Comprehensive CareNCT03238417
Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VAs
A study testing Evidence-Based Quality Improvement in people with Comprehensive Care, run by VA Office of Research and Development at 25 sites in United States.
Trial summary
Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in quality and patient experience among women seen in VA. VA policy action providing guidance on delivery of comprehensive healthcare services for women Veterans was disseminated nationally in 2010, followed by annual assessments and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comprehensive Care
- What is being tested?
- Evidence-Based Quality Improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 25 sitesUnited States
- Study dates
- 9 Jan 2017to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unit of randomization: VA healthcare facilities (VA medical center or community-based outpatient clinic)
- Subset of VA healthcare facilities identified as low-performing on the basis of composites of access/wait times, gender disparities in quality, e.g.:
- depression screening
- diabetic blood sugar control
- Presence/absence of VA-required structural facets of care, e.g.:
- designated women's health providers
Show all 28Show fewer
- mammography coordinator
- gynecology access
- Women Veteran Program Manager (WVPM)
- 3:1 staffing ratio for PACT teamlets
- Key Stakeholder Inclusion Criteria (qualitative interviews):
- Veteran Integrated Service Network (VISN) level leader (Director or Chief Medical Officer)
- VISN level WVPM Lead, VISN level primary care director, VISN level QI/system redesign lead)
- VA facility leader (Director or other member of senior leadership)
- Chief of Staff
- primary care director
- women's health medical director
- WVPM
- local EBQI champion
- other key personnel
- Provider/Staff Survey Inclusion Criteria:
- Primary care providers (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner [NP], physician assistant [PA]) delivering primary care in general primary care and/or women's health clinics
- PACT teamlet members (registered nurse [RN] care managers, licensed vocational nurse/licensed practical nurse [LVN/LPN]/health technicians, and clerks)
- larger PACT team members, e.g.:
- social workers
- dieticians
- health coaches
- integrated mental health
Who cannot join
- Facility-level exclusion: Facilities not identified in the initial sample of VA facilities (sample not renewed over time).
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, 21202
Bath VA Medical Center, Bath, NY
Bath, New York, 14810
Battle Creek VA Medical Center, Battle Creek, MI
Battle Creek, Michigan, 49037
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, 65201-5297
Chalmers P. Wylie Ambulatory Care Center, Columbus, OH
Columbus, Ohio, 43203-1278
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
Carl Vinson VA Medical Center, Dublin, GA
Dublin, Georgia, 31021
VA Black Hills Health Care System Fort Meade Campus, Fort Meade, SD
Fort Meade, South Dakota, 57741
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
Hampton VA Medical Center, Hampton, VA
Hampton, Virginia, 23667
VA Southern Nevada Healthcare System, North Las Vegas, NV
Las Vegas, Nevada, 89106
Marion VA Medical Center, Marion, IL
Marion, Illinois, 62959
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
Central Alabama Veterans Health Care System West Campus, Montgomery, AL
Montgomery, Alabama, 36109
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Northern Arizona VA Health Care System, Prescott, AZ
Prescott, Arizona, 86313
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, 28144
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
Overton Brooks VA Medical Center, Shreveport, LA
Shreveport, Louisiana, 71101
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504
Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA
Walla Walla, Washington, 99362
Robert J. Dole Department of Veterans Affairs Medical and Regional Office Center, Wichita, KS
Wichita, Kansas, 67218
About this study
Official title: Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VA Facilities (PEC 16-352)
Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in quality and patient experience among women seen in VA. VA policy action providing guidance on delivery of comprehensive healthcare services for women Veterans was disseminated nationally in 2010, followed by annual assessments and site visits evaluating local VA efforts. While substantial inroads have been made, policy implementation, even when leveraged by field-based women's health leaders, has not been uniformly successful in achieving delivery of comprehensive care by designated providers in gender-sensitive care environments that ensure women's privacy, dignity and safety, all tenets of the original guidance and the updated directive (2017).
Building on prior effectiveness of an evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model -- Patient Aligned Care Teams (PACT) -- to the needs of women Veterans, VA leaders in women's health adopted EBQI to help low-performing VAs systematically improve services.
Read more
The objectives of the resulting Partnered Evaluation Initiative (PEI) funded by VA's Quality Enhancement Research Initiative and VA Office of Women's Health were:
- To evaluate barriers and facilitators to achieving delivery of comprehensive women's health care in the identified low-performing VAs;
- To evaluate effectiveness of EBQI in supporting low-performing VA facilities achieve improved organizational features, provider/staff attitudes, quality of care, and patient experiences among women Veteran patients; and,
- To evaluate contextual factors, local implementation processes, and organizational changes in the participating facilities over time.
