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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02039856
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
University of California, Los Angeles
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patient-centered Medical Home Implementation Other: Multilevel stakeholder engagement Other: Quality improvement (QI) education/training Other: Technical support Other: Formative feedback Other: External practice facilitation Other: National policy guidance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial (cRCT) among 12 VAMCs with unbalanced allocation (2:1) blocked on VA network (Veterans Integrated Service Network or VISN)
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs
Actual Study Start Date : May 9, 2014
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Women's Health

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 Name: 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. Patient VA Primary Care Visits Per Year [ Time Frame: Baseline to 24month ]
    Average number of visits to VA primary care per year

  5. 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

  6. Patient VA Hospitalization [ Time Frame: Baseline to 24-month ]
    Average number of patient hospitalization for any cause in a year

  7. Patient Emergency Room Visits [ Time Frame: baseline to 24-month ]
    Average number of patient emergency room visits for any cause in a year

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only the patient survey component is gender-based (includes women Veterans only). Eligibility for provider/staff surveys or key stakeholder interviews is not gender-based.
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02039856

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United States, California
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2208
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, United States, 01053-9764
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, North Dakota
Fargo VA Healthcare System, Fargo, ND
Fargo, North Dakota, United States, 58102
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
United States, West Virginia
Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV
Clarksburg, West Virginia, United States, 26301
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
VA Office of Research and Development
University of California, Los Angeles
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Principal Investigator: Elizabeth M. Yano, PhD MSPH VA Greater Los Angeles Healthcare System, Sepulveda, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Publications of Results:

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development Identifier: NCT02039856     History of Changes
Other Study ID Numbers: CRE 12-026
First Posted: January 20, 2014    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Patient-centered medical homes
Primary care
Women's health