Screening

Two important things for screening: 1. Accuracy (Do not miss patients; do not enroll ineligible patients) 2. Documentation/Screening Log

Figure out a system of doing it that ensures these 2 things and fits into your personal workflow.

We have a month-by-month team screening log that lives in the "SCREENING" folder of the shared drive. Please add screened patients to that.

Sometimes sponsors will ask you to keep a screening log for them on their platform. (WAVE is an example.)

It is generally a good idea to inform physicians about screening efforts. A lot of them do not read all of their emails, but those that do have given feedback that this is helpful. The goal is for them to know that we are screening their patients, and to be ready to explain why a patient did not qualify for a study. I sometimes send out an email like this:

Procedures to Screen

Know which procedures to screen for each study.

Learn how to read procedure names from Snapboard.

For example:

• "IR Cerebral Arteriogram" - diagnostic cerebral arteriogram

• "IR Embolization Intracranial" - interventional cerebral arteriogram, i.e. for NECC

• "Left heart catheterization w/ possible intervention" - coronary arteriogram, they may balloon/stent/intervene if they find a treatment-eligible lesion

• "Abdominal Aortogram w/ Runoff" - to evaluate for/treat PAD

• etc.

You will get more used to these names over time! It can be confusing because sometimes a case will be scheduled with literally the name of multiple procedures. This is common because the physicians need to determine treatment after looking at the angiogram. So, they consent the patients for all the potential procedures.

Chart Review

Google/Ask others if you see something in a chart you don't understand, even if it does not seem directly related to the study. Be curious about the different types of procedures, medications, conditions, terminology, etc.

Chart review is a great learning opportunity.

• Snapshot

  • Medical and surgical history (look for I/E conditions)

  • Address

    • Note if the patient lives far away. That might be a problem if they are required to come back frequently for follow-up visits. Still approach the patient if they are eligible, but it is good to be aware of this when consenting

  • DOC (Department of Corrections) --> Always exclude incarcerated patients

  • Be wary if you see any documentation about dementia or cognitive decline --> We want to make sure patients have informed decision making capacity. Sometimes physicians may tell you it's OK to enroll the patient, but use your best judgement. If the patient does not seem 100% on board when you speak with them, do not consent them.

  • Anything that prevents the patient from consenting on their own accord (e.g. legal blindness, deafness, cognitive concerns) --> Exclude

  • Language

    • Do not exclude patient right away just because they are non-English speaking

    • Spanish-speaking patients: Assess capacity to use interpreters to consent them, and whether there is enough time to translate the study documents including ICF. (WAVE and NECC already have Spanish ICFs)

    • Other languages: Check with the physician and sponsor

    • See Non-English Speaking Patients for more instructions on how to handle these situations

• Chart Review

  • Notes

    • Progress Note / H&P - good overviews of the patient's health

      • Prioritize looking at ones that are from the service treating the patient (i.e. Neuroendovascular, Cardiology, Vascular Surgery)

      • Op Notes - review historical procedures, especially related procedures. Has the patient had a similar procedure before? Why? Is this a new issue or a recurring issue?

  • Encounters

    • Look at history of hospital admissions/encounters

    • This will be a more succinct tab than "Notes", as 1 encounter can have multiple notes (less scrolling)

    • Dialysis records will be classified as "Treatment"

  • Imaging

    • Look for recent angiograms, CTAs, DUS

    • Read the dictation

  • Heart/Vasc

    • Very similar to imaging tab; but focuses on cardiovascular studies

  • Labs

    • Check historical values to guesstimate eligibility

    • If there are no recent-enough labs, actual eligibility will depend on pre-op labs

  • Media

    • Browse medical records from other health systems (E.g. Duke, WakeMed, etc.)

  • Meds

    • Look out for I/E meds

• Research Studies

  • Most investigational studies will not allow concurrent participation in another investigational study (there are some caveats; when in doubt, double check with the study sponsor and PI)

  • Take note if patient has declined or participated in research studies in the past (Expectation management for when you consent them)

Under "Research Studies", select the study of interest, and mark the pt as:

• Ineligible, if pt is ineligible. Write a short note on why

• Identified, if pt meets general I/E, but has not signed ICF

• In Screening, if pt meets general I/E and signs ICF.

  • Change back to Ineligible if they fail angiographic I/E on the table

• Enrolled, if pt meets angiographic I/E and is enrolled during procedure.

• Declined, if pt is eligible, gets approached for consent, and says no