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Trial record 20 of 3439 for:    Facility

Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VA Facilities (WHS/QUERI PEI)

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ClinicalTrials.gov Identifier: NCT03238417
Recruitment Status : Active, not recruiting
First Posted : August 3, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in quality and patient experience among women seen in VA. VA policy action providing guidance on delivery of comprehensive healthcare services for women Veterans was disseminated nationally in 2010, followed by annual assessments and sites visits evaluating local VA efforts. While substantial inroads have been made, policy implementation, even when leveraged by field-based women's health leaders, has not been uniformly successful in achieving delivery of comprehensive care by designated providers in gender-sensitive care environments that ensure women's privacy, dignity and safety, all tenets of the original guidance and the updated VHA Directive (2017).

In collaboration with VA Women's Health Services (WHS), VA researchers developed a series of studies to better understand and help improve comprehensive care implementation through the Women Veterans' Healthcare CREATE Initiative. Among these, one focused on testing an evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model -- Patient Aligned Care Teams or PACT -- to the needs of women Veterans, which has yielded significant local improvements in women Veterans' care. EBQI emphasizes a multilevel partnered approach to building capacity for innovation, implementation and spread of evidence-based practice. With its demonstrated success in the CREATE PACT study and several other EBQI trials, WHS adopted EBQI as a strategy to help low-performing VA facilities systematically improve services.

The objectives of the WHS/QUERI Partnered Evaluation Initiative that this project represents are:

  1. To evaluate the barriers and facilitators to achieving delivery of comprehensive women's health care in the identified low-performing VA facilities;
  2. To evaluate the effectiveness of EBQI in supporting low-performing VA facilities achieve improved:

    1. Organizational features (e.g., level of comprehensive services available; care coordination arrangements; PACT features implemented; environment of care improvements);
    2. Provider/staff attitudes (e.g., improved gender awareness; women's health knowledge and practice);

    d) Quality of care and patient experiences among women Veteran patients using secondary data; and,

  3. To evaluate contextual factors, local implementation processes, and organizational changes in the participating facilities over time.

Results of the evaluation will be used to provide feedback to stakeholders, including women Veterans, at the local, network and national levels, while also being used to continuously refine EBQI implementation processes. The evaluation will also help inform optimal strategies for ongoing improvements in women Veterans' care in the 24 participating VA facilities, other VA facilities and for other improvement initiatives in this and other program offices.


Condition or disease Intervention/treatment Phase
Comprehensive Care Other: Evidence-Based Quality Improvement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Dynamic waitlist control design with seven VA facilities randomly allocated to Evidence-Based Quality Improvement (EBQI) in Year 1 (with 14 VA facilities serving as waitlist controls), a second seven VA facilities randomly allocated to EBQI in Year 2 (with 7 remaining VA facilities continuing to serve as waitlist controls), and the final 7 VA facilities getting EBQI in Year 3 (no waitlist controls remaining).
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VA Facilities (PEC 16-352)
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Women's Health

Arm Intervention/treatment
Experimental: Evidence-Based Quality Improvement (EBQI)
EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.
Other: Evidence-Based Quality Improvement
Multilevel research-clinical partnership approach to supporting local strategic planning, priority setting, skill building and engagement in addressing targeted healthcare delivery problems. Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI education/training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.
Other Name: EBQI

No Intervention: Waitlist Controls
Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.



Primary Outcome Measures :
  1. Gender-sensitive care environment [ Time Frame: 12-month change in gender-sensitivity of care environment ]
    Multi-item scale score reflecting survey items on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign to reduce harassment

  2. Gender-sensitive care environment [ Time Frame: 24-month change in gender-sensitivity of care environment ]
    Multi-item scale score reflecting survey items on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign to reduce harassment using practice surveys and key stakeholder interviews

  3. Gender awareness [ Time Frame: 12-month change in gender awareness among VA personnel ]
    Multi-item scale score reflecting survey items among providers and staff in primary care and women's health settings that reflect awareness and knowledge of women Veterans' military roles and healthcare needs

  4. Gender awareness [ Time Frame: 24-month change in gender awareness among VA personnel ]
    Multi-item scale score reflecting survey items among providers and staff in primary care and women's health settings that reflect awareness and knowledge of women Veterans' military roles and healthcare needs using web-based provider and staff surveys

  5. Local quality improvement [ Time Frame: 12-month change ]
    Completion of one or more quality improvement projects related to women Veterans' health and/or healthcare improvement through project logs and key stakeholder interviews

  6. Local quality improvement activity [ Time Frame: 24-month change ]
    Completion of one or more quality improvement projects related to women Veterans' health and/or healthcare improvement through project logs and key stakeholder interviews

  7. Quality improvement experience [ Time Frame: 12-month change ]
    Multi-item scale score from provider and staff surveys in primary care and women's health settings (including training, best practices, use of VA performance data, use of VA survey data, small tests of change)

  8. Quality improvement experience [ Time Frame: 24-month change ]
    Multi-item scale score from provider and staff surveys in primary care and women's health settings (including training, best practices, use of VA performance data, use of VA survey data, small tests of change) and from key stakeholder interviews


