Overcoming Barriers to Minority Representation in Clinical Trials

Overcoming Barriers to Minority Representation in Clinical Trials

Clinical research is one of the most important — and least openly discussed — cornerstones of medicine. This type of research enables scientists to develop new medications, cures, and preventative measures for some of the most difficult diseases facing the human race today. Likewise, clinical trials give scientists an avenue to test new treatments and determine their safety and effectiveness before they go to market and are distributed to the masses.

As great and important as clinical research is, it certainly isn’t free from its fair share of sticky problems. Perhaps one of the most pressing issues in clinical research today is a significant lack of equal representation in clinical trials. The vast majority of clinical research is tested on middle-aged white men, meaning that the side effects of certain treatments on minorities and occasionally even women are pretty unknown. There are a plethora of reasons for this lack of representation. For instance, research studies typically focus on those who volunteer to participate. Historically, many clinical trials involving minorities crossed clear ethical boundaries, which has led to continued widespread distrust of the system.

Lack of Inclusion in Clinical Trials

Unfortunately, minorities have typically been left out of clinical studies altogether. Outside of a few notorious — and disturbing — examples of minority-focused clinical research, most studies have long been predominantly white — upwards of 80-90% white.

Part of this is because rigorous scientific experimentation has long required limiting the number of variables or demographic differences amongst test subjects. Doing so makes it easier to clearly prove that the medication is what is making the difference in outcomes. The obvious negative to this type of research is that once a medication hits the market, it will be recommended to thousands of patients of different ethnicities — many of which the medication was never rigorously tested on in the trial phase.

Congress took a step in the right direction in 1993 with the passage of the National Institutes of Health Revitalization Act. This required the agency to include more women and people of color in their medical research studies. Fast forward to the era of COVID-19 and most ethnicities were represented in medical trials in a proportionately appropriate way. That is, except African Americans.

Lack of Trust

There is no mistaking that a lack of trust in the health care system and in medical research is a significant part of why these disparities exist. In reality, this distrust is completely fair. There are plenty of examples of unethical medical testing throughout history. Some of the most notable ones include the Tuskegee Syphilis Study, where black men were deliberately left untreated for syphilis, or the Plutonium Trials, where participants were given injections of plutonium without an adequate explanation of the risks.

Today, many people argue over the ethics of cutting-edge research studies into things like nootropics or stem cell research. However, even some of the most common research studies lack willing minority participants. For instance, in many cancer studies, medical researchers struggle to garner interest in many minority patients.

The most heartbreaking aspect of this phenomenon is that participating in this type of research may be what saves the lives of many other minority patients in the future. Oftentimes racially and ethnically diverse patients suffer from health issues disproportionately to their populations. Recruiting for studies can be difficult because many do not have access — due to finances or other resource availability — to treatment facilities where the studies are taking place.

Breaking Down Barriers in Clinical Trials

The need to break down these barriers is immense. Not only can including more minorities in medical research studies produce better results for the entire population, but it can save lives in the long run. So the question then becomes — how do we start to break down these barriers and build more trust?

For many medical experts, the answer lies in building a relationship with patients. Earning the trust and respect of a patient through conversations and getting to know them as an individual is important. Even on a very basic level, they have to trust that a medical professional truly has their best interests at heart and cares about them as a real person.

One study examining how health care providers could encourage greater minority enrollment in clinical trials indicated a few options such as:

  • Emphasizing the importance of personalized medical trials to increasing knowledge of how certain diseases and treatments impact minorities.
  • Improving access to medical information and trial opportunities at the local hospital level.
  • Expanding upon minority representation in healthcare career paths.
  • Providing educational materials that can help patients better understand the goals of medical research.

The value of medical research cannot be understated. However, there is a chronic lack of minority representation in the majority of clinical trials. Breaking down barriers that lead to a lack of inclusion and distrust in the system are important to improving the health of all patients. As a minority nurse, it is possible to play a pivotal role in starting to break these barriers down.

DUSON Launches New Center Focused on Latino Adolescent, Family Health

DUSON Launches New Center Focused on Latino Adolescent, Family Health

Latinos are the largest and youngest racial minority group in the U.S. – representing roughly a quarter of all people younger than 30 years old.

Duke University School of Nursing’s new Center for Latino Adolescent and Family Health (CLAFH) serves to engage in the health care of the Latino community by addressing the inequities facing it and by promoting the overall wellbeing of Latino youth and their families.

