Enrolling Procedures

Congratulations! Now that you have consented the patient, the next step is to actually enroll them in the study. Here are some key reminders to prepare for going to the procedure and capturing all the information needed for the study. Bear in mind these are general reminders that apply to most studies, but there are always studies with their own quirks. Modify this workflow as you need to.

A lot goes on during the procedures. There are multiple staff members in the room doing various tasks to keep the procedure going smoothly. It's normal to feel like it's an information overload at the beginning. Do your best to observe and ask questions. It will make more sense over time.

• Keep an eye on the snapboard! The schedule shifts around randomly at times.

• If applicable, get the devices from the device closet and bring them to the cath lab area. Make use of carts. Depending on size/space availability, I usually leave them in a the 'cath lab core' area.

• If the sponsor is sending a case support person, coordinate with them:

  • When to meet

  • Get them hospital scrubs

    • Option 1: Use your own card to check out scrubs for them

    • Option 2: Bring them to Stacy (or whoever) is at the cath lab front desk for scrubs. The case support person should be prepared to hand over something as "collateral" - usually car keys, license, etc.

• Print case worksheets for the procedure. Some coordinators have recommended bring an extra copy just in case. Or, if needed, you can also use one of the cath lab computers to print. Or keep copies of it on a USB drive, or in your email, so you can print it from any hospital work station.

• Bring any tools needed for the study. Some studies have a blindfold for patients (to blind them to which group they randomized to), some ask for a radiopaque ruler to be put on the patient, etc.

• If the study requires you to randomize the patient, check the randomization portal (usually just the EDC) and make sure it is ready. If applicable, enter all the patient information required for randomization.

• The case worksheets are what you will use to record data from the procedure. Take note of what data points you need to ask the physician for. And where they need to sign.

Some data points are routinely captured in the hospital's cath lab documenttion protocols, so no need for us to ask for them. We can just "fish them out" from Epic later. Ask Allie/Kyle about what those are.

• Go to the procedure. Try to get there before it starts. Introduce yourself to the cath lab team, give them some information about the study, and what study-specific reminders/instructions you have for them.

• When the physician arrives, remind them that the patient is being considered for a study. Be prepared to run through the key angiographic inclusion/exclusion criteria with them. (If you have a case support person, they can help with that too)

• Depending on your personal preference and what information the study requires from the procedure, you might want to get a spare lead vest and go into the procedure room. Otherwise, feel free to stay in the control room.

• Most studies will ask for the details of what devices are used in the procedure. Studies vary on what devices they want to know about. A general rule of thumb is, if it is an interventional device (e.g. a balloon, stent, thrombectomy device), record it. If it is a routine device used for gaining access (e.g. wire, sheath), most studies do not ask for it. But, always check what each study asks.

• The best way to collect information about devices is to get device stickers from the packaging. Even if you reminded them, sometimes it is easy for cath lab staff to intuitively throw the packaging away. Try to intercept them! If not, sometimes we do pick them out of the trash can if possible.

• Cath lab staff document all the devices used in a procedure. Research can sometimes throw a curveball in that process as research devices are not automatically captured in the cath inventory.

  • You may remind the cath lab monitor to "free text" in the name and size of the device if they need to

  • If the patient is blinded to the treatment they received, ask the monitor to "free text" a generic name like "study device" or "study stent"

• Another way is to take pictures of a device box with all the sizing specifications

• If the patient screen fails angiographically, you do not have to stay until the end of the procedure.

• If the patient enrolls successfully, you probably will need to intercept the physician right as they come out to ask for certain data points, or for them to sign some worksheets.

• Sometimes, I ask the physician if they are about to go speak with the patient's family and ask if I could go with them. Physicians sometimes just call with an update instead of go see the family right away, especially if they have a back-to-back case. I normally only do this for patients whose family members appear especially anxious or curious about the research study during consent.

  • Otherwise, I plan to go see the patient a while after just to inform them they have enrolled successfully, answer any questions, and give an implant card, ClinCard, etc. if applicable (see below)

• If any implants are made (e.g. stents), make sure the patient has an implant card in their folder to take home. The stent cards are usually in the device box, or you might have a supply of them mailed to you separately by the sponsor. Fill out the necessary information on the stent card.

  • Keep a photocopy of the stent card in the patient's binder

• Please remember to bring all devices back to the device closet. Physicians & cath lab staff are usually OK with having devices in the cath core area all day, but please take them back at the end of the day for safe-keeping.