Read the detailed description
Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in quality and patient experience among women seen in VA. VA policy action providing guidance on delivery of comprehensive healthcare services for women Veterans was disseminated nationally in 2010, followed by annual assessments and site visits evaluating local VA efforts. While substantial inroads have been made, policy implementation, even when leveraged by field-based women's health leaders, has not been uniformly successful in achieving delivery of comprehensive care by designated providers in gender-sensitive care environments that ensure women's privacy, dignity and safety, all tenets of the original guidance and the updated VA directive (2017).
In collaboration with VA Women's Health Services (WHS), VA researchers developed a series of studies to better understand and help improve comprehensive care implementation through the Women Veterans' Healthcare CREATE Initiative. Among these, one focused on testing an evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model -- Patient Aligned Care Teams (PACT) -- to the needs of women Veterans, which has yielded significant local improvements in women Veterans' care. EBQI emphasizes a multilevel partnered approach to building capacity for innovation, implementation and spread of evidence-based practice. With its demonstrated success in the CREATE PACT study and several other EBQI trials, WHS adopted EBQI as a strategy to help low-performing VA facilities systematically improve services.
The objectives of the WHS/QUERI Partnered Evaluation Initiative that this project represents are:
- To evaluate the barriers and facilitators to achieving delivery of comprehensive women's health care in the identified low-performing VA facilities;
- To evaluate the effectiveness of EBQI in supporting low-performing VA facilities achieve improved:
- Organizational features (e.g., level of comprehensive services available; care coordination arrangements; PACT features implemented; environment of care improvements);
- Provider/staff attitudes (e.g., improved gender awareness; women's health knowledge and practice);
- Quality of care and patient experiences among women Veteran patients using secondary data; and,
- To evaluate contextual factors, local implementation processes, and organizational changes in the participating facilities over time.
Results of the evaluation have been used to provide feedback to stakeholders, including women Veterans, at the local, network and national levels, while also being used to continuously refine EBQI implementation processes. The evaluation is also helping inform optimal strategies for ongoing improvements in women Veterans' care in the 21 participating VA facilities, other VA facilities and for other improvement initiatives in this and other national program offices.
- Conditions
- Comprehensive Care
- Being tested
- Evidence-Based Quality Improvement
- Keywords
- women's health, primary health care, mental health, Veterans, quality improvement
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-Based Quality ImprovementOther
Also called EBQI
Multilevel research-clinical partnership approach to supporting local strategic planning, priority setting, skill building and engagement in addressing targeted healthcare delivery problems. Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI education/training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-Based Quality Improvement (EBQI) | Experimental | EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams. Receives: Other: Evidence-Based Quality Improvement |
| Waitlist Controls | No intervention | Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender-sensitive Care Environment
Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.
Measured: 12-month change in gender-sensitive care environment
Gender-sensitive Care Environment
Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.
Measured: 24-month change in gender-sensitive care environment
Gender Awareness
A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military background and healthcare needs. The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.
Measured: 12-month change in gender awareness among VA primary care and women's health providers and staff.
Gender Awareness
A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military roles and healthcare needs . The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.
Measured: 24-month change in gender awareness among VA primary care and women's health providers and staff
Quality Improvement Experience
The count of quality improvement activities reported by providers and staff in primary care and women's health settings; including 1) training in quality improvement methods, 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.
Measured: 12-month change
Quality Improvement Experience
The count of quality improvement activities reported by provider and staff in primary care and women's health settings; including 1) training in quality improvement methods [e.g., LEAN], 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.
Measured: 24-month change
Secondary outcomes (12)
Gender-specific Preventive Care Delivery
Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.
Measured: 12-month change
Gender-specific Preventive Care Delivery
Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.
Measured: 24-month change in gender-specific preventive care delivery
Accessibility of Care
Women Veterans' ratings of accessibility based on the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded "always" to validated survey items measuring accessibility, the higher percentage representing better access.
Measured: 12-month change in accessibility
Accessibility of Care
Women Veterans' ratings of accessibility from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded "always" to validated survey items measuring accessibility, the higher percentage representing better access.
Measured: 24-month change in accessibility
Coordination of Care
Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded "always" to validated survey items measuring care coordination, the higher percentage representing better coordination.
Measured: 12-month change
Coordination of Care
Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded "always" to validated survey items measuring care coordination, the higher percentage representing better coordination.
Measured: 24-month change
Gender-neutral Guideline-concordant Preventive Care Receipt
Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics.
Measured: 12-month change
Gender-neutral Guideline-concordant Preventive Care Receipt
Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics
Measured: 24-month change
Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass
Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting.
