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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure
• Intervention / Treatment: Other: Routine Health Status Assessment

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Usual Care; Patients will not complete a patient-reported health status measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Changes	Number of medication changes per cardiology clinic visit (initiation, discontinuation, dose adjustment)	From date of randomization to study completion (up to 12 months)
Referrals	Number of referrals per cardiology clinic visit	From date of randomization to study completion (up to 12 months)
Diagnostic Tests	Number of diagnostic tests ordered per cardiology clinic visit	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	Beta-blocker therapy use among the sub-group of patients with baseline left ventricular ejection fraction ≤ 40%. Among those patients on therapy, the specific medication and dose will be collected.	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	Use of any renin-angiotensin-aldosterone system inhibitors among the sub-group of patients with baseline left ventricular ejection fraction ≤ 40%. These include angiotensin-converting enzyme inhibitor, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors. Among those patients on therapy, the specific medication and dose will be collected.	From date of randomization to study completion (up to 12 months)
Percentage of Patients on Mineralocorticoid Receptor Antagonist and Median Dose Among Patients with Reduced Ejection Fraction	Mineralocorticoid receptor antagonist use among the sub-group of patients with baseline left ventricular ejection fraction ≤ 40%. Among those patients on therapy, the specific medication and dose will be collected.Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction ≤ 40%. Among those patients on therapy, the specific medication and dose will be collected. Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction ≤ 40%. Among those patients on therapy, the specific medication and dose will be collected.	From date of randomization to study completion (up to 12 months)
Percentage of Patients on Sacubitril-Valsartan and Median Dose Among Patients with Reduced Ejection Fraction	Use of any sacubitril-valsartan among the sub-group of patients with baseline left ventricular ejection fraction ≤ 40%. These include angiotensin-converting enzyme inhibitor, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors. Among those patients on therapy, the specific medication and dose will be collected.	From date of randomization to study completion (up to 12 months)
Percentage of Patients on SGLT2i	Use of any SGLT2i	From date of randomization to study completion (up to 12 months)
Percentage of Patients with a Implantable Cardiac Defibrillator Among Patients with Reduced Ejection Fraction	Presence of an implantable cardiac defibrillator among the sub-group of patients with baseline left ventricular ejection fraction ≤ 35%.	From date of randomization to study completion (up to 12 months)
Percentage of Patients with a Cardiac Resynchronization Therapy Device Among Patients with Reduced Ejection	Presence of cardiac resynchronization therapy among the sub-group of patients with baseline left ventricular ejection fraction ≤ 35% with electrocardiogram findings consistent with the guideline recommendation for cardiac resynchronization therapy.	From date of randomization to study completion (up to 12 months)
Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients with Reduced Ejection Fraction	Referral to cardiac rehabilitation among the subgroup of patients with baseline left ventricular ejection fraction ≤ 35%.	From date of randomization to study completion (up to 12 months)
Hospitalizations	Number of heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period.	From date of randomization to study completion (up to 12 months)
Emergency Department Visits	Number of Stanford emergency department visits during the follow-up period	From date of randomization to study completion (up to 12 months)
Cardiology Clinic Visits	Number of visits (in-person or telemedicine) to general cardiology or heart failure clinics during the follow-up period	From date of randomization to study completion (up to 12 months)
Telephone Encounters	Number of telephone encounters with general cardiology or heart failure clinics during the follow-up period	From date of randomization to study completion (up to 12 months)
Formal Advanced Heart Failure Therapy Evaluation	Number of patients who undergo formal evaluation for advanced heart failure therapies (LVAD or transplant)	From date of randomization to study completion (up to 12 months)
Quality of Patient Clinic Experience	Patient report of satisfaction with clinic visit based on existing Stanford patient experience survey	From date of randomization to study completion (up to 12 months)
Diagnostic Testing	Number of diagnostic tests ordered in cardiology clinic (cardiac imaging [echocardiography, MRI, angiography, CT angiography, PET], non-cardiac imaging, rhythm monitoring, exercise testing, invasive hemodynamics, pulmonary function testing) during the follow-up period	From date of randomization to study completion (up to 12 months)

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Anticipated): September 7, 2023
• Study Completion (Anticipated): December 7, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 67173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No