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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
750
Prompts will be provided to clinicians signaling gaps in guideline-directed care
Patients will be referred to an interdisciplinary, expert guideline-directed medical therapy team
Cardiology Center of Amarillo
Amarillo, Texas, United States
RECRUITINGAdoption 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.
Time frame: 9 months
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.
Time frame: 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).
Time frame: 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.
Time frame: Study duration up to 1 year.
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