Clinical trial NCT02039856: Implementation of Women's Health Patient Aligned Care Teams
Official title: Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient-centered Medical Home Implementation
Keywords: Patient-centered medical homes
Primary care
Women's health
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, Los Angeles
name: RAND
First posted: 2014-01-20
Enrollment: 3900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: WH-PACT Achievement
timeFrame: Baseline to 24-month
Secondary outcomes:
measure: Providers' and Staff Gender Sensitivity
timeFrame: Baseline to 24-month
measure: Team Functioning
timeFrame: Baseline to 24-month
measure: Providers and Staff Burnout
timeFrame: 24-month
measure: Patient VA Primary Care Visits Per Year
timeFrame: Baseline to 24month
measure: Patient VA Women's Health Care Visits Per Year
timeFrame: Baseline to 24month
measure: Patient VA Hospitalization
timeFrame: Baseline to 24-month
measure: Patient Emergency Room Visits
timeFrame: baseline to 24-month
Other outcomes:
Locations:
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Iowa City
country: United States
facility: Iowa City VA Health Care System, Iowa City, IA
state: Iowa
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System, Leeds, MA
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Fargo
country: United States
facility: Fargo VA Healthcare System, Fargo, ND
state: North Dakota
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center, Philadelphia, PA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
city: Clarksburg
country: United States
facility: Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV
state: West Virginia
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
name: Elizabeth M. Yano, PhD MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.