The Center was founded by its director Vincent Guilamo-Ramos, PhD, MPH, LCSW, RN, ANP-BC, PMHNP-BC, AAHIVS, FAAN, dean, Duke School of Nursing, and vice chancellor for nursing affairs, Duke University, with a mission to reduce health inequities and promote overall wellbeing among Latino adolescents and their families. CLAFH accomplishes that mission through its four key thematic areas:

  • Meaningfully engages the Latino community to identify, understand and collaboratively address the underlying drivers of health and social inequities.
  • Strengthening the role of families in supporting adolescent and young adult health and life opportunities through the development and evaluation of family-based interventions.
  • Developing and evaluating innovative, nurse-driven models of health care delivery that improve access to and utilization of prevention and treatment services in underserved communities.
  • Promoting the scale-up of evidence-based interventions in underserved communities to drive real-world impact, locally and nationally.

CLAFH has several current research projects in progress, including:

  • The Nurse Community-Family Partnership (NCFP) Program: Increasing COVID-19 Testing in Underserved Communities
    • As part of NIH’s Rapid Acceleration of Diagnostics in Underserved Communities (RADx-UP) initiative, CLAFH has been conducting this randomized controlled trial to see how effective NCFP is at increasing COVID-19 testing, vaccination and mitigation behaviors and reducing secondary sequelae among families in structurally disadvantaged communities.
  • Families Talking Together Plus (FTT+)
    • FTT+ is a remotely delivered, parent-based intervention that CLAFH has been analyzing to check the effectiveness of FTT+ at delaying sexual debut and informing correct and consistent condom use in youth who are sexually active.
  • Exploring Father-Son Relationships to Promote Adolescent Life Opportunities
    • The objective of this mixed-methods study is to learn more about how the father-son relationship can impact adolescent male academic/economic, social and behavioral resilience in the context of large-scale societal events.
  • Research Focused on Latino Sexual Health
    • Two central areas of CLAFH’s research are investigating Latino sexual health disparities and developing interventions to prevent STIs and unplanned pregnancies.
  • Latino-Focused Global Research
    • CLAFH’s work includes research, educational partnerships and service in Mexico and the Spanish-speaking Caribbean.

CLAFH offers research opportunities to Duke University students and welcomes collaborations with researchers and research institutions that are interested in projects related to Latino health and social welfare disparities.

CLAFH also houses the Latinx Comprehensive Development of Empowered Leaders Against AIDS Institute [DILES (Tell Them) Institute]), a year-long program for fellows wanting to end the HIV epidemic for Latino men. Throughout the program, participants will be instilled with leadership skills to assist them in guiding substantial change in their communities. The application process will open later this fall.

Associates in Research Adam Benzekri and Marco Thimm-Kaiser join Ramos as members of CLAFH’s core team, in addition to María de Lourdes Rosas López, CLAFH’s primary collaborator in Mexico and an Universidad Popular Autónoma del Estado de Puebla professor.

For more information, visit the CLAFH website, or email the team.

ANA Takes a Stand on COVID-19 Vaccinations

ANA Takes a Stand on COVID-19 Vaccinations

As the Delta variant of COVID-19 spreads and numbers of those infected and being in treated in ICUs across the country keeps getting worse, it’s important for those not vaccinated to do so.

The American Nurses Association (ANA) recently spoke out and took a stand—stating that nurses should get vaccinated.

ANA President Ernest J. Grant, PhD, RN, FAAN, took the time to answer out questions about this and why it’s so important.

Why did the ANA feel the need to come out in favor of nurses getting the vaccine for COVID-19?

ANA has a longstanding history and commitment of supporting immunizations to protect nurses, health care professionals, and the public from highly communicable and deadly diseases—and COVID-19 is no different. For our nation to recover, heal, and return to a semblance of normalcy, enough individuals, nurses, and health care professionals must get vaccinated against COVID-19.

The swift development of COVID-19 vaccines and the execution of mass vaccination efforts is a significant public health victory and a scientifically proven strategy to slow the spread of COVID-19 and prevent the loss of more American lives. ANA continues to implore all health care professionals and the public to follow the science, adhere to the latest guidance of public health officials, and get vaccinated against COVID-19.

As we’ve seen, there are nurses and other health care workers willing to lose their jobs when they are required to get the vaccine. Why is this problematic? 

