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

Comprehensive Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238417
• Other study ID #: PEX 16-002
• Secondary ID: PEC 16-352
• Status: Completed
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Comprehensive Care

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.	12-month change in gender awareness among VA primary care and women's health providers and staff.
Primary	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.	24-month change in gender awareness among VA primary care and women's health providers and staff
Primary	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.	12-month change
Primary	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.	24-month change
Secondary	Gender-specific Preventive Care Delivery	Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.	12-month change
Secondary	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
Secondary	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.	12-month change in accessibility
Secondary	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.	24-month change in accessibility
Secondary	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.	12-month change
Secondary	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.	24-month change
Secondary	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.	12-month change
Secondary	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	24-month change
Secondary	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.	12-month change
Secondary	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	24-month change
Secondary	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.	12 month change
Secondary	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.	24-month change