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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Teaching - CardioSmart Resources + Clinician Education | |
| Decision Support | Active Comparator | Technology - Facilitated Solution (Existing Team) |
|
| Referral | Active Comparator | Teams - Protocol-Supported Team, (Virtual GDMT Team) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Support | Behavioral | Prompts will be provided to clinicians signaling gaps in guideline-directed care |
|
| 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 |
| 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 |
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Inclusion criteria:
Age ā„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:
Exclusion Criteria:
All patients
Heart Failure patients:
Atrial Fibrillation patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsey C Hill | Contact | 2026754144 | lhill2@acc.org | |
| Shilpa Patel | Contact | SPatel@acc.org |
| Name | Affiliation | Role |
|---|---|---|
| James MD Januzzi, MD | Massachusetts General Hospital | Principal Investigator |
| Ankeet S Bhatt, MD | Kaiser Permanente | Principal Investigator |
| Andrew Oseran, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Center of Amarillo | Recruiting | Amarillo | Texas | 79106 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2022 | Sep 30, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2022 | Sep 27, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003924 | Diabetes Mellitus, Type 2 |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Referral | Behavioral | Patients will be referred to an interdisciplinary, expert guideline-directed medical therapy team |
|
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 MeasureĀ® (PAM) from baseline, 3 and at 9 months. | Study duration up to 1 year. |
| 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 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |