Iron Infusion Notification for Heart Failure
(INITIATE-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The INITIATE-HF study is a cluster randomized controlled trial that aims to find out if reminding doctors about treatment guidelines for iron deficiency in adults with heart failure who are hospitalized and have evidence of iron deficiency changes the subsequent use of intravenous (IV) iron.
Two groups of hospitalized adult patients with known heart failure and iron deficiency will be compared:
* Group 1 will include doctors who receive a notification with their patient's iron storage test results and guideline recommendations related to the use of IV iron.
* Group 2 will include doctors who do not receive this notification and continue with usual standard of care.
The study will measure if this provider-facing notification affects physician use of recommended IV iron treatment in eligible patients with heart failure, left ventricular ejection fraction less than 50%, and iron deficiency. Secondarily, if there is an increased use of IV iron observed in the intervention group, this study will evaluate whether there are differential health outcomes (i.e., fewer subsequent hospital visits and lower risk of death) of patients whose providers were assigned to the intervention group.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Physicians of eligible patients in the intervention group receive a one-time notification about iron deficiency and guidelines for IV iron therapy
Treatment
Administration of IV iron during the index hospitalization for eligible patients
Follow-up
Participants are monitored for effectiveness outcomes, including all-cause death and heart failure-related hospitalization
What Are the Treatments Tested in This Trial?
Interventions
- No Notification Group
- Notification Group
How Is the Trial Designed?
2
Treatment groups
Active Control
In medical centers assigned to the intervention group, physicians of eligible patients will be sent a one-time notification with information about their patient's iron deficiency, current KPNC and national clinical practice guidelines about IV iron therapy, and available IV iron formulations and recommended dosages.
In medical centers assigned to the control group, physicians of eligible patients will NOT be sent information about their patients or current KPNC and national clinical practice guidelines about the use of IV iron therapy in the setting of heart failure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kaiser Permanente
Lead Sponsor
Garfield Memorial Fund
Collaborator
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