Infusing Needed Iron to Target Insufficiency in Adults Treated for Evidence of Heart Failure
Kaiser Permanente
Summary
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.
Description
The INITIATE-HF study will be managed at the Kaiser Permanente Northern California (KPNC) Division of Research and will include participants from KPNC medical centers. Up to 21 medical centers will be randomly assigned into two groups, with balanced populations between the groups based on demographic and heart failure-related characteristics. In medical centers assigned to the intervention group, physicians of eligible patients with heart failure and iron deficiency (i.e., TSAT \<20%) will be sent information from current KPNC and national clinical practice guidelines about the use of IV iron…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 (…
Interventions
- OtherNotification Group
In medical centers assigned to the intervention group within the INITIATE-HF study, physicians of eligible patients with HF and iron deficiency will be sent information from current KPNC and national guidelines about IV iron therapy.
- OtherNo Notification Group
In medical centers assigned to the control group, physicians will not receive information about current guidelines about the use of IV iron (i.e., usual care).
Location
- Division of ResearchPleasanton, California