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

NCT04266821 | Completed

• 1 other identifier: 01ETH2020
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain; Pain, Chronic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• CPV-measured baseline variation

  1 week

Study Arms (2)

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

Control

NO INTERVENTION

These providers will complete two rounds of three simulated patient cases (CPVs) only.

Interventions

Experimental Arm OTHER

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.

Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• Ethos Laboratories: collaborator

Study Sites (1)

QURE Healthcare

San Francisco, California, 94133, United States

Location

Related Publications (4)

• 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.

  PMID: 30328782 BACKGROUND

• 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.

  PMID: 28036350 BACKGROUND

• 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.

  PMID: 23667587 BACKGROUND

• 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.

  PMID: 19224955 BACKGROUND

MeSH Terms

Conditions

Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Peabody, MD, PhD

  President, QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 12, 2020
• Study Start: February 1, 2020
• Primary Completion: May 4, 2020
• Study Completion: May 31, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)