Trial Outcomes & Findings for Patient-Reported Outcome Measurement in Heart Failure Clinic (NCT NCT04164004)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1249 participants

Primary outcome timeframe

Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization

Results posted on

2026-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	625	624
Overall Study COMPLETED	624	624
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient-Reported Outcome Measurement in Heart Failure Clinic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) n=624 Participants 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.	Usual Care n=624 Participants 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.	Total n=1248 Participants Total of all reporting groups
Age, Continuous	64.1 years n=527 Participants	63.7 years n=527 Participants	63.9 years n=1054 Participants
Sex: Female, Male Female	248 Participants n=527 Participants	237 Participants n=527 Participants	485 Participants n=1054 Participants
Sex: Female, Male Male	376 Participants n=527 Participants	387 Participants n=527 Participants	763 Participants n=1054 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=527 Participants	56 Participants n=527 Participants	101 Participants n=1054 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	551 Participants n=527 Participants	526 Participants n=527 Participants	1077 Participants n=1054 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=527 Participants	42 Participants n=527 Participants	70 Participants n=1054 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=527 Participants	3 Participants n=527 Participants	7 Participants n=1054 Participants
Race (NIH/OMB) Asian	68 Participants n=527 Participants	75 Participants n=527 Participants	143 Participants n=1054 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=527 Participants	9 Participants n=527 Participants	15 Participants n=1054 Participants
Race (NIH/OMB) Black or African American	30 Participants n=527 Participants	27 Participants n=527 Participants	57 Participants n=1054 Participants
Race (NIH/OMB) White	412 Participants n=527 Participants	398 Participants n=527 Participants	810 Participants n=1054 Participants
Race (NIH/OMB) More than one race	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Race (NIH/OMB) Unknown or Not Reported	104 Participants n=527 Participants	112 Participants n=527 Participants	216 Participants n=1054 Participants
Region of Enrollment United States	624 participants n=527 Participants	624 participants n=527 Participants	1248 participants n=1054 Participants
Heart Failure or Cardiomyopathy Diagnosis	542 Participants n=527 Participants	547 Participants n=527 Participants	1089 Participants n=1054 Participants
Prior HF Clinic Encounter	520 participants n=527 Participants	526 participants n=527 Participants	1046 participants n=1054 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) n=528 Participants 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.	Usual Care n=513 Participants 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.
Kansas City Cardiomyopathy Questionnaire-12 Score	79.4 score on a scale Standard Error 1.0	79.7 score on a scale Standard Error 1.0

PRIMARY outcome

Timeframe: 1 year

Population: Participants in the KCCQ-12 arm

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.

Outcome measures

Outcome measures
Measure	Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm) n=1526 Requests 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.	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.
Kansas City Cardiomyopathy Questionnaire-12 Response Rate	1331 Requests	—

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within one year post-randomization

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 23 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 21 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alexander Sandhu

Stanford University

Phone: 9097671214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place