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

July 19, 2023 updated by: VA Office of Research and Development

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. To evaluate the barriers and facilitators to achieving delivery of comprehensive women's health care in the identified low-performing VA facilities;

  2. To evaluate the effectiveness of EBQI in supporting low-performing VA facilities achieve improved:

    1. Organizational features (e.g., level of comprehensive services available; care coordination arrangements; PACT features implemented; environment of care improvements);
    2. 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,

  3. 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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36109
        • Central Alabama Veterans Health Care System West Campus, Montgomery, AL
    • Arizona
      • Prescott, Arizona, United States, 86313
        • Northern Arizona VA Health Care System, Prescott, AZ
    • California
      • Sacramento, California, United States, 95655
        • VA Northern California Health Care System, Mather, CA
      • Sepulveda, California, United States, 91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA
    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Eastern Colorado Health Care System, Denver, CO
    • Florida
      • Gainesville, Florida, United States, 32608
        • North Florida/South Georgia Veterans Health System, Gainesville, FL
      • Miami, Florida, United States, 33125
        • Miami VA Healthcare System, Miami, FL
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical and Rehab Center, Decatur, GA
      • Dublin, Georgia, United States, 31021
        • Carl Vinson VA Medical Center, Dublin, GA
    • Illinois
      • Marion, Illinois, United States, 62959
        • Marion VA Medical Center, Marion, IL
    • Kansas
      • Wichita, Kansas, United States, 67218
        • Robert J. Dole Department of Veterans Affairs Medical and Regional Office Center, Wichita, KS
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Overton Brooks VA Medical Center, Shreveport, LA
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Rehabilitation R&D Service, Baltimore, MD
    • Michigan
      • Battle Creek, Michigan, United States, 49037
        • Battle Creek VA Medical Center, Battle Creek, MI
    • Missouri
      • Columbia, Missouri, United States, 65201-5297
        • Harry S. Truman Memorial, Columbia, MO
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • VA Southern Nevada Healthcare System, North Las Vegas, NV
    • New York
      • Bath, New York, United States, 14810
        • Bath VA Medical Center, Bath, NY
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
    • Ohio
      • Columbus, Ohio, United States, 43203-1278
        • Chalmers P. Wylie Ambulatory Care Center, Columbus, OH
    • South Dakota
      • Fort Meade, South Dakota, United States, 57741
        • VA Black Hills Health Care System Fort Meade Campus, Fort Meade, SD
    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Health Care System, San Antonio, TX
      • Temple, Texas, United States, 76504
        • Central Texas Veterans Health Care System, Temple, TX
    • Virginia
      • Hampton, Virginia, United States, 23667
        • Hampton VA Medical Center, Hampton, VA
    • Washington
      • Walla Walla, Washington, United States, 99362
        • Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evidence-Based Quality Improvement (EBQI)
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.
Other: Evidence-Based Quality Improvement
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
No Intervention: Waitlist Controls
Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-month change in 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.
24-month change in 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.
12-month change in gender awareness among VA primary care and women's health providers and staff.
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.
24-month change in gender awareness among VA primary care and women's health providers and staff
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.
12-month change
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.
24-month change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-month change
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.
24-month change in gender-specific preventive care delivery
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.
12-month change in accessibility
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.
24-month change in accessibility
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.
12-month change
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.
24-month change
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.
12-month change
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
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
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.
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
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
24-month change
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 month change
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.
24-month change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Elizabeth M Yano, PhD MSPH, VA Greater Los Angeles Healthcare System, Sepulveda, CA
  • Principal Investigator: Alison B Hamilton, PhD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2017

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEX 16-002
  • PEC 16-352 (Other Grant/Funding Number: QUERI Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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