NCT05658653

Brief Summary

This is a health system-level research study of physicians and care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and other) of a subset of common patient care indications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 16, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

December 2, 2022

Last Update Submit

March 27, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Clinical Performance and Value (CPV) -measured variation in assessment

    Using the responses to the simulated patient cases to measure the baseline levels of variation in the work-up, recognition, and management of medication non-adherence and/or DDI in patients with more than one cardiometabolic condition and associated polypharmacy. Work-up, recognition, and management scores will be combined to report variation in total assessment of the simulated patient cases.

    [4 months]

  • CPV-measured change in treatment Quality

    Measuring the difference in the quality of overall diagnostic scores between control participants using standard-of-care diagnostic tools and intervention participants using the CDMT. Scores will be on a scale of 0-100 with 100 representing the ideal management of a simulated patient.

    [4 months]

  • CPV-measured difference in amount of evidence-based decisions

    Differences in number of evidence-based decisions, particularly prescribing decisions, made by intervention providers and control providers, while controlling for provider and practice characteristics, between rounds 1 and 2.

    [4 months]

Secondary Outcomes (1)

  • CPV-measured differences in cost of care between control and intervention arms

    [4 months]

Study Arms (2)

Standard Practice

NO INTERVENTION

The Control group treats their simulated patients using standard practice and has no introduction to the new CDMT test.

Chronic Disease Management Test (CDMT)

EXPERIMENTAL

The intervention will receive information regarding the CDMT test and will be given the test results, whether selected or not, in Round 2 of CPV administration.

Other: Educational Materials for Chronic Disease Management Test (CDMT)

Interventions

These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.

Chronic Disease Management Test (CDMT)

Eligibility Criteria

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

You may qualify if:

  • Licensed primary care provider (PCP) (MD, DO, NP, PA) currently practicing in the following areas: a) Internal medicine b) Family medicine
  • Have practiced as a PCP in internal or family medicine for greater than 2 but less than 30 years
  • practicing in a community / non-academic based practice setting
  • ≥ 40 patients under care weekly
  • Commonly treats patients with congestive heart failure/atrial fibrillation, diabetes, hypertension, and COPD
  • Practicing in the United States
  • English-speaking
  • Access to the internet
  • Informed and voluntarily consented to be in the study

You may not qualify if:

  • Non-English speaking
  • Not a licensed primary care provider
  • Unable to access the internet
  • Not practicing in the U.S.
  • 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

MeSH Terms

Conditions

Chronic DiseaseMedication Adherence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The study will enroll physicians and care providers practicing in the VillageMD health system. Participants are randomly assigned to either control or intervention 1 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention arm only will receive educational material about the CDMT test in between these two rounds. Intervention arm participants only will receive the CDMT test results whether they select it or not.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 21, 2022

Study Start

August 16, 2022

Primary Completion

January 10, 2023

Study Completion

January 10, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations