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Smarter Care Virginia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053335
Recruitment Status : Active, not recruiting
First Posted : August 12, 2019
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
John N. Mafi, MD, MPH, University of California, Los Angeles

Brief Summary:
Low-value care is defined as patient care that provides no net benefit to patients in specific clinical scenarios, and it can cause patient harm. Prior research has documented high-rates of low-value care in Virginia, and this work has helped to inspire a Virginia government-sponsored quality improvement initiative to reduce low-value care. Funded by a $2.2 million Arnold Ventures grant, six large health systems in Virginia volunteered to partner with the Virginia Center for Health Innovation (VCHI) to reduce use of seven low-value health services (three preoperative testing measures, two cardiac screening measures, one diagnostic eye imaging measure, and one peripherally inserted central catheter [PICC] measure). These health systems include nearly 7,000 clinicians practicing across more than 1,000 sites. VCHI is implementing a step-wedge cluster-randomized physician peer-comparison feedback quality improvement intervention to reduce the use of these seven low-value services. VCHI will provide education, quality improvement training, and financial resources to each site, and VCHI will use the Milliman MedInsight Health Waste Calculator to create the peer comparison reports using the Virginia all payer claims database (APCD). Of note, the primary purpose of the initiative is to improve quality of care for Virginia residents and this initiative is not being done for research purposes, and step-wedge randomization is done to both ease logistical workload on VCHI and clarify impact of intervention (IRB exempt). Nevertheless, University of California, Los Angeles (UCLA) team plans to rigorously study and publish the impact of this intervention across the state of Virginia, which is why the UCLA team is preregistering the initiative. The UCLA team will use the Virginia APCD to evaluate the impact of the intervention. Because the APCD has a 1 year time-lag of data collection, the initial results of the impact of the intervention will not be available until August 2020 at the earliest.

Condition or disease Intervention/treatment
Chronic Kidney Diseases Eye Diseases Cardiac Disease Surgery Behavioral: Multicomponent Physician Performance Peer-Comparison Feedback Intervention

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Study Type : Observational
Estimated Enrollment : 1800000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Eliminating Low-Value Care in Virginia: Six Large Health Systems Sign On
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort 1: Multicomponent Physician Performance Peer-Comparison
Cohort 1 (2 groups): Runs July 2019 - December 2020 - Inova/Signature Parters and Sentara/Sentara Quality Care Network
Behavioral: Multicomponent Physician Performance Peer-Comparison Feedback Intervention

The intervention will consist of 5 components delivered simultaneously

  • Clinical Leadership Team: Each site will develop a Clinical Leadership Team (CLT), typically consisting of quality officers, clinician champions, etc. to implement and monitor the intervention
  • Speaker Series: VCHI will offer the CLTs access to national experts via a CME-approved speaker series and "office hours" to support the intervention.
  • Education Materials: The CLTs will distribute clinician and consumer education throughout the health systems calling to avoid 7 low-value services.
  • Clinician Report Cards: VCHI will distribute quarterly customized clinician performance report cards to the CLTs teams using the Milliman Health Waste Calculator and Virginia APCD
  • Quality improvement training: The intervention will provide the CLTs with in-person quality improvement and clinician performance feedback training, using principles of self-determination theory, and will include monthly check-in calls

Cohort 2: Multicomponent Physician Performance Peer-Comparison
Cohort 2 (2 groups): Runs November 2019 - April 2021 - Ballad Health and Carilion Clinic
Behavioral: Multicomponent Physician Performance Peer-Comparison Feedback Intervention

The intervention will consist of 5 components delivered simultaneously

  • Clinical Leadership Team: Each site will develop a Clinical Leadership Team (CLT), typically consisting of quality officers, clinician champions, etc. to implement and monitor the intervention
  • Speaker Series: VCHI will offer the CLTs access to national experts via a CME-approved speaker series and "office hours" to support the intervention.
  • Education Materials: The CLTs will distribute clinician and consumer education throughout the health systems calling to avoid 7 low-value services.
  • Clinician Report Cards: VCHI will distribute quarterly customized clinician performance report cards to the CLTs teams using the Milliman Health Waste Calculator and Virginia APCD
  • Quality improvement training: The intervention will provide the CLTs with in-person quality improvement and clinician performance feedback training, using principles of self-determination theory, and will include monthly check-in calls

Cohort 3: Multicomponent Physician Performance Peer-Comparison
Cohort 3 (2 groups): Runs March 2020 - August 2021 - Health Care Associates Virginia/Virginia Care Partners and Virginia and Commonwealth University Health System
Behavioral: Multicomponent Physician Performance Peer-Comparison Feedback Intervention

