Heart Failure
Conditions
Keywords
Quality of life, Patient-reported outcomes, Quality of care, Implementation research
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.
Interventions
OTHERKansas City Cardiomyopathy Questionnaire-12
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stanford Heart Failure clinic visit during enrollment period
Exclusion criteria
* Seen in amyloid clinic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
| 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 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 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. |
| 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 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. |
| 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%. |
| 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 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. |
| 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. |
| 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 |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexander T Sandhu, MD, MS
Instructor of Medicine
PRINCIPAL_INVESTIGATORPaul A Heidenreich, MD
Professor of Medicine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) 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.
Kansas City Cardiomyopathy Questionnaire-12: 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. | 624 |
| Usual Care 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.
Kansas City Cardiomyopathy Questionnaire-12: 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. | 624 |
| Total | 1,248 |
Baseline characteristics
| Characteristic | Usual Care | Total | Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) |
|---|---|---|---|
| Age, Continuous | 63.7 years | 63.9 years | 64.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 56 Participants | 101 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 526 Participants | 1077 Participants | 551 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 42 Participants | 70 Participants | 28 Participants |
| Heart Failure or Cardiomyopathy Diagnosis | 547 Participants | 1089 Participants | 542 Participants |
| Prior HF Clinic Encounter | 526 participants | 1046 participants | 520 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 75 Participants | 143 Participants | 68 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 57 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants | 15 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 112 Participants | 216 Participants | 104 Participants |
| Race (NIH/OMB) White | 398 Participants | 810 Participants | 412 Participants |
| Region of Enrollment United States | 624 participants | 1248 participants | 624 participants |
| Sex: Female, Male Female | 237 Participants | 485 Participants | 248 Participants |
| Sex: Female, Male Male | 387 Participants | 763 Participants | 376 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 624 | 21 / 624 |
| other Total, other adverse events | 0 / 624 | 0 / 624 |
| serious Total, serious adverse events | 0 / 624 | 0 / 624 |
Outcome results
Primary
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 number of responses divided by the total number of requests to complete the survey.
Time frame: 1 year
Population: Participants in the KCCQ-12 arm
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) | Kansas City Cardiomyopathy Questionnaire-12 Response Rate | 1331 Requests |
Primary
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. 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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) | Kansas City Cardiomyopathy Questionnaire-12 Score | 79.4 score on a scale | Standard Error 1 |
| Usual Care | Kansas City Cardiomyopathy Questionnaire-12 Score | 79.7 score on a scale | Standard Error 1 |
Secondary
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.
Time frame: Each clinic visit over one year follow-up and first heart failure clinic visit at least one year after randomization
Secondary
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.
Time frame: Within one year post-randomization
Secondary
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.
Time frame: First clinic visit post-randomization within approximately 14 days
Secondary
Count of Emergency Department Visits Per Patient
Stanford emergency department visits during the follow-up period.
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Secondary
Count of Heart Failure Clinic Visits Per Patient
Stanford heart failure clinic visits during the followup period.
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Secondary
Count of Hospitalizations Per Patient
Heart failure hospitalizations and non-heart failure hospitalizations in the Stanford healthcare system during the follow-up period.
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Secondary
Count of Telephone Encounters Per Patient
Stanford heart failure telephone encounters during the follow-up period.
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Secondary
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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization
Secondary
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
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview/web questionnaire 15 months post-randomization
Secondary
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.
Time frame: Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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.
Time frame: Within one year post-randomization
Secondary
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.
Time frame: Number of medication adjustments from randomization to one year post randomization
Secondary
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%.
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Secondary
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%.
Time frame: Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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%.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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%.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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%.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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%.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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%.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
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%.
Time frame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
Secondary
Percentage of Patients Who Undergo Formal Advanced Heart Failure Therapy Evaluation
Formal work-up for heart transplant or LVAD (left ventricular assist device) eligibility
Time frame: Within one year post-randomization
Secondary
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.
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Secondary
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%.
Time frame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
Secondary
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.
Time frame: First clinic visit post-randomization within approximately 14 days