Patient-Reported Outcome Measurement in Heart Failure Clinic

Study Overview
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Brief Summary
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This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City Cardiomyopathy Questionnaire). Participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. Patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. By comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.

Official Title
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Randomized Trial of Patient-Reported Outcome Measurement in Heart Failure Clinic

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Kansas City Cardiomyopathy Questionnaire-12


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stanford Heart Failure clinic visit during enrollment period Exclusion Criteria: Seen in amyloid clinic

Ages Eligible for Study
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Minimum Age: 18 Years

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: Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm)<br>Patients in the KCCQ-12 arm will undergo KCCQ-12 assessment of patient-reported heart failure health status in the electronic health record at each heart failure clinic visit beginning at the start of the trial. Assessment results will be available to clinicians in the electronic health record when making treatment decisions during each clinic visit. | Other: Kansas City Cardiomyopathy Questionnaire-12<br>* Health status assessment will be completed using the well-validated Kansas City Cardiomyopathy Questionnaire-12 prior to or at the time of heart failure clinic visits.<br>* Other names: KCCQ-12;|
| Active Comparator: Usual Care<br>Patients in the usual care arm will not complete KCCQ-12 assessments in the electronic health record with clinic visits. They will complete a KCCQ-12 assessment at baseline that will not be available to the treating clinician. | Other: Kansas City Cardiomyopathy Questionnaire-12<br>* Health status assessment will be completed using the well-validated Kansas City Cardiomyopathy Questionnaire-12 prior to or at the time of heart failure clinic visits.<br>* Other names: KCCQ-12;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kansas City Cardiomyopathy Questionnaire-12 Score | The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms. KCCQ-12 scores will be collected in the usual care arm starting one year after randomization. Scores will be adjusted for baseline KCCQ-12 in both arms. This will be the primary effectiveness outcome. KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Kansas City Cardiomyopathy Questionnaire-12 Response Rate | Frequency of KCCQ-12 response at each clinic visit among patients in the KCCQ-12 arm. This will be the primary implementation outcome. The rate will be calculated as the average number of responses divided by the total number of requests to complete the survey. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients on Beta-blocker Therapy Among Patients with Reduced Ejection Fraction | Beta-blocker therapy use among the sub-group of patients with left ventricular ejection fraction ≤ 40%. | Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Median Dose of Beta-Blocker Therapy Among Patients with Reduced Ejection Fraction | Among those patients on beta-blocker therapy, the specific medication and dose will be collected. | Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors Among Patients with Reduced Ejection Fraction | Use of any renin-angiotensin-aldosterone system inhibitors among the sub-group of patients with left ventricular ejection fraction ≤ 40%. These include angiotensin-converting enzyme inhibitor, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Median Dose of Renin-Angiotensin-Aldosterone System Inhibitors Among Patients with Reduced Ejection Fraction | Among those patients on renin-angiotensin-aldosterone system inhibitors with left ventricular ejection fraction ≤ 40%, the specific medication and dose will be collected. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients with Reduced Ejection Fraction | Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction ≤ 40%. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Median Dose of Mineralocorticoid Receptor Antagonist Among Patients with Reduced Ejection Fraction | Among the sub-group of patients with left ventricular ejection fraction ≤ 40% on Mineralocorticoid Receptor Antagonist therapy, the specific medication and dose will be collected. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients with Preserved/Mid-Range Ejection Fraction | Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction > 40%. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Median Dose of Mineralocorticoid Receptor Antagonist Among Patients with Preserved/Mid-Range Ejection Fraction | Among the sub-group of patients with left ventricular ejection fraction > 40% on Mineralocorticoid Receptor Antagonist therapy, the specific medication and dose will be collected. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Percentage of Patients on Hydralazine/Nitrate Therapy Among African-American Patients with Reduced Ejection Fraction | Hydralazine/nitrate use among the subgroup of African-American patients with left ventricular ejection fraction ≤ 40%. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Median Dose of Hydralazine/Nitrate Therapy Among African-American Patients with Reduced Ejection Fraction | Among the subgroup of African-American patients with left ventricular ejection fraction ≤ 40% on hydralazine/nitrate therapy, the specific dose will be collected | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Percentage of Patients on Sacubitril-Valsartan Therapy among the sub-group of patients with Reduced Ejection Fraction | Sacubitril-valsartan use among the sub-group of patients with left ventricular ejection fraction ≤ 40%. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Median Dose of Sacubitril-Valsartan Therapy among the sub-group of patients with Reduced Ejection Fraction | Among the sub-group of patients with left ventricular ejection fraction ≤ 40% on sacubitril-valsartan, the specific dose will be collected. