Implementation of Women's Health Patient Aligned Care Teams (WH-PACT)

June 15, 2023 updated by: VA Office of Research and Development

Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs

VA has undertaken a major initiative to transform care through implementation of Patient Aligned Care Teams (PACTs). Based on the patient-centered medical home (PCMH) concept, PACT aims to improve access, continuity, coordination and comprehensiveness using team-based care that is patient-driven and patient-centered. However, how VA should adapt PACT to meet the needs of special populations, such as women Veterans, is yet to be worked out. The main goal of this study was to develop and test an evidence-based quality improvement (EBQI) approach to adapting and implementing PACT for women Veterans, incorporating comprehensive women's health care in gender-sensitive care environments, thereby accelerating achievement of PACT tenets for women Veterans and reducing persistent gender disparities in VA quality of care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women Veterans' numerical minority in VA healthcare settings has created logistical challenges to delivering gender-sensitive comprehensive services. These challenges only grew as more women Veterans enrolled in VA care. Access and quality lagged behind that of male Veterans, while gender sensitivity, including adequate attention to privacy/safety and awareness of women's military roles and experiences, were often lacking. On-site availability of gender-specific services had also not kept pace, with women Veterans more likely to be outsourced for gender-specific care than they were ten years previously. Further, while the proportion of VA facilities having women's health (WH) clinics had increased, prior research demonstrated that as many as 40% of them were not delivering comprehensive primary care services, instead focusing only on gender-specific exams. Lack of gender-sensitive, comprehensive care for women has also been associated with measurable decrements in women's ratings of VA access, continuity and coordination, as well as measures of technical quality.

The investigators aimed to assess the effectiveness of evidence-based quality improvement (EBQI) methods for developing a WH PACT model using a cluster randomized controlled trial (cRCT) design (Aim #1); examine impacts of receipt of WH-PACT concordant care on women Veterans' outcomes (Aim #2); evaluate processes of EBQI-supported WH-PACT implementation (Aim #3); and develop implementation and evaluation tools for use in EBQI-supported WH-PACT model adaptation, implementation, sustainability and spread to additional VA facilities (Aim #4).

EBQI is a systematic approach to developing a multi-level research-clinical partnership approach to engaging local organizational senior leaders and quality improvement teams in adapting and implementing new care models in the context of prior evidence, local practice context, and provider behavior change methods, with researchers providing technical support and practice facilitation. In a cluster randomized trial, the investigators evaluated WH-PACT model achievement using patient, provider and practice surveys. The investigators examined intermediate changes in provider, staff and team knowledge and attitudes. Using analyses of secondary administrative and performance data, the investigators also explored impacts of receipt of WH-PACT care on quality of chronic disease care and prevention, health status, and utilization. Using mixed methods, the investigators assessed pre-post EBQI practice context; documented WH-PACT implementation; and examined barriers/facilitators to EBQI-supported WH-PACT implementation through a combination of semi-structured interviews and formative progress narratives and administrative data review.

Study Type

Interventional

Enrollment (Actual)

3900

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
    • California
      • Sepulveda, California, United States, 91343
        • VA Greater Los Angeles Healthcare System, Sepulveda, CA
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center, Chicago, IL
      • Hines, Illinois, United States, 60141-5000
        • Edward Hines Jr. VA Hospital, Hines, IL
    • Iowa
      • Iowa City, Iowa, United States, 52246-2208
        • Iowa City VA Health Care System, Iowa City, IA
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
      • Leeds, Massachusetts, United States, 01053-9764
        • VA Central Western Massachusetts Healthcare System, Leeds, MA
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System, Minneapolis, MN
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Fargo VA Healthcare System, Fargo, ND
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center, Philadelphia, PA
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • William S. Middleton Memorial Veterans Hospital, Madison, WI

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:

Facility inclusion criteria:

  • VA medical center (VAMC)
  • Located in a VISN that has 3 or more VAMCs
  • Membership in the Women's Health Practice Based Research Network (PBRN)

Key Stakeholder (interviews) inclusion criteria:

  • VISN and VAMC leaders, VAMC primary care/PACT directors, VAMC women's health medical directors, Women Veteran Program Managers (VISN and VAMC), VISN representatives in mental health, health information technology/informatics, quality improvement/system redesign, at least one Nurse Executive (VISN or VAMC)
  • Intervention and control VAMCs

Provider (surveys and interviews) inclusion criteria:

  • Primary care providers (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner [NP], physician assistant [PA]) who have seen 1+ women Veterans in the past year
  • Teamlet primary care provider interviews (MD, DO, NP, PA) at intervention VAMCs
  • Surveys of primary care providers (MD, DO, NP, PA) at intervention and control VAMCs
  • Surveys of larger primary care/PACT team members (e.g., clinical pharmacists, health coaches)

Staff (surveys and interviews) inclusion criteria:

