Transform: Teaching, Technology, and Teams

Not Applicable

Recruiting

• Conditions: Heart Failure; Atrial Fibrillation; Type 2 Diabetes
• Interventions: Behavioral: Referral; Behavioral: Decision Support

• Registration Number: NCT05572814
• Lead Sponsor: American College of Cardiology

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-27
• Study Start: 2022-09-30
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Referral	Referral	Teams - Protocol-Supported Team, (Virtual GDMT Team)
Decision Support	Decision Support	Technology - Facilitated Solution (Existing Team)

Primary Outcome Measures

Name	Time	Method
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.	9 months	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

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

Trial Locations

Locations (1)

Cardiology Center of Amarillo; 🇺🇸 Amarillo, Texas, United States