Clinical trial NCT03238417: Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VAs
Official title: Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VA Facilities (PEC 16-352)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comprehensive Care
Keywords: women's health
primary health care
mental health
Veterans
quality improvement
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-08-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Gender-sensitive Care Environment
timeFrame: 12-month change in gender-sensitive care environment
measure: Gender-sensitive Care Environment
timeFrame: 24-month change in gender-sensitive care environment
measure: Gender Awareness
timeFrame: 12-month change in gender awareness among VA primary care and women's health providers and staff.
measure: Gender Awareness
timeFrame: 24-month change in gender awareness among VA primary care and women's health providers and staff
measure: Quality Improvement Experience
timeFrame: 12-month change
measure: Quality Improvement Experience
timeFrame: 24-month change
Secondary outcomes:
measure: Gender-specific Preventive Care Delivery
timeFrame: 12-month change
measure: Gender-specific Preventive Care Delivery
timeFrame: 24-month change in gender-specific preventive care delivery
measure: Accessibility of Care
timeFrame: 12-month change in accessibility
measure: Accessibility of Care
timeFrame: 24-month change in accessibility
measure: Coordination of Care
timeFrame: 12-month change
measure: Coordination of Care
timeFrame: 24-month change
measure: Gender-neutral Guideline-concordant Preventive Care Receipt
timeFrame: 12-month change
measure: Gender-neutral Guideline-concordant Preventive Care Receipt
timeFrame: 24-month change
measure: Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass
timeFrame: 12-month change
measure: Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass
timeFrame: 24-month change
measure: Provider Rating
timeFrame: 12 month change
measure: Provider Rating
timeFrame: 24-month change
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Central Alabama Veterans Health Care System West Campus, Montgomery, AL
state: Alabama
city: Prescott
country: United States
facility: Northern Arizona VA Health Care System, Prescott, AZ
state: Arizona
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver, CO
state: Colorado
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
city: Miami
country: United States
facility: Miami VA Healthcare System, Miami, FL
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Dublin
country: United States
facility: Carl Vinson VA Medical Center, Dublin, GA
state: Georgia
city: Marion
country: United States
facility: Marion VA Medical Center, Marion, IL
state: Illinois
city: Wichita
country: United States
facility: Robert J. Dole Department of Veterans Affairs Medical and Regional Office Center, Wichita, KS
state: Kansas
city: Shreveport
country: United States
facility: Overton Brooks VA Medical Center, Shreveport, LA
state: Louisiana
city: Baltimore
country: United States
facility: Rehabilitation R&D Service, Baltimore, MD
state: Maryland
city: Battle Creek
country: United States
facility: Battle Creek VA Medical Center, Battle Creek, MI
state: Michigan
city: Columbia
country: United States
facility: Harry S. Truman Memorial, Columbia, MO
state: Missouri
city: Las Vegas
country: United States
facility: VA Southern Nevada Healthcare System, North Las Vegas, NV
state: Nevada
city: Bath
country: United States
facility: Bath VA Medical Center, Bath, NY
state: New York
city: Salisbury
country: United States
facility: Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
state: North Carolina
city: Columbus
country: United States
facility: Chalmers P. Wylie Ambulatory Care Center, Columbus, OH
state: Ohio
city: Fort Meade
country: United States
facility: VA Black Hills Health Care System Fort Meade Campus, Fort Meade, SD
state: South Dakota
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
city: Hampton
country: United States
facility: Hampton VA Medical Center, Hampton, VA
state: Virginia
city: Walla Walla
country: United States
facility: Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA
state: Washington
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
name: Elizabeth M Yano, PhD MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Alison B Hamilton, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.