Implementation of Women's Health Patient Aligned Care Teams

Not Applicable

Completed

• Conditions: Patient-centered Medical Home Implementation
• Interventions: Other: National policy guidance; Other: Multilevel stakeholder engagement; Other: Quality improvement (QI) education/training; Other: Technical support; Other: Formative feedback; Other: External practice facilitation

• Registration Number: NCT02039856
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Study Start: 2014-05-09
• Primary Completion: 2017-09-30
• Study Completion: 2018-09-30
• Results First Submitted: 2019-01-15
• Results First Submitted QC: 2019-08-13
• Results First Posted: 2019-08-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3900

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBQI-Supported WH-PACT Implementation	Technical support	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.
Routine WH-PACT Implementation	National policy guidance	National policy guidance
EBQI-Supported WH-PACT Implementation	Formative feedback	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.
EBQI-Supported WH-PACT Implementation	National policy guidance	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.
EBQI-Supported WH-PACT Implementation	Multilevel stakeholder engagement	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.
EBQI-Supported WH-PACT Implementation	Quality improvement (QI) education/training	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.
EBQI-Supported WH-PACT Implementation	External practice facilitation	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.

Primary Outcome Measures

Name	Time	Method
WH-PACT Achievement	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

Name	Time	Method
Providers' and Staff Gender Sensitivity	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.
Team Functioning	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.
Providers and Staff Burnout	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).
Patient VA Primary Care Visits Per Year	Baseline to 24month	Average number of visits to VA primary care per year
Patient VA Women's Health Care Visits Per Year	Baseline to 24month	Average number of patient visits to VA women's health care per year
Patient VA Hospitalization	Baseline to 24-month	Average number of patient hospitalization for any cause in a year
Patient Emergency Room Visits	baseline to 24-month	Average number of patient emergency room visits for any cause in a year

Trial Locations

Locations (13)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States

Philadelphia VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States

Fargo VA Healthcare System, Fargo, ND; 🇺🇸 Fargo, North Dakota, United States

VA Greater Los Angeles Healthcare System, Sepulveda, CA; 🇺🇸 Sepulveda, California, United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

Edward Hines Jr. VA Hospital, Hines, IL; 🇺🇸 Hines, Illinois, United States

Jesse Brown VA Medical Center, Chicago, IL; 🇺🇸 Chicago, Illinois, United States

Iowa City VA Health Care System, Iowa City, IA; 🇺🇸 Iowa City, Iowa, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States

VA Central Western Massachusetts Healthcare System, Leeds, MA; 🇺🇸 Leeds, Massachusetts, United States

Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV; 🇺🇸 Clarksburg, West Virginia, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

William S. Middleton Memorial Veterans Hospital, Madison, WI; 🇺🇸 Madison, Wisconsin, United States