Clinical trial NCT04080037: Assessing Opioid Care Practices Using CPV Patient Simulation Modules
Official title: Assessing Opioid Care Practices Using CPV Patient Simulation Modules to Improve Alignment With CDC Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Pain, Acute
Pain, Chronic
Pain, Neuropathic
Opioid-use Disorder
Opioid Abuse and Addiction
Opioid Withdrawal
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
Collaborators: name: Ascend Learning
First posted: 2019-09-06
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will enroll practicing PCPs in the US. All eligible and consented participants will complete a multiple-choice pre-assessment, the complete 6 weekly patient simulations with feedback and peer benchmarking, then complete a multiple-choice post-assessment.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and feedback. The cases and feedback have been designed to align with the latest CDC opioid guidelines. The study will also measure the impact of gaming-inspired competition and motivation, including a weekly leaderboard, to improve evidence-based care decisions. The quality of care decisions will be measured in the simulations and in a multiple-choice assessment administered before and after the patient simulations.

Detailed description: Primary care providers (PCPs) are often on the front lines of helping patients manage acute and chronic pain. These pain management decisions have become especially important in light of the national opioid crisis that has seen an unsettling rise in opioid dependency, over-doses and fatalities. The Centers for Disease Control has developed specific evidence-based guidelines to help clinicians make more informed decisions about appropriate use of opioids as well as identifying and managing patients at risk for opioid-use disorder and overdose.

The investigators' previous work has shown that patient simulations can rapidly and reliably measure unwarranted practice variation among providers. In addition, published work shows that patient simulations, when administered serially and combined with customized feedback on improvement opportunities can reduce practice variation and improve performance on patient-level quality measures. Given the challenge of the current opioid crisis and the large scope of unwarranted variation in medical practice, there is a need for scalable approaches to measure care decisions, provide feedback on improvement opportunities and benchmark performance to peers.

This study seeks to evaluate the impact of personalized measurement and feedback on evidence-based care decisions made by primary care providers across the country concerning opioid care. The study, a prospective cohort trial, will enroll primary care physicians (PCPs) practicing in the U.S. Upon enrollment, eligible providers will be asked to complete a questionnaire detailing their practice and professional background. They will then be asked to complete the following:

Pretest: Pre-project, participants will take a multiple-choice assessment test. These assessments measure CDC Opioid Guidelines knowledge and adherence. Study administrators will randomize half of providers to take Assessment A pre-intervention, and half to take Assessment B pre-intervention, and have attempted to make these two assessments of equal difficulty.

Intervention: All providers will then care for 1 online CPV QualityIQ patient simulation each week over the course of 6 weeks. The simulated patients will be adults aged 18-75 and present with clinical conditions commonly seen by PCPs, such as chronic or acute pain, for whom opioids are currently in use or may be considered. In the patient simulations, participants will make work-up, diagnostic and treatment decisions relevant to the patient's pain management and will receive real-time feedback on how those decisions align with the CDC recommendations. Each week, participants will receive an email notification with their case score from the previous week, how their care compares to their PCP peers, and a link their new case to be completed.

Posttest: Recruits will take the remaining assessment as described above after completion of the intervention.

Eligibility criteria: Inclusion Criteria:

1. Board-certified in internal medicine or family medicine
2. Minimum patient panel size of 1,000 patients
3. At least 5% of their patients currently or previously using opioid medications
4. English-speaking
5. Access to the internet
6. Informed, signed and voluntarily consented to be in the study

Exclusion Criteria:

1. Not board certified in either internal medicine or family medicine
2. Patient panel size less than 1,000 patients
3. Less than 5% of their patients currently or previously using opioid medications
4. Non-English speaking
5. Unable to access the internet
6. Do not voluntarily consent to be in the study

Primary outcomes:
measure: Change in provider scores on pre- and post-intervention assessments
timeFrame: 2 months
measure: Change in the overall and the diagnostic and treatment quality scores in the CPV QualityIQ patient simulations.
timeFrame: 2 months
Secondary outcomes:
measure: Participant satisfaction as measured by post-evaluation survey
timeFrame: 2 months
measure: Physician engagement throughout the study
timeFrame: 2 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
affiliation: QURE Healthcare
name: John Peabody, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Weigel PA, Ullrich F, Shane DM, Mueller KJ. Variation in Primary Care Service Patterns by Rural-Urban Location. J Rural Health. 2016 Spring;32(2):196-203. doi: 10.1111/jrh.12146. Epub 2015 Sep 16.
citation: Peabody JW, Luck J, Glassman P, Dresselhaus TR, Lee M. Comparison of vignettes, standardized patients, and chart abstraction: a prospective validation study of 3 methods for measuring quality. JAMA. 2000 Apr 5;283(13):1715-22. doi: 10.1001/jama.283.13.1715.
citation: Peabody JW, Luck J, Glassman P, Jain S, Hansen J, Spell M, Lee M. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004 Nov 16;141(10):771-80. doi: 10.7326/0003-4819-141-10-200411160-00008.
citation: Schieber LZ, Guy GP Jr, Seth P, Young R, Mattson CL, Mikosz CA, Schieber RA. Trends and Patterns of Geographic Variation in Opioid Prescribing Practices by State, United States, 2006-2017. JAMA Netw Open. 2019 Mar 1;2(3):e190665. doi: 10.1001/jamanetworkopen.2019.0665.