Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care (GREAT-HF Care)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,306
- 试验地点
- 2
- 主要终点
- HF GDMT prescription increased (yes/no)
研究概览
简要总结
Heart failure with reduced ejection fraction (HFrEF) is associated with high mortality and adverse events (hospitalization or urgent outpatient visits for HF), along with diminished quality of life. Despite convincing data that evidenced-based, guideline-directed medical therapies (GDMT) improve mortality and heart failure-related events, there remains insufficient utilization of these life-saving drugs (evidence-based beta-blockers (EBBB), angiotensin-neprilysin inhibitors (ARNI)/ angiotensin converting enzyme inhibitors (ACEi)/ angiotensin receptor blockers (ARB), mineralocorticoid receptor antagonists (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with HFrEF. The primary objective of this study is to implement and evaluate a multifaceted, interdisciplinary intervention to improve GDMT use, reduce mortality, and reduce future heart failure events in patients with HFrEF.
详细描述
This is a cluster randomized study designed to evaluate the effectiveness of interventions aimed at improving GDMT in patients with HFrEF. Clinicians stratified based on practice specialty, location, and pharmacist referral habits will be permuted block randomized to achieve 45%/45%/10% proportional distribution across the following arms respectively: (1) usual care, (2) multi-pronged clinical decision support (CDS) inclusive of a patient portal message about GDMT, an interruptive advisory upon chart entry as a notification to clinicians on GDMT consideration and a Best Practice Advisory (BPA) that includes a GDMT order set, and (3) multi-pronged CDS as in #2 but replacement of GDMT order set with referral to integrated clinical pharmacist co-management. Secondarily, each of the 5 clinical practice sites of roughly equal HFrEF patient loads were assigned to receive either an early or delayed education rollout. Exploratory analyses will look to determine the independent and incremental benefits of education with other interventional approaches.
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
- •Patients aged 18 years or older AND
- •Completed visit at included Geisinger cardiology outpatient clinics (office visit or telemedicine) AND
- •Clinicians are on a list of currently active Geisinger clinicians in outpatient cardiology clinics who can prescribe heart failure medications AND
- •Active problem list diagnosis of HFrEF at time of Cardiology clinic encounter OR Left Ventricular Ejection Fraction (LVEF) < 40: most recent to the cardiology clinic encounter within 2 years of the visit.
排除标准
- •Currently in hospice or palliative care (ICD 10 code: Z51.5)
- •Patient is allergic to each category of GDMT
- •Patient is prescribed medications from all four categories of GDMT, including ARNI specifically
结局指标
主要结局
HF GDMT prescription increased (yes/no)
时间窗: Within 30 days of index visit
New GDMT HF medication class added, switch to ARNI from ACE/ARB, or upward dose titration of existing GDMT HF medication.
次要结局
- HF GDMT prescription increased (yes/no)(Within 60 and 90 days of index visit)
- Addition of SGLT2i or ARNI for HFrEF (yes/no)(Within 30, 60 and 90 days of index visit)
研究者
Stephen Voyce
Associate Professor
Geisinger Clinic