Clinical trial NCT05564572: Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
Official title: Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Clinician action rating
timeFrame: From date of randomization to study completion (up to 12 months)
Secondary outcomes:
measure: Medication Changes
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Referrals
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Diagnostic Tests
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Percentage of Patients on Beta-blocker Therapy and Median Dose Among Patients with Reduced Ejection Fraction
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors and Median Dose Among Patients with Reduced Ejection Fraction
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Percentage of Patients on Mineralocorticoid Receptor Antagonist and Median Dose Among Patients with Reduced Ejection Fraction
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Percentage of Patients on Sacubitril-Valsartan and Median Dose Among Patients with Reduced Ejection Fraction
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Percentage of Patients on SGLT2i
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Percentage of Patients with a Implantable Cardiac Defibrillator Among Patients with Reduced Ejection Fraction
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Percentage of Patients with a Cardiac Resynchronization Therapy Device Among Patients with Reduced Ejection
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients with Reduced Ejection Fraction
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Hospitalizations
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Emergency Department Visits
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Cardiology Clinic Visits
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Telephone Encounters
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Formal Advanced Heart Failure Therapy Evaluation
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Quality of Patient Clinic Experience
timeFrame: From date of randomization to study completion (up to 12 months)
measure: Diagnostic Testing
timeFrame: From date of randomization to study completion (up to 12 months)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
Study officials:
References: