Update 3/1/2018: Wow. The link to the web site “randomise me” has been hijacked and is no longer valid.
I thought it might be fun to let you guys know how my Institutional Review Board (IRB) evaluation went for my proposed randomized trial regarding our Epic Delirium Order Set quality improvement study, which I’ve posted about previously. A couple of my colleagues thought the safest course would be to make sure this project wouldn’t qualify as human research.
Epic Delirium Order Set Usage: Does It Reduce the Number of Psychiatry Consultation Requests?
“My colleagues’ opinions differed about whether I needed to contact the IRB about this. Although this might not clearly be a research project and I got the idea from a website,
randomiseme.org (hijacked link and no longer valid). and wrote a blog about it, https://thepracticalpsychosomaticist.com/2013/12/21/randomise-or-randomize/
The idea really is to promote the use of the Epic Delirium Order Set by non-psychiatric clinicians so as to encourage the development of greater comfort with assessing and managing delirium in general medical units. I would like to track how often the order set is used by internal medicine and see whether that influences the number of psychiatric consultation requests. Currently, many patients are misdiagnosed with a primary mental disorder. Psychiatry is consulted often when the most I can do is to identify what the patient doesn’t have, i.e., a primary mental disorder. Since delirium is, by one definition, a medical emergency, scope of practice issues prevent me from tracking down the medical etiologies since internal medicine is not my specialty.
The outline would be:
Create a Trial Question: Does using the Epic Delirium Order Set cut down on the number of psychiatry consults for delirium?
Main Outcome Measure: Number of psychiatry consults.
Size of Trial: I’m not sure but we get about 100 consultations a month and at least 20% are for delirium.
Description of Trial: A randomized trial comparing the number of psychiatry consult requests between general medicine units which either do or don’t use the Epic Delirium Order Set. I expect the number of consult requests would be lower from the unit which uses the order set.
Trial Instructions: Residents on the test unit will enter the Delirium Order Set upon either learning of a positive Delirium Observation Screening Scale (DOSS) score from nurses or diagnosing delirium themselves by the informal use of the Confusion Assessment Method (CAM) and the Mini-Cog. Residents on the control unit will not enter the Delirium Order Set under the same conditions.
We would need to extract an Epic report for baseline number of times the Epic Delirium order set is used. We could randomize internal medicine residents from one medical unit team to use Epic, and another team to not use it.”
And the outcome was probably predictable. The determination by the IRB Chair was as follows:
I have determined that the project described in the application does not meet the regulatory definition of human subjects research and does not require review by the IRB, because this project is aimed at increasing the use of an existing clinical tool and assessing its effectiveness; it is not likely to produce generalizable knowledge. Also it looks like this project can be done looking at aggregate data from EPIC with identifiers, if the data are extracted by UI IT.
Any readers who know their way around an IRB will immediately see how amateurish my proposal is. Funny thing, the computer gave me conflicting answers about whether this project was human subjects research or not. On the one hand, I got the comment by the IRB Chair. On the other, I also got a memo at the same time which identified it as human subjects research, a blatant contradiction. So I called the IRB office and they said it was their mistake or a computer glitch. They said my project was definitely not human subjects research and the IRB chair would be sending me an email confirmation of that.
I think my wooly-worded summary probably just blew their algorithm. In any case, now I need to decide whether to go ahead with the project or not. You know, all I’m really trying to do is connect with my colleagues in internal medicine. I’ve been trying to engage them in the fight against delirium for so long. I don’t know if I ever had their attention, or maybe I did at one time and just lost it.