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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363308
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : July 24, 2020
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Jhpiego

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 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 : November 16, 2017
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Mean number or percent of items correctly answered [ Time Frame: 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.

  2. Intrapartum perinatal death ratio [ Time Frame: 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.

  3. 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. [ Time Frame: 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 :
  1. maternal mortality [ Time Frame: 3 days ]
    number of maternal deaths over number of live births



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363308


Locations
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Congo, The Democratic Republic of the
Jhpiego DRC
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
Jhpiego
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Virgile Kikaya Jhpiego DRC
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Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT03363308    
Other Study ID Numbers: OPP1156220
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stillbirth
Maternal Death
Death
Infant Death
Pathologic Processes
Fetal Death
Pregnancy Complications
Parental Death