PainNCT04266821
Establishing Clinical Utility of a New Diagnostic Test for Patients Suffering From Pain: A CPV® Randomized Controlled Trial
A study testing Experimental Arm in people with Pain and Pain, Chronic, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
This study will collect high-quality data on how practicing primary care physicians across the U.S. currently manage patients experiencing chronic pain and how the results of Ethos Laboratories' test change clinical decision making. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Pain, Chronic
- What is being tested?
- Experimental Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 31 May 2020
- Phase
- Interventional
- 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
Who may be able to join
- Board-certified physician for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- At least 15% of patient panel with chronic pain
- Prescribes opioids
- Practicing in the U.S.
- English speaking
- Access to the internet
- Informed, signed and voluntarily consented to be in the study
Who cannot join
- Non-English speaking
- Practicing in an academic setting
- Unable to access the internet
- Not practicing in the U.S.
- Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
- Less than 15% of panel with chronic pain
- Does not prescribe opioids
- Do not voluntarily consent to be in the study
Trial locations and contacts
1 site in 1 country.
About this study
This study will collect high-quality data on how practicing primary care physicians across the U.S. currently manage patients experiencing chronic pain and how the results of Ethos Laboratories' test change clinical decision making. To do so, this study leverages simulated patient cases called Clinical Performance and Value vignettes (CPVs) in a proven methodology to rapidly measure physician care decisions.
Read the detailed description
This study will collect high-quality randomized controlled data from a nationally representative sample of practicing physicians, specifically primary care physicians and pain specialists, to determine how they currently manage patients with pain and how the results of Ethos' test change their clinical decision making. Data from this study will better illuminate the clinical use cases in which the Ethos test has the most significant impact on clinical decision making (and thus the largest clinical utility) and the physician characteristics (e.g., age, practice setting, training) associated with practice change.
The study is a prospective cohort trial with six steps:
- Enrollment: The study will enroll an estimated 166 practicing primary care physicians who practice in the U.S. and are determined to be eligible by an eligibility screener.
- Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
- Randomization: The 166 physicians will be randomized into equally-sized control and intervention arms.
- CPVs (First Round): Physicians will complete three randomly-assigned CPV patient simulations. Cases will be identical across the intervention and control arms. All interactive cases are presented on an online platform, and are accessible via unique weblinks and any internet-connected computer.
- Intervention education: Intervention-arm physicians will receive educational materials describing the clinical validation and use cases of the Ethos test. This material will replicate what physicians would receive as part of an actual marketing push introducing them to the Ethos test. These materials may be comprised of a slide deck, fact sheet, webinar, and/or case studies.
- CPVs (Second Round): All participating physicians will then be asked to complete three additional CPV patient simulations. The cases are given to the doctors in a random order. Cases will be identical across the intervention and control arms, except that the intervention arm will receive Ethos test results at an appropriate point in each simulated case in the post-intervention round. Control arm physicians will continue to have access to standard of care diagnostic tools, but not the Ethos test results.
- Conditions
- Pain, Pain, Chronic
- Being tested
- Experimental Arm
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ArmOther
First, these providers will receive educational materials (e.g. a slide deck, mock test result and FAQ handout) meant to mimic what physicians will receive in the real-world market as they learn about the Ethos technology.
Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the Ethos test at the clinically-appropriate point in each case.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column: Receives: Other: Experimental Arm |
| Control | No intervention | These providers will complete two rounds of three simulated patient cases (CPVs) only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPV-measured pre-/post-difference in quality score between intervention and control physicians
Physicians completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the pre-/post-difference in these scores between control physicians using standard of care diagnostic tools and intervention physicians with access to Ethos test results, including by use case types
Measured: 2-4 weeks
CPV-measured differences in evidence-based decisions made by intervention physicians and control physicians between rounds 1 and 2
Physicians completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess differences in evidence-based decisions made by intervention physicians and control physicians between rounds 1 and 2, including by use case types
Measured: 2-4 weeks
CPV-measured cost difference
Difference in cost of care between control and intervention physicians, including by use case types. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm on their CPVs, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs.)
