PainNCT04080037
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
A study testing Quality IQ Patient Simulations in people with Pain and Pain, Acute, run by Qure Healthcare, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Pain, Acute, Pain, Chronic
- What is being tested?
- Quality IQ Patient Simulations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2019to 29 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Opioid-use Disorder, Opioid Abuse and Addiction
- Being tested
- Quality IQ Patient Simulations
- Medical subject headings
- Pain, Acute Pain, Chronic Pain, Neuralgia, Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality IQ Patient SimulationsOther
Also called Clinical Performance and Value Vignettes, CPVs
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality IQ Patient Simulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Secondary outcomes (2)
Participant satisfaction as measured by post-evaluation survey
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.
Measured: 2 months
Physician engagement throughout the study
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start3 Sep 2019
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ascend Learning
- Responsible party
- Sponsor
- Investigators
- John Peabody, MD, PhD, Principal investigator, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080037
- Sponsor's protocol ID
- 01-QALM-2019
- Status last verified
- Feb 2020
- First submitted
- 3 Sep 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers. Analysis will be conducted at the aggregate group level.
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.
PubMed 30328782Weigel 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.
PubMed 26376210Peabody 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.
PubMed 10755498Peabody 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.
PubMed 15545677Schieber 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.
PubMed 30874783
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Opioid Care Practices Using CPV Patient Simulation Modules to Improve Alignment With CDC Guidelines
- ClinicalTrials.gov ID
- NCT04080037
- Acronym / sponsor ID
- 01-QALM-2019
- Conditions
- Pain, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Opioid-use Disorder, Opioid Abuse and Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ascend Learning
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Experimental | Other: Quality IQ Patient SimulationsAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality IQ Patient SimulationsAlso: Clinical Performance and Value Vignettes, CPVsOnline 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 | Study Participants |
Primary outcome
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.
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 secondary outcomes
Participant satisfaction as measured by post-evaluation survey
Time frame: 2 months
Physician engagement throughout the study
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Background: PubMed 30328782Burgon 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.
- Background: PubMed 26376210Weigel 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.
- Background: PubMed 10755498Peabody 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.
- Background: PubMed 15545677Peabody 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.
- Background: PubMed 30874783Schieber 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers. Analysis will be conducted at the aggregate group level.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Peabody, MD, PhD principal investigator
QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality IQ Patient Simulations in people with Pain and Pain, Acute, run by Qure Healthcare, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in provider scores on pre- and post-intervention assessments (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080037, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.