It is very disheartening to hear reports of nurses who are willing to quit their jobs rather than get the COVID-19 vaccine. There is significant clinical evidence on the safety and effectiveness of the authorized COVID-19 vaccines being administered under the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA). To those who are apprehensive about taking a COVID-19 vaccine, I say trust the science and evidence. What is more, the pillars of patient-centered care and the nursing’s own professional standards ethically obligate nurses to model the same prevention measures that nurses recommend to their patients.

Nurses play a critical role in the monumental recovery efforts currently underway to end the COVID-19 pandemic. Our nation will only be successful in recovery efforts with a robust nursing workforce at peak health and wellness, providing safe patient care, administering COVID-19 vaccines, educating communities, and setting an example for millions of Americans.

There are nurses who don’t believe the vaccine works. What can other nurses say to them to help them understand?

It is paramount for nurses to remain knowledgeable and up-to-date on the science behind the vaccines, and the ongoing clinical studies that prove its efficacy. ANA has developed key principles to guide nurses and other health care professionals’ consideration for COVID-19 vaccines. These principles provide recommendations for access, transparency, equity, efficacy, and safety of COVID-19 vaccines. Additionally, ANA’s comprehensive COVID-19 vaccine resource page stays up-to-date on the latest clinical information and news. ANA has also created a focused video education series on COVID-19 topics, covering different aspects of this crisis and providing information that nurses can apply immediately when caring for COVID-19 patients. ANA’s COVID-19 videos are FREE for all nurses.

Has the ANA received any backlash from nurses about this stance?

We are seeing more and more nurses getting vaccinated. And based on what we’re hearing from our state associations, organizational affiliates across the country, and our most recent survey, nurses are in favor of the vaccine mandates and trust the COVID-19 safety and effectiveness of COVID-19 vaccines.

Tell us about the support that the ANA has received from this stance.

Nurses working across all areas of the health care system are disseminating culturally relevant information on the COVID-19 vaccines to the communities and patients that they serve. Nurses are connecting with their patients every day to have meaningful conversations and answer questions about COVID-19 vaccines. ANA applauds those nurses who are getting vaccinated against COVID-19 and proactively setting an example for their patients and the public.

Is the ANA’s hope that other health care associations will follow their example? Why would this be important?

We strongly encourage other health care organizations and health systems to support of mandatory vaccinations against COVID-19 for all health care professionals including nurses.

Most importantly, we urge everyone to follow the evidence and science, so our nation can continue making progress in recovering from this pandemic to restore our health care systems and communities.

Discussing Minority Mental Health

Discussing Minority Mental Health

July is known as Minority Mental Health Awareness Month and it offers many opportunities to talk about important mental health issues.

The month is sponsored by the U.S. Department of Health & Human Services Office of Minority Health (OMH) which emphasizes health policies and programs that will help eliminate health disparities.

The recent news of elite Olympic athletes prioritizing their mental health and their own physical wellness over their sport has focused a national spotlight on the complexities and the prevalence of mental health struggles. And while seeing people who are suffering from mental health issues is difficult, the athletes’ public struggles have opened a door that allows healthcare providers to raise the issue with patients and loved ones.

In some minority communities, mental health struggles remain taboo to discuss openly. People who are experiencing symptoms of illness such as depression, anxiety, or obsessive-compulsive disorder, or even life-threatening suicidal thoughts face a stigma that prevents them from even seeking care. When the issues are discussed, access to affordable and high-quality mental health providers can be a barrier to getting help, as can lack of insurance and any language barriers.

According to the OMH, mental health is a serious and common health issue with approximately 18 percent of the entire U.S. population having a diagnosable mental illness within any given year. Of that percentage, only 43 percent of people who need mental health care receive treatment or counseling. For minority mental health needs, the numbers are even more concerning. While 48 percent of whites receive care, only 31 percent of Blacks and Hispanics do. And statistics for Asians were even lower at just 22 percent receiving needed mental health services. Disparities in mental health care can lead to lack of treatment or ineffective treatment.

For most people, mental health treatment is effective and improves their quality of life. Whether people choose medication (psychiatric nurse practitioners are especially), talk therapy, or a combination of both, getting help can make symptoms abate significantly. In more transient cases of mental illness, for example depressive symptoms caused by a major life change, treatment can get someone back to feeling like their old selves and can improve their resiliency moving forward.

