Reproductive HealthSPARQINDIA2NCT04208841
Quality Improvement of Person-Centered Care for Maternal Health in Public Facilities in India, Phase 2
A study testing Person-Centered Care Quality Improvement Collaborative Sustain and Person-Centered Care Quality Improvement Collaborative Spread in people with Reproductive Health, run by University of California, San Francisco at 1 site in India.
Trial summary
Evaluating the spread of a quality improvement (QI) change package working to improve person-centered care (PCC) for maternal health (MH) services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health
- What is being tested?
- Person-Centered Care Quality Improvement Collaborative Sustain and Person-Centered Care Quality Improvement Collaborative Spread
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,971 participants
- Where
- 1 siteIndia
- Study dates
- 14 May 2018to 29 Jun 2019
- 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 years old
- Who agreed to participate
- Who delivered a baby at the facility where data collection is taking place within the last 7 days
- Agreed to participate
- Purposive sampling
- Permanent staff at the facility
Who cannot join
- 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
- Did not agree to participate
- Not permanent staff at the facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Reproductive Health
- Being tested
- Person-Centered Care Quality Improvement Collaborative Sustain, Person-Centered Care Quality Improvement Collaborative Spread
- Keywords
- Maternal Health, India, Person-Centered Care, Quality Improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-Centered Care Quality Improvement Collaborative SustainBehavioural
Sustain improvements during QI collaborative focused on PCC
Person-Centered Care Quality Improvement Collaborative SpreadBehavioural
Implement change package developed during QI Collaborative
| Study group | Role | What they receive |
|---|---|---|
| Control - Patient | No intervention | Participants who receive maternal health services at a facility not participating in the Quality Improvement Intervention or implementing the change package |
| Sustaining - Patients | Experimental | Participants who received maternal health services at a facility where a quality improvement collaborative had been implemented Receives: Behavioral: Person-Centered Care Quality Improvement Collaborative Sustain |
| Spread - Patients | Experimental | 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 Receives: Behavioral: Person-Centered Care Quality Improvement Collaborative Spread |
| Control - Providers | No intervention | Providers who work at a facility not participating in the Quality Improvement Intervention or implementing the change package |
| Sustaining - Providers | Experimental | Providers who work at a facility where a quality improvement collaborative had been implemented Receives: Behavioral: Person-Centered Care Quality Improvement Collaborative Sustain |
| Spread - Providers | Experimental | 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 Receives: Behavioral: Person-Centered Care Quality Improvement Collaborative Spread |
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: About 12 month post baseline
Person-Centered Scale Score
Survey conducted with providers: self-report of perceptions of care. Possible range 0-100; higher the score the better the experience of care
Measured: baseline
Person-Centered Scale Score
Survey conducted with providers: self-report of perceptions of care. Possible range 0-100; higher the score the better the experience of care
Measured: About 12 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 start14 May 2018
- Primary completion29 Jun 2019
- Study completion29 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Reproductive 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
- 1,971 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 Monatgu, DrPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208841
- Sponsor's protocol ID
- 15-18008_QI India_Phase2
- Acronym
- SPARQINDIA2
- 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
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.
PubMed 33704027Montagu 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 Person-centered Accessibility, Respect, and Quality of Maternal Health Services in India, Phase 2
- ClinicalTrials.gov ID
- NCT04208841
- Acronym / sponsor ID
- SPARQINDIA2 / 15-18008_QI India_Phase2
- Conditions
- Reproductive Health
- Keywords
- Maternal Health, India, Person-Centered Care, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,971 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Population Services International
- Study start
- 14 May 2018 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 29 Jun 2019 (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.
Evaluating the spread of a quality improvement (QI) change package working to improve person-centered care (PCC) for maternal health (MH) services.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control - Patient | No intervention | –Participants who receive maternal health services at a facility not participating in the Quality Improvement Intervention or implementing the change package |
| Sustaining - Patients | Experimental | Behavioral: Person-Centered Care Quality Improvement Collaborative SustainParticipants who received maternal health services at a facility where a quality improvement collaborative had been implemented |
| Spread - Patients | Experimental | Behavioral: Person-Centered Care Quality Improvement Collaborative SpreadParticipants 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 |
| Control - Providers | No intervention | –Providers who work at a facility not participating in the Quality Improvement Intervention or implementing the change package |
| Sustaining - Providers | Experimental | Behavioral: Person-Centered Care Quality Improvement Collaborative SustainProviders who work at a facility where a quality improvement collaborative had been implemented |
| Spread - Providers | Experimental | Behavioral: Person-Centered Care Quality Improvement Collaborative SpreadParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Agreed to participate
- Purposive sampling
Key exclusion criteria (5 listed)
- 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
- Did not agree to participate
- Not permanent staff at the 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 |
|---|---|---|
| Person-Centered Care Quality Improvement Collaborative SustainSustain improvements during QI collaborative focused on PCC | Behavioural | Sustaining - Patients, Sustaining - Providers |
| Person-Centered Care Quality Improvement Collaborative SpreadImplement change package developed during QI Collaborative | Behavioural | Spread - Patients, Spread - Providers |
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: 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
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
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
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 33704027Sudhinaraset 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.
- 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 Monatgu, 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 Person-Centered Care Quality Improvement Collaborative Sustain and Person-Centered Care Quality Improvement Collaborative Spread in people with Reproductive Health, 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 6 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 4 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 NCT04208841, which also lists 2 linked publications.
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.