Measured: 12-month change
Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass
Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting
Measured: 24-month change
Provider Rating
Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question on the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.
Measured: 12 month change
Provider Rating
Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question from the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.
Measured: 24-month change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start9 Jan 2017
- Primary completion30 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comprehensive CareStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Dynamic waitlist control design with a group of 7 VA facilities was randomly allocated to Evidence-Based Quality Improvement (EBQI) in Year 1 (while 14 VA facilities serving as waitlist controls), the second group of 7 VA facilities was randomly allocated to EBQI in Year 2 (while the 7 remaining VA facilities and the first 7 EBQI sites serving as control), and the final group of 7 VA facilities was randomly allocated to EBQI in Year 3 (while the first 14 EBQI facilities subsequently serving as control). By the end of the three year study period, a total of 21 VA facilities received at least 1 year of EBQI.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elizabeth M Yano, PhD MSPH, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CAAlison B Hamilton, PhD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238417
- Sponsor's protocol ID
- PEX 16-002
- Other IDs
- PEC 16-352
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2017
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamilton AB, Olmos-Ochoa TT, Canelo I, Rose D, Hoggatt KJ, Than C, Yano EM. Dynamic waitlisted design for evaluating a randomized trial of evidence-based quality improvement of comprehensive women's health care implementation in low-performing VA facilities. Implement Sci Commun. 2020 Jun 30;1:59. doi: 10.1186/s43058-020-00038-0. eCollection 2020.
PubMed 32885214
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VA Facilities (PEC 16-352)
- ClinicalTrials.gov ID
- NCT03238417
- Acronym / sponsor ID
- PEX 16-002
- Conditions
- Comprehensive Care
- Keywords
- women's health, primary health care, mental health, Veterans, quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Posted 3 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in quality and patient experience among women seen in VA. VA policy action providing guidance on delivery of comprehensive healthcare services for women Veterans was disseminated nationally in 2010, followed by annual assessments and site visits evaluating local VA efforts. While substantial inroads have been made, policy implementation, even when leveraged by field-based women's health leaders, has not been uniformly successful in achieving delivery of comprehensive care by designated providers in gender-sensitive care environments that ensure women's privacy, dignity and safety, all tenets of the original guidance and the updated directive (2017).
Building on prior effectiveness of an evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model -- Patient Aligned Care Teams (PACT) -- to the needs of women Veterans, VA leaders in women's health adopted EBQI to help low-performing VAs systematically improve services.
The objectives of the resulting Partnered Evaluation Initiative (PEI) funded by VA's Quality Enhancement Research Initiative and VA Office of Women's Health were:
- To evaluate barriers and facilitators to achieving delivery of comprehensive women's health care in the identified low-performing VAs;
- To evaluate effectiveness of EBQI in supporting low-performing VA facilities achieve improved organizational features, provider/staff attitudes, quality of care, and patient experiences among women Veteran patients; and,
- To evaluate contextual factors, local implementation processes, and organizational changes in the participating facilities over time.
Detailed description
Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in quality and patient experience among women seen in VA. VA policy action providing guidance on delivery of comprehensive healthcare services for women Veterans was disseminated nationally in 2010, followed by annual assessments and site visits evaluating local VA efforts. While substantial inroads have been made, policy implementation, even when leveraged by field-based women's health leaders, has not been uniformly successful in achieving delivery of comprehensive care by designated providers in gender-sensitive care environments that ensure women's privacy, dignity and safety, all tenets of the original guidance and the updated VA directive (2017).
In collaboration with VA Women's Health Services (WHS), VA researchers developed a series of studies to better understand and help improve comprehensive care implementation through the Women Veterans' Healthcare CREATE Initiative. Among these, one focused on testing an evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model -- Patient Aligned Care Teams (PACT) -- to the needs of women Veterans, which has yielded significant local improvements in women Veterans' care. EBQI emphasizes a multilevel partnered approach to building capacity for innovation, implementation and spread of evidence-based practice. With its demonstrated success in the CREATE PACT study and several other EBQI trials, WHS adopted EBQI as a strategy to help low-performing VA facilities systematically improve services.
The objectives of the WHS/QUERI Partnered Evaluation Initiative that this project represents are:
- To evaluate the barriers and facilitators to achieving delivery of comprehensive women's health care in the identified low-performing VA facilities;
- To evaluate the effectiveness of EBQI in supporting low-performing VA facilities achieve improved:
- Organizational features (e.g., level of comprehensive services available; care coordination arrangements; PACT features implemented; environment of care improvements);
- Provider/staff attitudes (e.g., improved gender awareness; women's health knowledge and practice);
- Quality of care and patient experiences among women Veteran patients using secondary data; and,
- To evaluate contextual factors, local implementation processes, and organizational changes in the participating facilities over time.
