Maternal HealthSPARQ_QII1NCT04208867
Quality Improvement Project for Reproductive Health Services in India, Phase 1
A study testing QI Collaborative in people with Maternal Health and Delivery, run by University of California, San Francisco at 1 site in India.
Trial summary
Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for reproductive health (RH) services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Delivery, Reproductive Health
- What is being tested?
- QI Collaborative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,989 participants
- Where
- 1 siteIndia
- Study dates
- 16 Sep 2016to 6 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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))
- Agreed/consented to participate
- Staff at facility
Who cannot join
- 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))
- Did not agree/consent to participate
- Not Staff at facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Maternal Health, Delivery, Reproductive Health
- Being tested
- QI Collaborative
- Keywords
- Maternal Health, Delivery, Person-centered Care, India, Family Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QI CollaborativeBehavioural
Facilities that participated in a QI collaborative to improve PCC for MH services
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Women | Experimental | Women who receive MH services from a facility participating in the QI collaborative to improve PCC Receives: Behavioral: QI Collaborative |
| Control - Women | No intervention | Women who receive MH services from a facility not participating in the QI collaborative to improve PCC |
| Intervention - Provider | Experimental | Provider working at a facility participating in the QI collaborative to improve PCC Receives: Behavioral: QI Collaborative |
| Control - Provider | No intervention | Provider working at a facility not participating in the QI collaborative to improve PCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: Baseline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: 2-weeks post basline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: 4 weeks post baseline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: 10 weeks post baseline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: About 12 months post baseline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: About 14 months post baseline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: about 24 months after baseline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: About 24.5 months post baseline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: 25 months post baseline
Person Centered Maternal Health Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care
Measured: 26.5 months past baseline
Person Centered Family Planning Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
Measured: Baseline
Person Centered Family Planning Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
Measured: 4 weeks post baseline
Person Centered Family Planning Scale Score
Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care
Measured: 10 weeks post baseline
Attitude toward Person-Centered Care
Survey and in-depth interviews conducted with providers; perceptions of person-centered care
Measured: About 12 months post baseline
Attitude toward Person-Centered Care
Survey and in-depth interviews conducted with providers; perceptions of person-centered care
Measured: About 24 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start16 Sep 2016
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,989 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Population Services International
- Responsible party
- Sponsor
- Investigators
- Dominic Montagu, DrPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208867
- Sponsor's protocol ID
- 15-18008_IndiaQI1
- Acronym
- SPARQ_QII1
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33276773
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening People-centered Accessibility, Respect, and Quality for Reproductive Health Services in Uttar Pradesh, India, Phase 1
- ClinicalTrials.gov ID
- NCT04208867
- Acronym / sponsor ID
- SPARQ_QII1 / 15-18008_IndiaQI1
- Conditions
- Maternal Health, Delivery, Reproductive Health
- Keywords
- Maternal Health, Delivery, Person-centered Care, India, Family Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,989 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Population Services International
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for reproductive health (RH) services.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention - Women | Experimental | Behavioral: QI CollaborativeWomen who receive MH services from a facility participating in the QI collaborative to improve PCC |
| Control - Women | No intervention | –Women who receive MH services from a facility not participating in the QI collaborative to improve PCC |
| Intervention - Provider | Experimental | Behavioral: QI CollaborativeProvider working at a facility participating in the QI collaborative to improve PCC |
| Control - Provider | No intervention | –Provider working at a facility not participating in the QI collaborative to improve PCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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))
- Agreed/consented to participate
- Staff at facility
Key exclusion criteria (5 listed)
- 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))
- Did not agree/consent to participate
- Not Staff at facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QI CollaborativeFacilities that participated in a QI collaborative to improve PCC for MH services | Behavioural | Intervention - Provider, Intervention - Women |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Derived from this study: PubMed 33276773Montagu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominic Montagu, DrPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QI Collaborative in people with Maternal Health and Delivery, run by University of California, San Francisco at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Person Centered Maternal Health Scale Score (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.