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Transform: Teaching, Technology, and Teams (T3)

Primary Purpose

Heart Failure, Type 2 Diabetes, Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Decision Support

Referral

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

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:
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

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
Transient ischemic attack in prior 3 days
Platelet count <70,000/ml
Hemoglobin concentration <8g/dl
History of or condition associated with increased bleeding risk, such as hemophilia
Major surgical procedure or trauma within 14 days
Clinically significant gastrointestinal bleeding within 8 weeks

Sites / Locations

Cardiology Center of AmarilloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Decision Support

Referral

Arm Description

Teaching - CardioSmart Resources + Clinician Education

Technology - Facilitated Solution (Existing Team)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

Quality of Life Outcome-PAM

Difference in patient reported outcomes on Patient Activation Measure® (PAM) from baseline, 3 and at 9 months.

Full Information

NCT ID

NCT05572814

First Posted

September 27, 2022

Last Updated

October 5, 2022

Sponsor

American College of Cardiology

1. Study Identification

Unique Protocol Identification Number

NCT05572814

Brief Title

Transform: Teaching, Technology, and Teams

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 30, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American College of Cardiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Type 2 Diabetes, Atrial Fibrillation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Teaching - CardioSmart Resources + Clinician Education

Arm Title

Decision Support

Arm Type

Active Comparator

Arm Description

Technology - Facilitated Solution (Existing Team)

Arm Title

Referral

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Decision Support

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Referral

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Quality of Life Outcome-MMA-4

Description

Difference in patient reported outcomes on Morisky Medication Adherence Scale (MMAS-4) from baseline, 3 and at 9 months.

Time Frame

Study duration up to 1 year.

Title

Quality of Life Outcome-KCCQ-12

Description

Difference in patient-reported outcome/KCCQ-12 scores from baseline to 9 months (applicable to HFrEF and HFpEF study cohorts only).

Time Frame

Study duration up to 1 year.

Title

Quality of Life Outcome-PAM

Description

Difference in patient reported outcomes on Patient Activation Measure® (PAM) from baseline, 3 and at 9 months.

Time Frame

Study duration up to 1 year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 Exclusion Criteria: 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 Transient ischemic attack in prior 3 days Platelet count <70,000/ml Hemoglobin concentration <8g/dl History of or condition associated with increased bleeding risk, such as hemophilia Major surgical procedure or trauma within 14 days Clinically significant gastrointestinal bleeding within 8 weeks

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lindsey C Hill

Phone

2026754144

lhill2@acc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Shilpa Patel

SPatel@acc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James MD Januzzi, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ankeet S Bhatt, MD

Organizational Affiliation

Kaiser Permanente

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrew Oseran, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Megan Welch, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jagmeet Singh, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Muthiah Vadduganathan, MD

Organizational Affiliation

Mass General Brigham

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiology Center of Amarillo

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandra Muniz

alexandramuniz@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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