- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04208841
Quality Improvement of Person-Centered Care for Maternal Health in Public Facilities in India, Phase 2 (SPARQINDIA2)
December 19, 2019 updated by: University of California, San Francisco
Strengthening Person-centered Accessibility, Respect, and Quality of Maternal Health Services in India, Phase 2
Evaluating the spread of a quality improvement (QI) change package working to improve person-centered care (PCC) for maternal health (MH) services.
Study Overview
Status
Completed
Conditions
Detailed Description
After implementing a quality improvement (QI) collaborative in public facilities in Uttar Pradesh, India, a second phase was done to evaluate if the "change package" developed during phase one could be implemented in similar facilities to improve the quality of person-centered care (PCC) for a maternal health (MH) services.
Study Type
Interventional
Enrollment (Actual)
1971
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 years old
- Who agreed to participate
- Who delivered a baby at the facility where data collection is taking place within the last 7 days
Exclusion Criteria for Women:
- Not a women aged 18-49
- Did not agree to participate
- Did not deliver a baby at the facility where data collection is taking place within the last 7 days
Inclusion Criteria for Providers:
- Agreed to participate
- Purposive sampling
- Permanent staff at the facility
Exclusion Criteria for Providers:
- Did not agree to participate
- Not permanent staff at the 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 - Patient
Participants who receive maternal health services at a facility not participating in the Quality Improvement Intervention or implementing the change package
|
|
Experimental: Sustaining - Patients
Participants who received maternal health services at a facility where a quality improvement collaborative had been implemented
|
Sustain improvements during QI collaborative focused on PCC
|
Experimental: Spread - Patients
Participants who received maternal health services at a facility that was provided a change package of ideas developed during the quality improvement collaborative (in phase 1) and used to make improvements on person-centered care
|
Implement change package developed during QI Collaborative
|
No Intervention: Control - Providers
Providers who work at a facility not participating in the Quality Improvement Intervention or implementing the change package
|
|
Experimental: Sustaining - Providers
Providers who work at a facility where a quality improvement collaborative had been implemented
|
Sustain improvements during QI collaborative focused on PCC
|
Experimental: Spread - Providers
Participants who work at a facility that was provided a change package of ideas developed during the quality improvement collaborative (in phase 1) and used to make improvements on person-centered care
|
Implement change package developed during QI Collaborative
|
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: About 12 month 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 month post baseline
|
Person-Centered Scale Score
Time Frame: baseline
|
Survey conducted with providers: self-report of perceptions of care.
Possible range 0-100; higher the score the better the experience of care
|
baseline
|
Person-Centered Scale Score
Time Frame: About 12 months post baseline
|
Survey conducted with providers: self-report of perceptions of care.
Possible range 0-100; higher the score the better the experience of care
|
About 12 months post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dominic Monatgu, 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
- Sudhinaraset M, Giessler K, Nakphong MK, Roy KP, Sahu AB, Sharma K, Montagu D, Green C. Can changes to improve person-centred maternity care be spread across public health facilities in Uttar Pradesh, India? Sex Reprod Health Matters. 2021 Dec;29(1):1-15. doi: 10.1080/26410397.2021.1892570.
- Montagu D, Giessler K, Nakphong MK, Green C, Roy KP, Sahu AB, Sharma K, Sudhinarset M. A comparison of intensive vs. light-touch quality improvement interventions for maternal health in Uttar Pradesh, India. BMC Health Serv Res. 2020 Dec 4;20(1):1121. doi: 10.1186/s12913-020-05960-6.
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)
May 14, 2018
Primary Completion (Actual)
June 29, 2019
Study Completion (Actual)
June 29, 2019
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-18008_QI India_Phase2
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.
Clinical Trials on Reproductive Health
-
Harvard UniversityWeiss Family Program Fund for Research in Development Economics; Harvard Lab...Completed
-
NYU Langone HealthFogarty International Center of the National Institute of HealthCompleted
-
NorthShore University HealthSystemUniversity of ChicagoCompleted
-
National Research Institute for Family Planning...UnknownReproductive HealthChina
-
University of California, San FranciscoPopulation Services InternationalCompletedMaternal Health | Delivery | Reproductive HealthIndia
-
Istanbul University - Cerrahpasa (IUC)CompletedHealth Risk Behaviors | Reproductive Health | Sexual HealthTurkey
-
Ebru Cirban EkremEge UniversityNot yet recruitingReproductive HealthTurkey
-
University of California, San FranciscoPublic Health Foundation of IndiaCompletedReproductive Health
-
University of California, San FranciscoInnovations for Poverty Action; Marie Stopes InternationalCompletedReproductive HealthKenya
-
University of California, Los AngelesCompleted
Clinical Trials on Person-Centered Care Quality Improvement Collaborative Sustain
-
Vanderbilt UniversityCompletedVentilator Associated Pneumonia | Central Line-associated Bloodstream Infection (CLABSI)United States
-
Children's Hospital of Fudan UniversityChinese Neonatal NetworkWithdrawnMortality | Extracorporeal Membrane Oxygenation | Quality Improvement | Intracranial Hemorrhage | Extracorporeal Life Support | Neonate
-
University of California, San FranciscoInnovations for Poverty ActionCompletedMaternal Health | Family Planning | DeliveryKenya
-
Children's Hospital of Fudan UniversityShanghai Children's Medical Center; Xinhua Hospital, Shanghai Jiao Tong University... and other collaboratorsWithdrawnMorbidity;Newborn | MoralityChina
-
Agency for Healthcare Research and Quality (AHRQ)National Institute of Mental Health (NIMH); Aetna, Inc.Unknown
-
New York UniversityUniversity of Pennsylvania; Yale UniversityCompleted
-
Fundacio d'Investigacio en Atencio Primaria Jordi...RecruitingEnd Stage Disease | Multiple Chronic ConditionsSpain
-
Göteborg UniversitySahlgrenska University Hospital, Sweden; Swedish Council for Working Life and...CompletedPsychosis | Inpatient | Patient-Centered Care | PsychiatrySweden
-
Montefiore Medical CenterAmerican Academy of PediatricsCompletedDiagnostic ErrorsUnited States
-
University of PittsburghPatient-Centered Outcomes Research Institute; Dartmouth CollegeCompletedSchizophrenia | Bipolar Disorder | Major DepressionUnited States