Transform: Teaching, Technology, and Teams (T3)

TRANSFORM3: Evaluation of Implementation Strategies of Teaching, Technology, and Teams to Optimize Medical Therapy in Cardiovascular Disease (T3)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Atrial Fibrillation; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Decision Support; Behavioral: Referral

Detailed Description

TRANSFORM3 is a Quality Improvement initiative conducted in parallel to the current TRANSFORM CVRiD study and aligned with its goals of using a real-world population study to enable the American College of Cardiology Foundation ("ACCF") to better identify impactful ways to improve guideline directed medical therapy for patients. TRANSFORM3 is focused on improving GDMT use in underserved patients and patients with a history of health care disparities who have one or more of the following: heart failure, atrial fibrillation, and ASCVD/Type 2 diabetes.

There is a significant disconnect between increasing availability of effective and safe therapeutics that significantly reduce CV event risk in patients with Heart Failure, T2D and ASCVD, and Atrial Fibrillation-and clear guideline recommendations endorsing these therapies-but very low adoption in clinical practice with the majority of eligible patients that are most likely to benefit from these therapies not receiving them. A high proportion of patients have more than one of these conditions further reducing the chances of receiving optimal guideline directed medical therapy and avoiding the CV events they are designed to prevent.

• Study Type: Interventional
• Enrollment (Anticipated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsey C Hill; Phone Number: 2026754144; Email: lhill2@acc.org
• Study Contact Backup: Name: Shilpa Patel; Email: SPatel@acc.org

Study Locations

• United States
  • Texas
    • Amarillo, Texas, United States, 79106
      • Recruiting
      • Cardiology Center of Amarillo
      • Contact: Alexandra Muniz; Email: alexandramuniz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Usual Care; Teaching - CardioSmart Resources + Clinician Education
ACTIVE_COMPARATOR: Decision Support; Technology - Facilitated Solution (Existing Team)	Behavioral: Decision Support; Prompts will be provided to clinicians signaling gaps in guideline-directed care
ACTIVE_COMPARATOR: Referral; Teams - Protocol-Supported Team, (Virtual GDMT Team)	Behavioral: Referral; Patients will be referred to an interdisciplinary, expert guideline-directed medical therapy team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	GDMT baseline to 9 month change in average composite endpoint of receiving the main classes of drugs (50% or higher of target doses for HF) among eligible patients. We're aiming to see a change or increase in guideline-directed care where there was an original gap.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Outcome-MMA-4	Difference in patient reported outcomes on Morisky Medication Adherence Scale (MMAS-4) from baseline, 3 and at 9 months.	Study duration up to 1 year.
Quality of Life Outcome-KCCQ-12	Difference in patient-reported outcome/KCCQ-12 scores from baseline to 9 months (applicable to HFrEF and HFpEF study cohorts only).	Study duration up to 1 year.
Quality of Life Outcome-PAM	Difference in patient reported outcomes on Patient Activation Measure® (PAM) from baseline, 3 and at 9 months.	Study duration up to 1 year.

Collaborators and Investigators

• Sponsor: American College of Cardiology
• Investigators: Principal Investigator: James MD Januzzi, MD, Massachusetts General Hospital; Principal Investigator: Ankeet S Bhatt, MD, Kaiser Permanente; Principal Investigator: Andrew Oseran, MD, Massachusetts General Hospital; Principal Investigator: Megan Welch, MD, Massachusetts General Hospital; Principal Investigator: Muthiah Vadduganathan, MD, Mass General Brigham

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (ACTUAL): October 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 59648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No