ClinicalTrials.gg
CompletedNCT03054090HVHUpdated Nov 9, 2018

Heart of Virginia Healthcare

An interventional study of Quality Improvement Support in Cardiovascular Diseases, sponsored by Virginia Commonwealth University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-09.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
231
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Most care for chronic conditions is provided by primary care clinicians. Although Virginia ranks 4th among the 50 states in average income, it ranks 27th in mortality due to heart attacks and strokes. The scope and focus of this project will materially improve the rates of screening and treatment of risk factors for heart attacks and strokes, and will give primary care clinicians the tools and training to improve the care of other chronic illnesses and the delivery of preventive services.

Read the detailed description

Restoring Primary Care in Virginia: Patient Centered Outcomes Research (PCOR) Learning as a Pathway to Value is an extension of the Virginia Center for Health Innovation's (VCHI) work to address primary care transformation in its Virginia Health Innovation Plan. VCHI, in partnership with four of Virginia's schools of medicine, the Virginia Center for Health Quality (VHQC), and evaluation specialists at George Mason University, will form the Virginia Primary Care Transformation Collaborative (VPCTC). They will use an evidence-based, comprehensive strategy to help up to 300 small-to-medium sized primary care practices: 1) accelerate incorporation of PCOR clinical and organizational findings into practice with an initial focus on cardiovascular health and the Aspirin, Blood Pressure, Cholesterol, and Smoking (ABCS); 2) increase their capacity to integrate new PCOR findings on an on-going basis; and 3) learn strategies that can help them sustain and revitalize their organizations while restoring the joy to primary care practice. Practice supports will include on-site coaching, expert consultation, collaborative learning events, an online support center, and data feedback and benchmarking. As a result of this project, "Restoring Primary Care in Virginia," participating practices will develop stronger Quality Improvement (QI) capacity and learn strategies that can help them sustain and revitalize their organizations while restoring the joy to primary care practice. The value proposition to recruit and retain participating practices includes: Improved financial performance; improved clinician, staff, and patient satisfaction; objectively improved quality of care; improved ability to negotiate for and receive pay for performance bonuses, including Electronic Medical Record (EMR) meaningful use stage 2; completion of Part IV certification by the American Board of Family Medicine (ABFM) and American Board of Internal Medicine (ABIM) for QI work completed in this initiative; and engagement in a self-sustaining learning collaborative of similar practices after the end of the project. The evaluation plan is designed to answer these questions: (1) Did the VPCTC intervention improve the performance of small physician practices in Virginia as measured by the individual ABCS? (2) Which elements of the intervention were most important to the physicians for performance improvement? (3) Did "maintenance" or follow-up intervention activities add value or was the initial intense intervention enough to produce the measured impact? (4) Which internal contextual or structural features of practices at baseline are most likely to be associated with improved performance (e.g., expansive use of EMRs, degree of adaptive reserve or change processing capacity, number of physicians in the practice, etc.)? (5) Did the VPCTC improve the capacity of small physician practices to implement future PCOR findings and improve quality on an ongoing basis? (6) Which elements of the intervention were most important to the physicians for QI capacity building? Multivariate statistical modeling of clinical performance and survey data will be performed to answer questions 1, 3, and 4.

Qualitative interviews, surveys and statistical analysis of survey results will answer questions 2, 5, and 6.

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Conditions studied

  • Cardiovascular Diseases

Keywords

  • Cardiovascular Diseases
  • Primary Care
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In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 231 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 82 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • small to medium sized primary care practices in virginia that serve adults

Exclusion criteria

Exclusion Criteria:

  • large sized primary care practices
  • pediatric practices
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
231 participants (actual)

Study arms

  • Other
    Quality Improvement support

    A blended support strategy will include practice facilitation, expert consultation, collaborative learning events, an online support center, and data feedback and benchmarking.

    Other: Quality Improvement Support

Interventions

  • OtherQuality Improvement Support

    Practices will receive a blended strategy of quality improvement facilitation to help participating practices incorporate PCOR clinical and organizational findings while building their overall practice capabilities. Primary care practices will be provided tools and training to improve the rates of screening and treatment of risk factors for heart attacks and strokes, as well as other chronic illnesses and the delivery of preventive services.

06

What researchers measure

Primary outcomes

  1. Aspirin prescriptions

    Practice level rates of aspirin or other anti-thrombotics being prescribed. The outcome measure will be assessed from data extracted from practice EMR.

    Time frame: 3 month

  2. Blood pressure

    Blood pressure control for hypertensives. The outcome measure will be assessed from data extracted from practice EMR.

    Time frame: 3 months

  3. Statin prescriptions

    Practice level rates of Statins being prescribed for categories of higher risk cholesterol levels. The outcome measure will be assessed from data extracted from practice EMR.

    Time frame: 3 months

  4. Smoking

    Smoking assessment. The outcome measure will be assessed from data extracted from practice EMR.

    Time frame: 3 months

  5. Smoking

    Smoking cessation counseling. The outcome measure will be assessed from data extracted from practice EMR.

    Time frame: 3 months

Secondary outcomes

  1. Capacities to incorporate new patient centered outcome research

    Capacities of practices to incorporate new patient centered outcome research into their care of patients. This outcome measure will be assessed using surveys.

    Time frame: 1 year after intervention

  2. Capacities to incorporate new patient centered outcome research

    Capacities of practices to incorporate new patient centered outcome research into their care of patients. This outcome measure will be assessed using interviews.

    Time frame: 1 year after intervention

  3. Joy in practice

    This outcome measure will be assessed by way of surveys.

    Time frame: 1 year after intervention

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Goldberg DG, Owens-Jasey C, Haghighat S, Kavalloor S. Implementation strategies for large scale quality improvement initiatives in primary care settings: a qualitative assessment. BMC Prim Care. 2023 Nov 17;24(1):242. doi: 10.1186/s12875-023-02200-8. PubMed 37978433 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03054090
Collaborators
Virginia Center for Health Innovation, Center for Health Policy Development, George Mason University, Health Quality Innovators, Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Sponsor
First posted
Feb 15, 2017
Start date
May 2015
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Last update
Nov 9, 2018

Study contacts

Anton Kuzel, MD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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