Consenting Patients

Consenting in Prep (Pre-Procedure)

This is the case for MOST studies.

Consenting in prep takes some planning. The main challenge is balancing between not disrupting the workflow of the prep nurses with trying to complete all the research-related tasks on time so that the patient’s case will not be delayed. It might seem difficult or awkward at first, but it’ll become second nature to you

• Note the patient's arrival time. It is generally ~2 hours before procedure start time. Be on standby.

• Have these items ready on a clipboard:

  • ICF

  • Any pre-procedure questionnaires & assessments

  • Copies of your business card

• Check the snapboard, when the patient's case turns yellow, it means they are in facility. It might still take a few minutes for them to be brought back to the prep area.

• Go to the prep area and look for the prep lead room to look at the whiteboard. Take note of which room they are in and who their nurse is.

• Place the “Research” magnet in the furthest right column on the marker board next to the patient’s name

• Find the nurse that the patient will have. If you ever need to reach NCHV PREP (let’s say it’s early in the morning and you’re driving to consent a patient and need to figure out where they are, just call: 919-784-6508). When you find the nurse, tell them you want to talk to their patient about research and ask them if they would rather you go in as soon as the patient is roomed or wait. Most nurses do not mind you going in first, but make sure you ALWAYS ASK!

Communication is KEY – if schedule is looking tight, communicate with prep nurse/charge nurse, person at cath lab front desk (usually Stacy), and the enrolling physician. If it looks like research will delay the procedure by a bit (usually does not occur), check to make sure getting what you need from patient is ok with physician. Physician may choose to decline research d/t scheduling constraints or emergent add-on’s.

Some studies require more extensive pre-procedure assessments (like questionnaires or a 6MWT). For those studies, it might be helpful to call the patient the day before to ask them to come in ~30 min early. Then bring them to James's office or a consult room to complete consent and assessments before the nurses prep them for procedure.

• Seeing the patient as soon as they are roomed is ideal. This will save you a LOT of waiting around. Many nurses are fine with completing their assessments in conjunction with the consent process (super efficient, but can draw attention away from the patients at times, depending on their cognitive ability). It will kind of be a dance. Each nurse has different preferences, so be adaptable.

• If the patient declines, just let the nurse know you are all done.

• If patient consents, put a patient ID sticker (get it from their chart folder) on the first page, then make a copy of the ICF for the patient to take home for reference & give them a business card with your contact information. Make sure you keep the original copy.

• Some studies will require baseline testing (labs, ABIs, etc.) pre-procedure. Find the APP to place those orders. Or contact one of our research nurses (Penny, Tiffany, Jenn).

Re: labs!

1. If you can catch the phlebotomist before they draw labs from the patient, you can let them know what you might need so they can draw an extra tube. This way, the patient gets one less needle stick.

2. Ask the APP if it is possible to add on a lab order to an existing sample. This also helps the patient avoid an extra needle stick.

   • The type of labs determine the type of tube they are drawn in. Labs drawn into the same tube can be added on to existing samples.

   • See this link from UNC Health Phlebotomy Services for the details

3. Watch out for wording on the protocol as to whether labs need to be drawn or resulted before procedure.

   • "Drawn": To avoid an extra needle stick for the patient, or just save time, an alternative option is to draw the lab from the access sheath in the cath, then send it to the lab via pneumatic tube system. The order must be placed beforehand. This could be clunky because drawing labs are not a usual part of the cath lab staff's routine, and some of them can get rather grouchy about it. There are things we can do as coordinators to streamline it, like help with printing sticker labels. Kyle is the best person to ask about this as he has had experience wrangling this for Target IV.

   • "Resulted": Especially if the lab value is an inclusion/exclusion criteria, be sure to check the value before the procedure starts. If it is out of range, screen fail the patient.

     • The most stressful part about this is, no one wants to be held up by waiting for a lab result. Sometimes, physicians will try to start a procedure and do the diagnostic angiogram (since only the interventional part of the procedure is the "research" portion). Check with the sponsor about how much leeway they can give about such arrangements to make sure you do not accidentally incur a PD.

     • PDs are not the end of the world. Missing out on an enrollment is not the end of the world. However, what we must avoid AT ALL COSTS is enrolling an ineligible patient. ☠️

If the patient needs a stat portable ABI done at bedside pre-procedure, it would be helpful to call the PVL (peripheral vascular lab) to give them a heads up. And emphasize urgency, yada yada yada.

There is a "research declines log" in the SCREENING folder of the shared drive. It is no longer very active now, so no pressure to use it. I personally found it helpful to keep a log of why typically decline or what are common concerns that come up about each study. This helps me be prepared or adjust my consent approach in the future.  

Consenting inpatients, in clinic, or in pre-admissions testing

The key points to take note of are same as consenting in prep. It is usually a little less frantic since there is less of a time crunch, especially when it comes to placing orders and waiting for tests to result.

As always, COMMUNICATION and ADAPTABILITY are key. When speaking with an inpatient, check with their nurse whether it is a good time to go in and see the patient. Same as for pre-admissions testing.

Most of the hospital staff are not familiar with research and a lot of times you would find yourself "inserting" yourself into some sort of pre-established workflow. Be strategic about doing this as seamlessly as possible. Be assertive when needed because you should not need to "feel bad/awkward" for doing your job.

Tips for going through an ICF with patients

The basics:

1. Introduce yourself and your intentions

2. Loop in family/friends/other accompanying persons into the conversation. A good way to start is "Who do you have here with you today?" to not assume.

3. Check for consent and understanding in small segments ("Would you like to hear more? Do you have any questions")

4. Tailor your explanation to individual patient needs and understanding levels. Ask them (or check their chart) if they have had a similar procedure before. Ask them what they already understand and go from there.

5. Review all the information in the ICF. The gold standard is to go page by page. Some patients prefer to do more independent reading. Adjust as necessary.

6. Speak confidently and lean towards using positive/opportunity-oriented terminology, but remember it is not your job to "convince" the patient to be in the study. That decision has to be completely up to them.

The "fun" parts:

I think getting to explain studies to patients is one of the most rewarding parts of the job. There are many ways to do it that are definitely wrong, but there is no one right or formulaic way to do it. Over time, you will probably notice some personal styles emerge in the way you approach patients about consent.

Extra resources:

1. This document from a previous coordinator

1. Use ChatGPT as a reference for "what are good ways to explain xyz"