Smarter Care Virginia, Examining Low-Value Care in Virginia

NCT ID: NCT04053335

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-25

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases Eye Diseases Cardiac Disease Surgery Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: Multicomponent Physician Performance Peer-Comparison

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.

Multicomponent Physician Performance Peer-Comparison Feedback Intervention

Intervention Type BEHAVIORAL

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 9 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 (6 groups): Six comparable control health systems identified via matching

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 9 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John N. Mafi, MD, MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

75486025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Health Disparities on the Labor Floor
NCT04633824 ACTIVE_NOT_RECRUITING
Relational Playbook Pilot Study
NCT06456021 COMPLETED NA
Precision Feedback to Improve Health Care Quality
NCT05923463 ACTIVE_NOT_RECRUITING NA
UCLA Health Patient Cardiology Care Gaps
NCT06277323 ACTIVE_NOT_RECRUITING NA
Uncertainty Management Intervention
NCT00938795 COMPLETED NA
Agent-Enhanced Document Explanation
NCT02668705 TERMINATED NA