How doctors’ reminders about iron treatment may change IV iron use in adults with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

INITIATE-HF is a cluster randomized trial conducted at Kaiser Permanente Northern California to see if physician-facing notifications about iron deficiency and IV iron guidelines increase the use of IV iron in eligible heart failure patients. Hospitals are randomly assigned to either receive patient-specific iron status notices and guideline information or continue with usual care. The study focuses on adults with heart failure and reduced or mildly reduced ejection fraction and iron deficiency (TSAT < 20%), checking if provider prompts translate into greater IV iron treatment. It does not involve direct patient contact by the study team, and decisions remain with treating clinicians. Outcomes include changes in IV iron administration patterns among eligible inpatients, with secondary analyses on uptake of guideline-based therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adults (age \>18 years); Diagnosed heart failure with most recent left ventricular ejection fraction \<50%; Hospitalized for any reason for the index admission; Documented iron deficiency defined as TSAT \<20% during the index hospitalization; At least 6 months of health plan coverage and prescription drug benefit before admission

Exclusion Criteria:

A documented allergy to IV iron in the Kaiser Permanente Northern California (KPNC) electronic health record (EHR) system; A history of hemochromatosis (i.e., iron overload) based on KPNC EHR data; End-stage kidney disease (defined as receiving chronic dialysis or a prior kidney transplant) or advanced chronic kidney disease (i.e., estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m2) based on most recent pre-admission outpatient laboratory results or the KPNC regional End-Stage Kidney Disease Treatment Registry; Serum ferritin \>300 ng/mL based on KPNC EHR data; Diagnosed with metastatic cancer and/or receiving systemic chemotherapy based on KPNC EHR data; Institutionalized (e.g., prison) and/or receiving palliative care per KPNC EHR data

Where it's running

• Division of Research
  Pleasanton, California, United States Recruiting

Study contacts

• Study coordinator: Alan S Go, MD
• Email: alan.s.go@kp.org
• Phone: 510-821-0904

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.