Transform: Teaching, Technology, and Teams

NCT05572814 | Unknown

• 1 other identifier: 59648
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of Life Outcome-MMA-4

  Study duration up to 1 year.

• Quality of Life Outcome-KCCQ-12

  Study duration up to 1 year.

• Quality of Life Outcome-PAM

  Study duration up to 1 year.

Study Arms (3)

Usual Care

NO INTERVENTION

Teaching - CardioSmart Resources + Clinician Education

Decision Support

ACTIVE COMPARATOR

Technology - Facilitated Solution (Existing Team)

Behavioral: Decision Support

Referral

ACTIVE COMPARATOR

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

Behavioral: Referral

Interventions

Decision Support BEHAVIORAL

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

Decision Support

Referral BEHAVIORAL

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

Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Personal access to a computer and/or Smartphone for app download
• Heart Failure (reduced and preserved ejection fraction) AND/OR
• 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
• T2D and ASCVD, defined as follows:
• Known CAD, prior ACS, or coronary artery revascularization
• Prior TIA/stroke or known carotid or intracerebral atherosclerosis
• Prior PAD including requiring revascularization

You may not qualify if:

• All patients
• Current or anticipated participation in an interventional clinical trial of a drug/device
• Currently receiving comfort care or enrolled in hospice
• Life expectancy \<1 year
• Pregnancy or active breastfeeding
• Current or anticipated participation in an interventional clinical trial (other than TRANSFORM3 GDMT)
• Patients without a clinical encounter within three years of study start date
• Heart Failure patients:
• History of or plan for heart transplantation or left ventricular assist de-vice
• Palliative chronic inotropic therapy
• NYHA Class 4 heart failure
• Atrial Fibrillation patients:
• Current prescription for OAC
• Reversible cause of atrial fibrillation, such as post-cardiothoracic surgery or thyrotoxicosis
• History of ischemic stroke in prior 7 days

Sponsors & Collaborators

• American College of Cardiology: lead

Study Sites (1)

Cardiology Center of Amarillo

Amarillo, Texas, 79106, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus, Type 2; Atrial Fibrillation

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• 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

• Jagmeet Singh, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Muthiah Vadduganathan, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey C Hill

CONTACT

2026754144; lhill2@acc.org

Shilpa Patel

CONTACT

SPatel@acc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 10, 2022
• Study Start: September 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)