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

NCT05564572 | Unknown

• 1 other identifier: 67173
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinician action rating

  Aggregate count of medication changes, referrals, and diagnostic tests ordered per clinic visit

  From date of randomization to study completion (up to 12 months)

Secondary Outcomes (18)

• Medication Changes

  From date of randomization to study completion (up to 12 months)

• Referrals

  From date of randomization to study completion (up to 12 months)

• Diagnostic Tests

  From date of randomization to study completion (up to 12 months)

• Percentage of Patients on Beta-blocker Therapy and Median Dose Among Patients with Reduced Ejection Fraction

  From date of randomization to study completion (up to 12 months)

• Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors and Median Dose Among Patients with Reduced Ejection Fraction

  From date of randomization to study completion (up to 12 months)

Study Arms (2)

Health Status Assessment

EXPERIMENTAL

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.

Other: Routine Health Status Assessment

Usual Care

NO INTERVENTION

Patients will not complete a patient-reported health status measures.

Interventions

Routine Health Status Assessment OTHER

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.

Health Status Assessment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Enrolled in PRO-HF trial

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital & Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: October 3, 2022
• Study Start: September 7, 2022
• Primary Completion: September 7, 2023
• Study Completion: December 7, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)