Patient-Reported Outcome Measurement in Heart Failure Clinic (PRO-HF)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Kansas City Cardiomyopathy Questionnaire-12

• Study Type: Interventional
• Enrollment (Actual): 1248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Stanford Heart Failure clinic visit during enrollment period

Exclusion Criteria:

• Seen in amyloid clinic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: KCCQ-12
Active Comparator: 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.	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.; Other Names: KCCQ-12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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
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
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)
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)
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)
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)
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Alexander T Sandhu, MD, MS, Instructor of Medicine; Principal Investigator: Paul A Heidenreich, MD, Professor of Medicine

Publications and helpful links

General Publications

• Sandhu AT, Zheng J, Kalwani NM, Gupta A, Calma J, Skye M, Lan R, Yu B, Spertus JA, Heidenreich PA. Impact of Patient-Reported Outcome Measurement in Heart Failure Clinic on Clinician Health Status Assessment and Patient Experience: A Substudy of the PRO-HF Trial. Circ Heart Fail. 2023 Feb;16(2):e010280. doi: 10.1161/CIRCHEARTFAILURE.122.010280. Epub 2022 Nov 5.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Patient-reported outcomes; Quality of care; Implementation research
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 53713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No