Patient-Reported Outcome Measurement in Heart Failure Clinic

Not Applicable

Completed

Conditions: Heart Failure

Interventions: Other: Kansas City Cardiomyopathy Questionnaire-12

Registration Number: NCT04164004

Lead Sponsor: Stanford University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1249

Inclusion Criteria

Stanford Heart Failure clinic visit during enrollment period

Exclusion Criteria

Seen in amyloid clinic

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Kansas City Cardiomyopathy Questionnaire-12	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.
Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm)	Kansas City Cardiomyopathy Questionnaire-12	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.

Primary Outcome Measures

Name	Time	Method
Kansas City Cardiomyopathy Questionnaire-12 Score	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	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. Domain scores are scaled 0-100, and the overall score is the average of the domain scores. For the domain and overall scores, 0 denotes the lowest reportable health status and 100 the highest. Higher values represent a better outcome.
Kansas City Cardiomyopathy Questionnaire-12 Response Rate	1 year	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 number of responses divided by the total number of requests to complete the survey.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients on Beta-blocker Therapy Among Patients With Reduced Ejection Fraction	Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Beta-blocker therapy use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.
Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	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.
Median Dose of Beta-Blocker Therapy Among Patients With Reduced Ejection Fraction	Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Among those patients on beta-blocker therapy, the specific medication and dose will be collected.
Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.
Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	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.
Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Mineralocorticoid receptor antagonist use among the sub-group of patients with left ventricular ejection fraction \> 40%.
Median Dose of Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Among those patients on renin-angiotensin-aldosterone system inhibitors with left ventricular ejection fraction ≤ 40%, the specific medication and dose will be collected.
Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	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.
Median Dose of Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Among the sub-group of patients with left ventricular ejection fraction ≤ 40% on sacubitril-valsartan, the specific dose will be collected.
Percentage of Patients on Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Hydralazine/nitrate use among the subgroup of African-American patients with left ventricular ejection fraction ≤ 40%.
Median Dose of Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Among the subgroup of African-American patients with left ventricular ejection fraction ≤ 40% on hydralazine/nitrate therapy, the specific dose will be collected
Percentage of Patients on Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Sacubitril-valsartan use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.
Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Preserved/Mid-range Ejection Fraction.	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Sodium/glucose cotransporter-2 inhibitors use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.
Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy 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	Sodium/glucose cotransporter-2 inhibitors use among the sub-group of patients with left ventricular ejection fraction \> 40%.
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	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	Ivabradine use among patients with left ventricular ejection fraction ≤ 35% and a heart rate above 70 beats per minute in sinus rhythm.
Median Dose of Ivabradine Therapy Among Patients With Reduced Ejection Fraction With a Heart Rate Above 70 Beats Per Minute on Beta-Blocker Therapy	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization	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.
Percentage of Patients With a Implantable Cardiac Defibrillator Among Patients With Reduced Ejection Fraction	Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)	Presence of an implantable cardiac defibrillator among the sub-group of patients with left ventricular ejection fraction ≤ 35%.
Percentage of Patients With a Cardiac Resynchronization Therapy Device Among Patients With Reduced Ejection	Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)	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.
Count of Hospitalizations Per Patient	Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)	Heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period.
Count of Emergency Department Visits Per Patient	Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)	Stanford emergency department visits during the follow-up period.
Count of Heart Failure Clinic Visits Per Patient	Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)	Stanford heart failure clinic visits during the followup period.
Count of Telephone Encounters Per Patient	Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)	Stanford heart failure telephone encounters during the follow-up period.
Percentage of Patients Who Undergo Formal Advanced Heart Failure Therapy Evaluation	Within one year post-randomization	Formal work-up for heart transplant or LVAD (left ventricular assist device) eligibility
Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients With Reduced Ejection Fraction	Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)	Referral to cardiac rehabilitation among the subgroup of patients with left ventricular ejection fraction ≤ 35%.
Number of Medication Adjustments Per Heart Failure Clinic Visit	Within one year post-randomization	The number of medication adjustments made at each heart failure clinic visit. These will include dose changes, new medications, and discontinuation of prior medicines.
Average Daily Loop Diuretic Dose	Each clinic visit over one year follow-up and first heart failure clinic visit at least one year after randomization	The specific loop diuretic and dose will be collected. Diuretic doses will be converted into a standard total daily dose of loop diuretic.
Quality of Patient Clinic Experience	First clinic visit post-randomization within approximately 14 days	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.
Correlation Between Clinician and Patient Perception of Health Status	First clinic visit post-randomization within approximately 14 days	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.
Cardiovascular Diagnostic Test Frequency	Within one year post-randomization	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.
Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Heart Failure or Cardiomyopathy	Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization	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.
Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Sub-optimal Health Status 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	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
Number of Total Heart Failure Medication Adjustments	Number of medication adjustments from randomization to one year post randomization	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.