Electricity Access and Maternal Care in Rural Health Facilities in Uganda

Quality of Care Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589625
• Other study ID #: IRB-18-0406
• Status: Completed
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2020
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1268
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

For women delivering at facility:

Inclusion Criteria:

• Pregnant women who are admitted for labor and delivery at participating facilities.

• Women aged 16 years or older.

Exclusion Criteria:

• Pregnant women who present to participating facilities for abortion or abortion-related complications, miscarriage, ectopic pregnancy, antenatal or postnatal complications of pregnancy (not an observation of labor)

• Women who are immediately transferred to another hospital, or are taken straight to surgical theatre (limited or no period of observation possible)

• Women who deliver at home but are brought to the facility for any complication.

• Women who deliver outside the maternity ward or delivery area

• Women who deliver in ambulance while on the way to the facility (woman admitted in the facility for placenta removal)

• Women who have not given consent

• Health worker objects to the observation.

For eligibility of health facility:

Inclusion criteria:

• government health facilities level 2, 3, or 4

• are open 24 hours a day

• conduct deliveries at night

• have unreliable electricity (have either no source of electricity, or have only 1 functional source of electricity and experience blackouts at least several times a week and had power available only sometimes in the past week).

Exclusion criteria:

• facility already has a Solar Suitcase

Related Conditions & MeSH terms

• Quality of Care

Intervention

Other:
• Solar Suitcase
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.

Locations

Country	Name	City	State
Uganda	Innovations for Poverty Action	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health	Innovations for Poverty Action, University College Dublin

