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

Medical College of Wisconsin

Status: Begins enrollment in 9 months

Conditions: Cardiotoxicity; Hypertension; Coronary Artery Disease; Peripheral Artery Disease; Diabetes Mellitus; Ischemia; Heart Failure; Cardiomyopathies

Treatments: Other: Clinical Decision Aid; Other: Standard Care

Study type: Observational

Funder types: Other

Identifiers

NCT05377320

PRO00039290

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Clinical Decision Aid Group

Description:

In this group, physicians will use standard care plus the clinical decision aid.

Treatment:

Other: Clinical Decision Aid

Control Group

Description:

In this group, physicians will use standard care only.

Treatment:

Other: Standard Care