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Completed

NCT Number: NCT03238417

Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VAs

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:

1. To evaluate barriers and facilitators to achieving delivery of comprehensive women's health care in the identified low-performing VAs; 2. 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, 3. To evaluate contextual factors, local implementation processes, and organizational changes in the participating facilities over time.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Alabama Veterans Health Care System West Campus, Montgomery, AL, Montgomery, Alabama, United States

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About this study

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);

d) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • Facility-level exclusion: Facilities not identified in the initial sample of VA facilities (sample not renewed over time).

Treatment and study plan

Evidence-Based Quality Improvement

Other

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.

Other names: EBQI

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Gender-specific Preventive Care Delivery

    Time frame: 12-month change

    Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.

  2. Gender-specific Preventive Care Delivery

    Time frame: 24-month change in gender-specific preventive care delivery

    Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.

  3. Accessibility of Care

    Time frame: 12-month change in accessibility

    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.

  4. Accessibility of Care

    Time frame: 24-month change in accessibility

    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.

  5. Coordination of Care

    Time frame: 12-month change

    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.

  6. Coordination of Care

    Time frame: 24-month change

    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.

  7. Gender-neutral Guideline-concordant Preventive Care Receipt

    Time frame: 12-month change

    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.

  8. Gender-neutral Guideline-concordant Preventive Care Receipt

    Time frame: 24-month change

    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

  9. 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

    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.

  10. 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

    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

  11. Provider Rating

    Time frame: 12 month change

    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.

  12. Provider Rating

    Time frame: 24-month change

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VA Facilities (PEC 16-352)

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2017
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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