Measured: 2-4 weeks
Secondary outcomes (1)
CPV-measured baseline variation
Physicians completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Feb 2020
- Primary completion4 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study will enroll practicing primary care physicians in the US. Physicians are randomly assigned to either a control or intervention arm upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention arm only will receive educational material about the Ethos test in between these two rounds, and be provided simulated Ethos test results in the second round of simulated cases.
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ethos Laboratories
- Responsible party
- Sponsor
- Investigators
- John Peabody, MD, PhD, Principal investigator, President, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266821
- Sponsor's protocol ID
- 01ETH2020
- Status last verified
- Sep 2020
- First submitted
- 7 Feb 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burgon TB, Cox-Chapman J, Czarnecki C, Kropp R, Guerriere R, Paculdo D, Peabody JW. Engaging Primary Care Providers to Reduce Unwanted Clinical Variation and Support ACO Cost and Quality Goals: A Unique Provider-Payer Collaboration. Popul Health Manag. 2019 Aug;22(4):321-329. doi: 10.1089/pop.2018.0111. Epub 2018 Oct 17.
PubMed 30328782Peabody J, Martin M, DeMaria L, Florentino J, Paculdo D, Paul M, Vanzo R, Wassman ER, Burgon T. Clinical Utility of a Comprehensive, Whole Genome CMA Testing Platform in Pediatrics: A Prospective Randomized Controlled Trial of Simulated Patients in Physician Practices. PLoS One. 2016 Dec 30;11(12):e0169064. doi: 10.1371/journal.pone.0169064. eCollection 2016.
PubMed 28036350Peabody JW, Strand V, Shimkhada R, Lee R, Chernoff D. Impact of rheumatoid arthritis disease activity test on clinical practice. PLoS One. 2013 May 7;8(5):e63215. doi: 10.1371/journal.pone.0063215. Print 2013.
PubMed 23667587Solon O, Woo K, Quimbo SA, Shimkhada R, Florentino J, Peabody JW. A novel method for measuring health care system performance: experience from QIDS in the Philippines. Health Policy Plan. 2009 May;24(3):167-74. doi: 10.1093/heapol/czp003. Epub 2009 Feb 18.
PubMed 19224955
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility of a New Diagnostic Test for Patients Suffering From Pain: A CPV® Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04266821
- Acronym / sponsor ID
- 01ETH2020
- Conditions
- Pain, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ethos Laboratories
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 12 Feb 2020 (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.
This study will collect high-quality data on how practicing primary care physicians across the U.S. currently manage patients experiencing chronic pain and how the results of Ethos Laboratories' test change clinical decision making. To do so, this study leverages simulated patient cases called Clinical Performance and Value vignettes (CPVs) in a proven methodology to rapidly measure physician care decisions.
Detailed description
This study will collect high-quality randomized controlled data from a nationally representative sample of practicing physicians, specifically primary care physicians and pain specialists, to determine how they currently manage patients with pain and how the results of Ethos' test change their clinical decision making. Data from this study will better illuminate the clinical use cases in which the Ethos test has the most significant impact on clinical decision making (and thus the largest clinical utility) and the physician characteristics (e.g., age, practice setting, training) associated with practice change.
The study is a prospective cohort trial with six steps:
- Enrollment: The study will enroll an estimated 166 practicing primary care physicians who practice in the U.S. and are determined to be eligible by an eligibility screener.
- Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
- Randomization: The 166 physicians will be randomized into equally-sized control and intervention arms.
- CPVs (First Round): Physicians will complete three randomly-assigned CPV patient simulations. Cases will be identical across the intervention and control arms. All interactive cases are presented on an online platform, and are accessible via unique weblinks and any internet-connected computer.
- Intervention education: Intervention-arm physicians will receive educational materials describing the clinical validation and use cases of the Ethos test. This material will replicate what physicians would receive as part of an actual marketing push introducing them to the Ethos test. These materials may be comprised of a slide deck, fact sheet, webinar, and/or case studies.
