Back Pain, LowSCV LBPNCT05413070
Quality Improvement re: Choosing Wisely Back Pain Measures
An observational study of Back Pain, Low and Back Pain, run by Carilion Clinic at 1 site in United States.
Trial summary
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Low, Back Pain, Back Pain Lower Back Chronic
- What is being tested?
- Multimodal approach to QI for Low-Value Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 31 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary care clinicians (physicians, PAs, NPs)
Who may be able to join
- Current primary care clinician in a top or bottom performing practice
Who cannot join
- <90 days of tenure in current position
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Clinic Dept of Family and Community Medicine
Roanoke, Virginia, 24016
About this study
Official title: Improving Performance on Choosing Wisely Low Back Pain Measures in Primary Care: Learning From Within
As
Read the detailed description
Two common low-value services are related to acute low back pain. Choosing Wisely advises avoiding the use of imaging during the first 6 weeks of low back pain (per the American Academy of Family Physicians and other organizations). Similarly, Choosing Wisely advises avoiding opioids in the treatment of low back pain until other alternatives have been attempted (per the North American Spine Society). Together, overutilization of these two services (imaging and opioids for low back pain) costs more than $500 annually, not including downstream costs, and is a source of patient harm. In the state of Virginia, the Virginia Center for Health Innovation has identified the two back pain measures as priority for reducing as part of their 3-year intervention (Smarter Care Virginia): https://www.vahealthinnovation.org/scv/
As a participant in Smarter Care Virginia (SCV), Carilion receives data showing each Carilion Clinic clinician's performance on SCV measures, including the two back pain measures. For example, Carilion receives a database that lists the clinician's name, department, number of appropriate orders for each SCV measure made and the number of low-value orders for each SCV measure made. Carilion (and the other 7 participating health systems) are asked to use this information to generate quality improvement initiatives. We have designed a quality improvement initiative focused on family and community medicine clinicians and the two back pain measures.
First, we will use the most recent data provided by the SCV project (2020 and Q1-Q2 of 2021) to rank FCM practices and clinicians by utilization of low-value back pain services, their waste index, and impact score. We will identify from this ranking the top 5 to 10 performing practices and the bottom 5 to 10 performing practices. If there are any outlier clinicians who are bottom performing (ie: provide the most low-value services or have the highest impact score) but who do not fall among the bottom performing practices, we will consider including their practice among the bottom 5 to 10.
We will survey clinicians in top and bottom performing practices to learn more about their knowledge, perceptions, and practice workflow related to the two back pain measures. They will also be asked about their trust in data measures. No identifying information will be collected from clinicians in the survey.
From what we learn from survey data, we will design up to four brief education points to be communicated during regular practice quality improvement meetings with population health managers.
Prior to the delivery of quality improvement education about back pain measures, we will obtain an EMR report for the top and bottom performing practices showing utilization rate of both back pain measures. We will also conduct a chart review (Epic) to identify indication for provision of the back pain services that could not be detected in claims data or Epic data. This addresses a common concern of clinicians - that clinical nuance is not being detected and low value care is being over-assigned. The Epic reports and chart reviews will continue monthly for the first 3 months and then at months 6 and 12.
- Conditions
- Back Pain, Low, Back Pain, Back Pain Lower Back Chronic
- Being tested
- Multimodal approach to QI for Low-Value Care
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal approach to QI for Low-Value CareBehavioural
Up to 4 brief educational components in existing quality meetings Informational email/newsletter Individualized performance feedback reports Educational resources for patients
| Study group | Role | What they receive |
|---|---|---|
| Lowest Performing Practices | This is the group of 5 to 10 primary care practices that incurred the highest amount of low-value back pain imaging based on claims data reports. This group will receive the survey and the intervention (brief training sessions in existing quality improvement meetings, performance reports, etc.). Receives: Behavioral: Multimodal approach to QI for Low-Value Care | |
| Highest Performing Practices | This is the group of 5 primary care practices that incurred the lowest amount of low-value back pain imaging based on claims data reports. This group will only receive the survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, perceptions, decision-making related to back pain imaging
Survey responses
Measured: June-August 2022
Rate of low-value back pain imaging
Derived from APC data, via Milliman Health Waste Calculator
Measured: June-August 2022
Rate of low-value back pain imaging
Derived from EMR measures (live)
Measured: August 2022-December 2023
Clinical documentation comparison
Comparison of EMR chart review reason for ordering imaging vs. EMR-derived measure
Measured: August 2022-December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start15 Jun 2022
- Primary completion14 Jun 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain, LowStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Center for Health Innovation
- Responsible party
- Principal investigator, Michelle Rockwell, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413070
- Sponsor's protocol ID
- IRB-22-1568
- Acronym
- SCV LBP
- Status last verified
- Aug 2023
- First submitted
- 7 Jun 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Performance on Choosing Wisely Low Back Pain Measures in Primary Care: Learning From Within
- ClinicalTrials.gov ID
- NCT05413070
- Acronym / sponsor ID
- SCV LBP / IRB-22-1568
- Conditions
- Back Pain, Low, Back Pain, Back Pain Lower Back Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Center for Health Innovation
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2022 (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.
