Smarter Care Virginia, Examining Low-Value Care in Virginia

Completed

• Conditions: Cardiac Disease; Chronic Kidney Diseases; Surgery; Low Back Pain; Eye Diseases
• Interventions: Behavioral: Multicomponent Physician Performance Peer-Comparison Feedback Intervention

• Registration Number: NCT04053335
• Lead Sponsor: 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 can cause patient harm. Prior research has documented high-rates of low-value care in Virginia; this work has helped to inspire a Virginia government-sponsored quality improvement initiative to reduce low-value care. Funded by an Arnold Ventures grant, six large health systems in Virginia volunteered to partner with the Virginia Center for Health Innovation (VCHI) to reduce use of nine low-value health services (three preoperative testing measures, two cardiac screening measures, one diagnostic eye imaging measure, one low-back pain opioid measure, one low-back pain imaging measure and one peripherally inserted central catheter \[PICC\] measure). These health systems include nearly 7000 clinicians practicing across more than 1000 sites.

VCHI is implementing a nonrandomized physician peer-comparison feedback quality improvement intervention to reduce use of nine low-value services. Modeling will be used to identify and use propensity score matching to match six intervention health systems to six comparable control health systems. 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). VCHI will use additional measures from The Agency for Healthcare Research and Quality (AHRQ). Additionally, VCHI will use AHRQ data to attribute physicians and health care facilities to health systems.

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. Nevertheless, University of California, Los Angeles (UCLA) plans to rigorously study and publish the impact of this intervention across the state of Virginia, which is why the UCLA team pre-registered the initiative. The UCLA team will use the Virginia APCD to evaluate the impact of the intervention. Please note: the APCD has a 1-year time-lag of data collection and is a dynamic database, meaning that its population of enrollees changes from year to year. This intervention was initially designed as a randomized step-wedge intervention; the intervention was delayed by the COVID-19 pandemic and began in September 2020 for all intervention groups. The intervention period was extended through December 2022. As a result, the initial design was modified.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-25
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1: Multicomponent Physician Performance Peer-Comparison	Multicomponent Physician Performance Peer-Comparison Feedback Intervention	Cohort 1 (6 groups): Inova/Signature Parters, Sentara/Sentara Quality Care Network, Ballad Health, Carilion Clinic, Health Care Associates Virginia/Virginia Care Partners, and Virginia and Commonwealth University Health System Note that the original design for the intervention was a step-wedge randomization. However, this was changed due to the COVID-19 pandemic, which necessitated a delay in all study activities from March 2020 - September 2020. The intervention began in September 2020. Data collection concluded in December 2022.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with low-value utilization across the 9 low-value care measures	36 months	Measures defined using evidence-based guidelines such as the USPSTF, American College of Cardiology, Choosing Wisely and others.; The primary measure is global percentage of use among eligible patients across 9 measures (see eligibility criteria for measure-specific denominators): * 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 nephrology consult; * Opioid prescribing for low back pain (added Jan 2022); * Imaging for nonspecific low back pain (added Jan 2022); UCLA statisticians will independently assess measures using the Virginia APCD, which includes paid claims for Commercial, Medicaid, and Medicare insured patients

Secondary Outcome Measures

Name	Time	Method
Percentage participants with high-value utilization across the 9 measures (e.g., balancing measures)	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.
Percentage of participants with adverse events (e.g., peri-operative medical complications)	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.
Reduction in low- and high-value services by socioeconomic status	36 months	We will also assess for unintended consequences with an equity lens. For example, we will assess whether reductions in the high-value care measures disproportionately affected socioeconomically disadvantaged populations (e.g., those living in vulnerable neighborhoods or those with Medicaid insurance)
Total costs (estimates from percent effort of clinical leadership team, utilization trends	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.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States