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

Primary Purpose

Maternal Death, Infant Death, Stillbirth

Status
Completed
Phase
Not Applicable
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
training for health care workers supplmented by QI teams
Sponsored by
Jhpiego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jhpiego DRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Phase 1

Phase 2

Arm Description

training for health care workers supplemented by QI teams

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

maternal mortality
number of maternal deaths over number of live births

Full Information

First Posted
November 30, 2017
Last Updated
July 22, 2020
Sponsor
Jhpiego
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03363308
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jhpiego
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Death, Infant Death, Stillbirth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a cluster-randomized trial in phase I and interrupted time series in phase II
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1
Arm Type
Experimental
Arm Description
training for health care workers supplemented by QI teams
Arm Title
Phase 2
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
training for health care workers supplmented by QI teams
Other Intervention Name(s)
Practice coordinator training after training session, Practice sessions using anatomic models, SMS reminder messages and quizzes, Routine calls between mentors and providers, Health information officer training, Data collection and use training, Supply of simulators, equipment, kits and other, Develop quality improvement teams and review of action plans, Routine calls between project staff and mentors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean number or percent of items correctly answered
Description
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.
Time Frame
1 day
Title
Intrapartum perinatal death ratio
Description
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.
Time Frame
1 day
Title
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.
Description
Percent of women after childbirth who adopt a family planning method over all women who give birth in a facility
Time Frame
3 days
Secondary Outcome Measure Information:
Title
maternal mortality
Description
number of maternal deaths over number of live births
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virgile Kikaya
Organizational Affiliation
Jhpiego DRC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jhpiego DRC
City
Kinshasa
Country
Congo, The Democratic Republic of the

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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