Heart FailureT3NCT05572814
Transform: Teaching, Technology, and Teams
A study testing Decision Support and Referral in people with Heart Failure and Type 2 Diabetes, run by American College of Cardiology at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Type 2 Diabetes, Atrial Fibrillation
- What is being tested?
- Decision Support and Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Shilpa Patel contact
United States1 site, 1 recruiting
- Recruiting
Cardiology Center of Amarillo
Amarillo, Texas, 79106
Alexandra Muniz, alexandramuniz@gmail.com
About this study
Official title: TRANSFORM3: Evaluation of Implementation Strategies of Teaching, Technology, and Teams to Optimize Medical Therapy in Cardiovascular Disease (T3)
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.
Read the 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.
- Conditions
- Heart Failure, Type 2 Diabetes, Atrial Fibrillation
- Being tested
- Decision Support, Referral
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Type 2, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision SupportBehavioural
Prompts will be provided to clinicians signaling gaps in guideline-directed care
ReferralBehavioural
Patients will be referred to an interdisciplinary, expert guideline-directed medical therapy team
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Teaching - CardioSmart Resources + Clinician Education |
| Decision Support | Active comparator | Technology - Facilitated Solution (Existing Team) Receives: Behavioral: Decision Support |
| Referral | Active comparator | Teams - Protocol-Supported Team, (Virtual GDMT Team) Receives: Behavioral: Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: Study duration up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start30 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American College of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James MD Januzzi, MD, Principal investigator, Massachusetts General HospitalAnkeet S Bhatt, MD, Principal investigator, Kaiser PermanenteAndrew Oseran, MD, Principal investigator, Massachusetts General HospitalMegan Welch, MD, Principal investigator, Massachusetts General HospitalJagmeet Singh, MD, Principal investigator, Massachusetts General HospitalMuthiah Vadduganathan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572814
- Sponsor's protocol ID
- 59648
- Acronym
- T3
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSFORM3: Evaluation of Implementation Strategies of Teaching, Technology, and Teams to Optimize Medical Therapy in Cardiovascular Disease (T3)
- ClinicalTrials.gov ID
- NCT05572814
- Acronym / sponsor ID
- T3 / 59648
- Conditions
- Heart Failure, Type 2 Diabetes, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- American College of CardiologyUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Teaching - CardioSmart Resources + Clinician Education |
| Decision Support | Active comparator | Behavioral: Decision SupportTechnology - Facilitated Solution (Existing Team) |
| Referral | Active comparator | Behavioral: ReferralTeams - Protocol-Supported Team, (Virtual GDMT Team) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision SupportPrompts will be provided to clinicians signaling gaps in guideline-directed care | Behavioural | Decision Support |
| ReferralPatients will be referred to an interdisciplinary, expert guideline-directed medical therapy team | Behavioural | Referral |
Primary outcome
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.
Time frame: 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.
3 secondary outcomes
Quality of Life Outcome-MMA-4
Time frame: Study duration up to 1 year.
Quality of Life Outcome-KCCQ-12
Time frame: Study duration up to 1 year.
Quality of Life Outcome-PAM
Time frame: Study duration up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shilpa Patel contact
James MD Januzzi, MD principal investigator
Massachusetts General Hospital
Ankeet S Bhatt, MD principal investigator
Kaiser Permanente
Andrew Oseran, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support and Referral in people with Heart Failure and Type 2 Diabetes, run by American College of Cardiology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindsey C Hill (2026754144, lhill2@acc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.