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

NCT03238417 | Completed Results

• 2 other identifiers: PEX 16-002PEC 16-352
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 25

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

Conditions

Comprehensive Care

Keywords

women's health; primary health care; mental health; Veterans; quality improvement

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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 Outcomes (12)

• Gender-specific Preventive Care Delivery

  12-month change

• Gender-specific Preventive Care Delivery

  24-month change in gender-specific preventive care delivery

• Accessibility of Care

  12-month change in accessibility

• Accessibility of Care

  24-month change in accessibility

• Coordination of Care

  12-month change

Study Arms (2)

Evidence-Based Quality Improvement (EBQI)

EXPERIMENTAL

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

Waitlist Controls

NO INTERVENTION

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

Interventions

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.

Also known as: EBQI

Evidence-Based Quality Improvement (EBQI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• :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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (25)

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

Montgomery, Alabama, 36109, United States

Location

Northern Arizona VA Health Care System, Prescott, AZ

Prescott, Arizona, 86313, United States

Location

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

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

Gainesville, Florida, 32608, United States

Location

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Carl Vinson VA Medical Center, Dublin, GA

Dublin, Georgia, 31021, United States

Location

Marion VA Medical Center, Marion, IL

Marion, Illinois, 62959, United States

Location

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

Wichita, Kansas, 67218, United States

Location

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, 71101, United States

Location

Rehabilitation R&D Service, Baltimore, MD

Baltimore, Maryland, 21202, United States

Location

Battle Creek VA Medical Center, Battle Creek, MI

Battle Creek, Michigan, 49037, United States

Location

Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri, 65201-5297, United States

Location

VA Southern Nevada Healthcare System, North Las Vegas, NV

Las Vegas, Nevada, 89106, United States

Location

Bath VA Medical Center, Bath, NY

Bath, New York, 14810, United States

Location

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

Salisbury, North Carolina, 28144, United States

Location

Chalmers P. Wylie Ambulatory Care Center, Columbus, OH

Columbus, Ohio, 43203-1278, United States

Location

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

Fort Meade, South Dakota, 57741, United States

Location

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504, United States

Location

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia, 23667, United States

Location

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

Walla Walla, Washington, 99362, United States

Location

Related Publications (1)

• 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.

  PMID: 32885214 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Results Point of Contact

• Title: Elizabeth M. Yano, PhD, MSPH
• Organization: VA Greater Los Angeles Healthcare System

elizabeth.yano@va.gov

818-891-7711

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 3, 2017
• Study Start: January 9, 2017
• Primary Completion: September 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 27, 2023
• Results First Posted: August 3, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)