Randomized Trial of Patient-Reported Outcome Measurement in Heart Failure Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,249
- 试验地点
- 2
- 主要终点
- Kansas City Cardiomyopathy Questionnaire-12 Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stanford Heart Failure clinic visit during enrollment period
排除标准
- •Seen in amyloid clinic
结局指标
主要结局
Kansas City Cardiomyopathy Questionnaire-12 Score
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- Percentage of Patients Who Undergo Formal Advanced Heart Failure Therapy Evaluation(Within one year post-randomization)
- 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))
- Number of Medication Adjustments Per Heart Failure Clinic Visit(Within one year post-randomization)
- 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)
- Quality of Patient Clinic Experience(First clinic visit post-randomization within approximately 14 days)
- Correlation Between Clinician and Patient Perception of Health Status(First clinic visit post-randomization within approximately 14 days)
- Cardiovascular Diagnostic Test Frequency(Within one year post-randomization)
- 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)
- 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)
- Number of Total Heart Failure Medication Adjustments(Number of medication adjustments from randomization to one year post randomization)
研究者
Alexander Sandhu
Advanced Heart Failure Fellow, Principal Investigator
Stanford University