Heart Failure Clinical Trial

Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology

Summary

This randomized quality improvement study evaluates the routine assessment of patient-reported heath status, using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) among adult outpatients seen in heart failure clinic or seen in general cardiology clinic with a history of heart failure. Patients will be randomized 4:1 to KCCQ-12 assessment or usual care. Participants randomized to KCCQ-12 assessment will complete the KCCQ-12 at every heart failure clinic visit. Their results will be available to clinicians to assist with clinical management. Heath status surveys will not be integrated into clinical care for patients in the usual care arm. The primary objective is to evaluate the impact of routine assessment of patient-reported heath status on clinical processes of care. As the primary outcome, we will evaluate clinician inertia by measuring the clinician action rating (CAR) - an aggregate count of medication changes, referrals, and diagnostic tests. As secondary outcomes, we will measure individual components of the composite outcome, therapy rates, resource utilization, and patient experience.

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Eligibility Criteria

Inclusion Criteria:

Seen in Stanford general cardiology clinic with a diagnosis of heart failure or cardiomyopathy or in heart failure clinic

Exclusion Criteria:

Enrolled in PRO-HF trial

Study is for people with:

Heart Failure

Estimated Enrollment:

3000

Study ID:

NCT05564572

Recruitment Status:

Enrolling by invitation

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford Hospital & Clinics
Stanford California, 94305, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

3000

Study ID:

NCT05564572

Recruitment Status:

Enrolling by invitation

Sponsor:


Stanford University

How clear is this clinincal trial information?

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