Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa

Stillbirth Clinical Trial

Official title:

Effects of a Health Workforce Capacity Building and Quality Improvement Intervention on Intrapartum Stillbirth, Early Newborn Mortality and Post-pregnancy Family Planning in Kinshasa: a Cluster Randomized Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363308
• Other study ID #: OPP1156220
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.

Description:

The health workforce capacity building and quality improvement intervention will be implemented in two phases: eight facilities will receive the intervention in phase 1 and the remaining eight facilities will receive the intervention in phase 2.

Objective 1: For objective 2 on facility-based health outcomes, the study design is a cluster-randomized evaluation in phase 1. The intervention's effects will be assessed by comparing an intervention group and a control group of facilities. These will be selected from 16 Kinshasa health facilities. Intervention and control facilities' monthly reported health outcomes will be compared in a 12-month baseline period and 12-month period during and after the intervention implementation (Phase 1) in a difference-in-difference analysis. In Phase 2, all facilities will have their monthly service statistics and health outcomes reviewed for trends in improvement.

Overall, in Phase 1, eight intervention sites will be matched to eight sites serving as controls. In Phase 2, the eight Phase 1 control sites will then receive the same package as the intervention sites in Phase 1. Sites will be stratified by case load, low and high (over 90 births per month), and funding (public or private funding). Within each stratum, prior to start of the intervention, there will be random selection to intervention and control groups to allow for baseline comparability between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Health providers:

• Currently on the roster of maternity ward providers working at one of the 16 selected facilities at the time of the training module.

• Willing to attend a Jhpiego clinical training workshop and offer consent as study participant.

• Age 18 or older.

Exclusion Criteria:

• there are no exclusion criteria

Related Conditions & MeSH terms

• Death
• Infant Death
• Maternal Death
• Stillbirth

Intervention

Behavioral:
• training for health care workers supplmented by QI teams
Jhpiego will deliver maternal and newborn health and family planning (MNH+FP) training using evidence-based low-dose, high-frequency (LDHF) learning approaches and support hospital staff-led quality improvement efforts to increase the coverage of facility-based high-impact interventions, including care of the mother and newborn on the day of birth and through the first week postpartum and post abortion services.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Jhpiego DRC	Kinshasa

Sponsors (2)

Lead Sponsor	Collaborator
Jhpiego	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number or percent of items correctly answered	Each observed structured clinical exam (OSCE) or knowledge tests has between 13 and 38 items. A participant needs to achieve 85% correct score to pass at post-training to assess provider competencies. The main indicator for analysis will be the mean number of items (or percent of items) correctly answered. This mean percent of items correctly answered will be done pre-training, post-training and after 6 months. This will be done in the 8 intervention group facilities only in Phase I and again in the 8 new facilities in Phase II.	1 day
Primary	Intrapartum perinatal death ratio	Defined as death of a fetus during labor who had heart tones documented on arrival in the maternity and neonatal deaths prior to 24 hours, divided by total births.	1 day
Primary	Percent of women after childbirth who adopt a family planning method immediately post-pregnancy or intend to adopt a method by six weeks post-pregnancy.	Percent of women after childbirth who adopt a family planning method over all women who give birth in a facility	3 days
Secondary	maternal mortality	number of maternal deaths over number of live births	3 days