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CompletedNCT03363308Updated Jul 24, 2020

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

An interventional study of training for health care workers supplmented by QI teams in Maternal Death, Infant Death and Stillbirth, sponsored by Jhpiego. Completed at 1 site in Congo, The Democratic Republic of the. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-24.

Sponsored by Jhpiego · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Maternal Death
  • Infant Death
  • Stillbirth
03

In context

Maternal Death

77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.

This study's enrollment of 250 is below the median of 1,126 across 57 interventional studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

Jhpiego is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • there are no exclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Phase 1

    training for health care workers supplemented by QI teams

    Behavioral: training for health care workers supplmented by QI teams

  • No intervention
    Phase 2

Interventions

  • Behavioraltraining 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.

    Also known as: 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  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.

    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 outcomes

  1. maternal mortality

    number of maternal deaths over number of live births

    Time frame: 3 days

07

Study locations

1 site
  • Jhpiego DRC
    Kinshasa, Congo, The Democratic Republic of the
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Jun 2020, 31 months.

Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's 31 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2017
First posted
Dec 6, 2017
StartActual
Nov 16, 2017
Primary completionActual
Jun 30, 2020
CompletionActual
Jun 30, 2020
Last update
Jul 24, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03363308
Lead sponsor
Jhpiego
Collaborators
Bill and Melinda Gates Foundation
Responsible party
Sponsor
First posted
Dec 6, 2017
Start date
Nov 16, 2017
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Jul 24, 2020

Study contacts

Virgile Kikaya
principal investigator · Jhpiego DRC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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