Clinical trial NCT03589625: Electricity Access and Maternal Care in Rural Health Facilities in Uganda
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Care
Keywords: electricity and health
maternal health
quality of care
solar power
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: Innovations for Poverty Action
First posted: 2018-07-18
Enrollment: 1268
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge cluster-randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average brightness of room during labor and delivery as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Satisfactory light source used for entire delivery as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Adequate Light as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: 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
timeFrame: up to 6 months after installation
measure: 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
timeFrame: up to 6 months after installation
measure: 6-item delays in care index as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Health Worker Satisfaction with Electricity as measured by health worker survey
timeFrame: up to 6 months after installation
measure: Overall job satisfaction index as measured by health worker survey
timeFrame: up to 6 months after installation
Secondary outcomes:
measure: Mean level of brightness over 4 periods of labor and delivery on brightness scale as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Minutes of delivery observation without satisfactory light as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Consistent satisfactory light source as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Fetal Doppler Use as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Phone availability as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: APGAR Score Assigned as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Basic emergency obstetric care signal functions as measured by facility assessment
timeFrame: up to 6 months after installation
measure: Basic emergency newborn care signal functions as measured by facility assessment
timeFrame: up to 6 months after installation
measure: Routine obstetric care signal functions as measured by facility assessment
timeFrame: up to 6 months after installation
measure: Routine newborn care signal functions as measured by facility assessment
timeFrame: up to 6 months after installation
measure: Time between delivery and when suturing began (minutes) as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: 4-item quality of suturing index as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: 10-item patient treatment index as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: 14-item Partograph Completeness index as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Time between contractions as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Dilation at first exam as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Monthly Delivery Volumes as measured by facility register
timeFrame: up to 6 months after installation
measure: Monthly Nighttime Delivery Volumes as measured by facility register
timeFrame: up to 6 months after installation
measure: Monthly ANC Volumes as measured by facility register
timeFrame: up to 6 months after installation
measure: Monthly Referral Volumes as measured by facility register
timeFrame: up to 6 months after installation
measure: Sensor Brightness as measured by sensor
timeFrame: up to 6 months after installation
measure: Depletion of Solar Suitcase Battery Based on Voltage as measured by sensor
timeFrame: up to 6 months after installation
measure: Depletion of Solar Suitcase Battery Based on Charge Time as measured by sensor
timeFrame: up to 6 months after installation
measure: Solar Suitcase Use for Deliveries as measured by enumerator recorded questionnaire
timeFrame: up to 6 months after installation
measure: Health Worker Assessment of Overhead Light Availability as measured by health worker survey
timeFrame: up to 6 months after installation
measure: Health Worker Assessment of Task Light Availability as measured by health worker survey
timeFrame: up to 6 months after installation
measure: Health Worker Assessment of Overhead Light Brightness as measured by health worker survey
timeFrame: up to 6 months after installation
measure: Health Worker Assessment of Task Light Brightness as measured by health worker survey
timeFrame: up to 6 months after installation
measure: 14-item index of Health worker assessment of impact of blackouts on their ability to perform job functions as measured by health worker survey
timeFrame: up to 6 months after installation
measure: Initial exam Bleeding Assessment as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Initial exam Headaches/Blurred Vision Assessment as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: HIV testing as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Takes Pulse as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Takes Blood Pressure as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Wears Sterile Gloves as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Communication with Patient as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Partograph Use as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Hand Washing as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Preparation of Uterotonic as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Preparation of Bag and Mask as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Administration of Oxytocin as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Assessment of Completeness of Placenta as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Assessment of Lacerations as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Skin-to-Skin as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Drying Newborn as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Cord Clamping as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Vital Signs Postpartum as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Palpation of Uterus as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Breastfeeding within 1 Hour as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Initial Exam: Previous Pregnancy Inquiry as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Initial Exam: Hand Washing as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Initial Exam Temperature Assessment as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Initial Exam Fundal Height Assessment as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Initial Exam Fetal Presentation Assessment as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Initial Exam Fetal Heart Rate Assessment as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Initial Exam: Vaginal Examination as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Sterile Gloves for All Exams as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Preparation for Delivery: Cord ties/clamps and sterile scissors/blade as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Support of Perineum as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Cord Traction as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Uterine Massage as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Newborn Temperature as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Assistance with Breastfeeding as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Sterilization of Equipment as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Waste Disposal as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Hand Hygiene after Clean Up as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Delay in Facility Arrival as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Delay in First Exam as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Delay in Uterotonic as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Delay in Assessment for Lacerations as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Delay in Drying Newborn as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
measure: Delay in Breastfeeding Initiation as measured by observer recorded questionnaire
timeFrame: up to 6 months after installation
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Innovations for Poverty Action
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Jessica Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Slawa Rokicki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: USAID. Maternal and Child Health Integrated Program (MCHIP), Washington DC: USAID/Jhpiego; 2013.
citation: 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.
citation: Rokicki 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.