Cardiometabolic SyndromeNCT05910684
Establishing Clinical Utility Evidence for Chronic Disease Management Testing Patient Study
A study testing Aegis CDM Test and Educational Materials in people with Cardiometabolic Syndrome, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and others) of a subset of common patient care indications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiometabolic Syndrome
- What is being tested?
- Aegis CDM Test and Educational Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 30 Jan 2024
- 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
- Board-certified physician currently practicing in either Family Medicine or Internal Medicine.
- Have practiced as a board-certified physician in internal or family medicine or greater than 2 but less than 30 years
- Community/non-academic based practice setting
- ≥ 40 patients under care weekly
- Commonly treats patients with atrial fibrillation, coronary artery disease, congestive heart failure, diabetes, hypertension, and hyperlipidemia
- Patient HIPAA Authorization form signed upon initial enrollment into the provider's practice
Show all 10Show fewer
- Practicing in the U.S.
- English-speaking
- Access to the internet
- Informed and voluntarily consented to be in the study
Who cannot join
- Not a board-certified physician
- Not practicing in the United States
- Not informed and voluntarily consented to be in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Clinical Utility Evidence for Chronic Disease Management Testing: A CPV® and Chart Abstraction Randomized Controlled Trial
This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and others) of a subset of common patient care indications.
Read the detailed description
In the original study protocol (approved on October 19th, 2021), which the investigators are now referring to as Phase 1, the investigators measured changes in clinical practice using Clinical Performance and Value (CPVs) vignettes, described below. Phase 1 utilized simulated patients to determine clinical variation in the management of chronic cardiometabolic diseases and assessed the impact of the CDMT results on physicians' clinical decision-making.
CPVs are QURE's scientifically-validated measurement tool, first described in JAMA, 2000, and now used in scores of scientific investigations. In this research and derivative peer-reviewed publications, QURE's CPV studies efficiently measure clinical practice patterns among active physicians to determine if there is value in new technologies to payers.
This amendment allows us to ask the same physicians if they change their practice in an actual clinical setting.
Phase 2 extends the findings from Phase 1 by measuring the change in clinical practice using CPVs and securing data on practice patterns from abstracted medical records. the investigators will look for the same changes the investigators found in Phase 1 to determine the impact of CDMT on real-world clinical decisions and patient outcomes. The advantage of Phase 2 is that it leverages the same sample frame and the randomization by returning to the physicians in Round 1 who indicated that CDMT would change their practice. These physicians will be given, free of charge, the option of using CDMT on their real patients who share similar medical diagnoses as the CPV simulated patients. Phase 2 will thus provide patient-level data on the impact of medication adherence assessment on quality outcomes including, but not limited to, blood pressure control, blood sugar control, and parameters of disease progression
- Conditions
- Cardiometabolic Syndrome
- Being tested
- Aegis CDM Test and Educational Materials
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aegis CDM Test and Educational MaterialsDiagnostic test
The Aegis CDM diagnostic test will be given to intervention participants to use on their patients. The participants will receive the results of the test through a web portal. Investigators will analyze the differences in quality of care between the control arm and the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | These participants will complete their online simulations and treat their real-life patients without access to the Aegis test. |
| Educational Materials and Test Access | Experimental | These participants will complete their online simulations and treat their real-life patients with access to educational materials and the Aegis test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm. Receives: Diagnostic Test: Aegis CDM Test and Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart abstraction measured variation in quantity of care
Measuring the difference in the quality of care between the control arm and the intervention arm as measured by the number of care decisions made in the second round of chart abstraction.
These care decisions might include decisions such as avoidance of invasive diagnostic tests, reductions in unneeded specialist referrals, increased diagnosis and treatment of drug-drug interactions, or care decisions related to costs.
Measured: [19 months]
Chart abstraction measured variation in quality of care
Measuring the difference in the quality of care between the control arm and the intervention arm as measured by the quality of care decisions made in the second round of chart abstraction.
These care decisions might include decisions such as avoidance of invasive diagnostic tests, reductions in unneeded specialist referrals, increased diagnosis and treatment of drug-drug interactions, or care decisions related to costs.
Measured: [19 months]
Chart abstraction measured variation in clinical decisions
Measuring the variation in amount of evidence based clinical decisions among practicing primary care physicians in the assessment, recognition, and adjustment of treatment due to medication non-adherence and DDIs in patients with chronic cardiometabolic diseases.
Measured: [19 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start19 Jul 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
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 Cardiometabolic SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll primary care physicians practicing in the US from a population of participants who completed phase 1 of the study. All participants will keep their arm assignments from the phase 1 study. All eligible and consented participants will complete a round of three patient simulations. The intervention arm will have access to the Aegis test and will be asked to use this test on patients who meet the eligibility criteria.
- Masking
- None (open label)
- Enrolment
- 114 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
- NCT05910684
- Sponsor's protocol ID
- Pro00060013
- Status last verified
- Apr 2024
- First submitted
- 6 Jun 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
David RE, Ferrara KG, Schrecker J, Paculdo D, Johnson S, Bentley-Lewis R, Heltsley R, Peabody JW. Impact of medication nonadherence and drug-drug interaction testing on the management of primary care patients with polypharmacy: a randomized controlled trial. BMC Med. 2024 Nov 18;22(1):540. doi: 10.1186/s12916-024-03757-6.
