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GDMT Strategies for Heart Failure (GREAT-HF Care Trial)

N/A

Recruiting

Research Sponsored by Geisinger Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30, 60 and 90 days of index visit

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if evidence-based heart failure drugs improve mortality & reduce heart failure events in people with HFrEF.

Who is the study for?

This trial is for adults over 18 with heart failure who have a left ventricular ejection fraction of 40% or less. They must have visited certain cardiology clinics and not be in hospice care or allergic to all four categories of guideline-directed medical therapies.

What is being tested?

The study tests an approach combining computer decision support, pharmacist co-management, focused education, and a set order for medications to improve the use of life-saving drugs in patients with reduced heart function.

What are the potential side effects?

While specific side effects are not listed here, typical ones from heart failure medications may include low blood pressure, kidney problems, increased potassium levels, dizziness, changes in heartbeat rhythm and allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30, 60 and 90 days of index visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30, 60 and 90 days of index visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30, 60 and 90 days of index visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Addition of SGLT2i or ARNI for HFrEF (yes/no)

HF GDMT prescription increased (yes/no)

Other study objectives

All-cause mortality, emergency visit for heart failure or hospitalization for heart failure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Multiprong CDS with referral to pharmacist co-management + focused educationExperimental Treatment2 Interventions

Clinicians in this arm will receive focused education along with clinicians/patient CDS. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.

Group II: Multiprong CDS with referral to pharmacist co-managementExperimental Treatment1 Intervention

Clinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.

Group III: Multiprong CDS with GDMT order set + focused educationExperimental Treatment2 Interventions

Clinicians in this arm will receive focused education in addition to clinician BPA heads-up and BPA with GDMT order set for their eligible patients with HFrEF.

Group IV: Multiprong CDS with GDMT order setExperimental Treatment1 Intervention

Clinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The CDS will inform, encourage, and facilitate prescribing of GDMT via a focused order set.

Group V: Focused educationExperimental Treatment1 Intervention

Clinicians in this arm will receive focused education and no CDS.

Group VI: ControlActive Control1 Intervention

Clinicians in this arm will not receive CDS or focused education and will experience usual care.

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