- CPVs (Second Round): All participating physicians will then be asked to complete three additional CPV patient simulations. The cases are given to the doctors in a random order. Cases will be identical across the intervention and control arms, except that the intervention arm will receive Ethos test results at an appropriate point in each simulated case in the post-intervention round. Control arm physicians will continue to have access to standard of care diagnostic tools, but not the Ethos test results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will enroll practicing primary care physicians in the US. Physicians are randomly assigned to either a control or intervention arm upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention arm only will receive educational material about the Ethos test in between these two rounds, and be provided simulated Ethos test results in the second round of simulated cases.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Experimental ArmExperimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column: |
| Control | No intervention | –These providers will complete two rounds of three simulated patient cases (CPVs) only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Board-certified physician for at least two years
- Averaging at least 20 hours per week of clinical and patient care duties over the last six months
- At least 15% of patient panel with chronic pain
- Prescribes opioids
- Practicing in the U.S.
Key exclusion criteria (8 listed)
- Non-English speaking
- Practicing in an academic setting
- Unable to access the internet
- Not practicing in the U.S.
- Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
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 |
|---|---|---|
| Experimental ArmFirst, these providers will receive educational materials (e.g. a slide deck, mock test result and FAQ handout) meant to mimic what physicians will receive in the real-world market as they learn about the Ethos technology. Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the Ethos test at the clinically-appropriate point in each case. | Other | Experimental |
Primary outcome
CPV-measured pre-/post-difference in quality score between intervention and control physicians
Time frame: 2-4 weeks
Physicians completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the pre-/post-difference in these scores between control physicians using standard of care diagnostic tools and intervention physicians with access to Ethos test results, including by use case types
CPV-measured differences in evidence-based decisions made by intervention physicians and control physicians between rounds 1 and 2
Time frame: 2-4 weeks
Physicians completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess differences in evidence-based decisions made by intervention physicians and control physicians between rounds 1 and 2, including by use case types
CPV-measured cost difference
Time frame: 2-4 weeks
Difference in cost of care between control and intervention physicians, including by use case types. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm on their CPVs, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs.)
1 secondary outcome
CPV-measured baseline variation
Time frame: 1 week
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 16 Sep 2020.
- Background: PubMed 30328782Burgon TB, Cox-Chapman J, Czarnecki C, Kropp R, Guerriere R, Paculdo D, Peabody JW. Engaging Primary Care Providers to Reduce Unwanted Clinical Variation and Support ACO Cost and Quality Goals: A Unique Provider-Payer Collaboration. Popul Health Manag. 2019 Aug;22(4):321-329. doi: 10.1089/pop.2018.0111. Epub 2018 Oct 17.
- Background: PubMed 28036350Peabody J, Martin M, DeMaria L, Florentino J, Paculdo D, Paul M, Vanzo R, Wassman ER, Burgon T. Clinical Utility of a Comprehensive, Whole Genome CMA Testing Platform in Pediatrics: A Prospective Randomized Controlled Trial of Simulated Patients in Physician Practices. PLoS One. 2016 Dec 30;11(12):e0169064. doi: 10.1371/journal.pone.0169064. eCollection 2016.
- Background: PubMed 23667587Peabody JW, Strand V, Shimkhada R, Lee R, Chernoff D. Impact of rheumatoid arthritis disease activity test on clinical practice. PLoS One. 2013 May 7;8(5):e63215. doi: 10.1371/journal.pone.0063215. Print 2013.
- Background: PubMed 19224955Solon O, Woo K, Quimbo SA, Shimkhada R, Florentino J, Peabody JW. A novel method for measuring health care system performance: experience from QIDS in the Philippines. Health Policy Plan. 2009 May;24(3):167-74. doi: 10.1093/heapol/czp003. Epub 2009 Feb 18.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
John Peabody, MD, PhD principal investigator
President, QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Arm in people with Pain and Pain, Chronic, run by Qure Healthcare, LLC 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 8 inclusion and 8 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 16 Sep 2020. 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?
CPV-measured pre-/post-difference in quality score between intervention and control physicians (time frame: 2-4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266821, which also lists 4 linked publications.
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 16 Sep 2020.