The intervention will consist of 5 components delivered simultaneously

  • Clinical Leadership Team: Each site will develop a Clinical Leadership Team (CLT), typically consisting of quality officers, clinician champions, etc. to implement and monitor the intervention
  • Speaker Series: VCHI will offer the CLTs access to national experts via a CME-approved speaker series and "office hours" to support the intervention.
  • Education Materials: The CLTs will distribute clinician and consumer education throughout the health systems calling to avoid 7 low-value services.
  • Clinician Report Cards: VCHI will distribute quarterly customized clinician performance report cards to the CLTs teams using the Milliman Health Waste Calculator and Virginia APCD
  • Quality improvement training: The intervention will provide the CLTs with in-person quality improvement and clinician performance feedback training, using principles of self-determination theory, and will include monthly check-in calls




Primary Outcome Measures :
  1. Percentage of participants with low-value utilization across the 7 low-value care measures [ Time Frame: 36 months ]

    The 7 measures are defined using evidenced-based guidelines such as the USPSTF, American College of Cardiology, Choosing Wisely, among other guidelines.

    The primary measure is a global percentage of use among eligible patients across the 7 measures (see eligibility criteria for each measure-specific denominator):

    • Preoperative laboratory testing
    • Preoperative EKGs, chest x-rays, and pulmonary function testing
    • Preoperative cardiac imaging/stress testing
    • Annual EKG/other cardiac screening for low-risk adults
    • Cardiac stress imaging/cardiac imaging in low-risk adults
    • Diagnostic eye imaging in low-risk patients
    • Peripherally inserted central catheters in stage 3-5 chronic kidney disease patients without consulting nephrology

    UCLA statisticians will independently assess these measures using the Virginia APCD, which includes paid claims for Commercial, Medicaid, Medicare insured patients, and includes demographics, procedure/diagnostic codes.



Secondary Outcome Measures :
  1. Percentage participants with high-value utilization across the 7 measures (e.g., balancing measures) [ Time Frame: 36 months ]
    These balancing measures will assess the use of high-value services. For example, the UCLA team will assess whether symptomatic (e.g., chest pain) patients continue to receive testing (e.g., EKGs) prior to low-risk surgery, or whether patients with eye disease continue to receive eye imaging, etc.

  2. Percentage of participants with adverse events (e.g., peri-operative medical complications) [ Time Frame: 36 months ]
    While VCHI, the UCLA team, and health systems do not expect adverse events (AEs) to increase in this evidenced-based quality improvement initiative, the UCLA team will monitor for them. AEs will be measure specific. For example, patients with preoperative visits will be evaluated for 30 day peri/post-operative medical complications (e.g., myocardial infarction). Patient eligible to receive cardiac screening (and do not receive it) will be evaluated for 30-day myocardial infarction diagnoses and hospitalization rates. Patients eligible to receive eye imaging and do not receive it will be evaluated for 1-year eye disease progression or new diagnosis rates. Patients eligible to receive a PICC line and do not will be evaluated for 30-day readmission rates. Each local health system QI team will also be provided education on how careful, nuanced attention to guidelines can reduce the risk of potential AEs.

  3. Total costs (estimates from percent effort of clinical leadership team, utilization trends [ Time Frame: 36 months ]
    The cost analysis will estimate costs based on changes in utilization over time using costs as defined by the total amount paid to each provider (including out-of-pocket costs) available in the Virginia APCD. The UCLA team will also estimate the percent effort of each member of the clinical leadership team during the study time-frame to estimate investment costs. These latter data will be obtained via surveys and/or interviews of the clinical leadership teams.



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
Sampling Method:   Non-Probability Sample
Study Population
The study population includes patients who receive care at six large health systems (and their three clinically integrated networks) in Virginia: (1) Ballad Health, (2) Carilion Clinic, (3) Hospital Corporation of America and Virginia Care Partners, (4) Inova and Signature Partners (Inova/Signature Patners will not be in main analysis) (5) Sentara Health System and Sentara Quality Care Network, (6) and Virginia Commonwealth University Health System.
Criteria

Inclusion Criteria

All adult patients (aged 18 or older) at each of the six health systems who are at risk for receiving low-value care across each of the seven measures.

  • For preoperative testing, eligible patients include those with a health system evaluation and management visits 30 days prior to low-risk surgery.
  • For eye imaging, eligible patients will be patients with evaluation and management visits with a health system ophthalmologist/optometrist.
  • For cardiac screening, eligible patients are patients with an ambulatory evaluation and management visit (all specialties).
  • For the PICC line measure, eligible patients would include hospitalized patients.

Exclusion Criteria

  • Patients under the age of 18.
  • Patients who do not meet the above criteria.
  • Patients who do not receive care at each of the six health systems.

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): NCT04053335


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: John N. Mafi, MD, MPH, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04053335    
Other Study ID Numbers: 75486025
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022
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
Additional relevant MeSH terms:
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Eye Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Urologic Diseases
Renal Insufficiency
Cardiovascular Diseases