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.
None
None
Parallel
Notification Group
Other interventionIn 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.
No Notification Group
Other interventionIn 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).
% of patients receiving IV iron within 7 days of hospital admission
The primary outcome is the implementation outcome of the percentage of patients who receive IV iron within 7 days of hospitalization to determine how the provider-facing notification influences provider behavior and care processes.
% of patients who experience the composite outcome of all-cause death and heart failure-related hospitalization
The secondary outcome will be a percentage of patients who experience the composite outcome of all-cause death and heart failure-related hospitalization, to determine whether any observed changes in the implementation process outcome also translate into improved patient outcomes during the 12 months after randomization.
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Kaiser Permanente
Lead sponsor
Garfield Memorial Fund
Collaborator
