NCT04080037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

September 3, 2019

Last Update Submit

February 6, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in provider scores on pre- and post-intervention assessments

    At the beginning and end of the study, participants with complete a 20 multiple-choice question assessment to measure familiarity with the latest CDC opioid guidelines. The assessment scales are known as the "QURE-Ascend Learning Modules: Opioids, Assessment A" and "QURE-Ascend Learning Modules: Opioids, Assessment B," both of which measure familiarity with the latest CDC guidelines via multiple-choice questions. Scores on the scales range from 0 to 100%, with a higher score representing greater familiarity with evidence-based care. There are no subscales within the measures. Between the assessment, they will care for online simulated patients and receive feedback on their care decisions. A primary outcome in the study will be to measure whether performance on the assessments improves after caring for the simulated patients and receiving feedback. Higher scores on the second assessment represent a better outcome.

    2 months

  • Change in the overall and the diagnostic and treatment quality scores in the CPV QualityIQ patient simulations.

    In each case, participants will answer multiple-choice questions about their preferred course of action to work-up, diagnose and treat patients in the primary care setting. Each question has specific evidence-based scoring criteria identifying necessary and unnecessary care decisions. Each provider will get a score for each case, ranging from 0 to 100 percentage based on the care decisions they make in the case. Over the course of the project, the investigators will track the percentage of correct, evidence-based care decisions made by participants, with the hypothesis that serial measurement and feedback on evidence-based care decisions will lead to increases in appropriate decisions over time. Higher scores represent a better outcome.

    2 months

Secondary Outcomes (2)

  • Participant satisfaction as measured by post-evaluation survey

    2 months

  • Physician engagement throughout the study

    2 months

Study Arms (1)

Study Participants

EXPERIMENTAL

All eligible and consented participants will be asked complete a multiple-choice opioid assessment based on the latest CDC opioid guidelines, then care for 6 online QualityIQ patient simulations and receive feedback on their care decisions. They will then all complete an other multiple-choice assessment at the conclusion of the study.

Other: Quality IQ Patient Simulations

Interventions

Online patient cases designed to simulate typical patients seen in a primary care practice. In each case, providers will answer multiple-choice questions about their preferred course of action to work-up, diagnose and treat patients in the primary care setting. After each question, providers will receive evidence-based feedback, including references, on the appropriateness of each of their care decisions. Feedback will be supported with relevant reference to evidence-based guidelines, with a specific focus on the CDC opioid guidelines. Cases will cover typical primary care patients presenting with acute and chronic pain, who may or may not be already taking opioid medication.

Also known as: Clinical Performance and Value Vignettes, CPVs
Study Participants

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, United States

Location

Related Publications (5)

  • 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: 30328782BACKGROUND
  • 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.

    PMID: 26376210BACKGROUND
  • 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.

    PMID: 10755498BACKGROUND
  • 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.

    PMID: 15545677BACKGROUND
  • 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.

    PMID: 30874783BACKGROUND

MeSH Terms

Conditions

PainAcute PainChronic PainNeuralgiaOpioid-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • John Peabody, MD, PhD

    QURE Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

September 3, 2019

Primary Completion

October 29, 2019

Study Completion

October 29, 2019

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared with other researchers. Analysis will be conducted at the aggregate group level.

Locations