Clinical trial NCT03363308: Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Death
Infant Death
Stillbirth
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2017-12-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster-randomized trial in phase I and interrupted time series in phase II
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean number or percent of items correctly answered
timeFrame: 1 day
measure: Intrapartum perinatal death ratio
timeFrame: 1 day
measure: 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.
timeFrame: 3 days
Secondary outcomes:
measure: maternal mortality
timeFrame: 3 days
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Jhpiego DRC
Study officials:
affiliation: Jhpiego DRC
name: Virgile Kikaya
role: PRINCIPAL_INVESTIGATOR
References: