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Is your patient on a clinical trial?

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By: Elizabeth Johnson, PhD, MS-CRM, RN

One simple question can make all the difference.

Takeaways:

  • The billions of prescriptions filled by Americans every year demonstrate the altruism of clinical trial participants who accept risk and discomfort to aid research.
  • Without key safety information, nurses and providers remain in the dark about the best approach for care delivery when trial participants seek clinical management outside of the research team.

In the early hours of the morning, Sonya Robinson* arrives at the community emergency department (ED) with a fever and nausea. During the health history and patient interview, the ED nurse learns that Ms. Robinson has Type 2 diabetes and uses metformin as an anti-hyperglycemic agent. After the ED team administers fluids and standard therapies, Ms. Robinson’s condition begins to deteriorate and she’s admitted to the hospital.

The admissions nurse, looking through the medications the patient brought with her, discovers a bottle of capsules with an unfamiliar drug name. After the nurse enters the name into the drug database with no results, he asks Ms. Robinson about it. She says that it’s her “diabetes research medication” and points to a phone number on the label.

Without realizing it, the healthcare team has administered a standard therapy contraindicated for this investigational drug, causing an adverse event. The admissions nurse calls the number and a research nurse answers, who provides information about which standard therapies are safe for the patient as a clinical trial participant.

Because Ms. Robinson received a contraindicated therapy, the trial sponsor withdraws her from the research. She can no longer receive the investigational drug or continue with specialty visits or laboratory monitoring that were part of the trial.

Clinical trial participants volunteer to take part in research intended to evaluate the safety and efficacy of drugs or devices, which come with side effect profiles and care management guidelines that most healthcare professionals are unaware of. Without key safety information, nurses and providers remain in the dark about the best approach for care delivery when trial participants seek clinical management outside of the research team. Effective communication during the initial patient interview can help identify clinical trial participants.

How have clinical trials changed?

Since the 2012 publication of the series by Parreco and colleagues about nurse involvement in research, clinical trial participation in the United States has increased. Use of decentralized clinical trials, which can be conducted without frequent visits to larger medical centers and allow participants to remain in their communities with familiar healthcare facilities and providers, also has increased.

As investigational products become more specific in action with fewer potential systemic side effects, researchers approach patients to consider trial participation earlier in their disease process or symptom sequelae. (See Clinical trial advancements.)

Clinical trial advancements

According to the U.S. Food and Drug Administration, increased clinical trial participation has made the United States a leader in research and innovation, accounting for 35% of the total global clinical trial enrollment. Between 2015 and 2019, over 292,000 individuals worldwide supported hundreds of thousands of clinical trials across the spectrum of diseases and disorders. A study by Darrow and colleagues found that not only had drug approvals increased between 2010 and 2018 (totaling 41) compared to between 2000 and 2009 (25), but also a shift occurred in the complexity in the mechanisms of action of these new drugs. Particularly with regard to oncology and arthritis, novel therapies target genetically predisposed pathways of disease.

Healthcare providers must identify trial participants early in clinical care encounters to uncover the use of complex medications that may affect multiple body systems or have side effects that mask what otherwise appear to be benign symptoms. For example, what may appear to be generalized nausea and vomiting may actually be the start of more insidious sequelae if the care team is unaware of an investigational drug that targets certain types of cells or tumor markers.

Clinical trial sponsors have integrated remote components into overall trial conduct. For example, they allow flexible visit schedules and remote data collection so participants can continue care within their communities, including with primary care providers and with local EDs and urgent care centers. These steps make trial participation easier for patients, but details about the investigative drug, such as which standard of care medications may cause an interaction or other prohibited treatments, must be communicated to community providers to ensure patient safety and trial success.

When should nurses ask about trial participation?

Drugs and devices tested in clinical trials may interact with other drugs or therapies, cause serious injury, exacerbate existing health conditions, and have contraindications and mechanisms of action not available in drug guides or electronic health record (EHR) drug databases. However, no standardized method exists to share trial information with healthcare providers outside of clinical trials. Wallet cards, “Dear Provider” letters, or the rare connection between organizations’ EHR systems lack consistency and may not be updated as frequently as safety information evolves during the course of an individual’s trial participation. When nurses ask about clinical trial participation and request research team contact information, they can help the care team align the care plan with the limitations of the drug’s protocol to avoid injury, death, and trial withdrawal.

The initial patient interview provides the perfect opportunity to learn whether a patient seeking care also is a clinical trial participant. Simply asking, “Are you involved in any research study or clinical trial?” helps to prompt patient recall of trial information. Schoenenberger-Arnaiz and colleagues, in their study of 20 adult clinical trial participants, found that 90% could recall the name of the principal investigator and 70% could describe details of their disease process and trial participation. Only 15% of the 20 trial participants in the study had been provided with a wallet card, which highlights the importance of nurses asking the question.

What if the patient is a clinical trial participant?

If your patient is participating in a clinical trial, you’ll want to ask these follow-up questions to determine next steps in care plan development:

  • Do you have any research documents or information with you?
  • Do you have contact information for your research team?

