AzTrials
AzTrials

Cardiovascular DiseasesHVHNCT03054090

Heart of Virginia Healthcare

A study testing Quality Improvement Support in people with Cardiovascular Diseases, run by Virginia Commonwealth University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Quality Improvement Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
No sites listed yet
Study dates
May 2015to 30 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • large sized primary care practices
  • pediatric practices

About this study

Official title: Restoring Primary Care in Virginia: PCOR Learning as a Pathway to Value

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.

Being tested
Quality Improvement Support
Keywords
Cardiovascular Diseases, Primary Care
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality Improvement SupportOther

    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.

Study groups in NCT03054090
Study groupRoleWhat they receive
Quality Improvement supportOtherA blended support strategy will include practice facilitation, expert consultation, collaborative learning events, an online support center, and data feedback and benchmarking.
Receives: Other: Quality Improvement Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 month

  2. Blood pressure

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

    Measured: 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.

    Measured: 3 months

  4. Smoking

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

    Measured: 3 months

  5. Smoking

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

    Measured: 3 months

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 1 year after intervention

  3. Joy in practice

    This outcome measure will be assessed by way of surveys.

    Measured: 1 year after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2017
  2. Study startMay 2015
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03054090
Sponsor's protocol ID
1R18HS023913-01
Acronym
HVH
Status last verified
Nov 2018
First submitted
22 Sep 2016
Last updated
9 Nov 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Quality Improvement Support in people with Cardiovascular Diseases, run by Virginia Commonwealth University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aspirin prescriptions (time frame: 3 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03054090, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in