These care disparities have lasting impact. According to the American Psychiatric Association minority and white populations have similar rates of mental illness, with white populations being slightly higher in some instances. But when Black and Hispanic people have depression, for example, the effects are more persistent. And systemic racism plays a role in proper care. The report states that “Racial/ethnic minority youth with behavioral health issues are more readily referred to the juvenile justice system than to specialty primary care, compared with white youth.” If mental health needs aren’t addressed and youth don’t receive proper care, that can lead to a disciplinary cycle that impedes educational and employment opportunities.

As a healthcare provider, keeping conversations about minority mental health open and ongoing with patients and having easily accessible resources available can make all the difference to helping patients get the care they need. From understanding the different types of mental health professionals and what they do to addressing medications or alternative therapies in a comprehensive treatment approach can help patients understand the range of help available. And with a recent uptick in the availability and acceptance of virtual therapy appointments, accessing care is somewhat easier for people.

Raising awareness and broaching the topic about minority mental health is important to removing the stigma and helping people move toward care that works for them.

Self-Care Tips for Nurses

Self-Care Tips for Nurses

Oftentimes, nurses don’t take care of themselves like they should. While they focus on taking care of others, their self-care falls by the wayside. Especially during COVID-19 and the pandemic, they’ve put everyone else first.

Imani Wilform, MHC-LP, with Empower Your Mind Therapy, took time to answer our questions and give self-care tips on what nurses can do to make sure that they are making time for self-care. Our interview, which follows, has been edited for length and clarity.

Dealing with COVID-19 and the pandemic has been tough on everyone, but especially difficult on frontline workers such as nurses. Why should nurses be sure to practice self-care now?

As much as nurses care for everyone else, it’s crucial to pay attention to your own needs too. By its own true definition, self-care is about taking intentional care yourself: your mind, your body, your environment, and your spirit.

If we don’t practice self-care, we can become burned out, resentful, angry, and may even start feeling depressed. This also lowers your immune system and can make you feel tired and low. If you’re not feeling your best, how can you manage caring for others?

What are some things that nurses can do to be sure to remember self-care and to fit it into their busy days?

While the occasional self-indulgence like a spa day or getaway can be a great way to express some gratitude to yourself and all you accomplish, self-care is about more than an occasional treat. An intentionally cultivated daily self-care routine can make a huge difference in our lives and allow us to be balanced & more restored.

Today, ask yourself:

  • How do I typically take care of myself day to day?
  • Do I take time to regularly assess and address my needs?
  • How is that impacting both my mental and physical health?

I really want you to think about how (or if) you set aside time each day to take care of yourself. Do you have time to sit back and assess your needs? Do you listen to your body when it tells you that you need a break? When you’re mentally strained, do you have a routine that helps you rest and rejuvenate?

Is there anything they can do at work on a break or at home?

There are a lot of little things that are self-care, but aren’t exciting or Instagram-able. You can do these quickly:

  • Write down your to do list for the week to stop the constant nagging in your head.
  • Set a time to be done with screens before bed.
  • Make a meal plan that gets you excited to eat 3 meals a day.
  • Take a look at your calendar: are you overbooked, need a fun outing to look forward to, need to make a doctor’s appointment?
  • Call a friend to catch up.
  • Spend time outside.

What are absolute must-dos regarding self-care?

Assess your true needs: when we’re talking about daily self-care we’re talking mainly about wellness (mental & physical). For a week, keep a log of your physical and mental expressions of stress or strain. Are you tired? Do you have frequent headaches? Look at what comes up for you and come up with small, incremental steps to take action. Maybe you have constant headaches because you’re dehydrated. Start carrying a water bottle, set some reminders on your phone to actually drink from it.

Take a critical look at your routine: What is taking up your time on a daily basis? Often times we fall so behind on creating an actual daily routine that serves us that we end up playing perpetual catch up. Finding the right way to balance what you need day to day will help ease stress and keep you feeling more balanced and in control.

Prioritize rest: if you have to put it in your schedule or “to do” list to make sure you get time to rest and recharge then do it. Maybe it’s yoga, reading, taking a bath. Rest and rejuvenation should be a priority in your daily routine. Set aside small chunks of time each day where you stop the machine, ignore “productivity” and let yourself rest.

What would you say to a nurse who says s/he doesn’t have time for self-care because too much is going on?

Self-care can be something quick and small to help yourself with your own mental and physical well-being. As a nurse, it’s important to remember that you are just as important as your patients and family. Others rely on you, so rely on yourself too. Even if it’s a quick walk around the block during lunchtime or outsourcing personal to-dos to another family member—such as creating a shopping list or picking up a birthday gift for someone—try to take some time for yourself. Also remember that self-care shouldn’t create more pressure. If it’s too much to take time every day, start with setting aside some time once a month to check in with yourself.

