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

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VA Office of Research and Development

Status

Completed

Conditions

Patient-centered Medical Home Implementation

Treatments

Other: Technical support
Other: Quality improvement (QI) education/training
Other: Formative feedback
Other: Multilevel stakeholder engagement
Other: External practice facilitation
Other: National policy guidance

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02039856
CRE 12-026

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,900 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,900 participants in 2 patient groups

EBQI-Supported WH-PACT Implementation
Experimental group
Description:
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.
Treatment:
Other: External practice facilitation
Other: National policy guidance
Other: Technical support
Other: Quality improvement (QI) education/training
Other: Multilevel stakeholder engagement
Other: Formative feedback
Routine WH-PACT Implementation
Active Comparator group
Description:
National policy guidance
Treatment:
Other: National policy guidance

Trial documents
1

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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