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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

GREAT-HF Care Trial 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.Check my eligibility
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.See study design
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.

GREAT-HF Care Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Addition of SGLT2i or ARNI for HFrEF (yes/no)
HF GDMT prescription increased (yes/no)
Other outcome measures
All-cause mortality, emergency visit for heart failure or hospitalization for heart failure

GREAT-HF Care 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.

Find a Location

Who is running the clinical trial?

Geisinger ClinicLead Sponsor
149 Previous Clinical Trials
1,881,835 Total Patients Enrolled
5 Trials studying Heart Failure
3,062 Patients Enrolled for Heart Failure

Media Library

Multiprong CDS with GDMT order set + focused education Clinical Trial Eligibility Overview. Trial Name: NCT05990296 — N/A
Heart Failure Research Study Groups: Control, Multiprong CDS with GDMT order set + focused education, Multiprong CDS with GDMT order set, Multiprong CDS with referral to pharmacist co-management, Focused education, Multiprong CDS with referral to pharmacist co-management + focused education
Heart Failure Clinical Trial 2023: Multiprong CDS with GDMT order set + focused education Highlights & Side Effects. Trial Name: NCT05990296 — N/A
Multiprong CDS with GDMT order set + focused education 2023 Treatment Timeline for Medical Study. Trial Name: NCT05990296 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available in this clinical experiment for participants?

"Affirmative. Clinicaltrials.gov details that this clinical trial, which was published on August 1st 2023, is still actively recruiting participants. 4300 individuals are required to be recruited from a single medical centre."

Answered by AI

How many people are currently involved in this research endeavor?

"Affirmative. The online clinical trial register confirms that this medical examination is presently in search of volunteers. It was initially posted on the 1st August 2023 and revised most recently on 11th August 2023, with 4300 applicants sought from a single centre."

Answered by AI
~1881 spots leftby Dec 2024