Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-26 @ 6:11 PM
Study NCT ID:
NCT02039856
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implementation of Women's Health Patient Aligned Care Teams
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WH-PACT
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: