Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
Primary Purpose
Heart Failure
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Routine Health Status Assessment
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure
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
Sites / Locations
- Stanford Hospital & Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Health Status Assessment
Usual Care
Arm Description
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.
Patients will not complete a patient-reported health status measures.
Outcomes
Primary Outcome Measures
Clinician action rating
Aggregate count of medication changes, referrals, and diagnostic tests ordered per clinic visit
Secondary Outcome Measures
Medication Changes
Number of medication changes per cardiology clinic visit (initiation, discontinuation, dose adjustment)
Referrals
Number of referrals per cardiology clinic visit
Diagnostic Tests
Number of diagnostic tests ordered per cardiology clinic visit
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.
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.
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.
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.
Percentage of Patients on SGLT2i
Use of any SGLT2i
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%.
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.
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%.
Hospitalizations
Number of heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period.
Emergency Department Visits
Number of Stanford emergency department visits during the follow-up period
Cardiology Clinic Visits
Number of visits (in-person or telemedicine) to general cardiology or heart failure clinics during the follow-up period
Telephone Encounters
Number of telephone encounters with general cardiology or heart failure clinics during the follow-up period
Formal Advanced Heart Failure Therapy Evaluation
Number of patients who undergo formal evaluation for advanced heart failure therapies (LVAD or transplant)
Quality of Patient Clinic Experience
Patient report of satisfaction with clinic visit based on existing Stanford patient experience survey
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
Full Information
NCT ID
NCT05564572
First Posted
September 1, 2022
Last Updated
September 29, 2022
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT05564572
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
September 7, 2023 (Anticipated)
Study Completion Date
December 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Health Status Assessment
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients will not complete a patient-reported health status measures.
Intervention Type
Other
Intervention Name(s)
Routine Health Status Assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician action rating
Description
Aggregate count of medication changes, referrals, and diagnostic tests ordered per clinic visit
Time Frame
From date of randomization to study completion (up to 12 months)
Secondary Outcome Measure Information:
Title
Medication Changes
Description
Number of medication changes per cardiology clinic visit (initiation, discontinuation, dose adjustment)
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Referrals
Description
Number of referrals per cardiology clinic visit
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Diagnostic Tests
Description
Number of diagnostic tests ordered per cardiology clinic visit
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Percentage of Patients on Beta-blocker Therapy and Median Dose Among Patients with Reduced Ejection Fraction
Description
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.
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors and Median Dose Among Patients with Reduced Ejection Fraction
Description
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.
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Percentage of Patients on Mineralocorticoid Receptor Antagonist and Median Dose Among Patients with Reduced Ejection Fraction
Description
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.
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Percentage of Patients on Sacubitril-Valsartan and Median Dose Among Patients with Reduced Ejection Fraction
Description
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.
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Percentage of Patients on SGLT2i
Description
Use of any SGLT2i
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Percentage of Patients with a Implantable Cardiac Defibrillator Among Patients with Reduced Ejection Fraction
Description
Presence of an implantable cardiac defibrillator among the sub-group of patients with baseline left ventricular ejection fraction ≤ 35%.
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Percentage of Patients with a Cardiac Resynchronization Therapy Device Among Patients with Reduced Ejection
Description
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.
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients with Reduced Ejection Fraction
Description
Referral to cardiac rehabilitation among the subgroup of patients with baseline left ventricular ejection fraction ≤ 35%.
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Hospitalizations
Description
Number of heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period.
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Emergency Department Visits
Description
Number of Stanford emergency department visits during the follow-up period
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Cardiology Clinic Visits
Description
Number of visits (in-person or telemedicine) to general cardiology or heart failure clinics during the follow-up period
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Telephone Encounters
Description
Number of telephone encounters with general cardiology or heart failure clinics during the follow-up period
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Formal Advanced Heart Failure Therapy Evaluation
Description
Number of patients who undergo formal evaluation for advanced heart failure therapies (LVAD or transplant)
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Quality of Patient Clinic Experience
Description
Patient report of satisfaction with clinic visit based on existing Stanford patient experience survey
Time Frame
From date of randomization to study completion (up to 12 months)
Title
Diagnostic Testing
Description
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
Time Frame
From date of randomization to study completion (up to 12 months)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Stanford Hospital & Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
We'll reach out to this number within 24 hrs