STARR 911 Provides Clinical Researchers With Actionable Guidance for At-Risk Volunteers

Having a chronic condition increases the odds of suicide by 363%, and patients with mental illness are particularly at risk.[1] For individuals contacting sites about possible enrollment in a clinical trial, the call may be their first attempt to reach out for help – yet many do not receive the education and support that could make a difference.

To tackle this challenge, Premier Research’s Krista Armstrong, Senior Vice President, Clinical Development Services & Global Head of Neuroscience, and Jessica Barag, Senior Business Analyst, Therapeutic Franchises, recently joined other thought leaders from the pharmaceutical industry, contract research organizations, research sites, and patient advocacy groups as part of our ongoing partnership with the STARR Coalition. The result is Project STARR 911, a new initiative introduced at the 2018 ASCP Annual Meeting in Miami.

What Is STARR 911?

Although the goal of clinical research studies is improved mental health, many at-risk people fall through the cracks. The STARR 911 initiative now seeks to implement industry guidance that would turn these first contacts into actionable moments that could ultimately save lives.

Volunteers for mental health and substance abuse studies are rigorously screened to meet the necessary criteria. But some individuals fall outside the parameters because they harbor suicidal tendencies. Without strong policy and best practices in place to provide critical support and intervention for these valued members of our community, many are simply told they do not meet the criteria for a study before even seeing a medical professional and do not receive any further assistance. That’s where STARR 911 comes in.

Rather than shuffle at-risk individuals along, STARR 911 provides guidance to ensure that those suffering suicidal inclinations are provided with pertinent information. They can be transferred to the National Suicide Prevention Lifeline phone number or connected with a mental health professional with experience assisting at-risk populations.

Although the STARR 911 initiative establishes only a single lifeline between clinical researchers and support systems, it represents a major step toward developing improved industry standards and best practices to further the industry’s ultimate goals.

Understanding the Need

One of the glaring statistics about people contemplating suicide is that upwards of 64 percent seek professional help within 30 days before an attempt.[2] The data currently points to at-risk individuals engaging with a professional such as a doctor.

But the lingering question is whether or not applying to a research study is another way that at-risk people are asking for help. That blurred line creates a gap between first contact, treatment, and support. Also, does being deemed ineligible present our suffering community members with the feeling another door has just closed and a sense of hopelessness?

To better understand these risks, the STARR Coalition worked with clinical research sites to identify current screening processes and responses for callers who report suicidal thoughts. In addition, 52 calls were made to random sites with callers posing as potential volunteers who reported suicidal thoughts and actions.

When prospective volunteers were deemed ineligible due to suicidal feelings, 96 percent of those rejected were simply told to try again in one year with the screeners making no attempt to provide educational support or direct the callers to a mental health professional.

Developing the Solution

The data collected into clinical research screening protocols brought two things to light:

  • Research center staff members were trained, knowledgeable, and reasonably proficient at identifying at-risk people.
  • Staff members were not appropriately trained in next-steps procedures that would guide the identified at-risk individuals to important support resources.

Clearly, staff members who facilitate the volunteer selection process are adept at recognizing people with suicidal leanings. The STARR 911 program provides them with actionable guidance to serve the community. At the end of the day, STARR 911 can help save lives.

The STARR 911 guidance helps to close the gap between two groups of mental health specialists so that members of the communities we serve do not fall through the cracks. The end goal remains the improved mental health of our community by supporting individual community members. Those at risk of suicide require immediate support, and clinical research study screenings are a significant point of contact.

Premier Research is proud to support the STARR Coalition and other initiatives. For more information on the STARR 911 process, stay tuned for our upcoming blog or contact the STARR Coalition at STARR911@thestarr.org or by calling (833) STARR 911 or (833) 782-7791.

Read the full scientific poster here.

[1] Ferro MA, Rhodes AE, Kimber M, et al. “Suicidal behaviour among adolescents and young adults with self-reported chronic illness.” The Canadian Journal of Psychiatry. 2017 August 17.

[2] Ahmedani, Brian K. “Racial/Ethnic Differences in Health Care Visits Made Before Suicide Attempt Across the United States.” Medical Care 53.5 (May 2015): 430-35. Web.