PubMed 39551766
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility Evidence for Chronic Disease Management Testing: A CPV® and Chart Abstraction Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05910684
- Acronym / sponsor ID
- Pro00060013
- Conditions
- Cardiometabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 20 Jun 2023 (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 national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and others) of a subset of common patient care indications.
Detailed description
In the original study protocol (approved on October 19th, 2021), which the investigators are now referring to as Phase 1, the investigators measured changes in clinical practice using Clinical Performance and Value (CPVs) vignettes, described below. Phase 1 utilized simulated patients to determine clinical variation in the management of chronic cardiometabolic diseases and assessed the impact of the CDMT results on physicians' clinical decision-making.
CPVs are QURE's scientifically-validated measurement tool, first described in JAMA, 2000, and now used in scores of scientific investigations. In this research and derivative peer-reviewed publications, QURE's CPV studies efficiently measure clinical practice patterns among active physicians to determine if there is value in new technologies to payers.
This amendment allows us to ask the same physicians if they change their practice in an actual clinical setting.
Phase 2 extends the findings from Phase 1 by measuring the change in clinical practice using CPVs and securing data on practice patterns from abstracted medical records. the investigators will look for the same changes the investigators found in Phase 1 to determine the impact of CDMT on real-world clinical decisions and patient outcomes. The advantage of Phase 2 is that it leverages the same sample frame and the randomization by returning to the physicians in Round 1 who indicated that CDMT would change their practice. These physicians will be given, free of charge, the option of using CDMT on their real patients who share similar medical diagnoses as the CPV simulated patients. Phase 2 will thus provide patient-level data on the impact of medication adherence assessment on quality outcomes including, but not limited to, blood pressure control, blood sugar control, and parameters of disease progression
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will enroll primary care physicians practicing in the US from a population of participants who completed phase 1 of the study. All participants will keep their arm assignments from the phase 1 study. All eligible and consented participants will complete a round of three patient simulations. The intervention arm will have access to the Aegis test and will be asked to use this test on patients who meet the eligibility criteria.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –These participants will complete their online simulations and treat their real-life patients without access to the Aegis test. |
| Educational Materials and Test Access | Experimental | Diagnostic Test: Aegis CDM Test and Educational MaterialsThese participants will complete their online simulations and treat their real-life patients with access to educational materials and the Aegis test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Board-certified physician currently practicing in either Family Medicine or Internal Medicine.
- Have practiced as a board-certified physician in internal or family medicine or greater than 2 but less than 30 years
- Community/non-academic based practice setting
- ≥ 40 patients under care weekly
- Commonly treats patients with atrial fibrillation, coronary artery disease, congestive heart failure, diabetes, hypertension, and hyperlipidemia
Key exclusion criteria (3 listed)
- Not a board-certified physician
- Not practicing in the United States
- Not informed and voluntarily consented 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 |
|---|---|---|
| Aegis CDM Test and Educational MaterialsThe Aegis CDM diagnostic test will be given to intervention participants to use on their patients. The participants will receive the results of the test through a web portal. Investigators will analyze the differences in quality of care between the control arm and the intervention arm. | Diagnostic test | Educational Materials and Test Access |
Primary outcome
Chart abstraction measured variation in quantity of care
Time frame: [19 months]
Measuring the difference in the quality of care between the control arm and the intervention arm as measured by the number of care decisions made in the second round of chart abstraction. These care decisions might include decisions such as avoidance of invasive diagnostic tests, reductions in unneeded specialist referrals, increased diagnosis and treatment of drug-drug interactions, or care decisions related to costs.
Chart abstraction measured variation in quality of care
Time frame: [19 months]
Measuring the difference in the quality of care between the control arm and the intervention arm as measured by the quality of care decisions made in the second round of chart abstraction. These care decisions might include decisions such as avoidance of invasive diagnostic tests, reductions in unneeded specialist referrals, increased diagnosis and treatment of drug-drug interactions, or care decisions related to costs.
Chart abstraction measured variation in clinical decisions
Time frame: [19 months]
Measuring the variation in amount of evidence based clinical decisions among practicing primary care physicians in the assessment, recognition, and adjustment of treatment due to medication non-adherence and DDIs in patients with chronic cardiometabolic diseases.
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 2 Apr 2024.
- Derived from this study: PubMed 39551766David RE, Ferrara KG, Schrecker J, Paculdo D, Johnson S, Bentley-Lewis R, Heltsley R, Peabody JW. Impact of medication nonadherence and drug-drug interaction testing on the management of primary care patients with polypharmacy: a randomized controlled trial. BMC Med. 2024 Nov 18;22(1):540. doi: 10.1186/s12916-024-03757-6.
- Individual participant dataSharing planned: No
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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 Aegis CDM Test and Educational Materials in people with Cardiometabolic Syndrome, 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 10 inclusion and 3 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 2 Apr 2024. 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?
Chart abstraction measured variation in quantity of care (time frame: [19 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 NCT05910684, 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 2 Apr 2024.