NCT02039856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 9, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 21, 2019

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

3.4 years

First QC Date

January 14, 2014

Results QC Date

January 15, 2019

Last Update Submit

June 15, 2023

Conditions

Keywords

Patient-centered medical homesPrimary careWomen's healthVeterans

Outcome Measures

Primary Outcomes (1)

  • WH-PACT Achievement

    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 Outcomes (7)

  • Providers' and Staff Gender Sensitivity

    Baseline to 24-month

  • Team Functioning

    Baseline to 24-month

  • Providers and Staff Burnout

    24-month

  • Patient VA Primary Care Visits Per Year

    Baseline to 24month

  • Patient VA Women's Health Care Visits Per Year

    Baseline to 24month

  • +2 more secondary outcomes

Study Arms (2)

EBQI-Supported WH-PACT Implementation

EXPERIMENTAL

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 engagementOther: Quality improvement (QI) education/trainingOther: Technical supportOther: Formative feedbackOther: External practice facilitationOther: National policy guidance

Routine WH-PACT Implementation

ACTIVE COMPARATOR

National policy guidance

Other: National policy guidance

Interventions

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

EBQI-Supported WH-PACT Implementation

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

EBQI-Supported WH-PACT Implementation

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)

EBQI-Supported WH-PACT Implementation

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

EBQI-Supported WH-PACT Implementation

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

Also known as: Facilitation
EBQI-Supported WH-PACT Implementation

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

EBQI-Supported WH-PACT ImplementationRoutine WH-PACT Implementation

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsOnly the patient survey component is gender-based (includes women Veterans only). Eligibility for provider/staff surveys or key stakeholder interviews is not gender-based.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

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

West Haven, Connecticut, 06516, United States

Location

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

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

Boston, Massachusetts, 02130, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Fargo VA Healthcare System, Fargo, ND

Fargo, North Dakota, 58102, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

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

Clarksburg, West Virginia, 26301, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

Related Publications (24)

  • 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.

    PMID: 24715407BACKGROUND
  • 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.

    PMID: 24715395BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Interventions

Quality ImprovementEducational Status

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureQuality of Health CareHealth Services AdministrationSocioeconomic FactorsPopulation Characteristics

Limitations and Caveats

Control arm VAMCs are active controls given national mandates to implement PACT and WH PACT. Low response rates among providers/staff may have resulted in under- or over-estimation of effects, despite weighting for non-response.

Results Point of Contact

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

Study Officials

  • Elizabeth M. Yano, PhD MSPH

    VA Greater Los Angeles Healthcare System, Sepulveda, 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
PARALLEL
Model Details: Cluster randomized controlled trial (cRCT) among 12 VAMCs with unbalanced allocation (2:1) blocked on VA network (Veterans Integrated Service Network or VISN)
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 20, 2014

Study Start

May 9, 2014

Primary Completion

September 30, 2017

Study Completion

September 30, 2018

Last Updated

June 18, 2023

Results First Posted

August 21, 2019

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations