Cardiovascular DiseasesHVHNCT03054090
Heart of Virginia Healthcare
A study testing Quality Improvement Support in people with Cardiovascular Diseases, run by Virginia Commonwealth University.
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.
- Conditions
- Cardiovascular Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Quality Improvement support | Other | A 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.
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
Blood pressure
Blood pressure control for hypertensives. The outcome measure will be assessed from data extracted from practice EMR.
Measured: 3 months
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
Smoking
Smoking assessment. The outcome measure will be assessed from data extracted from practice EMR.
Measured: 3 months
Smoking
Smoking cessation counseling. The outcome measure will be assessed from data extracted from practice EMR.
Measured: 3 months
Secondary outcomes (3)
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
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
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.
- First posted15 Feb 2017
- Study startMay 2015
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Anton Kuzel, MD, Principal investigator, Virginia Commonwealth University
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Primary Care in Virginia: PCOR Learning as a Pathway to Value
- ClinicalTrials.gov ID
- NCT03054090
- Acronym / sponsor ID
- HVH / 1R18HS023913-01
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Virginia Center for Health Innovation, Center for Health Policy Development, George Mason University, Health Quality Innovators, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- May 2015
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality Improvement support | Other | Other: Quality Improvement SupportA blended support strategy will include practice facilitation, expert consultation, collaborative learning events, an online support center, and data feedback and benchmarking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- small to medium sized primary care practices in virginia that serve adults
Key exclusion criteria (2 listed)
- large sized primary care practices
- pediatric practices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Improvement SupportPractices 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. | Other | Quality Improvement support |
Primary outcome
Aspirin prescriptions
Time frame: 3 month
Practice level rates of aspirin or other anti-thrombotics being prescribed. The outcome measure will be assessed from data extracted from practice EMR.
Blood pressure
Time frame: 3 months
Blood pressure control for hypertensives. The outcome measure will be assessed from data extracted from practice EMR.
Statin prescriptions
Time frame: 3 months
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.
Smoking
Time frame: 3 months
Smoking assessment. The outcome measure will be assessed from data extracted from practice EMR.
Smoking
Time frame: 3 months
Smoking cessation counseling. The outcome measure will be assessed from data extracted from practice EMR.
3 secondary outcomes
Capacities to incorporate new patient centered outcome research
Time frame: 1 year after intervention
Capacities to incorporate new patient centered outcome research
Time frame: 1 year after intervention
Joy in practice
Time frame: 1 year after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Derived from this study: PubMed 37978433Goldberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Kuzel, MD principal investigator
Virginia Commonwealth University
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.