Lost in the Shuffle: Navigating Patient Follow-up in Clinical Trials

April 10 2024

Written by Mark Fischer BS, CCRP, Quality Assurance Monitor, University of New Mexico Comprehensive Cancer Center, New Mexico MU-NCORP

As clinical research professionals we all take immense pride in our dedication to our patients who agree to participate and partner with us in clinical trials. We often develop a strong relationship with each of our patients throughout the trial process. These relationships not only help improve patient safety but also may increase patient satisfaction with their care.

Navigating cancer care within a clinical trial is a complex and challenging endeavor for many patients. Patients may feel overwhelmed and lost due to the high demands of their care schedule. Participating in a clinical trial may contribute to these feelings.

The phenomenon of patients lost to follow-up represents a relatively infrequent occurrence, yet it poses a significant and tangible concern for both patients and investigators involved in clinical trials. This issue introduces a level of uncertainty that compromises both patient safety and the ability to contribute to trial data requirements.

NRG provides a clear definition of when a study participant may be considered lost to follow-up.

Per the NRG Lost to Follow-up guidance document:

“A patient will be deemed to be lost to follow-up only if the site has been unable to get ANY vital statistics information related to the patient for 2 continuous years. Attempts to locate the patient are expected to continue during this 2-year period.”

There are several strategies we can employ to ensure we do not reach this point:

  • Establish rapport with your patient and the medical team.
    • Clear and genuine communication is key to compliance and quality customer service. Demonstrating to your patient that you are invested in them instills confidence and establishes you as a member of their care team rather than simply “that person from the study.”
    • Frequent and efficient communication with the oncologist, nurse navigator, clinic nurses, infusion nurses, radiologic technologists, phlebotomists etc. about patient trial participation and scheduling helps ensure each part of the care plan stays on track and reinforces your role as a member of the care team.
  • Obtain Accurate Contact Information
    • Verify primary contact information with your patient including telephone numbers, email, and physical address, and request the same for any anyone else with whom you have obtained permission to contact.
    • Should you find that your patient has missed their scheduled appointment, and you are having difficulty reaching them you will have these resources ready to quickly re-establish communication.
  • Identify other healthcare providers the patient may be seeing.
    • Provider appointments within your medical system can be identified through the EMR.
    • Any outside providers from which you have obtained medical records for trial eligibility may be contacted throughout trial participation.

Accurate and complete documentation of attempts to reach your patient are essential to good clinical practice and demonstration of due diligence. It is recommended that your site consider developing a Lost to-Follow-up SOP and form to document contact attempts in case a patient does enter lost to follow-up status. Missed visits, exams and assessments are evaluated at the time of audit. Clear documentation regarding contact attempts is an important component of an auditor’s review.

Patients are at risk of falling off schedule at any point during study participation. CRPs should make every effort to establish contact at every study required time point. Over the course of two years attempting to re-establish contact, NRG still requires RAVE data submission at each time point stating that no contact occurred and the date of the attempt to contact the patient.

Per the NRG Lost to Follow-up guidance document:

“Several different contact strategies are recommended: contact the study participant by phone, search medical records, contact the study participant’s primary care physician if permitted, search registries for their region as appropriate, contact the study participant by registered or certified letter, contact the study participant by email or other electronic means if permitted and check the Social Security Index.

Three or more attempts using the above strategies must be made. Such attempts should be made over the course of two consecutive years.”

If, despite your best efforts, the patient meets the lost to follow-up criteria, the guidance document has instructions for submission of the Lost to Follow-up Status in RAVE.

Lastly, do not give up! Even if your patient enters lost-to follow-up status they can still be found, and you are required to continue attempts to obtain vital statistics information at least until the end of the protocol defined follow-up period. The frequency of attempts by the coordinator should be addressed in your site SOP.

The Lost-to Follow-up status can be rescinded in RAVE if you find your patient again. In this case, give yourself a round of applause for a job well done! A member of the NRG Data Management Team will contact you regarding submission of the latest information.

The NRG Lost to Follow-up guidance document and a valuable Never Say Lost booklet are available on the NRG Data Management Resources page.

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