With this information, the care team can develop an informed care plan. For example, if the documentation or a conversation with the research team reveals that the patient can’t receive steroids because they may trigger an interaction with the experimental drug, the team now knows to seek other treatment options. Speaking with the research team gives the clinical care team the opportunity to discuss the patient’s status and ask questions about navigating any restrictions on standard clinical care pathways.

To ensure continuity of care, document trial participation information, including treatment restrictions, in the patient’s EHR. Verify that the information is visible to all providers so that they may interpret its impact on the anticipated plan of care. For example, bedside nurses may have to alter standard therapy dosages or change care delivery approaches for these patients to ensure they can stay in the trial and to prevent inadvertent injury.

If the patient seeks clinical care because of symptom progression, disease status change, or an acute injury, the research team may request documentation to complete federally required reporting to oversight entities, such as the Food and Drug Administration. Clear, concise, and consistent documentation permits an in-depth understanding of clinical events related to the trial participant, which can then guide researchers in evaluating patient care and data management. The research team can help guide the clinical team regarding necessary documentation. (See APRNs and clinical trials.)

APRNs and clinical trials

Advanced practice RNs (APRNs) across various specialties have an opportunity to contribute to clinical trials or research studies as either lead investigators or sub-investigators (collaborating research colleagues). APRNs’ extensive training in disease management, combined with additional training in conducting clinical trials, positions them, clinical nurse specialists, and nurse scientists to serve as key members of the clinical trial team. In a recent survey by Braun-Inglis and colleagues, oncology nurses were asked about their perceptions of clinical trial involvement and management. The nurses reported that their role included identification, recruitment, and coordination of clinical trial participants and research-based care.

A different outcome

Could Sonya Robinson’s experience have resulted in a different outcome? Consider this alternative:

The ED nurse, as part of an updated initial triage interview, asks Ms. Robinson if she’s involved in any clinical trials or research. The patient nods, prompting the nurse to ask the patient if she has any research-related information with her. The patient provides a medication bottle with a phone number for a research nurse who’s part of a team conducting a large Type 2 diabetes investigative drug trial. When the ED nurse calls the number, the research nurse describes the typical side effects of the investigative drug and also provides recommended management for the fever and nausea seen in the first weeks of experimental treatment. The clinical team treats the patient according to the research team’s instructions and discharges the patient, who later sees the research team for further evaluation. The nurse documents Ms. Robinson’s clinical trial involvement in the EHR, alerting other providers in the hospital should she need future clinical care. The ED nurse’s initial question about trial participation avoided a hospital admission and allowed the patient to continue in the clinical trial.

Ask a simple question

The billions of prescriptions filled by Americans every year demonstrate the altruism of clinical trial participants who accept risk and discomfort to aid research. As nurses, we can extend patient advocacy to this pioneering group by identifying them during initial assessments and interviews. Acknowledging trial participants allows providers to connect with research teams and develop tailored care plans that match the requirements of the clinical trial. Adding a simple question—“Are you involved in any research study or clinical trial?”—supports patient safety and possibly the next breakthrough in biomedical research. AN

*Name is fictitious.

Elizabeth Johnson is an assistant professor at Montana State University – Mark and Robyn Jones College of Nursing in Bozeman.

References

Braun-Inglis C, Shvetsov YB, Springer A, et al. Understanding attitudes and roles of oncology advanced practitioners in the setting of cancer clinical trials: A pilot study. J Adv Pract Oncol. 2021;12(5):465-76. doi:10.6004/jadpro.2021.12.5.2

Darrow JJ, Avorn J, Kesselheim AS. FDA approval and regulation of pharmaceuticals, 1983-2018 [published correction appears in JAMA. 2020;323(6):573]. JAMA. 2020;
323(2):164-76. doi:10.1001/jama.2019.20288

IQVIA. Medication use and spending in the U.S. May 9, 2019. iqvia.com/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-a-review-of-2018-and-outlook-to-2023

Parreco LK, Ness E, Galassi A, O’Mara A. Care of clinical trial participants: What nurses need to know. American Nurse Today. 2012;7(6). myamericannurse.com/care-of-clinical-trial-participants-what-nurses-need-to-know

Parreco LK, Ness E, Galassi A, O’Mara A. Are you ready to care for patients in clinical trials? American Nurse Today. 2012;7(2). myamericannurse.com/are-you-ready-to-care-for-patients-in-clinical-trials/

Schoenenberger-Arnaiz JA, Solanilla-Puertolas M, Acer-Puig M, Gomez-Arbones J. Informing primary care physicians of patients’ involvement in clinical trials carried out at a specialist care level. Open Access J Clin Trials. 2017;9:59-64. doi:10.2147/OAJCT.S134555

U.S. Food and Drug Administration. 2015-2019 Drug trials snapshots summary report: Five-year summary and analysis of clinical trial participation and demographics. November 2020. fda.gov/media/143592/download

American Nurse Journal. 2022; 27 (11). Doi: 10.51256/ANJ112229

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