5 Ways Nurses Can Increase Diversity in Lupus Clinical Trials

Nurses are among the most trusted professionals in the United States, giving them a unique opportunity to help increase clinical trial enrollment among racial and ethnic minority populations.  

Here are five ways nurses can help increase diversity in lupus clinical trials: 

1. Understand and Support the importance of diversity in lupus clinical trials

Diverse participation in lupus clinical trials is essential for the development of new, safe, and effective therapies. Racial and ethnic minority populations are disproportionately impacted by lupus and are underrepresented in lupus clinical trials.

• Lupus is ranked in the top 10 leading causes of death from illness for Black and Hispanic/Latino women ages 15 to 44 years.
• Black people are estimated to make up 43% of systemic lupus erythematosus cases, yet they are only 14% of participants in lupus clinical trials.

Medical products are safer and more effective for everyone when clinical research includes diverse populations. 

2. Recognize barriers and engage facilitators in clinical trials enrollment

Barriers are anything that makes it more difficult for eligible patients to enroll or participate in a clinical trial. They decrease the chance that an eligible participant will want to enroll. Common barriers to clinical trial participation include:

• Patient’s health status -  A patient may be too sick, they may not have a confirmed diagnosis of lupus or they may have a history of prior withdrawal in clinical trials due to medical complications. 
• Confusing materials -  Unclear and lengthy consent forms, inaccessible recruitment documents and confusing explanations of the study’s protocol can make patients less likely to want to participate in a clinical trial.
• Lack of peer or family support - If patients are lacking peer or family support it decreases their likelihood of wanting to enroll in a clinical trial. This has included family or friends seeing clinical trials as “unsafe” or being confused about what a clinical trial is and what enrollment in one will mean for their loved one.
• Historical injustice and racism - Past and present experiences of discrimination and racism in healthcare and every day life may contribute to mistrust and limit participation.
• Health literacy challenges - Descriptions of study drugs or study protocol in overly-medical terms may limit clinical trial participation. Health care providers must meet the participant at their literacy level using materials that are linguistically and culturally appropriate. 
• Financial and time constraints - Patients may not be able to take time off of work to go to study visits or have competing obligations.  Financial burden of paying for childcare, transportation or parking to attend study visits.

Facilitators are things that make it easier for someone to participate in a clinical trial. They increase the chance that an eligible participant will want to enroll in a trial - they are helpers. Facilitators include:

• Family, peer or partner support  - Inclusion of a patient’s support network as part of the clinical trial recruitment process and allowing time to address their questions. 
• Supportive relationship with healthcare providers -  Patients and providers should be able to discuss the risks and benefits of a clinical trial, both before the patient is enrolled and during the study. 
• Patient interest or need to explore new treatment options - A patient may be motivated to explore clinical trials if they are at a compelling stage of the disease that leads into finding “other” treatment solutions.
• Clear explanation of the study’s purpose and goals, and the patient’s rights - Participants should understand why the study is being conducted and why they are eligible
• Allowing time for informed consent - Patients should be given enough information about the risks and benefits of enrolling in a study to make the decision that is right for them
• Open communications between patient, study’s principal investigator (PI) and staff - Patients should feel comfortable asking the study staff and PI questions, which will most likely be answered with multiple conversations. 

3. Educate patients about clinical trials

Many people don’t know or understand much about clinical trials and don’t see themselves as someone who could participate in one. You can educate patients about clinical trials by:

• Asking what a patient knows about their lupus, treatment options and clinical trials.
• Offering general information about clinical trials by answering questions like,
  • What is research?
  • How is a clinical trial different from medical care?
  • What is the purpose of a clinical trial?
  • Why is it important for people to participate in clinical trials?
• Building trust by sharing that clinical trial participation is voluntary, people can quit at any time and that participants have rights.
• Providing easy-to-understand education materials about clinical trials.

4. Use culturally appropriate communication

According to the Agency for Healthcare Research and Quality, culturally competent care “respects diversity in the patient population and cultural factors that can affect health and health care, such as language, communication styles, beliefs, attitudes, and behaviors.” Communicating in a culturally and linguistically appropriate manner is critical to building patient knowledge and trust. You can engage in effective cross-cultural communication by:

• Asking about language preferences and providing language assistance – Patients with limited English proficiency should be provided with a qualified interpreter, not a child or other relative.
• Translating written materials – Education materials about clinical trials should be provided in the patient's preferred language.
• Adapting your communication style – Be mindful of your patient’s cultural identity and preferred communication style and follow their cues during your conversation.
• Use therapeutic communication techniques - The techniques can help enhance the development of a therapeutic and trusting nurse-patient relationship.
  
  Active, attentive listening cultivates an environment where the patient can communicate and the nurse communicates acceptance and respect for the patient which leads to trust. Nonverbal behaviors can promote and facilitate attentive listening. Using the acronym SOLER includes:
  • S: Sit squarely facing the patient which shows the nurse is interested in what the patient is saying.
  • O: Observe an open posture where arms and legs remain uncrossed. The nurse should remain open to communicate openness to what the patient has to say
  • L: Lean forward toward the patients to convey involved interaction and interest in what's being said
  • E: Establish eye contact to convey involvement and willingness to hear and listen to the patient.  Ensure eye contact conveys warmth by smiling and nodding but avoid staring and glaring which might make the patient uncomfortable.  In some cultures (e.g. Hispanic, Asian, Middle Eastern, and Native American) eye contact may be perceived as aggressive so use with caution.
  • R: Relax and get comfortable with the patient. Try to avoid appearing anxious, restless and fidgety which may convey a feeling of discomfort.
• Encouraging questions and discussion – Ask “What questions do you have?” or “What would you like to know more about?” Answer questions clearly, completely and respectfully.

5. Advocate for patients 

It can be difficult for patients to ask about or express interest in clinical trials during a busy medical appointment. You can help make sure that the possibility of participating in a clinical trial isn’t forgotten by:

• Giving patients a voice: Speak with physicians about clinical trials opportunities on behalf of your patient.
• Protecting patients’ rights by upholding the values and ethics of the nursing profession.
• Ensuring patient safety and protection.
• Directing patients to resources about clinical trial participation.

Research Opportunities to Share with Lupus Patients

• Antidote and ClinicalTrials.gov are just a couple ways you can Search for Clinical Trials near your patient. 
• Enrollment in RAY®: Research Accelerated by You is a good first step to engage in lupus research. Participants can share information about their lupus experience to help researchers accelerate the development of new treatments and improve disease outcomes. And through RAY they can learn about research opportunities they may want to consider. 

Resources About Clinical Trials Available for Your Patients

• Clinical Trials and Lupus:  Frequently Asked Questions - Download this guide (PDF) to learn about the different types of lupus clinical trials, participation, benefits, risks and safety.
• Helpful Resources for Lupus and Clinical Trials: Download this informational guide (PDF) that contains resources for lupus, clinical trials, and how to access them.
• Patient Bill of Rights - Guide for patients: People with lupus can learn about their rights before and during a clinical trial. Download (PDF).
• You Can Make a Difference: Lupus Clinical Trials and African Americans: Information about lupus clinical trials and what to expect if you are interested in participating. Download (PDF)
• African Americans and Clinical Research: Download this guide (PDF) to learn about research, why you are needed in clinical trials and how you are protected.
• Frequently Asked Questions About Lupus and Clinical Trials:  Download this guide (PDF) to learn about the different types of lupus clinical trials, participation, benefits, risks and safety.