Establishing Clinical Utility of a New Diagnostic Test for Patients Suffering From Pain: A CPV® Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Chronic
• Intervention / Treatment: Other: Experimental Arm

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:

1. 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.
2. Provider survey: Once providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background.
3. Randomization: The 166 physicians will be randomized into equally-sized control and intervention arms.
4. 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.
5. 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.
6. 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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94133
      • QURE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Board-certified physician for at least two years
2. Averaging at least 20 hours per week of clinical and patient care duties over the last six months
3. At least 15% of patient panel with chronic pain
4. Prescribes opioids
5. Practicing in the U.S.
6. English speaking
7. Access to the internet
8. Informed, signed and voluntarily consented to be in the study

Exclusion Criteria:

1. Non-English speaking
2. Practicing in an academic setting
3. Unable to access the internet
4. Not practicing in the U.S.
5. Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
6. Less than 15% of panel with chronic pain
7. Does not prescribe opioids
8. Do not voluntarily consent to be in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Experimental-arm providers will complete two rounds of three simulated patient cases (CPVs) with two additions described in the next column:	Other: Experimental Arm; 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.
No Intervention: Control; These providers will complete two rounds of three simulated patient cases (CPVs) only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.)	2-4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 week

Collaborators and Investigators

• Sponsor: Qure Healthcare, LLC
• Collaborators: Ethos Laboratories

Publications and helpful links

General 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.
• Peabody 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.
• Peabody 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.
• Solon 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): May 4, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 01ETH2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No