Chronic Kidney DiseasesNCT04053335
Smarter Care Virginia, Examining Low-Value Care in Virginia
An observational study of Chronic Kidney Diseases and Eye Diseases, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Eye Diseases, Cardiac Disease
- What is being tested?
- Multicomponent Physician Performance Peer-Comparison Feedback Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2019to 31 Dec 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90024
About this study
Official title: Eliminating Low-Value Care in Virginia: Six Large Health Systems
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.
- Conditions
- Chronic Kidney Diseases, Eye Diseases, Cardiac Disease, Surgery, Low Back Pain
- Being tested
- Multicomponent Physician Performance Peer-Comparison Feedback Intervention
- Medical subject headings
- Renal Insufficiency, Chronic, Eye Diseases, Heart Diseases, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Physician Performance Peer-Comparison Feedback InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multicomponent Physician Performance Peer-Comparison Feedback Intervention | |
| Cohort 2: Multicomponent Physician Performance Peer-Comparison | Cohort 2 (6 groups): Six comparable control health systems identified via matching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with low-value utilization across the 9 low-value care measures
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
Measured: 36 months
Secondary outcomes (4)
Percentage participants with high-value utilization across the 9 measures (e.g., balancing measures)
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.
Measured: 36 months
Percentage of participants with adverse events (e.g., peri-operative medical complications)
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.
Measured: 36 months
Reduction in low- and high-value services by socioeconomic status
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)
Measured: 36 months
Total costs (estimates from percent effort of clinical leadership team, utilization trends
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start25 Jul 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John N. Mafi, MD, MPH, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053335
- Sponsor's protocol ID
- 75486025
- Status last verified
- Jun 2023
- First submitted
- 5 Aug 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminating Low-Value Care in Virginia: Six Large Health Systems
- ClinicalTrials.gov ID
- NCT04053335
- Acronym / sponsor ID
- 75486025
- Conditions
- Chronic Kidney Diseases, Eye Diseases, Cardiac Disease, Surgery, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000,000 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Aug 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Multicomponent Physician Performance Peer-Comparison | – | Behavioral: Multicomponent Physician Performance Peer-Comparison Feedback InterventionCohort 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. |
| Cohort 2: Multicomponent Physician Performance Peer-Comparison | – | –Cohort 2 (6 groups): Six comparable control health systems identified via matching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Multicomponent Physician Performance Peer-Comparison Feedback InterventionThe 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 | Behavioural | Cohort 1: Multicomponent Physician Performance Peer-Comparison |
Primary outcome
Percentage of participants with low-value utilization across the 9 low-value care measures
Time frame: 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
4 secondary outcomes
Percentage participants with high-value utilization across the 9 measures (e.g., balancing measures)
Time frame: 36 months
Percentage of participants with adverse events (e.g., peri-operative medical complications)
Time frame: 36 months
Reduction in low- and high-value services by socioeconomic status
Time frame: 36 months
Total costs (estimates from percent effort of clinical leadership team, utilization trends
Time frame: 36 months
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 3 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Eye Diseases, run by University of California, Los Angeles at 1 site in United States.
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 6 inclusion and 3 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Percentage of participants with low-value utilization across the 9 low-value care measures (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.