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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Routine Health Status Assessment


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Status Assessment<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>Patients will not complete a patient-reported health status measures. | |

What is the study measuring?
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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) |