Results of the evaluation have been used to provide feedback to stakeholders, including women Veterans, at the local, network and national levels, while also being used to continuously refine EBQI implementation processes. The evaluation is also helping inform optimal strategies for ongoing improvements in women Veterans' care in the 21 participating VA facilities, other VA facilities and for other improvement initiatives in this and other national program offices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dynamic waitlist control design with a group of 7 VA facilities was randomly allocated to Evidence-Based Quality Improvement (EBQI) in Year 1 (while 14 VA facilities serving as waitlist controls), the second group of 7 VA facilities was randomly allocated to EBQI in Year 2 (while the 7 remaining VA facilities and the first 7 EBQI sites serving as control), and the final group of 7 VA facilities was randomly allocated to EBQI in Year 3 (while the first 14 EBQI facilities subsequently serving as control). By the end of the three year study period, a total of 21 VA facilities received at least 1 year of EBQI.
| Arm | Type | Receives |
|---|---|---|
| Evidence-Based Quality Improvement (EBQI) | Experimental | Other: Evidence-Based Quality ImprovementEBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams. |
| Waitlist Controls | No intervention | –Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Unit of randomization: VA healthcare facilities (VA medical center or community-based outpatient clinic)
- Subset of VA healthcare facilities identified as low-performing on the basis of composites of access/wait times, gender disparities in quality, e.g.:
- Presence/absence of VA-required structural facets of care, e.g.:
- Veteran Integrated Service Network (VISN) level leader (Director or Chief Medical Officer)
- VISN level WVPM Lead, VISN level primary care director, VISN level QI/system redesign lead)
Key exclusion criteria (1 listed)
- Facility-level exclusion: Facilities not identified in the initial sample of VA facilities (sample not renewed over time).
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 |
|---|---|---|
| Evidence-Based Quality ImprovementAlso: EBQIMultilevel research-clinical partnership approach to supporting local strategic planning, priority setting, skill building and engagement in addressing targeted healthcare delivery problems. Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI education/training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines. | Other | Evidence-Based Quality Improvement (EBQI) |
Primary outcome
Gender-sensitive Care Environment
Time frame: 12-month change in gender-sensitive care environment
Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.
Gender-sensitive Care Environment
Time frame: 24-month change in gender-sensitive care environment
Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.
Gender Awareness
Time frame: 12-month change in gender awareness among VA primary care and women's health providers and staff.
A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military background and healthcare needs. The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.
Gender Awareness
Time frame: 24-month change in gender awareness among VA primary care and women's health providers and staff
A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military roles and healthcare needs . The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.
Quality Improvement Experience
Time frame: 12-month change
The count of quality improvement activities reported by providers and staff in primary care and women's health settings; including 1) training in quality improvement methods, 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.
Quality Improvement Experience
Time frame: 24-month change
The count of quality improvement activities reported by provider and staff in primary care and women's health settings; including 1) training in quality improvement methods [e.g., LEAN], 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.
12 secondary outcomes
Gender-specific Preventive Care Delivery
Time frame: 12-month change
Gender-specific Preventive Care Delivery
Time frame: 24-month change in gender-specific preventive care delivery
Accessibility of Care
Time frame: 12-month change in accessibility
Accessibility of Care
Time frame: 24-month change in accessibility
Coordination of Care
Time frame: 12-month change
Coordination of Care
Time frame: 24-month change
Gender-neutral Guideline-concordant Preventive Care Receipt
Time frame: 12-month change
Gender-neutral Guideline-concordant Preventive Care Receipt
Time frame: 24-month change
Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass
Time frame: 12-month change
Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass
Time frame: 24-month change
Provider Rating
Time frame: 12 month change
Provider Rating
Time frame: 24-month change
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32885214Hamilton AB, Olmos-Ochoa TT, Canelo I, Rose D, Hoggatt KJ, Than C, Yano EM. Dynamic waitlisted design for evaluating a randomized trial of evidence-based quality improvement of comprehensive women's health care implementation in low-performing VA facilities. Implement Sci Commun. 2020 Jun 30;1:59. doi: 10.1186/s43058-020-00038-0. eCollection 2020.
- Individual participant dataSharing planned: No
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Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
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.
Elizabeth M Yano, PhD MSPH principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Alison B Hamilton, PhD MPH principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-Based Quality Improvement in people with Comprehensive Care, run by VA Office of Research and Development at 25 sites in United States.
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 28 inclusion and 1 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gender-sensitive Care Environment (time frame: 12-month change in gender-sensitive care environment). The study lists 6 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 NCT03238417, 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 27 Jul 2023.