Assessing Opioid Care Practices Using CPV Patient Simulation Modules

February 6, 2020 updated by: Qure Healthcare, LLC

Assessing Opioid Care Practices Using CPV Patient Simulation Modules to Improve Alignment With CDC Guidelines

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • QURE Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Participants
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

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.

Other Names:
  • CPVs
  • Clinical Performance and Value Vignettes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in provider scores on pre- and post-intervention assessments
Time Frame: 2 months

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.
Time Frame: 2 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant satisfaction as measured by post-evaluation survey
Time Frame: 2 months
Investigators will measure participant satisfaction as measured by post-evaluation survey. On a scale of 1 to 5 (with 5 being the highest), participants will be asked about the overall quality of the material, the relevance to their practice and the educational content. Higher scores represent a better outcome.
2 months
Physician engagement throughout the study
Time Frame: 2 months
The investigators will track the percentage of enrolled participants who stay engaged in the study and complete at least 80% of their patient simulation cases.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qure Healthcare, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ascend Learning

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Peabody, MD, PhD, QURE Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01-QALM-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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