Chronic DiseaseNCT05658653
Clinical Utility of CDMT Among VillageMD Providers
A study testing Educational Materials for Chronic Disease Management Test (CDMT) in people with Chronic Disease and Drug Drug Interaction, run by Qure Healthcare, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Disease, Drug Drug Interaction, Medication Adherence
- What is being tested?
- Educational Materials for Chronic Disease Management Test (CDMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 10 Jan 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- English-speaking
- Access to the internet
- Informed and voluntarily consented to be in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Clinical Utility of Aegis's Chronic Disease Management Test Among VillageMD Providers: A CPV Randomized Control Trial
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.
Read the detailed description
The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 150 physicians.
Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.
If physicians are randomized to the intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. The time to review educational materials is estimated to be approximately 15 minutes.
Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll in a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.
- Conditions
- Chronic Disease, Drug Drug Interaction, Medication Adherence
- Being tested
- Educational Materials for Chronic Disease Management Test (CDMT)
- Medical subject headings
- Chronic Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Materials for Chronic Disease Management Test (CDMT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Materials for Chronic Disease Management Test (CDMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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.
Measured: [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.
Measured: [4 months]
Secondary outcomes (1)
CPV-measured differences in cost of care between control and intervention arms
Difference in the cost of care between control and intervention participants (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs per above).
Measured: [4 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start16 Aug 2022
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658653
- Sponsor's protocol ID
- Pro00064387
- Status last verified
- Mar 2023
- First submitted
- 2 Dec 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burgon T, Paculdo D, Schrecker J, Ferrara KG, David RE, Johnson S, Valdenor C, Peabody JW. Helping primary care providers recognize and respond to medication non-adherence and drug-drug interactions: A randomized-controlled clinical utility trial in a value-based care setting. PLoS One. 2026 Mar 16;21(3):e0344906. doi: 10.1371/journal.pone.0344906. eCollection 2026.
PubMed 41838747
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Clinical Utility of Aegis's Chronic Disease Management Test Among VillageMD Providers: A CPV Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05658653
- Acronym / sponsor ID
- Pro00064387
- Conditions
- Chronic Disease, Drug Drug Interaction, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 21 Dec 2022 (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 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.
Detailed description
The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 150 physicians.
Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.
If physicians are randomized to the intervention group in this study, they will receive educational materials on a novel diagnostic test after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. The time to review educational materials is estimated to be approximately 15 minutes.
Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll in a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Educational Materials for Chronic Disease Management Test (CDMT)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Educational Materials for Chronic Disease Management Test (CDMT)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. | Other | Chronic Disease Management Test (CDMT) |
Primary outcome
Clinical Performance and Value (CPV) -measured variation in assessment
Time frame: [4 months]
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.
CPV-measured change in treatment Quality
Time frame: [4 months]
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.
CPV-measured difference in amount of evidence-based decisions
Time frame: [4 months]
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.
1 secondary outcome
CPV-measured differences in cost of care between control and intervention arms
Time frame: [4 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 29 Mar 2023.
- Derived from this study: PubMed 41838747Burgon T, Paculdo D, Schrecker J, Ferrara KG, David RE, Johnson S, Valdenor C, Peabody JW. Helping primary care providers recognize and respond to medication non-adherence and drug-drug interactions: A randomized-controlled clinical utility trial in a value-based care setting. PLoS One. 2026 Mar 16;21(3):e0344906. doi: 10.1371/journal.pone.0344906. eCollection 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Materials for Chronic Disease Management Test (CDMT) in people with Chronic Disease and Drug Drug Interaction, 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 9 inclusion and 5 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 29 Mar 2023. 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?
Clinical Performance and Value (CPV) -measured variation in assessment (time frame: [4 months]). The study lists 3 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 NCT05658653, which also lists 1 linked publication.
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 29 Mar 2023.