Implementation of Women's Health Patient Aligned Care Teams

NCT ID: NCT02039856

Last Updated: 2023-06-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-09

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient-centered Medical Home Implementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial (cRCT) among 12 VAMCs with unbalanced allocation (2:1) blocked on VA network (Veterans Integrated Service Network or VISN)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Multilevel stakeholder engagement

Intervention Type OTHER

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

Quality improvement (QI) education/training

Intervention Type OTHER

Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement

Technical support

Intervention Type OTHER

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)

Formative feedback

Intervention Type OTHER

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

External practice facilitation

Intervention Type OTHER

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

National policy guidance

Intervention Type OTHER

VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Routine WH-PACT Implementation

National policy guidance

Group Type ACTIVE_COMPARATOR

National policy guidance

Intervention Type OTHER

VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Interventions

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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

Intervention Type OTHER

Quality improvement (QI) education/training

Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement

Intervention Type 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)

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Facilitation

Eligibility Criteria

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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)


* 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


* 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)


* 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


\- 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

* 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


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


* 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


* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

RAND

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth M. Yano, PhD MSPH

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Locations

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VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, United States

Site Status

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Site Status

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

Site Status

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Site Status

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, United States

Site Status

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Site Status

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, United States

Site Status

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Site Status

Fargo VA Healthcare System, Fargo, ND

Fargo, North Dakota, United States

Site Status

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Site Status

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status

Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV

Clarksburg, West Virginia, United States

Site Status

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Yano EM, Bair MJ, Carrasquillo O, Krein SL, Rubenstein LV. Patient Aligned Care Teams (PACT): VA's journey to implement patient-centered medical homes. J Gen Intern Med. 2014 Jul;29 Suppl 2(Suppl 2):S547-9. doi: 10.1007/s11606-014-2835-8. No abstract available.

Reference Type BACKGROUND
PMID: 24715407 (View on PubMed)

Yano EM, Haskell S, Hayes P. Delivery of gender-sensitive comprehensive primary care to women veterans: implications for VA Patient Aligned Care Teams. J Gen Intern Med. 2014 Jul;29 Suppl 2(Suppl 2):S703-7. doi: 10.1007/s11606-013-2699-3.

Reference Type BACKGROUND
PMID: 24715395 (View on PubMed)

Chuang E, Brunner J, Mak S, Hamilton AB, Canelo I, Darling J, Rubenstein LV, Yano EM. Challenges with Implementing a Patient-Centered Medical Home Model for Women Veterans. Womens Health Issues. 2017 Mar-Apr;27(2):214-220. doi: 10.1016/j.whi.2016.11.005. Epub 2017 Jan 4.

Reference Type RESULT
PMID: 28063848 (View on PubMed)

Hamilton AB, Brunner J, Cain C, Chuang E, Luger TM, Canelo I, Rubenstein L, Yano EM. Engaging multilevel stakeholders in an implementation trial of evidence-based quality improvement in VA women's health primary care. Transl Behav Med. 2017 Sep;7(3):478-485. doi: 10.1007/s13142-017-0501-5.

Reference Type RESULT
PMID: 28585163 (View on PubMed)

Goldstein KM, Vogt D, Hamilton A, Frayne SM, Gierisch J, Blakeney J, Sadler A, Bean-Mayberry BM, Carney D, DiLeone B, Fox AB, Klap R, Yee E, Romodan Y, Strehlow H, Yosef J, Yano EM. Practice-based research networks add value to evidence-based quality improvement. Healthc (Amst). 2018 Jun;6(2):128-134. doi: 10.1016/j.hjdsi.2017.06.008. Epub 2017 Jul 13.

Reference Type RESULT
PMID: 28711505 (View on PubMed)

Meredith LS, Azhar G, Okunogbe A, Canelo IA, Darling JE, Street AE, Yano EM. Primary Care Providers with More Experience and Stronger Self-Efficacy Beliefs Regarding Women Veterans Screen More Frequently for Interpersonal Violence. Womens Health Issues. 2017 Sep-Oct;27(5):586-591. doi: 10.1016/j.whi.2017.06.003. Epub 2017 Jul 25.

