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

Not yet recruiting

• Conditions: Cardiotoxicity; Peripheral Artery Disease; Hypertension; Diabetes Mellitus; Cardiomyopathies; Heart Failure; Ischemia; Coronary Artery Disease
• Interventions: Other: Standard Care; Other: Clinical Decision Aid

• Registration Number: NCT05377320
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Standard Care	In this group, physicians will use standard care only.
Clinical Decision Aid Group	Clinical Decision Aid	In this group, physicians will use standard care plus the clinical decision aid.

Primary Outcome Measures

Name	Time	Method
Imaging surveillance	Week 24	The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Medication use	Week 24	The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.

Trial Locations

Locations (1)

Froedtert & the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States