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

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. — View Citation

USAID. Maternal and Child Health Integrated Program (MCHIP), Washington DC: USAID/Jhpiego; 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 6 months after installation
Primary	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.	up to 6 months after installation
Primary	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.	up to 6 months after installation
Primary	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.	up to 6 months after installation
Primary	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.	up to 6 months after installation
Primary	6-item delays in care index as measured by observer recorded questionnaire	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.	up to 6 months after installation
Primary	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) 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	up to 6 months after installation
Primary	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: 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.	up to 6 months after installation
Secondary	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	up to 6 months after installation
Secondary	Minutes of delivery observation without satisfactory light as measured by observer recorded questionnaire	Satisfactory light source defined in Primary Outcome 2.	up to 6 months after installation
Secondary	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.	up to 6 months after installation
Secondary	Fetal Doppler Use as measured by observer recorded questionnaire	Number of times the provider used a fetal doppler during labor and delivery	up to 6 months after installation
Secondary	Phone availability as measured by observer recorded questionnaire	Phone is available and on for deliveries	up to 6 months after installation
Secondary	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.	up to 6 months after installation
Secondary	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	up to 6 months after installation
Secondary	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	up to 6 months after installation
Secondary	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	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	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.	up to 6 months after installation
Secondary	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.	up to 6 months after installation
Secondary	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.	up to 6 months after installation
Secondary	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.	up to 6 months after installation
Secondary	Time between contractions as measured by observer recorded questionnaire	Time between contractions at first exam (mins)	up to 6 months after installation
Secondary	Dilation at first exam as measured by observer recorded questionnaire	Degree of dilation at woman's first exam (cm)	up to 6 months after installation
Secondary	Monthly Delivery Volumes as measured by facility register	Average Number of Monthly Deliveries	up to 6 months after installation
Secondary	Monthly Nighttime Delivery Volumes as measured by facility register	Average Number of Nighttime Deliveries per Month	up to 6 months after installation
Secondary	Monthly ANC Volumes as measured by facility register	Average Number of Antenatal Clients per Month	up to 6 months after installation
Secondary	Monthly Referral Volumes as measured by facility register	Average Number of Monthly Referrals Out of Facility for Mothers and Newborns	up to 6 months after installation
Secondary	Sensor Brightness as measured by sensor	Recorded brightness at sensor sight in the two hours around delivery of baby.	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	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	up to 6 months after installation
Secondary	Solar Suitcase Use for Deliveries as measured by enumerator recorded questionnaire	Fraction of deliveries in which enumerator recorded usage of suitcase	up to 6 months after installation
Secondary	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?"	up to 6 months after installation
Secondary	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?"	up to 6 months after installation
Secondary	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?"	up to 6 months after installation
Secondary	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?"	up to 6 months after installation
Secondary	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.	up to 6 months after installation
Secondary	Initial exam Bleeding Assessment as measured by observer recorded questionnaire	Provider asks whether woman has experienced vaginal bleeding during current pregnancy (binary)	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	HIV testing as measured by observer recorded questionnaire	Provider offers woman an HIV test or checks her HIV status (binary)	up to 6 months after installation
Secondary	Takes Pulse as measured by observer recorded questionnaire	Provider takes pulse of mother during initial exam (binary)	up to 6 months after installation
Secondary	Takes Blood Pressure as measured by observer recorded questionnaire	Provider takes both systolic and diastolic blood pressure measurements of mother during initial exam (binary)	up to 6 months after installation
Secondary	Wears Sterile Gloves as measured by observer recorded questionnaire	Provider wears sterile gloves for initial vaginal exam (binary)	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	Partograph Use as measured by observer recorded questionnaire	Provider starts partograph to monitor progress of labour. (binary)	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	Preparation of Uterotonic as measured by observer recorded questionnaire	Uterotonic is prepared for Active Management of the Third Stage of Labor (AMTSL). (binary)	up to 6 months after installation
Secondary	Preparation of Bag and Mask as measured by observer recorded questionnaire	Prepares self-inflating ventilation bag and newborn face mask. (binary)	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	Assessment of Completeness of Placenta as measured by observer recorded questionnaire	Provider assesses completeness of the placenta and membranes. (binary)	up to 6 months after installation
Secondary	Assessment of Lacerations as measured by observer recorded questionnaire	Assesses completeness of the placenta and membranes. (binary)	up to 6 months after installation
Secondary	Skin-to-Skin as measured by observer recorded questionnaire	Provider places baby on mother's abdomen or chest skin-to-skin. (binary)	up to 6 months after installation
Secondary	Drying Newborn as measured by observer recorded questionnaire	Provider immediately dries baby with towel. (binary)	up to 6 months after installation
Secondary	Cord Clamping as measured by observer recorded questionnaire	Provider ties or clamps cord. (binary)	up to 6 months after installation
Secondary	Vital Signs Postpartum as measured by observer recorded questionnaire	Provider takes mother's vital signs after delivery. (binary)	up to 6 months after installation
Secondary	Palpation of Uterus as measured by observer recorded questionnaire	Provider palpates uterus after delivery of placenta. (binary)	up to 6 months after installation
Secondary	Breastfeeding within 1 Hour as measured by observer recorded questionnaire	Breastfeeding is initiated within one hour of delivery. (binary)	up to 6 months after installation
Secondary	Initial Exam: Previous Pregnancy Inquiry as measured by observer recorded questionnaire	Provider asks about complications during previous pregnancies. (binary)	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	Initial Exam Temperature Assessment as measured by observer recorded questionnaire	Provider takes mother's temperature during initial exam. (binary)	up to 6 months after installation
Secondary	Initial Exam Fundal Height Assessment as measured by observer recorded questionnaire	Provider checks fundal height during initial exam. (binary)	up to 6 months after installation
Secondary	Initial Exam Fetal Presentation Assessment as measured by observer recorded questionnaire	Provider checks fetal presentation by palpation of abdomen. (binary)	up to 6 months after installation
Secondary	Initial Exam Fetal Heart Rate Assessment as measured by observer recorded questionnaire	Provider checks fetal heart rate with fetoscope/Doppler/ultrasound. (binary)	up to 6 months after installation
Secondary	Initial Exam: Vaginal Examination as measured by observer recorded questionnaire	Provider performs vaginal examination at initial exam. (binary)	up to 6 months after installation
Secondary	Sterile Gloves for All Exams as measured by observer recorded questionnaire	Provider wears sterile gloves for all vaginal examinations. (binary)	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	Support of Perineum as measured by observer recorded questionnaire	Provider supports perineum after baby's head is delivered. (binary)	up to 6 months after installation
Secondary	Cord Traction as measured by observer recorded questionnaire	Applies traction to the cord while applying suprapubic counter traction. (binary)	up to 6 months after installation
Secondary	Uterine Massage as measured by observer recorded questionnaire	Provider performs uterine massage immediately following the delivery of the placenta. (binary)	up to 6 months after installation
Secondary	Newborn Temperature as measured by observer recorded questionnaire	Provider checks newborn's temperature. (binary)	up to 6 months after installation
Secondary	Assistance with Breastfeeding as measured by observer recorded questionnaire	Provider assists mother with breastfeeding. (binary)	up to 6 months after installation
Secondary	Sterilization of Equipment as measured by observer recorded questionnaire	Provider sterilizes or uses high-level disinfection for all reusable instruments. (binary)	up to 6 months after installation
Secondary	Waste Disposal as measured by observer recorded questionnaire	Provider disposes of all contaminated waste in leak-proof containers. (binary)	up to 6 months after installation
Secondary	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)	up to 6 months after installation
Secondary	Delay in Facility Arrival as measured by observer recorded questionnaire	Time between facility arrival and first contact with health worker (mins)	up to 6 months after installation
Secondary	Delay in First Exam as measured by observer recorded questionnaire	Time between facility arrival and first assessment (mins)	up to 6 months after installation
Secondary	Delay in Uterotonic as measured by observer recorded questionnaire	Time between delivery and uterotonic (mins)	up to 6 months after installation
Secondary	Delay in Assessment for Lacerations as measured by observer recorded questionnaire	Time between delivery and assessment of perineal and vaginal lacerations (mins)	up to 6 months after installation
Secondary	Delay in Drying Newborn as measured by observer recorded questionnaire	Time between delivery and drying baby with towel (mins)	up to 6 months after installation
Secondary	Delay in Breastfeeding Initiation as measured by observer recorded questionnaire	Time between delivery and initiation of breastfeeding (mins)	up to 6 months after installation