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

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.

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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