Clinical trial NCT04164004: Patient-Reported Outcome Measurement in Heart Failure Clinic
Official title: Randomized Trial of Patient-Reported Outcome Measurement in Heart Failure Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Quality of life
Patient-reported outcomes
Quality of care
Implementation research
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 1249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_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.


Eligibility criteria: Inclusion Criteria:

* Stanford Heart Failure clinic visit during enrollment period

Exclusion Criteria:

* Seen in amyloid clinic

Primary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire-12 Score
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Kansas City Cardiomyopathy Questionnaire-12 Response Rate
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of Patients on Beta-blocker Therapy Among Patients With Reduced Ejection Fraction
timeFrame: Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Median Dose of Beta-Blocker Therapy Among Patients With Reduced Ejection Fraction
timeFrame: Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Median Dose of Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Median Dose of Mineralocorticoid Receptor Antagonist Among Patients With Preserved/Mid-Range Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Percentage of Patients on Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Median Dose of Hydralazine/Nitrate Therapy Among African-American Patients With Reduced Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Percentage of Patients on Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Median Dose of Sacubitril-Valsartan Therapy Among the Sub-group of Patients With Reduced Ejection Fraction
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Preserved/Mid-range Ejection Fraction.
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Percentage of Patients on Sodium/Glucose Cotransporter-2 Inhibitors Therapy Among the Sub-group of Patients With Left Ventricular Ejection Fraction > 40%.
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: 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
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Median Dose of Ivabradine Therapy Among Patients With Reduced Ejection Fraction With a Heart Rate Above 70 Beats Per Minute on Beta-Blocker Therapy
timeFrame: Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization
measure: Percentage of Patients With a Implantable Cardiac Defibrillator Among Patients With Reduced Ejection Fraction
timeFrame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
measure: Percentage of Patients With a Cardiac Resynchronization Therapy Device Among Patients With Reduced Ejection
timeFrame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
measure: Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients With Reduced Ejection Fraction
timeFrame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
measure: Number of Medication Adjustments Per Heart Failure Clinic Visit
timeFrame: Within one year post-randomization
measure: Average Daily Loop Diuretic Dose
timeFrame: Each clinic visit over one year follow-up and first heart failure clinic visit at least one year after randomization
measure: Count of Hospitalizations Per Patient
timeFrame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
measure: Count of Emergency Department Visits Per Patient
timeFrame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
measure: Count of Heart Failure Clinic Visits Per Patient
timeFrame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
measure: Count of Telephone Encounters Per Patient
timeFrame: Evaluated through trial completion (first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization)
measure: Percentage of Patients Who Undergo Formal Advanced Heart Failure Therapy Evaluation
timeFrame: Within one year post-randomization
measure: Quality of Patient Clinic Experience
timeFrame: First clinic visit post-randomization within approximately 14 days
measure: Correlation Between Clinician and Patient Perception of Health Status
timeFrame: First clinic visit post-randomization within approximately 14 days
measure: Cardiovascular Diagnostic Test Frequency
timeFrame: Within one year post-randomization
measure: Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Heart Failure or Cardiomyopathy
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
measure: Kansas City Cardiomyopathy Questionnaire-12 Score Among Patients With Sub-optimal Health Status at Baseline
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
measure: Number of Total Heart Failure Medication Adjustments
timeFrame: Number of medication adjustments from randomization to one year post randomization
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
Study officials:
affiliation: Instructor of Medicine
name: Alexander T Sandhu, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medicine
name: Paul A Heidenreich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.