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Percentage of Patients on Sodium/glucose cotransporter-2 inhibitors Therapy among the sub-group of patients with preserved/mid-range ejection fraction. | Sodium/glucose cotransporter-2 inhibitors use among the sub-group of patients with left ventricular ejection fraction ≤ 40%. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Percentage of Patients on Sodium/glucose cotransporter-2 inhibitors therapy among the sub-group of patients with left ventricular ejection fraction > 40%. | Sodium/glucose cotransporter-2 inhibitors use among the sub-group of patients with left ventricular ejection fraction > 40%. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Percentage of Patients on Ivabradine Therapy Among Patients with Reduced Ejection Fraction with a Heart Rate above 70 Beats per Minute on Beta-Blocker Therapy | Ivabradine use among patients with left ventricular ejection fraction ≤ 35% and a heart rate above 70 beats per minute in sinus rhythm. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| Median Dose of Ivabradine Therapy Among Patients with Reduced Ejection Fraction with a Heart Rate above 70 Beats per Minute on Beta-Blocker Therapy | Among patients with left ventricular ejection fraction ≤ 35% and a heart rate above 70 beats per minute in sinus rhythm on ivabradine, the medication dose will be collected. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization | 
| 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 left ventricular ejection fraction ≤ 35%. | Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization) | 
| 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 left ventricular ejection fraction ≤ 35% with electrocardiogram findings consistent with a left bundle branch block with QRS width >150ms. | Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization) | 
| Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients with Reduced Ejection Fraction | Referral to cardiac rehabilitation among the subgroup of patients with left ventricular ejection fraction ≤ 35%. | Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization) | 
| Number of Medication Adjustments per Heart Failure Clinic Visit | The number of medication adjustments made at each heart failure clinic visit. These will include dose changes, new medications, and discontinuation of prior medicines. | Within one year post-randomization | 
| Average Daily Loop Diuretic Dose | The specific loop diuretic and dose will be collected. Diuretic doses will be converted into a standard total daily dose of loop diuretic. | Each clinic visit over one year follow-up and first heart failure clinic visit at least one year after randomization | 
| Count of Hospitalizations per Patient | Heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period. | Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization) | 
| Count of Emergency Department Visits per Patient | Stanford emergency department visits during the follow-up period. | Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization) | 
| Count of Heart Failure Clinic Visits per Patient | Stanford heart failure clinic visits during the followup period. | Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization) | 
| Count of Telephone Encounters per Patient | Stanford heart failure telephone encounters during the follow-up period. | Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization) | 
| Percentage of Patients who Undergo Formal Advanced Heart Failure Therapy Evaluation | Formal work-up for heart transplant or LVAD (left ventricular assist device) eligibility | Within one year post-randomization | 
| Quality of Patient Clinic Experience | The results from a 10-question survey with ordinal responses regarding patient experience in clinic to a sub-study of all participants enrolled after the first month. | First clinic visit post-randomization within approximately 14 days | 
| Correlation Between Clinician and Patient Perception of Health Status | Patient and clinician perception of health status will be collected. Patient perception is collected via the KCCQ-12 while clinicians will be surveyed regarding health status. We will determine the correlation between patient and clinician perception using an ordinal scale. We will compare correlation across arms. | First clinic visit post-randomization within approximately 14 days | 
| Cardiovascular Diagnostic Test Frequency | Number of diagnostic tests performed between randomization and one year post-randomization. Diagnostic tests include cardiovascular imaging (echocardiography, MRI, cardiac CT, nuclear scan), invasive testing (coronary angiography, right heart catheterization), or ambulatory rhythm monitoring. | Within one year post-randomization | 
| Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients with Heart Failure or Cardiomyopathy | The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms among patients with heart failure or cardiomyopathy The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms. KCCQ-12 scores will be collected in the usual care arm starting one year after randomization. Scores will be adjusted for baseline KCCQ-12 in both arms. This will be the primary effectiveness outcome. KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest. | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization | 
| Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients with Sub-optimal health status at baseline | The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms among patients with baseline KCCQ <100 at baseline | Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization | 
| Number of Total Heart Failure Medication Adjustments | The total number of heart failure medication adjustments. Heart failure medications include beta-blockers, renin-angiotensin-aldosterone system inhibitors, mineralocorticoid receptor antagonists, sodium/glucose cotransporter-2 inhibitors, hydralazine/nitrate therapy, ivabradine, or loop diuretics. | Number of medication adjustments from randomization to one year post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Patient-reported outcomes, Quality of care, Implementation research