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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05564572
• Other study ID #: 67173
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: December 7, 2023

Study information

• Verified date: September 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: December 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Hospital & Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Referrals	Number of referrals per cardiology clinic visit	From date of randomization to study completion (up to 12 months)
Secondary	Diagnostic Tests	Number of diagnostic tests ordered per cardiology clinic visit	From date of randomization to study completion (up to 12 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Percentage of Patients on SGLT2i	Use of any SGLT2i	From date of randomization to study completion (up to 12 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)