Reference Type RESULT
PMID: 28754476 (View on PubMed)

Meredith LS, Wang Y, Okunogbe A, Bergman AA, Canelo IA, Darling JE, Yano EM. Attitudes, Practices, and Experiences with Implementing a Patient-Centered Medical Home for Women Veterans. Womens Health Issues. 2017 Mar-Apr;27(2):221-227. doi: 10.1016/j.whi.2016.11.008. Epub 2017 Jan 10.

Reference Type RESULT
PMID: 28087130 (View on PubMed)

Yano EM, Hamilton AB. Accelerating delivery of trauma-sensitive care: Using multilevel stakeholder engagement to improve care for women veterans. Fam Syst Health. 2017 Sep;35(3):373-375. doi: 10.1037/fsh0000288.

Reference Type RESULT
PMID: 28945449 (View on PubMed)

Hamilton AB, Yano EM. The importance of symbolic and engaged participation in evidence-based quality improvement in a complex integrated healthcare system: response to "The science of stakeholder engagement in research". Transl Behav Med. 2017 Sep;7(3):492-494. doi: 10.1007/s13142-017-0528-7.

Reference Type RESULT
PMID: 28929322 (View on PubMed)

Brunner J, Chuang E, Washington DL, Rose DE, Chanfreau-Coffinier C, Darling JE, Canelo IA, Yano EM. Patient-Rated Access to Needed Care: Patient-Centered Medical Home Principles Intertwined. Womens Health Issues. 2018 Mar-Apr;28(2):165-171. doi: 10.1016/j.whi.2017.12.001. Epub 2018 Jan 12.

Reference Type RESULT
PMID: 29339012 (View on PubMed)

Narain K, Bean-Mayberry B, Washington DL, Canelo IA, Darling JE, Yano EM. Access to Care and Health Outcomes Among Women Veterans Using Veterans Administration Health Care: Association With Food Insufficiency. Womens Health Issues. 2018 May-Jun;28(3):267-272. doi: 10.1016/j.whi.2018.01.002. Epub 2018 Feb 21.

Reference Type RESULT
PMID: 29475630 (View on PubMed)

Hoggatt KJ, Simpson T, Schweizer CA, Drexler K, Yano EM. Identifying women veterans with unhealthy alcohol use using gender-tailored screening. Am J Addict. 2018 Mar;27(2):97-100. doi: 10.1111/ajad.12689.

Reference Type RESULT
PMID: 29489045 (View on PubMed)

Yano EM, Darling JE, Hamilton AB, Canelo I, Chuang E, Meredith LS, Rubenstein LV. Cluster randomized trial of a multilevel evidence-based quality improvement approach to tailoring VA Patient Aligned Care Teams to the needs of women Veterans. Implement Sci. 2016 Jul 19;11(1):101. doi: 10.1186/s13012-016-0461-z.

Reference Type RESULT
PMID: 27435723 (View on PubMed)

Brunner J, Cain CL, Yano EM, Hamilton AB. Local Leaders' Perspectives on Women Veterans' Health Care: What Would Ideal Look Like? Womens Health Issues. 2019 Jan-Feb;29(1):64-71. doi: 10.1016/j.whi.2018.10.005. Epub 2018 Nov 16.

Reference Type RESULT
PMID: 30455089 (View on PubMed)

Klap R, Darling JE, Hamilton AB, Rose DE, Dyer K, Canelo I, Haskell S, Yano EM. Prevalence of Stranger Harassment of Women Veterans at Veterans Affairs Medical Centers and Impacts on Delayed and Missed Care. Womens Health Issues. 2019 Mar-Apr;29(2):107-115. doi: 10.1016/j.whi.2018.12.002. Epub 2019 Jan 25.

Reference Type RESULT
PMID: 30686577 (View on PubMed)

Bergman AA, Hamilton AB, Chrystal JG, Bean-Mayberry BA, Yano EM. Primary Care Providers' Perspectives on Providing Care to Women Veterans with Histories of Sexual Trauma. Womens Health Issues. 2019 Jul-Aug;29(4):325-332. doi: 10.1016/j.whi.2019.03.001. Epub 2019 Apr 23.

