Patient Safety / Quality

Care of clinical trial participants: What nurses need to know

Editor’s note: This is the third in a four-part series on clinical trials written by nurses at the National Cancer Institute at the National Institutes of Health. Read Part 1: Are you ready to care for patients in clinical trials? and Part 2: Clinical trials 101.

Hundreds of clinical trials are started each year by government sponsors, pharmaceutical companies, and private entities. Thousands of patients volunteer to participate in clinical trials, which study new treatments, interventions, or products (that is, drugs, biologics, and devices). These studies occur in inpatient and outpatient settings across the United States and abroad, which means nurses are likely to encounter patients who are considering participating, actively participating, or have previously participated in a clinical trial.

Each scenario requires the nurse to understand clinical trials, but too often, nurses don’t receive specific information about this type of research in their academic curriculum, making them feel ill-prepared for an unexpected encounter with a patient in a clinical trial. Knowing some basic information about clinical trials—and knowing how to access helpful resources—can enhance nurses’ confidence in caring for patients participating in these studies.

Understanding clinical trial activities

Clinical trial participants frequently interact with the members of their research team—research nurse, study coordinator, investigator—throughout the evaluation, study entry, intervention, and follow-up phases of a clinical trial. The research team is responsible for managing all of the details of the clinical trial, but clinical nurses who provide direct care to patients on a clinical trial are also important members of the team.

Clinical trial activities occur in a care delivery system in which the participant will interact with many other health professionals in addition to the research team. For example, a cancer patient participating in a clinical trial of a new chemotherapy agent may arrive in the emergency department with febrile neutropenia. Or, a participant in a device study may learn at his nurse practitioner’s office that he has hypertension. This system makes nurses vital caretakers of both the safety of the clinical trial participant and the integrity of the clinical research process.

One way nurses and organizations can support clinical trials is by ensuring that procedures are in place to identify patients who are participating in a clinical trial. Once a patient has been identified as a clinical trial participant, the “protocol” serves as an indispensable document for both education and care. Nurses should contact the research team if they can’t locate the protocol on the unit. The protocol describes the research plan and ensures that all activities are done the same way and at the same time points. Protocols are considered intellectual property and need to be treated as such.


Though protocols vary in length and complexity, a set of core activities is common to all:

  • Supporting the informed consent process
  • Administering the study agent(s) or intervention(s)
  • Monitoring responses to intervention(s)
  • Collecting data and documenting

(See Checklist of common protocol activities below.)

Checklist of common protocol activities

This checklist helps ensure clinical care is delivered safely and the protocol is followed.

Supporting the informed consent (IC) process

  • Know where to locate the IC document.
  • Read the IC document.
  • Support the patient and family decision-making process in a culturally competent manner. Ensure key decision makers are included in the discussion and adequate time to read the materials and ask questions is provided. Be sure the patient can read and understand the IC document.
  • Ask open-ended, nondirective questions to assess whether the patient understands the study.
  • Serve as a witness if requested. Know your organization’s definitions and policies for witnessing IC. Some organizations define witness as observing the signature of the participant and others define it as observing the IC discussion between the investigator and the participant.

Administering the study agent(s) or intervention(s)

  • Locate the study agent section of the protocol and review the treatment plan and the agent information.
  • Determine if other medications are required (for example, an antiemetic regimen before chemotherapy administration) or permitted (for example, over-the-counter [OTC] medications, vitamin supplements).
  • Know how to identify, handle, store, administer, and dispose of the agent.
  • If the study agent is self-administered, ensure the participant understands how to take the agent, what to do for a missed dose, how to store the agent, and how to dispose of the agent.

Monitoring responses to intervention(s)

  • Review the study calendar section of the protocol to see what laboratory or imaging studies may be used to monitor the response to the intervention.
  • Understand what an “adverse event&334; is: any unfavorable and unintended sign, symptom, or disease having been absent at baseline, or, if present at baseline, appears to worsen AND is temporarily associated with medical treatment or procedure, regardless of the relationship of the event to the medical treatment or procedure. Adverse event is the term used in research instead of side effect or toxicity, which implies a relationship between the intervention and the event.
  • Ask open-ended questions about how the participant is tolerating the intervention. This will help prevent bias in collecting adverse event information. For instance, don’t ask the participant about specific events that might be anticipated, such as nausea, headache, or nervousness.
  • Know when to report an adverse event to the study team, and place their contact information in the medical record.

Collecting data and documenting

  • Record concomitant medication use and duration, including OTC medications and complementary and alternative therapies.
  • Record the start and stop time of an intravenous study agent as well as the condition of the site and whether there was a blood return.
  • Record details of an adverse event, including start date and time, description of the event, any treatment required, and resolution of the event.
  • If the protocol requires biospecimen collection, understand the requirements for timing, method of collection, and handling. Record what type of specimen was collected and the time of collection.

Clinical trial roles and responsibilities

In addition to understanding common protocol activities and providing clinical care, nurses are vital in the support they provide patients and the clinical trial enterprise as advocates, educators, and collaborators. Nurses who fulfill these roles are essential to safe, effective patient care and to a smoothly running clinical trial. (See Nursing roles in caring for clinical trial participants below.)

Nursing roles in caring for clinical trial participants

Weighted Checklist

Here is a closer look at some of these roles.

Advocate

Nurses advocate for clinical research, the clinical trial participant, and the clinical research protocol.

Nurses advocate for clinical research by

  • raising awareness of clinical trials as a potential option for care
  • providing accurate information about clinical research and clinical trials
  • dispelling myths and misconceptions about clinical research
  • providing culturally appropriate resource materials
  • helping patients formulate questions about participating in a clinical trial
  • collecting quality data in accordance with the protocol.

Nurses advocate for the clinical trial participant by

  • confirming that the participant understands the difference between receiving a standard of care and participating in research
  • assessing the participant’s understanding of the purpose, risks, benefits, and voluntary aspect of participation
  • helping participants define their own goals and purpose for participating in a clinical trial, as necessary
  • recognizing issues that need to be discussed with the research team
  • ensuring that the IC process takes place in a culturally competent manner
  • supporting the participant’s ability to adhere to the study schedule by identifying resources for transportation, child care, and financial counseling.

Nurses advocate for the protocol by

  • understanding the importance of adhering to the protocol—from the eligibility criteria to the treatment and testing schedule; if the protocol isn’t followed, usefulness of the data may be compromised
  • being aware of time-sensitive issues and coordinating patient-care activities accordingly.

Educator

Nurses play an important role by providing patients and families information about clinical trials. This information may include a description of the purpose of clinical trials, the safeguards in place to protect participants, how to locate a trial, questions to ask the physician, and how to assess the risks and benefits of participation. A variety of patient and family education materials are available in print and online. (See Clinical trial education resources for patients and families below.)

Clinical trial education resources for patients and families

Patients actively considering participating in a clinical trial typically receive most of their protocol-specific education from the research team; however, the patient may ask you questions or express their concerns. The protocol document, the IC document, and the research team are there to help you help your patients.

Educating staff happens in a variety of ways, and as a clinical nurse specialist or nurse educator you may be responsible for providing this education. The goals of staff education focus on improving knowledge and skills to ensure the delivery of safe, effective care that adheres to the specific protocol requirements. Research team members may also provide additional protocol-specific training as necessary.

A wealth of resources is available for nurses caring for clinical trial participants. (See Resources for nurses caring for clinical trial patients below.)

Resources for nurses caring for clinical trial patients

  • Manual for Clinical Trials Nursing by Klimaszewski A, Bacon M, Deininger H, et al. (Pittsburgh, PA: Oncology Nursing Society; 2008)
  • A Step-by-Step Guide to Clinical Trials by Mulay M. (Sudbury, MA: Jones and Bartlett Publishers; 2001)
  • NIH Clinical Research Trials and You. Information targeted to healthcare providers. Includes importance of clinical research awareness, promotional materials, tips for talking with patients about clinical trials, and how to refer patients for a clinical trial. http://www.nih.gov/health/clinicaltrials/providers/index.htm
  • Protecting Human Research Participants. NIH Office of Extramural Research. Computer-based training program available in English and Spanish. http://phrp.nihtraining.com/users/login.php
  • AccrualNet. An online resource and community of practice that contains descriptions and links to professional and patient educational resources about clinical trials. https://accrualnet.cancer.gov

Raising the public’s awareness about the value of clinical trial participation is another important part of the educator role. According to CenterWatch, 94% of people recognize the importance of participating in clinical research to help advance medical science, yet three in four state they have little to no knowledge about clinical research and the participation process. This gap points to the need to increase the public awareness of clinical research. The National Institutes of Health recently launched a new Web page, “NIH Clinical Research Trials and You,” located at http://www.nih.gov/health/clinicaltrials/.

Collaborator

Detailed planning and implementation are essential for a successful clinical trial. In their role as collaborators, nurses ensure safe care, optimize clinical outcomes, and support data integrity. Collaborative communication with the research team ensures that care is coordinated, roles are clearly defined, and issues are identified and resolved.

Nurses can be instrumental by recommending workable strategies to solve problems. For example, nurses may collaborate with the research team to discuss how a new research procedure can be implemented on the unit, or how to effectively manage potential adverse effects of the intervention being tested. As clinical trial participants move from inpatient to outpatient settings, or from specialist care back to primary care, collaboration between the research team and clinical staff is necessary to ensure protocol adherence and safe clinical care. Without clear coordination, clinical trial participants may receive incomplete, contradictory, or confusing information. These collaborations between nurses and research teams create a unique opportunity for continued learning and professional growth.

Nurses’ support is vital

Nurses play a key role throughout the continuum of the research process and greatly influence the experience of the individual participating in a trial. Many resources are available to help nurses gain competence and confidence in the roles of advocate, educator, and collaborator. The support and involvement of nurses are key to successfully completing trials, which advances both clinical discovery and public health.

Linda K. Parreco, Elizabeth Ness, Annette Galassi, and Ann M. O’Mara work at the National Cancer Institute, National Institutes of Health, in Rockville, Maryland. Elizabeth Ness is the director of staff development at the Center for Cancer Research; Linda Parreco and Annette Galassi are public health advisors for the Office of Communication and Education; and Ann M. O’Mara is the head of Palliative Care Research in the Division of Cancer Prevention.

Selected references

Castro K, Bevans M, Miller-Davis C, et al. Validating the clinical research nursing domain of practice. Oncol Nurs Forum. 2011;38(2): E72-80. http://ons.metapress.com/content/v37762736wm55568. Accessed May 19, 2012.

Clinical trial facts & figures: Public attitudes and perceptions. The Center for Information & Study on Clinical Research Participation. http://www.ciscrp.org/professional/facts_pat.html. Accessed May 19, 2012.

Grady C, Edgerly M. Science, technology, and innovation: nursing responsibilities in clinical research. Nurs Clin North Am. 2009;44:471-481.

Offenhartz M, McClary K, Hastings C. Nursing and new realities of clinical research. Nurs Manag. 2008;39(11):34-39.

Ulrich CM, Zhou Q, Grady C. Recommending research participation to patients: an ethical imperative? Clin Sch Rev. 2009;2(2):41-44.

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