- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04208867
Quality Improvement Project for Reproductive Health Services in India, Phase 1 (SPARQ_QII1)
December 19, 2019 updated by: University of California, San Francisco
Strengthening People-centered Accessibility, Respect, and Quality for Reproductive Health Services in Uttar Pradesh, India, Phase 1
Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for reproductive health (RH) services.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Evaluation of a quality improvement (QI) collaborative in public facilities in Uttar Pradesh, India aimed at improving person-centered care (PCC) for reproductive health (RH) services.
Study Type
Interventional
Enrollment (Actual)
2989
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
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, India
- Population Services International
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria for Women:
- Women aged 18-49
- Agree/consent to participate
- Delivered a baby at the facility within 7 days (or adopted a family planning method at time of visit (baseline only, not part of intervention))
Exclusion Criteria for Women:
- Not a women aged 18-49
- Did not agree/consent to participate
- Did not deliver a baby at the facility within 7 days (or adopted a family planning method at time of visit (baseline only, not part of intervention))
Inclusion Criteria for Providers:
- Agreed/consented to participate
- Staff at facility
Exclusion Criteria for Provider:
- Did not agree/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 |
---|---|
Experimental: Intervention - Women
Women who receive MH services from a facility participating in the QI collaborative to improve PCC
|
Facilities that participated in a QI collaborative to improve PCC for MH services
|
No Intervention: Control - Women
Women who receive MH services from a facility not participating in the QI collaborative to improve PCC
|
|
Experimental: Intervention - Provider
Provider working at a facility participating in the QI collaborative to improve PCC
|
Facilities that participated in a QI collaborative to improve PCC for MH services
|
No Intervention: Control - Provider
Provider working at a facility not participating in the QI collaborative to improve PCC
|
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 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: 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 Maternal Health Scale Score
Time Frame: 2-weeks post basline
|
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 basline
|
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: 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 12 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 12 months post baseline
|
Person Centered Maternal Health Scale Score
Time Frame: About 14 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 14 months post baseline
|
Person Centered Maternal Health Scale Score
Time Frame: about 24 months after 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 after baseline
|
Person Centered Maternal Health Scale Score
Time Frame: About 24.5 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 24.5 months post baseline
|
Person Centered Maternal Health Scale Score
Time Frame: 25 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
|
25 months post baseline
|
Person Centered Maternal Health Scale Score
Time Frame: 26.5 months past baseline
|
Survey conducted with women: self report of experiences of care.
Possible range 0-100; higher the score the better the experience of care
|
26.5 months past baseline
|
Attitude toward Person-Centered Care
Time Frame: About 12 months post baseline
|
Survey and in-depth interviews conducted with providers; perceptions of person-centered care
|
About 12 months post baseline
|
Attitude toward Person-Centered Care
Time Frame: About 24 months post baseline
|
Survey and in-depth interviews conducted with providers; perceptions of person-centered care
|
About 24 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 16, 2016
Primary Completion (Actual)
December 6, 2018
Study Completion (Actual)
December 6, 2018
Study Registration Dates
First Submitted
December 18, 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_IndiaQI1
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
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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