First Randomized Patient!!!!!

BeachNurse · Feb 5, 2005

I've been on the guard all this time for a pt that met the inclusion criteria! The biggies were: pts were never on insulin (greater than 1 week) and their a1C being >8.0 We finally randomized a patient on Friday!! I never knew there would be so much paperwork!! Its just me and the Doc doing the study..so you do the math to figure out the quantity of my work..lol
Finally...once I had given up my hunt..(they were all canidates except for one reason: heart failure, A1c was too low, they were already started on insulin......)
FINALLY!!! We have randomized a patient!! She got the intensive dietary management arm which I was hoping for....I'm so excited! I don't care about the 5 extra phone calls to her I've made this week...she's a great lady, and will benifit well from the study!
Do you guys get excited like that? =0) or will I soon learn that all this needs to be taken with a grain of salt?
Jules
P.S. We are doing an open label study on the effects of a mixed insulin on a standardized titration dose vs. the effects of the insulin named above doses along with standard (1 call only) dietary counceling or intensive (3 calls during the 12 weeks study) dietary counceling.

CONGRATS!!!!

Yes I do get excited..they are always pressuring us to enroll. I work in infectious disease and coordinate 10 different studies. Paperwork, paperwork, paperwork!

Good job finding a pt! The work is worth it. :balloons:

hypnotic_nurse · Feb 6, 2005

I've been doing studies for 15 years now and I still get excited about enrolling. :) Congrats!

JnJTyson · Feb 6, 2005

Its going pretty great. The patient came back for her first visit after the start date. She's doing pretty good. She still wants to call me when she has to do the averages of her blood sugars so she can titrate the insulin dose....but other than that, she's getting everything about the study just fine.

I thought it was pretty funny, the doc went in to say hi and check how her blood sugars were..and he told her to increase her evening insulin dose. When I came back in, I read the progress note, and had to tell her to leave it as it is because with the study rules, you titrate the dose every three days!! I tried not to make it sound like the doc didnt know what he was doing...but the pt said "so, I should just listen to you when it comes to the study huh?"

We have a few other pts on our list of possible study canidates. Can't wait!

What type of studies do you do? This is my first, and its an open label study.so its a drug already on the market, and the pt knows what they are taking. no placebos. Are you guys doing studies of meds not on the market yet? I can't imagine how much paperwork is involved with those!! Oye!

Jules

BeachNurse · Feb 6, 2005

Its going pretty great. The patient came back for her first visit after the start date. She's doing pretty good. She still wants to call me when she has to do the averages of her blood sugars so she can titrate the insulin dose....but other than that, she's getting everything about the study just fine.
I thought it was pretty funny, the doc went in to say hi and check how her blood sugars were..and he told her to increase her evening insulin dose. When I came back in, I read the progress note, and had to tell her to leave it as it is because with the study rules, you titrate the dose every three days!! I tried not to make it sound like the doc didnt know what he was doing...but the pt said "so, I should just listen to you when it comes to the study huh?"
We have a few other pts on our list of possible study canidates. Can't wait!
What type of studies do you do? This is my first, and its an open label study.so its a drug already on the market, and the pt knows what they are taking. no placebos. Are you guys doing studies of meds not on the market yet? I can't imagine how much paperwork is involved with those!! Oye!
Jules

I have a couple open label studies but some of them are Phase I/II. I have to conduct 12-hour PK (pharmacokinetic) studies on three of them. PK studies involve the patient being in the clinic for 12 hours where they take the study drug and have blood drawn at specific time points, usually twice in the first hour then every 2, 4, 6 up till 12 hours. They have to try and determine the safest, most effective doses for drugs that are not FDA approved (in children) in these studies. I am also working on a new vaccine not on the market yet. It is a childhood vaccine that is an improvement over the comparable one that's out right now.

hypnotic_nurse · Feb 7, 2005

I just started *this* research job in otorhinolaryngology. Dept. chair really wants the research end to take off. I have one study ready to go which uses a device + chemo to treat ca of the mouth and throat -- this one also has a PK component for the first 96 hours (luckily we only do 2 subjects with PK). I'm trying to get another study for our docs which involves a new antibiotic for earache. And all of our residents and fellows are responsible for writing at least one research study and carrying it out. So I am looking forward to a ton of work but am a little slow right now.

marys · Feb 25, 2005

Hi,

I am a 3rd semester RN student that will complete my Rn in Dec 2005, my BSN in two more semesters after Dec. I also have a BS in Biology/Chemistry. My prior life was an Software project manager and Protocol Coordinator for a cancer research center in Houston (M.D. Anderson).

I absolutely love the research side of nursing and was wondering what people look for in new hires...

Would greatly appreaciate any insight...

mar:rolleyes: