Maternal HealthSPARQ_QIKNCT04208191
Quality Improvement Project for Maternal Health and Family Planning Services in Kenya
A study testing Quality Improvement Collaborative in people with Maternal Health and Family Planning, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Family Planning, Delivery
- What is being tested?
- Quality Improvement Collaborative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,354 participants
- Where
- 1 siteKenya
- Study dates
- 8 Aug 2016to 12 Apr 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women aged 15-49 years old
- Agreed/consented to participate
- Delivered at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
- Has a working mobile phone and specified service provider (airtel/safaricom)
- Agreed/consented to participate
- Staff at facility
Who cannot join
- Not a women aged 15-49 years old
- Did no agreed/consented to participate
- Did not deliver at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
- Does not have a working mobile phone or specified service provider (airtel/safaricom)
- Did no agreed/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 Maternal Health and Family Planning Services in Nairobi, Kenya
Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services
Read the detailed description
Evaluation of a quality improvement (QI) collaborative in public facilities in Nairobi and Kiambu Counties in Kenya aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services.
- Conditions
- Maternal Health, Family Planning, Delivery
- Being tested
- Quality Improvement Collaborative
- Keywords
- Maternal Health, Family Planning, Quality Improvement, Person Centered Care, Kenya, Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement CollaborativeBehavioural
Facilities that participated in a QI collaborative to improve PCC for MH and FP services
| Study group | Role | What they receive |
|---|---|---|
| Control - Women | No intervention | Participants who delivered or received family planning services at a facility that was not implementing a QI project on PCC |
| Intervention - Women | Experimental | Participants who delivered or received family planning services at a facility that was implementing a QI project on PCC Receives: Behavioral: Quality Improvement Collaborative |
| Control - Provider | No intervention | Provider working in a facility that is not implementing a QI project on PCC |
| Intervention - Provider | Experimental | Provider working in a facility that is implementing a QI project on PCC Receives: Behavioral: Quality Improvement Collaborative |
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 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: 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: 6-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 24 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 26 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 30 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 30.5 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: about 31 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: 31.5 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: 32 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: 32.5 months 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: 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: 6 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: 8 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
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: About 24 months 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: About 26 months 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: About 30 months 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: About 31 months 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: About 31.5 months 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: About 32 months 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: About 32.5 months post baseline
Attitudes toward Person-Centered Care
Survey and In-depth interviews conducted with providers; perceptions of person-centered care
Measured: Baseline
Attitudes toward Person-Centered Care
Survey conducted with providers; perceptions of person-centered care
Measured: About 24 months post baseline
Attitudes toward Person-Centered Care
Survey conducted with providers; perceptions of person-centered care
Measured: About 26 months post baseline
Attitudes toward Person-Centered Care
Survey and In-depth interviews conducted with providers; perceptions of person-centered care
Measured: About 30 months post baseline
The Model for Understanding Success in Quality Survey
Survey conducted with intervention providers on facility readiness to implement QI; Possible range 0-154; higher the score the more ready facility is to participate in QI activities
Measured: About 30 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 start8 Aug 2016
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 3,354 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action
- Responsible party
- Sponsor
- Investigators
- Dominic Montagu, DrPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208191
- Sponsor's protocol ID
- 15-18008_KenyaQI
- Acronym
- SPARQ_QIK
- Status last verified
- Dec 2019
- First submitted
- 19 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
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 Maternal Health and Family Planning Services in Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT04208191
- Acronym / sponsor ID
- SPARQ_QIK / 15-18008_KenyaQI
- Conditions
- Maternal Health, Family Planning, Delivery
- Keywords
- Maternal Health, Family Planning, Quality Improvement, Person Centered Care, Kenya, Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,354 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Innovations for Poverty Action
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 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.
Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services
Detailed description
Evaluation of a quality improvement (QI) collaborative in public facilities in Nairobi and Kiambu Counties in Kenya aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control - Women | No intervention | –Participants who delivered or received family planning services at a facility that was not implementing a QI project on PCC |
| Intervention - Women | Experimental | Behavioral: Quality Improvement CollaborativeParticipants who delivered or received family planning services at a facility that was implementing a QI project on PCC |
| Control - Provider | No intervention | –Provider working in a facility that is not implementing a QI project on PCC |
| Intervention - Provider | Experimental | Behavioral: Quality Improvement CollaborativeProvider working in a facility that is implementing a QI project on PCC |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 15-49 years old
- Agreed/consented to participate
- Delivered at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
- Has a working mobile phone and specified service provider (airtel/safaricom)
- Agreed/consented to participate
Key exclusion criteria (6 listed)
- Not a women aged 15-49 years old
- Did no agreed/consented to participate
- Did not deliver at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
- Does not have a working mobile phone or specified service provider (airtel/safaricom)
- Did no agreed/consent to participate
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 |
|---|---|---|
| Quality Improvement CollaborativeFacilities that participated in a QI collaborative to improve PCC for MH and FP 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 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: 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: 6-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 24 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 26 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 30 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 30.5 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: about 31 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: 31.5 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: 32 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: 32.5 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 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: 6 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: 8 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
Person Centered Family Planning Scale Score
Time frame: About 24 months 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: About 26 months 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: About 30 months 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: About 31 months 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: About 31.5 months 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: About 32 months 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: About 32.5 months 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
Attitudes toward Person-Centered Care
Time frame: Baseline
Survey and In-depth interviews conducted with providers; perceptions of person-centered care
Attitudes toward Person-Centered Care
Time frame: About 24 months post baseline
Survey conducted with providers; perceptions of person-centered care
Attitudes toward Person-Centered Care
Time frame: About 26 months post baseline
Survey conducted with providers; perceptions of person-centered care
Attitudes toward Person-Centered Care
Time frame: About 30 months post baseline
Survey and In-depth interviews conducted with providers; perceptions of person-centered care
The Model for Understanding Success in Quality Survey
Time frame: About 30 months post baseline
Survey conducted with intervention providers on facility readiness to implement QI; Possible range 0-154; higher the score the more ready facility is to participate in QI activities
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.
- 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 Quality Improvement Collaborative in people with Maternal Health and Family Planning, run by University of California, San Francisco at 1 site in Kenya.
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 6 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 Kenya. 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 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.