Clinical trial NCT04053335: Smarter Care Virginia, Examining Low-Value Care in Virginia
Official title: Eliminating Low-Value Care in Virginia: Six Large Health Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Eye Diseases
Cardiac Disease
Surgery
Low Back Pain
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 5000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility 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 nine 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.
* For the low-back pain measures, eligible patients include those who have a diagnosis of low-back pain or acute low-back pain.

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.

Primary outcomes:
measure: Percentage of participants with low-value utilization across the 9 low-value care measures
timeFrame: 36 months
Secondary outcomes:
measure: Percentage participants with high-value utilization across the 9 measures (e.g., balancing measures)
timeFrame: 36 months
measure: Percentage of participants with adverse events (e.g., peri-operative medical complications)
timeFrame: 36 months
measure: Reduction in low- and high-value services by socioeconomic status
timeFrame: 36 months
measure: Total costs (estimates from percent effort of clinical leadership team, utilization trends
timeFrame: 36 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References: