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Quality IQ Patient Simulation Physician Practice Measurement and Engagement (Q-IQ)

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ClinicalTrials.gov Identifier: NCT03800901
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
CE Outcomes
Information provided by (Responsible Party):
Qure Healthcare, LLC

Brief Summary:
This study will test the quality of 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 study will also measure the impact of gaming-inspired competition and motivation, including a weekly leaderboard, to improve evidence-based care decisions. In addition, the study the test the impact of CME and MOC credits on participant engagement in the process.

Condition or disease Intervention/treatment Phase
Diabetes Hypertension Depression Osteoarthritis Asthma Pain Heart Failure Other: Continuing Medical Education Other: Quality IQ Patient Simulations Not Applicable

Detailed Description:

Primary care providers (PCPs) make many of the most important care decisions, especially for patients with chronic conditions and multiple co-morbidities. Studies have confirmed that unwarranted variation is common among PCPs, with high level of variation in care documented between urban and rural practices, across regions, and even among providers within a single healthcare system.

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 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 measurement, feedback and competition on evidence-based care decisions made by primary care providers across the country. It is a randomized, controlled trial with multiple measurements across key domains of clinical care. All participants are asked to care for simulated patients designed to look like 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, including national MIPS quality measures.

All participants will receive the following interventions:

  • Feedback on care decisions made in each Quality IQ case, which will identify correct care, unneeded care, or gaps in care. This feedback will recommend or reinforce evidence-based care decisions and includes references.
  • All cases will be scored against evidence-based criteria. For each case, providers will start with 100 base points. Correct care decisions will add to that total, while unnecessary care decisions will subtract from that total. A weekly leaderboard will be posted online, allowing participants to see how they are performing relative to their peers across the country. Participants will have the opportunity to select a unique username or an anonymous user ID to be identified on the leaderboard, to maintain anonymity.

Half of the recruits will be offered Category I CME credit approved by The University of California, San Francisco School of Medicine (UCSF) which has been accredited by the Accreditation Council of Continuing Medical Education to provide CME for physicians and MOC points in the ABIM's MOC program.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study will enroll practicing PCPs in the US. Once eligibility is determined and providers are enrolled in the study, they will be randomized into one of two arms:

  • Control: will not be offered CME or ABIM MOC credits for their participation.
  • CME Arm: will be offered CME or ABIM MOC credits for their participation. Between the two arms, all other aspects of the study will remain constant.

All providers will then care for 1 Quality IQ patient simulation each week over the course of 6-8 weeks.

Masking: Single (Participant)
Masking Description: The Control arm, who are not offered CME or ABIM MOC credits for their participation, will be unaware of the interventional CME arm. The CME arm will also be unaware of the Control arm. Per recommendations from the IRB, all participants at the end of the study will receive a study debrief letter informing them of the other study arms.
Primary Purpose: Health Services Research
Official Title: Quality IQ Patient Simulation Physician Practice Measurement and Engagement
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
The Control arm will be asked to care for online, Quality IQ patient simulations and will receive feedback based on their care decisions made in each case. The feedback will identify correct care, unneeded care, or gaps in care and recommend or reinforce evidence-based care decisions and includes references. This arm will not be offered Continuing Medical Education (CME) or American Board of Internal Medicine (ABIM) Part II Maintenance of Certification (MOC) credits for their participation.
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, including national MIPS quality measures.

Cases will cover clinical conditions aligned with MIPS measures that are commonly seen in the primary care setting including: diabetes, hypertension, depression, osteoarthritis, asthma and pain control.

Other Names:
  • Clinical Performance and Value vignettes
  • CPVs

Experimental: CME
The CME arm will be asked to care for online, Quality IQ patient simulations and will receive feedback based on their care decisions made in each case. The feedback will identify correct care, unneeded care, or gaps in care and recommend or reinforce evidence-based care decisions and includes references. This arm will be offered Continuing Medical Education (CME) and American Board of Internal Medicine (ABIM) Part II Maintenance of Certification (MOC) credits for their participation.
Other: Continuing Medical Education
CME or ABIM MOC credits
Other Name: CME

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, including national MIPS quality measures.