  • Primary care/PACT clinical staff (non-providers) in primary care/PACT teams/teamlets that have seen 1+ women Veterans in the past year
  • Teamlet member interviews at Intervention VAMCs

Patient inclusion criteria:

- Women Veterans seen in participating VAMCs with 3+ primary care visits in general primary care and/or women's health clinics in the past year

Exclusion Criteria:

Facility exclusion criteria:

  • VA facilities that are not VAMCs (e.g., community-based outpatient clinics or CBOCs)
  • VAMCs in VISNs with fewer than 3 VAMCs
  • VAMCs that are not members of the WH PBRN

Key Stakeholder (interviews) exclusion criteria:

- Stakeholders outside of the participating VISNs (1, 4, 12, 23) and VAMCs (see study sites)

Provider (surveys and interviews) exclusion criteria:

  • VA providers who do not deliver primary care in participating VAMCs
  • VA primary care providers who have not seen or do not see women Veteran patients for primary care delivery at a participating VAMC
  • Teamlet providers at control VAMCs will not be interviewed

Staff (surveys and interviews) exclusion criteria:

  • Primary care clinical staff not participating in PACT (e.g., assigned to primary care rolls but not actually associated with primary care/PACT direct patient care delivery)
  • Primary care/PACT clinical staff at control VAMCs will not be interviewed

Patient exclusion criteria:

  • Women Veterans who do not use the VA for their health care or for their primary care needs
  • Women Veterans with fewer than 3 VA primary care visits in the prior year and therefore not exposed to PACT or WH PACT
  • Women Veterans with terminal illness and/or poor prognosis or other health concerns for whom enrollment and survey participation would prove an inappropriate burden

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBQI-Supported WH-PACT Implementation
Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.
Other: Multilevel stakeholder engagement
Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings
Other: Quality improvement (QI) education/training
Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement
Other: Technical support
Research team provided technical review of and feedback on local QI project proposals, helped develop and/or recommend process/outcome measures, identified and shared relevant published literature (e.g., measures, interventions), and provided general technical support (e.g., how to analyze local data, how to conduct a local focus group)
Other: Formative feedback
Research team provided aggregated all-site and local data from baseline patient and provider/staff surveys, 12-month patient surveys, and other data and findings to local teams for ongoing and new QI project idea development
Other: External practice facilitation
Within and across site calls with local teams to review progress, identify needs, help solve problems, discuss current and new projects, as well as potential for spread
Other Names:
  • Facilitation
Other: National policy guidance
VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities
Active Comparator: Routine WH-PACT Implementation
National policy guidance
Other: National policy guidance
VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WH-PACT Achievement
Time Frame: Baseline to 24-month
The Women's Health Patient-Aligned Care Team achievement, based on four patient-reported measures of access to care, patient-provider communication, comprehensiveness of care, and gender-appropriateness of care. The WH-PACT achievement is an aggregate score from -4 to +4, with the higher score meaning better PACT achievement.
Baseline to 24-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Providers' and Staff Gender Sensitivity
Time Frame: Baseline to 24-month
Gender sensitivity score based on 10 survey items related to providers' and staff's sensitivity towards women Veterans during patient care. The score ranged from 1 to 5 with the higher score reflecting greater gender sensitivity toward women Veterans.
Baseline to 24-month
Team Functioning
Time Frame: Baseline to 24-month
Perceived team functioning of primary care and women's health providers and staff, measured based on responses to 7 survey items. The team functioning score ranged from 1 to 5 , with the higher score indicating better team functioning.
Baseline to 24-month
Providers and Staff Burnout
Time Frame: 24-month
Burnout was measured using one item: "How often does the following statement apply to you: I feel burned out from my work" with options for 1.Never, 2. A few times a year, 3. Every month, 4. A few times a month, 5. Every week, 6. A few times a week, 7. Every day. We recoded the responses into a binary value: never/less than a few times a month (1-4) and every week-to-everyday (5-7).
24-month
Patient VA Primary Care Visits Per Year
Time Frame: Baseline to 24month
Average number of visits to VA primary care per year
Baseline to 24month
Patient VA Women's Health Care Visits Per Year
Time Frame: Baseline to 24month
Average number of patient visits to VA women's health care per year
Baseline to 24month
Patient VA Hospitalization
Time Frame: Baseline to 24-month
Average number of patient hospitalization for any cause in a year
Baseline to 24-month
Patient Emergency Room Visits
Time Frame: baseline to 24-month
Average number of patient emergency room visits for any cause in a year
baseline to 24-month

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Collaborators

University of California, Los Angeles
RAND

Investigators

  • Principal Investigator: Elizabeth M. Yano, PhD MSPH, VA Greater Los Angeles Healthcare System, Sepulveda, 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)

May 9, 2014

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimated)

January 20, 2014

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRE 12-026

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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