NCT05564572

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	Routine Health Status Assessment	Completion of a patient-reported health status assessment preceding each clinic visit. The health status assessment consists of the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) along with additional select questions. The results of the assessment will be available to clinicians in the electronic health record.

Timeline

• Start date: 2022-09-07
• Primary completion: 2023-09-07
• Completion: 2023-12-07
• First posted: 2022-10-03
• Last updated: 2022-10-03

Locations

1 site across 1 country: United States