Reference Type RESULT
PMID: 31027706 (View on PubMed)

Dyer KE, Potter SJ, Hamilton AB, Luger TM, Bergman AA, Yano EM, Klap R. Gender Differences in Veterans' Perceptions of Harassment on Veterans Health Administration Grounds. Womens Health Issues. 2019 Jun 25;29 Suppl 1:S83-S93. doi: 10.1016/j.whi.2019.04.016.

Reference Type RESULT
PMID: 31253247 (View on PubMed)

Yano EM, Than C, Brunner J, Canelo IA, Meredith LS, Rubenstein LV, Hamilton AB. Impact of Evidence-Based Quality Improvement on Tailoring VA's Patient-Centered Medical Home Model to Women Veterans' Needs. J Gen Intern Med. 2024 Jun;39(8):1349-1359. doi: 10.1007/s11606-024-08647-4. Epub 2024 Feb 29.

Reference Type DERIVED
PMID: 38424344 (View on PubMed)

Sheahan KL, Goldstein KM, Than CT, Bean-Mayberry B, Chanfreau CC, Gerber MR, Rose DE, Brunner J, Canelo IA, Darling Mshs JE, Haskell S, Hamilton AB, Yano EM. Women Veterans' Healthcare Needs, Utilization, and Preferences in Veterans Affairs Primary Care Settings. J Gen Intern Med. 2022 Sep;37(Suppl 3):791-798. doi: 10.1007/s11606-022-07585-3. Epub 2022 Aug 30.

Reference Type DERIVED
PMID: 36042076 (View on PubMed)

Carlson GC, Than CT, Rose D, Brunner J, Chanfreau-Coffinier C, Canelo IA, Klap R, Bean-Mayberry B, Agrawal A, Hamilton AB, Gerber MR, Yano EM. What Drives Women Veterans' Trust in VA Healthcare Providers? Womens Health Issues. 2022 Sep-Oct;32(5):499-508. doi: 10.1016/j.whi.2022.02.004. Epub 2022 Mar 30.

Reference Type DERIVED
PMID: 35367107 (View on PubMed)

Danan ER, Brunner J, Bergman A, Spoont M, Chanfreau C, Canelo I, Krebs EE, Yano EM. The Relationship Between Sexual Assault History and Cervical Cancer Screening Completion Among Women Veterans in the Veterans Health Administration. J Womens Health (Larchmt). 2022 Jul;31(7):1040-1047. doi: 10.1089/jwh.2021.0237. Epub 2022 Jan 18.

Reference Type DERIVED
PMID: 35049381 (View on PubMed)

Shipherd JC, Darling JE, Klap RS, Rose D, Yano EM. Experiences in the Veterans Health Administration and Impact on Healthcare Utilization: Comparisons Between LGBT and Non-LGBT Women Veterans. LGBT Health. 2018 Jul;5(5):303-311. doi: 10.1089/lgbt.2017.0179.

Reference Type DERIVED
PMID: 29979640 (View on PubMed)

Narain K, Jeffers KS, Bean-Mayberry B, Canelo I, Darling JE, Yano EM. The Association of Food Insufficiency with Patient Activation Among Women Veterans Using Veterans Administration Healthcare: a Cross-Sectional Analysis. J Gen Intern Med. 2018 Sep;33(9):1417-1418. doi: 10.1007/s11606-018-4476-9. No abstract available.

Reference Type DERIVED
PMID: 29766383 (View on PubMed)

Brunner J, Schweizer CA, Canelo IA, Leung LB, Strauss JL, Yano EM. Timely access to mental health care among women veterans. Psychol Serv. 2019 Aug;16(3):498-503. doi: 10.1037/ser0000226. Epub 2018 Apr 5.

Reference Type DERIVED
PMID: 29620391 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CRE 12-026

Identifier Type: -

Identifier Source: org_study_id

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