Recruiting

Observational Study

Sponsor:

American College of Cardiology

Code:

NCT05572814

Conditions

Heart Failure

Type 2 Diabetes

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Decision Support

Referral

Study Details

Brief summary:

This initiative supports a quality improvement effort evaluating the use of strategies (including technology-based decision support, referral to a virtual GDMT team, and general educational tools/resources for clinicians and patients) to improve use of guideline-directed therapeutics known to lower cardiovascular (CV) events among patients with cardiovascular diseases of heart failure, atrial fibrillation and type 2 diabetes (T2D)/ASCVD with a specific focus on underserved populations and those with a history of health care disparities.

Conditions

Heart Failure

Type 2 Diabetes

Atrial Fibrillation

Study ID

NCT05572814

Start date

Sep 30, 2022

Status verified date

Sep, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion criteria:

1. Age ≥18 years
2. Personal access to a computer and/or Smartphone for app download
3. Heart Failure (reduced and preserved ejection fraction) AND/OR
4. Atrial Fibrillation with CHA2DS2-VASc score greater than or equal to 2 in men and greater than or equal to 3 in women AND/OR
5. T2D and ASCVD, defined as follows:

1. Known CAD, prior ACS, or coronary artery revascularization
2. Prior TIA/stroke or known carotid or intracerebral atherosclerosis
3. Prior PAD including requiring revascularization

Exclusion Criteria:

All patients

1. Current or anticipated participation in an interventional clinical trial of a drug/device
2. Currently receiving comfort care or enrolled in hospice
3. Life expectancy <1 year
4. Pregnancy or active breastfeeding
5. Current or anticipated participation in an interventional clinical trial (other than TRANSFORM3 GDMT)
6. Patients without a clinical encounter within three years of study start date

Heart Failure patients:

1. History of or plan for heart transplantation or left ventricular assist de-vice
2. Palliative chronic inotropic therapy
3. NYHA Class 4 heart failure

Atrial Fibrillation patients:

1. Current prescription for OAC
2. Reversible cause of atrial fibrillation, such as post-cardiothoracic surgery or thyrotoxicosis
3. History of ischemic stroke in prior 7 days
4. Transient ischemic attack in prior 3 days
5. Platelet count <70,000/ml
6. Hemoglobin concentration <8g/dl
7. History of or condition associated with increased bleeding risk, such as hemophilia
8. Major surgical procedure or trauma within 14 days
9. Clinically significant gastrointestinal bleeding within 8 weeks

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Usual Care

Teaching - CardioSmart Resources + Clinician Education

active comparator: Decision Support

Technology - Facilitated Solution (Existing Team)

active comparator: Referral

Teams - Protocol-Supported Team, (Virtual GDMT Team)

Interventions

Decision Support

Prompts will be provided to clinicians signaling gaps in guideline-directed care

Referral

Patients will be referred to an interdisciplinary, expert guideline-directed medical therapy team

Primary outcome measure

  • Adoption of evidence-based CV-risk reduction and disease management therapies for HF, AF, and T2D/ASCVD. This data will be found in the patient's medical record. [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Shilpa Patel

SPatel@acc.org

Locations

Cardiology Center of Amarillo

Recruiting

Amarillo, Texas, United States, 79106

Contacts

More Information

Sponsor

American College of Cardiology

Last update posted

Oct 10, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American College of Cardiology on 2022-10-10.