Patient-Reported Outcome Measurement in Heart Failure Clinic

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.

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.

Beta-blocker therapy use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.

Among those patients on beta-blocker therapy, the specific medication and dose will be collected.

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.

Among those patients on renin-angiotensin-aldosterone system inhibitors with left ventricular ejection fraction ≤ 40%, 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 the sub-group of patients with left ventricular ejection fraction ≤ 40% on Mineralocorticoid Receptor Antagonist 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 the sub-group of patients with left ventricular ejection fraction > 40% on Mineralocorticoid Receptor Antagonist therapy, the specific medication and dose will be collected.

Hydralazine/nitrate use among the subgroup of African-American patients with left ventricular ejection fraction ≤ 40%.

Among the subgroup of African-American patients with left ventricular ejection fraction ≤ 40% on hydralazine/nitrate therapy, the specific dose will be collected

Sacubitril-valsartan use among the sub-group of patients with left ventricular ejection fraction ≤ 40%.

Among the sub-group of patients with left ventricular ejection fraction ≤ 40% on sacubitril-valsartan, the specific dose will be collected.

Sodium/glucose cotransporter-2 inhibitors use 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%.

Ivabradine use among patients with left ventricular ejection fraction ≤ 35% and a heart rate above 70 beats per minute in sinus rhythm.

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.

Presence of an implantable cardiac defibrillator among the sub-group of patients with left ventricular ejection fraction ≤ 35%.

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.

Referral to cardiac rehabilitation among the subgroup of patients with left ventricular ejection fraction ≤ 35%.

The number of medication adjustments made at each heart failure clinic visit. These will include dose changes, new medications, and discontinuation of prior medicines.

The specific loop diuretic and dose will be collected. Diuretic doses will be converted into a standard total daily dose of loop diuretic.

Heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period.

Stanford emergency department visits during the follow-up period.

Stanford heart failure clinic visits during the followup period.

Stanford heart failure telephone encounters during the follow-up period.

Formal work-up for heart transplant or LVAD (left ventricular assist device) eligibility

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.

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.

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.

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.

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

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.