Patient-Reported Outcome Measurement in Heart Failure Clinic

Heart Failure Clinical Trial

— PRO-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164004
• Other study ID #: 53713
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: November 3, 2023

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1248
• Est. completion date: November 3, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stanford Heart Failure clinic visit during enrollment period

Exclusion Criteria:

• Seen in amyloid clinic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Stanford Hospital & Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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. 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
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 average number of responses divided by the total number of requests to complete the survey.	1 year
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%.	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 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
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.	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.	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%.	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.	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%.	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.	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 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
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	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%.	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.	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%.	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%.	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.	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.	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 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)
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.	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 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)
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.	Within one year post-randomization
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.	Each clinic visit over one year follow-up and first heart failure clinic visit at least one year after 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.	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 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)
Secondary	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)
Secondary	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)
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	Within one year 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.	First clinic visit post-randomization within approximately 14 days
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.	First clinic visit post-randomization within approximately 14 days
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.	Within one year 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.	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	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	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