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

Sponsor

Jhpiego (Other)

Overall Status

Completed

CT.gov ID

NCT03363308

Collaborator

Bill and Melinda Gates Foundation (Other)

250

Enrollment

Location

Arms

31.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Death Infant Death Stillbirth	Behavioral: training for health care workers supplmented by QI teams	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a cluster-randomized trial in phase I and interrupted time series in phase IIThis is a cluster-randomized trial in phase I and interrupted time series in phase II

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 16, 2017

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1 training for health care workers supplemented by QI teams	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. Other Names: 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
No Intervention: Phase 2

Arm

Intervention/Treatment

Experimental: Phase 1

training for health care workers supplemented by QI teams

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.

Other Names:

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

No Intervention: Phase 2

Outcome Measures

Primary Outcome Measures

Mean number or percent of items correctly answered [1 day]
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 [1 day]
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. [3 days]
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 [3 days]
number of maternal deaths over number of live births

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jhpiego DRC	Kinshasa		Congo, The Democratic Republic of the

Sponsors and Collaborators

Jhpiego
Bill and Melinda Gates Foundation

Investigators

Principal Investigator: Virgile Kikaya, Jhpiego DRC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jhpiego

ClinicalTrials.gov Identifier:

NCT03363308

Other Study ID Numbers:

OPP1156220

First Posted:

Dec 6, 2017

Last Update Posted:

Jul 24, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2020