Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs (WH PACTs)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, Los Angeles
RAND, Santa Monica, CA
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02039856
First received: January 14, 2014
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 is 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.


Condition Intervention
Patient-centered Medical Home Implementation
Other: Evidence Based Quality Improvement (EBQI) Intervention Practices
Other: Routine PACT Implementation (Naturalistic Control Practices)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • WH PACT model achievement: This measure assesses changes in level of achievement of WH-PACT features: access, continuity, care coordination, patient-centeredness, comprehensiveness and gender sensitivity [ Time Frame: Components of this measure will be measured at three time points in time (baseline, 12- and 24-months follow-up) between October 2013 and March 2016 ] [ Designated as safety issue: No ]
    This measure is intended to assess the effectiveness of EBQI methods for accelerating the implementation of WH-PACT in experimental practices (8 VAMCs) compared to naturalistic routine PACT implementation controls (4 VAMCs), randomly assigned within four VISNs (2 E-to-1 C within each VISN).


Estimated Enrollment: 420
Study Start Date: May 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evidence Based Quality Improvement
Intervention at eight of 12 study sites consisting of VISN/facility-level stakeholder panel meetings designed to set evidence-based priorities for quality improvement (QI) in the context of local data and needs; local practice quality improvement team design meetings; QI training and education; iterative formative data feedback; across intervention-practice QI collaboration calls; and practice facilitation. Local leadership, QI champions and frontline staff will develop and implement innovation projects aimed at improving aspects of WH PACT implementation based on site-level and VISN priorities in the context of national PACT and WH guidelines.
Other: Evidence Based Quality Improvement (EBQI) Intervention Practices
Intervention at eight of 12 study sites consisting of VISN/facility-level stakeholder panel meetings designed to set evidence-based priorities for quality improvement (QI) in the context of local data and needs; local practice quality improvement team design meetings; QI training and education; iterative formative data feedback; across intervention-practice QI collaboration calls; and practice facilitation. Local leadership, QI champions and frontline staff will develop and implement innovation projects aimed at improving aspects of WH PACT implementation based on site-level and VISN priorities in the context of national PACT and WH guidelines.
Other Name: WH PACT EBQI
Active Comparator: Routine PACT Implementation
PACT implementation is a nationally mandated initiative in VA primary care and women's health clinic settings, with audit-and-feedback of PACT-related performance measures, incentives for achievement of PACT attributes and continual guidance on PACT and WH policy and procedures from VA primary care and women's health leaders.
Other: Routine PACT Implementation (Naturalistic Control Practices)
PACT implementation is a nationally mandated initiative in VA primary care and women's health clinic settings, with audit-and-feedback of PACT-related performance measures, incentives for achievement of PACT attributes and continual guidance on PACT and WH policy and procedures from VA primary care and women's health leaders.
Other Name: Control Practices

Detailed Description:

Women Veterans' numerical minority in VA healthcare settings has created logistical challenges to delivering gender-sensitive comprehensive services. These challenges have only grown as more women Veterans have enrolled in VA care. Access and quality have lagged behind that of male Veterans, while gender sensitivity, including adequate attention to privacy/safety and awareness of women's military roles and experiences, is often lacking. On-site availability of gender-specific services has also not kept pace, with women Veterans more likely to be outsourced for gender-specific care now than they were ten years ago. Further, while the proportion of VA facilities having women's health (WH) clinics has increased, prior research has 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.

We aim to assess the effectiveness of evidence-based quality improvement (EBQI) methods for developing a WH PACT model using a cluster randomized trial 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 trials, we will evaluate WH-PACT model achievement using patient, provider and practice surveys. We will examine intermediate changes in provider, staff and team knowledge and attitudes. Using analyses of secondary administrative and performance data, we will also explore impacts of receipt of WH-PACT care on quality of chronic disease care and prevention, health status, utilization and costs. Using mixed methods, we will assess pre-post EBQI practice context; document WH-PACT implementation; and examine barriers/facilitators to EBQI-supported WH-PACT implementation through a combination of semi-structured interviews and monthly formative progress narratives and administrative data review.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (SES), 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 (MD, DO, NP, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039856

Locations
United States, California
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, United States, 91343
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2208
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, United States, 01053-9764
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, North Dakota
Fargo VA Healthcare System, Fargo, ND
Fargo, North Dakota, United States, 58102
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
United States, West Virginia
Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV
Clarksburg, West Virginia, United States, 26301
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of California, Los Angeles
RAND, Santa Monica, CA
Investigators
Principal Investigator: Elizabeth M. Yano, PhD MSPH VA Greater Los Angeles Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02039856     History of Changes
Other Study ID Numbers: CRE 12-026
Study First Received: January 14, 2014
Last Updated: June 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Patient-centered medical homes
Primary care
Women's health
Veterans

ClinicalTrials.gov processed this record on August 20, 2014