- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04208191
Quality Improvement Project for Maternal Health and Family Planning Services in Kenya (SPARQ_QIK)
December 19, 2019 updated by: University of California, San Francisco
Strengthening People-centered Accessibility, Respect, and Quality for Maternal Health and Family Planning Services in Nairobi, Kenya
Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Evaluation of a quality improvement (QI) collaborative in public facilities in Nairobi and Kiambu Counties in Kenya aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services.
Study Type
Interventional
Enrollment (Actual)
3354
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nairobi, Kenya
- Innovations for Poverty Action
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria for Women:
- 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)
Exclusion Criteria for Women:
- 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)
Inclusion Criteria for Providers:
- Agreed/consented to participate
- Staff at facility
Exclusion Criteria for Providers
- Did no agreed/consent to participate
- Not staff at facility
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control - Women
Participants who delivered or received family planning services at a facility that was not implementing a QI project on PCC
|
|
Experimental: Intervention - Women
Participants who delivered or received family planning services at a facility that was implementing a QI project on PCC
|
Facilities that participated in a QI collaborative to improve PCC for MH and FP services
|
No Intervention: Control - Provider
Provider working in a facility that is not implementing a QI project on PCC
|
|
Experimental: Intervention - Provider
Provider working in a facility that is implementing a QI project on PCC
|
Facilities that participated in a QI collaborative to improve PCC for MH and FP services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Person Centered Maternal Health Scale Score
Time Frame: Baseline
|
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
Time Frame: 2-weeks post baseline
|
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
Time Frame: 4-weeks post baseline
|
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
Time Frame: 6-weeks post baseline
|
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
Time Frame: 10-weeks post baseline
|
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
Time Frame: About 24 months post baseline
|
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
Time Frame: About 26 months post baseline
|
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
Time Frame: About 30 months post baseline
|
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
Time Frame: About 30.5 months post baseline
|
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
Time Frame: about 31 months post baseline
|
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
Time Frame: 31.5 months post baseline
|
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
Time Frame: 32 months post baseline
|
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
Time Frame: 32.5 months post baseline
|
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
Time Frame: Baseline
|
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
Time Frame: 4 weeks post baseline
|
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
Time Frame: 6 weeks post baseline
|
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
Time Frame: 8 weeks post baseline
|
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
Time Frame: 10 weeks post baseline
|
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
Time Frame: About 24 months post baseline
|
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
Time Frame: About 26 months post baseline
|
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
Time Frame: About 30 months post baseline
|
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
Time Frame: About 31 months post baseline
|
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
Time Frame: About 31.5 months post baseline
|
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
Time Frame: About 32 months post baseline
|
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
Time Frame: About 32.5 months post baseline
|
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
Time Frame: Baseline
|
Survey and In-depth interviews conducted with providers; perceptions of person-centered care
|
Baseline
|
Attitudes toward Person-Centered Care
Time Frame: About 24 months post baseline
|
Survey conducted with providers; perceptions of person-centered care
|
About 24 months post baseline
|
Attitudes toward Person-Centered Care
Time Frame: About 26 months post baseline
|
Survey conducted with providers; perceptions of person-centered care
|
About 26 months post baseline
|
Attitudes toward Person-Centered Care
Time Frame: About 30 months post baseline
|
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
Time Frame: About 30 months post baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dominic Montagu, DrPH, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2016
Primary Completion (Actual)
April 12, 2019
Study Completion (Actual)
April 12, 2019
Study Registration Dates
First Submitted
December 19, 2019
First Submitted That Met QC Criteria
December 19, 2019
First Posted (Actual)
December 23, 2019
Study Record Updates
Last Update Posted (Actual)
December 23, 2019
Last Update Submitted That Met QC Criteria
December 19, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 15-18008_KenyaQI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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