PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

Hypertension Clinical Trial

Official title:

PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05377320
• Other study ID #: PRO00039290
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

Description:

For this feasibility study, the researchers will create the clinical decision aid and test the central hypothesis that this novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists and will favorably impact appropriate medication use and cardiac imaging surveillance. The hypothesis is supported by preliminary data suggesting that an initial and rudimentary version of the clinical aid increases appropriate medication use and imaging follow-up in cardio-oncology patients. Success will be determined by ≥85% of clinic visits using the clinical decision aid resulting in pursuit of medication use and cardiac imaging surveillance patterns commensurate with recommendations specific to cancer survivors, with overall rates the same or higher than the group without the clinical decision aid, as well as overall favorable patient and physician focus group comments and survey responses.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients =18 years with a history of cancer.

2. Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.

3. Clinically at intermediate, high, or very high risk for cardiovascular diseases determined based on imprecise clinical risk models, such as those used for cardiac dysfunction.

4. Ability to understand a written informed consent form, and willing to sign it prior to study registration.

Exclusion Criteria:

1. Patient <18 years.

2. Without a personal history of cancer.

3. Existing cardiomyopathy diagnosed after cancer diagnosis.

4. Documented cognitive impairment.

5. Patient or patient representative who is unable and unwilling to sign the informed consent form.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiotoxicity
• Coronary Artery Disease
• Diabetes Mellitus
• Heart Failure
• Hypertension
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• Clinical Decision Aid
The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.
• Standard Care
Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.

Locations

Country	Name	City	State
United States	Froedtert & the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brown SA, Chung BY, Doshi K, Hamid A, Pederson E, Maddula R, Hanna A, Choudhuri I, Sparapani R, Bagheri Mohamadi Pour M, Zhang J, Kothari AN, Collier P, Caraballo P, Noseworthy P, Arruda-Olson A; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity (CAIPE) Research Team Investigators. Patient similarity and other artificial intelligence machine learning algorithms in clinical decision aid for shared decision-making in the Prevention of Cardiovascular Toxicity (PACT): a feasibility trial design. Cardiooncology. 2023 Jan 23;9(1):7. doi: 10.1186/s40959-022-00151-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication use	The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.	Week 0
Primary	Medication use	The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.	Week 12
Primary	Medication use	The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.	Week 24
Primary	Imaging surveillance	The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.	Week 0
Primary	Imaging surveillance	The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.	Week 12
Primary	Imaging surveillance	The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.	Week 24