Cases will cover clinical conditions aligned with MIPS measures that are commonly seen in the primary care setting including: diabetes, hypertension, depression, osteoarthritis, asthma and pain control.

Other Names:
  • Clinical Performance and Value vignettes
  • CPVs




Primary Outcome Measures :
  1. Change in the percentage of evidence-based diagnostic and treatment decisions made in the simulations. [ Time Frame: 3 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.


Secondary Outcome Measures :
  1. Change in MIPS-relevant care decisions made in the patient simulations [ Time Frame: 3 months ]
    As described in the primary outcome measure, the investigators will track the percentage of evidence-based care decisions made by participants in the patient simulations. A subset of these care decisions tie directly to quality measures tracked by Medicare through the Merit-based Incentive Payment System (MIPS). For this outcome measure, the investigators will track changes in the percentage of MIPS-relevant work-up and treatment decisions made in the patient simulations. Higher scores represent a better outcome.

  2. Change in ordering of unneeded work-up tests made in the patient simulations [ Time Frame: 3 months ]
    As described in the primary outcome measure, the investigators will track the percentage of evidence-based care decisions made by participants in the patient simulations. A subset of these care decisions tie to ordering of unneeded laboratory and imaging testing that is not supported by the evidence-based guidelines. For this outcome measure, the investigators will track changes in the frequency with which unneeded tests are ordered in the patient simulations. Higher scores represent a better outcome.

  3. Participant case completion rate [ Time Frame: 3 months ]
    The investigators will track the percentage of enrolled participants who stay engaged in the study and complete at least 75% of their patient simulation cases.

  4. Participant Satisfaction [ Time Frame: 3 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.

  5. Impact of available CME and ABIM MOC on recruitment rate [ Time Frame: 3 months ]
    Operating under the hypothesis that physicians offered CME and MOC credits are more likely to participate in a quality improvement program like this, the investigators will track the rate at which a randomized group of primary care physicians enroll in the program when offered CME and MOC credit and compare that to a group that is not offered CME and MOC credit for their participation.

  6. Impact of available CME and ABIM MOC on retention rate [ Time Frame: 3 months ]
    Operating under the hypothesis that physicians offered CME and MOC credits are more likely to continue participating in a quality improvement program, the investigators will track the rate at which a primary care physicians eligible to earn CME and MOC credit complete the full 8 week project and compare that to a group that is not offered CME and MOC credit.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Board-certified in internal medicine or family medicine
  2. Minimum patient panel size of 1,500 patients
  3. English-speaking
  4. Access to the internet
  5. 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 1,500 patients
  3. Non-English speaking
  4. Unable to access the internet
  5. Does not voluntarily consent to be in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800901


Contacts
Contact: Trever Burgon, PhD 415-321-3388 ext 2 tburgon@qurehealthcare.com
Contact: John Peabody, MD, PhD 415-321-3388 ext 1 jpeabody@qurehealthcare.com

Locations
United States, California
QURE Healthcare Recruiting
San Francisco, California, United States, 94109
Contact: John W Peabody, MD    415-321-3388 ext 1    jpeabody@qurehealthcare.com   
Contact: Mary T Tran, MS    4153213388 ext 1    mtran@qurehealthcare.com   
Principal Investigator: John W Peabody, MD         
Sponsors and Collaborators
Qure Healthcare, LLC
CE Outcomes
Investigators
Principal Investigator: John Peabody, MD, PhD QURE Healthcare

Publications:
Responsible Party: Qure Healthcare, LLC
ClinicalTrials.gov Identifier: NCT03800901     History of Changes
Other Study ID Numbers: 01-QIQ-K-2018
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers. Analysis will be conducted at the aggregate group level.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Osteoarthritis
Heart Diseases
Cardiovascular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases