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

NCT ID: NCT03238417

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-09
• Study Completion Date: 2020-11-30

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.

Conditions

Comprehensive Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Evidence-Based Quality Improvement

Intervention Type: 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.

Waitlist Controls

Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

EBQI

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

• 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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth M Yano, PhD MSPH

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Alison B Hamilton, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Locations

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

Montgomery, Alabama, 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

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, United States

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, United States

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Carl Vinson VA Medical Center, Dublin, GA

Dublin, Georgia, United States

Marion VA Medical Center, Marion, IL

Marion, Illinois, United States

Robert J. Dole Department of Veterans Affairs Medical and Regional Office Center, Wichita, KS

Wichita, Kansas, United States

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, United States

Rehabilitation R&D Service, Baltimore, MD

Baltimore, Maryland, 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

VA Southern Nevada Healthcare System, North Las Vegas, NV

Las Vegas, Nevada, United States

Bath VA Medical Center, Bath, NY

Bath, New York, United States

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

Salisbury, North Carolina, United States

Chalmers P. Wylie Ambulatory Care Center, Columbus, OH

Columbus, Ohio, United States

VA Black Hills Health Care System Fort Meade Campus, Fort Meade, SD

Fort Meade, South Dakota, United States

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, United States

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia, United States

Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA

Walla Walla, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32885214 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PEC 16-352

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PEX 16-002

Identifier Type: -

Identifier Source: org_study_id