Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Clinician action rating
研究概览
简要总结
This randomized quality improvement study evaluates the routine assessment of patient-reported heath status, using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) among adult outpatients seen in heart failure clinic or seen in general cardiology clinic with a history of heart failure. Patients will be randomized 4:1 to KCCQ-12 assessment or usual care. Participants randomized to KCCQ-12 assessment will complete the KCCQ-12 at every heart failure clinic visit. Their results will be available to clinicians to assist with clinical management. Heath status surveys will not be integrated into clinical care for patients in the usual care arm. The primary objective is to evaluate the impact of routine assessment of patient-reported heath status on clinical processes of care. As the primary outcome, we will evaluate clinician inertia by measuring the clinician action rating (CAR) - an aggregate count of medication changes, referrals, and diagnostic tests. As secondary outcomes, we will measure individual components of the composite outcome, therapy rates, resource utilization, and patient experience.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seen in Stanford general cardiology clinic with a diagnosis of heart failure or cardiomyopathy or in heart failure clinic
排除标准
- •Enrolled in PRO-HF trial
研究组 & 干预措施
Health Status Assessment
Completion of a patient-reported health status assessment preceding each clinic visit. The health status assessment consists of the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) along with additional select questions. The results of the assessment will be available to clinicians in the electronic health record.
干预措施: Routine Health Status Assessment (Other)
Usual Care
Patients will not complete a patient-reported health status measures.
结局指标
主要结局
Clinician action rating
时间窗: From date of randomization to study completion (up to 12 months)
Aggregate count of medication changes, referrals, and diagnostic tests ordered per clinic visit
次要结局
- Formal Advanced Heart Failure Therapy Evaluation(From date of randomization to study completion (up to 12 months))
- Medication Changes(From date of randomization to study completion (up to 12 months))
- Quality of Patient Clinic Experience(From date of randomization to study completion (up to 12 months))
- Diagnostic Tests(From date of randomization to study completion (up to 12 months))
- Percentage of Patients on Beta-blocker Therapy and Median Dose Among Patients with Reduced Ejection Fraction(From date of randomization to study completion (up to 12 months))
- Diagnostic Testing(From date of randomization to study completion (up to 12 months))
- Referrals(From date of randomization to study completion (up to 12 months))
- Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors and Median Dose Among Patients with Reduced Ejection Fraction(From date of randomization to study completion (up to 12 months))
- Percentage of Patients with a Cardiac Resynchronization Therapy Device Among Patients with Reduced Ejection(From date of randomization to study completion (up to 12 months))
- Telephone Encounters(From date of randomization to study completion (up to 12 months))
- Percentage of Patients on Mineralocorticoid Receptor Antagonist and Median Dose Among Patients with Reduced Ejection Fraction(From date of randomization to study completion (up to 12 months))
- Percentage of Patients on Sacubitril-Valsartan and Median Dose Among Patients with Reduced Ejection Fraction(From date of randomization to study completion (up to 12 months))
- Percentage of Patients on SGLT2i(From date of randomization to study completion (up to 12 months))
- Percentage of Patients with a Implantable Cardiac Defibrillator Among Patients with Reduced Ejection Fraction(From date of randomization to study completion (up to 12 months))
- Percentage of Patients Given Cardiac Rehabilitation Referral Among Patients with Reduced Ejection Fraction(From date of randomization to study completion (up to 12 months))
- Hospitalizations(From date of randomization to study completion (up to 12 months))
- Emergency Department Visits(From date of randomization to study completion (up to 12 months))
- Cardiology Clinic Visits(From date of randomization to study completion (up to 12 months))
研究者
Alexander Sandhu
Instructor of Medicine
Stanford University