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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2989

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • India
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention - Women
Women who receive MH services from a facility participating in the QI collaborative to improve PCC
Behavioral: QI Collaborative
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
Behavioral: QI Collaborative
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Population Services International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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