NCT04208191

Brief Summary

Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

2.7 years

First QC Date

December 19, 2019

Last Update Submit

December 19, 2019

Conditions

Keywords

Maternal HealthFamily PlanningQuality ImprovementPerson Centered CareKenyaDelivery

Outcome Measures

Primary Outcomes (30)

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    Baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    2-weeks post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    4-weeks post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    6-weeks post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    10-weeks post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    About 24 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    About 26 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    About 30 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    About 30.5 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    about 31 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    31.5 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    32 months post baseline

  • Person Centered Maternal Health Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care

    32.5 months post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    Baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    4 weeks post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    6 weeks post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    8 weeks post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    10 weeks post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    About 24 months post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    About 26 months post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    About 30 months post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    About 31 months post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    About 31.5 months post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    About 32 months post baseline

  • Person Centered Family Planning Scale Score

    Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care

    About 32.5 months post baseline

  • Attitudes toward Person-Centered Care

    Survey and In-depth interviews conducted with providers; perceptions of person-centered care

    Baseline

  • Attitudes toward Person-Centered Care

    Survey conducted with providers; perceptions of person-centered care

    About 24 months post baseline

  • Attitudes toward Person-Centered Care

    Survey conducted with providers; perceptions of person-centered care

    About 26 months post baseline

  • Attitudes toward Person-Centered Care

    Survey and In-depth interviews conducted with providers; perceptions of person-centered care

    About 30 months post baseline

  • The Model for Understanding Success in Quality Survey

    Survey conducted with intervention providers on facility readiness to implement QI; Possible range 0-154; higher the score the more ready facility is to participate in QI activities

    About 30 months post baseline

Study Arms (4)

Control - Women

NO INTERVENTION

Participants who delivered or received family planning services at a facility that was not implementing a QI project on PCC

Intervention - Women

EXPERIMENTAL

Participants who delivered or received family planning services at a facility that was implementing a QI project on PCC

Behavioral: Quality Improvement Collaborative

Control - Provider

NO INTERVENTION

Provider working in a facility that is not implementing a QI project on PCC

Intervention - Provider

EXPERIMENTAL

Provider working in a facility that is implementing a QI project on PCC

Behavioral: Quality Improvement Collaborative

Interventions

Facilities that participated in a QI collaborative to improve PCC for MH and FP services

Intervention - ProviderIntervention - Women

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 15-49 years old
  • Agreed/consented to participate
  • Delivered at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
  • Has a working mobile phone and specified service provider (airtel/safaricom)

You may not qualify if:

  • Not a women aged 15-49 years old
  • Did no agreed/consented to participate
  • Did not deliver at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
  • Does not have a working mobile phone or specified service provider (airtel/safaricom)
  • Agreed/consented to participate
  • Staff at facility
  • Did no agreed/consent to participate
  • Not staff at facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action

Nairobi, Kenya

Location

Study Officials

  • Dominic Montagu, DrPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 23, 2019

Study Start

August 8, 2016

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

December 23, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations