucker L, Cohen JL. Shedding light on quality of care: a study protocol for a randomized trial evaluating the impact of the Solar Suitcase in rural health facilities on maternal and newborn care quality in Uganda. BMC Pregnancy Childbirth. 2019 Aug 22;19(1):306. doi: 10.1186/s12884-019-2453-x.
PubMed 31438896
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03589625
- Acronym / sponsor ID
- IRB-18-0406
- Conditions
- Quality of Care
- Keywords
- electricity and health, maternal health, quality of care, solar power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,268 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- University College Dublin, Innovations for Poverty Action
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Solar Suitcase Installation First Group | Experimental | Other: Solar SuitcaseFacilities will receive the installation of the Solar Suitcase shortly after baseline data collection. |
| Solar Suitcase Installation Second Group | Experimental | Other: Solar SuitcaseFacilities will act as a comparator for experimental group 1 and then will receive the installation of the Solar Suitcase shortly after midline data collection. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women who are admitted for labor and delivery at participating facilities.
- Women aged 16 years or older.
- government health facilities level 2, 3, or 4
- are open 24 hours a day
- conduct deliveries at night
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solar SuitcaseThe 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. | Other | Solar Suitcase Installation First Group, Solar Suitcase Installation Second Group |
Primary outcome
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
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.
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.
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
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.
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
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.
6-item delays in care index as measured by observer recorded questionnaire
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.
Health Worker Satisfaction with Electricity as measured by health worker survey
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
Overall job satisfaction index as measured by health worker survey
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.
72 secondary outcomes
Mean level of brightness over 4 periods of labor and delivery on brightness scale as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Minutes of delivery observation without satisfactory light as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Consistent satisfactory light source as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Fetal Doppler Use as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Phone availability as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
APGAR Score Assigned as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Basic emergency obstetric care signal functions as measured by facility assessment
Time frame: up to 6 months after installation
Basic emergency newborn care signal functions as measured by facility assessment
Time frame: up to 6 months after installation
Routine obstetric care signal functions as measured by facility assessment
Time frame: up to 6 months after installation
Routine newborn care signal functions as measured by facility assessment
Time frame: up to 6 months after installation
Time between delivery and when suturing began (minutes) as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
4-item quality of suturing index as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
10-item patient treatment index as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
14-item Partograph Completeness index as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Time between contractions as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Dilation at first exam as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Monthly Delivery Volumes as measured by facility register
Time frame: up to 6 months after installation
Monthly Nighttime Delivery Volumes as measured by facility register
Time frame: up to 6 months after installation
Monthly ANC Volumes as measured by facility register
Time frame: up to 6 months after installation
Monthly Referral Volumes as measured by facility register
Time frame: up to 6 months after installation
Sensor Brightness as measured by sensor
Time frame: up to 6 months after installation
Depletion of Solar Suitcase Battery Based on Voltage as measured by sensor
Time frame: up to 6 months after installation
Depletion of Solar Suitcase Battery Based on Charge Time as measured by sensor
Time frame: up to 6 months after installation
Solar Suitcase Use for Deliveries as measured by enumerator recorded questionnaire
Time frame: up to 6 months after installation
Health Worker Assessment of Overhead Light Availability as measured by health worker survey
Time frame: up to 6 months after installation
Health Worker Assessment of Task Light Availability as measured by health worker survey
Time frame: up to 6 months after installation
Health Worker Assessment of Overhead Light Brightness as measured by health worker survey
Time frame: up to 6 months after installation
Health Worker Assessment of Task Light Brightness as measured by health worker survey
Time frame: 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
Time frame: up to 6 months after installation
Initial exam Bleeding Assessment as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Initial exam Headaches/Blurred Vision Assessment as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
HIV testing as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Takes Pulse as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Takes Blood Pressure as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Wears Sterile Gloves as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Communication with Patient as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Partograph Use as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Hand Washing as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Preparation of Uterotonic as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Preparation of Bag and Mask as measured by observer recorded questionnaire
Time frame: up to 6 months after installation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Background: PubMed 26107655Tripathi V, Stanton C, Strobino D, Bartlett L. Development and Validation of an Index to Measure the Quality of Facility-Based Labor and Delivery Care Processes in Sub-Saharan Africa. PLoS One. 2015 Jun 24;10(6):e0129491. doi: 10.1371/journal.pone.0129491. eCollection 2015.
- BackgroundUSAID. Maternal and Child Health Integrated Program (MCHIP), Washington DC: USAID/Jhpiego; 2013.
- Derived from this study: PubMed 35351147Chang W, Cohen J, Mwesigwa B, Waiswa P, Rokicki S. Impact of reliable light and electricity on job satisfaction among maternity health workers in Uganda: A cluster randomized trial. Hum Resour Health. 2022 Mar 29;20(1):30. doi: 10.1186/s12960-022-00722-3.
- Derived from this study: PubMed 31438896Rokicki S, Mwesigwa B, Schmucker L, Cohen JL. Shedding light on quality of care: a study protocol for a randomized trial evaluating the impact of the Solar Suitcase in rural health facilities on maternal and newborn care quality in Uganda. BMC Pregnancy Childbirth. 2019 Aug 22;19(1):306. doi: 10.1186/s12884-019-2453-x.
- Individual participant dataSharing planned: Undecided. After manuscript publication, fully de-identified data may be shared with researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Cohen, PhD principal investigator
Harvard School of Public Health (HSPH)
Slawa Rokicki, PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solar Suitcase in people with Quality of Care, run by Harvard School of Public Health (HSPH) at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average brightness of room during labor and delivery as measured by observer recorded questionnaire (time frame: up to 6 months after installation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589625, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.