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Rationale and Design of the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
Alexander J Blood1,2,3, Ozan Unlu1,2,3,4, John W Ostrominski1,2,3,5
1Accelerator for Clinical Transformation, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Insights
The COPILOT-HF study tested a remote, navigator-led strategy to improve guideline-directed medical therapies (GDMT) for heart failure (HF) patients. This approach aims to optimize HF treatment across all ejection fractions, addressing slow GDMT uptake.
Area of Science:
- Cardiology
- Pharmacology
- Health Services Research
Background:
- Guideline-directed medical therapies (GDMT) offer significant clinical benefits for heart failure (HF) patients, yet their adoption remains suboptimal.
- Existing strategies to improve GDMT implementation are often ineffective, resource-intensive, or narrowly focused on HF with reduced ejection fraction (HFrEF).
- There is a critical need for scalable, comprehensive approaches to optimize GDMT across the full spectrum of HF, including HF with preserved ejection fraction (HFpEF).
Purpose of the Study:
- To evaluate the effectiveness of the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure (COPILOT-HF) study.
- To compare a remote, navigator-led, algorithm-driven GDMT optimization strategy against standard patient and provider education.
- To assess GDMT optimization across the full spectrum of heart failure ejection fractions.
Main Methods:
- A pragmatic, randomized, open-label intervention trial design.
- Implementation of a comprehensive, remote, navigator-led, algorithm-driven strategy for GDMT optimization.
- Comparison with a control intervention focused on patient and provider education regarding GDMT.
Main Results:
- The primary efficacy endpoint is the proportion of patients receiving optimal HF treatment at 3 months.
- Secondary outcomes include optimal HF therapy rates at 6 and 12 months.
- Health resource utilization, including hospitalizations and mortality, will also be assessed.
Conclusions:
- The COPILOT-HF study will determine the efficacy of a remote pharmacist-led medication titration strategy.
- This strategy aims to improve GDMT implementation across the entire spectrum of heart failure.
- The findings will inform scalable solutions for optimizing HF pharmacotherapy.
Background:
Despite overwhelming evidence of clinical benefit for patients with heart failure (HF), the uptake of guideline-directed medical therapies (GDMT) has been slow. Collaborative approaches are critically needed to improve alignment between evidence and clinical practice. Many strategies proposed to improve GDMT implementation have been either ineffective or too resource-intensive to implement at scale across different practice contexts. Furthermore, most existing approaches focus primarily on patients with HF and reduced EF, despite growing evidence for effective pharmacologic therapy in those with HF and mildly reduced or preserved ejection fraction (HFpEF).
Hypothesis:
Based on this experience, we designed the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure (COPILOT-HF) study (NCT05734690).
Methods:
This is a pragmatic, randomized, open-label intervention trial to compare a comprehensive, remote, navigator-led, algorithm-driven strategy for optimization of GDMT prescribing in patients with HF across the full spectrum of ejection fraction with a control intervention focused on patient and provider education regarding the importance of GDMT optimization.
Results:
The primary efficacy endpoint of the study is the proportion of patients receiving optimal HF treatment at 3 months. Additional outcomes of interest include the proportion of patients with optimal HF therapy at 6 months and 12 months as well as health resource utilization, including hospitalizations and deaths.
Conclusions:
COPILOT-HF will evaluate the effectiveness of an early implementation of a remote pharmacist-led medication titration strategy across the HF spectrum.
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