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

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05377320

Collaborator

The Cleveland Clinic (Other)

Enrollment

Location

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Coronary Artery Disease Peripheral Artery Disease Ischemia Hypertension Diabetes Mellitus Cardiomyopathies Cardiotoxicity	Other: Clinical Decision Aid Other: Standard Care

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Clinical Decision Aid Group In this group, physicians will use standard care plus the clinical decision aid.	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.
Control Group In this group, physicians will use standard care only.	Other: Standard Care Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.

Arm

Intervention/Treatment

Clinical Decision Aid Group

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

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.

Control Group

In this group, physicians will use standard care only.

Other: Standard Care

Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.

Outcome Measures

Primary Outcome Measures

Medication use [Week 0]
The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.
Medication use [Week 12]
The number of subjects in which medication use 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.
Imaging surveillance [Week 0]
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Imaging surveillance [Week 12]
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Imaging surveillance [Week 24]
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients ≥18 years with a history of cancer.
Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.
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.
Ability to understand a written informed consent form, and willing to sign it prior to study registration.

Exclusion Criteria:

Patient <18 years.
Without a personal history of cancer.
Existing cardiomyopathy diagnosed after cancer diagnosis.
Documented cognitive impairment.
Patient or patient representative who is unable and unwilling to sign the informed consent form.