As
Detailed description
Two common low-value services are related to acute low back pain. Choosing Wisely advises avoiding the use of imaging during the first 6 weeks of low back pain (per the American Academy of Family Physicians and other organizations). Similarly, Choosing Wisely advises avoiding opioids in the treatment of low back pain until other alternatives have been attempted (per the North American Spine Society). Together, overutilization of these two services (imaging and opioids for low back pain) costs more than $500 annually, not including downstream costs, and is a source of patient harm. In the state of Virginia, the Virginia Center for Health Innovation has identified the two back pain measures as priority for reducing as part of their 3-year intervention (Smarter Care Virginia): https://www.vahealthinnovation.org/scv/
As a participant in Smarter Care Virginia (SCV), Carilion receives data showing each Carilion Clinic clinician's performance on SCV measures, including the two back pain measures. For example, Carilion receives a database that lists the clinician's name, department, number of appropriate orders for each SCV measure made and the number of low-value orders for each SCV measure made. Carilion (and the other 7 participating health systems) are asked to use this information to generate quality improvement initiatives. We have designed a quality improvement initiative focused on family and community medicine clinicians and the two back pain measures.
First, we will use the most recent data provided by the SCV project (2020 and Q1-Q2 of 2021) to rank FCM practices and clinicians by utilization of low-value back pain services, their waste index, and impact score. We will identify from this ranking the top 5 to 10 performing practices and the bottom 5 to 10 performing practices. If there are any outlier clinicians who are bottom performing (ie: provide the most low-value services or have the highest impact score) but who do not fall among the bottom performing practices, we will consider including their practice among the bottom 5 to 10.
We will survey clinicians in top and bottom performing practices to learn more about their knowledge, perceptions, and practice workflow related to the two back pain measures. They will also be asked about their trust in data measures. No identifying information will be collected from clinicians in the survey.
From what we learn from survey data, we will design up to four brief education points to be communicated during regular practice quality improvement meetings with population health managers.
Prior to the delivery of quality improvement education about back pain measures, we will obtain an EMR report for the top and bottom performing practices showing utilization rate of both back pain measures. We will also conduct a chart review (Epic) to identify indication for provision of the back pain services that could not be detected in claims data or Epic data. This addresses a common concern of clinicians - that clinical nuance is not being detected and low value care is being over-assigned. The Epic reports and chart reviews will continue monthly for the first 3 months and then at months 6 and 12.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lowest Performing Practices | – | Behavioral: Multimodal approach to QI for Low-Value CareThis is the group of 5 to 10 primary care practices that incurred the highest amount of low-value back pain imaging based on claims data reports. This group will receive the survey and the intervention (brief training sessions in existing quality improvement meetings, performance reports, etc.). |
| Highest Performing Practices | – | –This is the group of 5 primary care practices that incurred the lowest amount of low-value back pain imaging based on claims data reports. This group will only receive the survey. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinicians (physicians, PAs, NPs)
Key inclusion criteria (1 listed)
- Current primary care clinician in a top or bottom performing practice
Key exclusion criteria (1 listed)
- <90 days of tenure in current position
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 |
|---|---|---|
| Multimodal approach to QI for Low-Value CareUp to 4 brief educational components in existing quality meetings Informational email/newsletter Individualized performance feedback reports Educational resources for patients | Behavioural | Lowest Performing Practices |
Primary outcome
Knowledge, perceptions, decision-making related to back pain imaging
Time frame: June-August 2022
Survey responses
Rate of low-value back pain imaging
Time frame: June-August 2022
Derived from APC data, via Milliman Health Waste Calculator
Rate of low-value back pain imaging
Time frame: August 2022-December 2023
Derived from EMR measures (live)
Clinical documentation comparison
Time frame: August 2022-December 2023
Comparison of EMR chart review reason for ordering imaging vs. EMR-derived measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual data will be shared.
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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 Back Pain, Low and Back Pain, run by Carilion Clinic 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Aug 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?
Results are not available in the source record.
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?
Knowledge, perceptions, decision-making related to back pain imaging (time frame: June-August 2022). The study lists 4 primary outcomes in all. 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 8 Aug 2023.