Addressing the Minds and Bodies of Minorities: How the Covid-19 Pandemic Has Compounded Behavioral Health Issues

Addressing the Minds and Bodies of Minorities: How the Covid-19 Pandemic Has Compounded Behavioral Health Issues

The coronavirus has hit minority communities harder in terms of health by amplifying social and economic factors while also revealing deep-rooted inequities. Racial disparities that were present before the pandemic have only been compounded and are evident in the rates of minorities contracting the virus compared with their percentage of the population. This has especially been seen in Latino and multiracial communities in the United States. According to the CDC, Latinos make up 18% of the population and account for nearly 29% of Covid-19 cases. Similarly, those who identify as multiracial (non-Hispanic) make up 2% of the population but 5% of Covid-19 cases.

Source: CDC Covid Data Tracker (as of 5/20/21)

As a result of the pandemic, racial and ethnic disparities in access to behavior health care have also been illuminated. Interestingly, the rates of behavioral health disorders in Blacks and Latinos do not differ from the general population. Yet, they do have markedly less access to mental health and substance-use treatment services. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), of the 4.8 million African Americans that live with mental health disorders 69.4% of them receive no treatment. Of the 6.9 million Hispanics who live with mental health disorders 67.1% receive no treatment. Both these statistics are alarmingly high when compared with the 56.7% of the overall U.S. population that do not receive treatment for mental illness. Likewise, alarming numbers can be seen in those with substance use disorder. Of the 2.3 million African Americans who have Substance Use Disorder, 88.7% do not receive treatment. Of the 3.3 million Hispanics who have Substance Use Disorder, 89.7% do not receive treatment.

There are already many barriers in place for Blacks and Latinos due to social determinants that only increase the vulnerability of those with mental illness. Black and Latinos have lower access to health care, are found to terminate care prematurely, and receive less culturally responsive care. The opioid pandemic is perhaps hitting the Black and Latinos the hardest due to their limited access to preventive treatment and recovery resources for substance use disorders. Despite Blacks having comparable rates of opioid misuse as the general U.S. population, they were found to have the greatest rate of overdose methadone synthetic opioid deaths.

Nurses must work with the health care team to prevent the interruption of substance use treatment and recovery services. Telehealth services must be expanded. Those with substance use disorders and mental illness who have Covid-19 particularly need support during this time. Recovery support groups that have been stopped, clinics that have closed, and the discontinuing of harm reduction services like syringe service programs have the potential to trigger relapses in our patients as well as increase the rates of HIV and hepatitis. According to SAMHSA, Blacks and Latinos who have substance use disorders and mental health disorders are found to be more likely to be homeless and incarcerated which further increases their risk of Covid-19.

There is much potential for managing this identified risk and problem in Black and Latino populations. Policy efforts can be made in the form of disaggregating data so that resources can be targeted based on more specific data. Policies and treatments should be more flexible. For example, SAMHSA released a guide which enabled dispensable take-home methadone treatment programs during the pandemic. There should also be a push for expanded and flexible coverage of telehealth so patients can continue to receive treatment via the telephone or video-conferencing.

Communication, health literacy, and public awareness must also be accounted for. Covid-19 education should be translated into the language of those in the communities we serve. Also, messages should be culturally tailored so that concepts presented like social distancing are culturally appropriate. Communication channels are also important so perhaps using Black and Latino radio stations, websites, and trusted media figures to deliver important messages about prevention strategies

Workforce efforts can also be had by augmenting the workforce with culturally competent healthcare professionals. The workforce is in dire need of the individuals. Perhaps fast-tracking immigrants, refugees, and bilingual health care professionals could create a much needed pool of such health care workers in the United States. Peer navigators and coaches are also valuable for creating outreach and engagement of Black and Latino communities so that they can be properly linked with mental and substance use disorder treatment. Peer navigators know the communities we serve well and know how to effectively communicate with clients. These could be made virtual to ensure Black and Latino communities receive proper behavioral health care.

Blacks’ and Latinos’ physical health have greatly been impacted by the pandemic with a disproportionate rate of Covid-19 infection. However, the pandemic is not only affecting the nation physically—but also behaviorally. As nurses we address the physical and emotional health of our clients because we see them as a whole being. Therefore, we must work hard to address these issues and advocate for our patients so that they can live healthy lives, not just in their bodies—but in their minds as well.

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