Secondary Outcome Measures :
  1. Gender-specific preventive care delivery [ Time Frame: 12-month change in gender-specific preventive care delivery ]
    Composite measure of gender-specific preventive services (i.e., breast and cervical cancer screening rates) using the VA External Peer Review Program (EPRP) chart-based quality metrics and Corporate Data Warehouse (CDW) derived quality metrics

  2. Gender-specific preventive care delivery [ Time Frame: 24-month change in gender-specific preventive care delivery ]
    Composite measure of gender-specific preventive services (i.e., breast and cervical cancer screening rates) using the VA External Peer Review Program (EPRP) chart-based quality metrics and Corporate Data Warehouse (CDW) derived quality metrics

  3. Quality of care rating [ Time Frame: 12-month change in quality of care ratings ]
    Aggregated measures of women Veterans' ratings of VA care quality using CAHPS/PCMH/SHEPs (Survey of Healthcare Experiences for Patients) data aggregated to the facility level

  4. Quality of care rating [ Time Frame: 24-month change in quality of care ratings ]
    Aggregated measures of women Veterans' ratings of VA care quality using CAHPS/PCMH/SHEPs (Survey of Healthcare Experiences for Patients) data aggregated to the facility level

  5. Accessibility of care [ Time Frame: 12-month change in accessibility ]
    Women Veterans' ratings of accessibility using a previously validated and reliable survey items and mean scale score from CAHPS/PCMH/SHEPs (Survey of Healthcare Experiences for Patients)

  6. Accessibility of care [ Time Frame: 24-month change in accessibility ]
    Women Veterans' ratings of accessibility using a previously validated and reliable survey items and mean scale score from CAHPS/PCMH/SHEPs (Survey of Healthcare Experiences for Patients)

  7. Coordination of care [ Time Frame: 12-month change ]
    Women Veterans' ratings of care coordination using a previously validated and reliable survey items and mean scale scores from CAHPS/PCMH/SHEPs (Survey of Healthcare Experiences for Patients)

  8. Coordination of care [ Time Frame: 24-month change ]
    Women Veterans' ratings of care coordination using a previously validated and reliable survey items and mean scale scores from CAHPS/PCMH/SHEPs (Survey of Healthcare Experiences for Patients)

  9. Gender-neutral preventive care [ Time Frame: 12-month change ]
    Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for colorectal cancer screening) using VA External Peer Review Program chart-based quality metrics and Corporate Data Warehouse (CDW) quality metrics

  10. Gender-neutral guideline-concordant preventive care receipt [ Time Frame: 24-month change ]
    Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for colorectal cancer screening) using VA External Peer Review Program chart-based quality metrics and Corporate Data Warehouse (CDW) quality metrics

  11. Assignment to a designated women's health provider [ Time Frame: 12-month change ]
    Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting

  12. Assignment to a designated women's health provider [ Time Frame: 24-month change ]
    Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting

  13. PACT implementation [ Time Frame: 12-month change ]
    Aggregated score of PACT features implemented since baseline using practice surveys and key stakeholder interviews

  14. PACT implementation [ Time Frame: 24-month change ]
    Aggregated score of PACT features implemented since baseline using practice surveys and key stakeholder interviews



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unit of randomization: VA healthcare facilities (VA medical center or community-based outpatient clinic)
  • Subset of VA healthcare facilities identified as low-performing on the basis of composites of access/wait times, gender disparities in quality, e.g.:

    • depression screening
    • diabetic blood sugar control
  • Presence/absence of VA-required structural facets of care, e.g.:

    • designated women's health providers
    • mammography coordinator
    • gynecology access
    • Women Veteran Program Manager
    • 3:1 staffing ratio for PACT teamlets

Key Stakeholder Inclusion Criteria (qualitative interviews):

  • VISN level leader (Director or Chief Medical Officer)
  • VISN level WVPM Lead, VISN level primary care director, VISN level QI/system redesign lead)
  • VA facility leader (Director or other quadrad member)
  • Chief of Staff
  • primary care director
  • women's health medical director
  • WVPM
  • local EBQI champion
  • other key personnel

Provider/Staff Survey Inclusion Criteria:

  • Primary care providers (MD, DO, NP, PA) delivering primary care in general primary care and/or women's health clinics
  • PACT teamlet members (RN care managers, LVN/LPN/health technicians, and clerks)
  • larger PACT team members, e.g.:

    • social workers
    • dieticians
    • health coaches
    • integrated mental health

Exclusion Criteria:

  • Facility-level exclusion: Facilities not identified in the initial sample of VA facilities (sample not renewed over time).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238417


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Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Elizabeth M Yano, PhD MSPH VA Greater Los Angeles Healthcare System, Sepulveda, CA
Principal Investigator: Alison B Hamilton, PhD MPH VA Greater Los Angeles Healthcare System, West Los Angeles, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03238417     History of Changes
Other Study ID Numbers: PEX 16-002
PEC 16-352 ( Other Grant/Funding Number: QUERI Program )
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
women's health
primary health care
mental health
Veterans
quality improvement