Chest pain is the second most frequent cause of emergency department visits among adults. However, as many as 8 out of 10 of those patients are not experiencing a heart attack or related cardiac event. Anxiety can be an exacerbating and contributing factor of physical symptoms in about half of patients deemed “low-risk chest pain” who are experiencing what may mimic a heart attack.
Paul Musey, MD, an assistant professor with the Department of Emergency Medicine at Indiana University School of Medicine and an IU Health hospital-based physician, is leading a collaborative research project evaluating the most effective way to direct these patients to enhanced care for underlying anxiety.
The Patient-Centered Outcomes Research Institute (PCORI) awarded IU School of Medicine a three-year, $3,358,251 funding support contract to conduct a clinical trial among qualifying patients who go to the emergency department with chest pain but are not experiencing an emergent cardiovascular event and screen positive for elevated anxiety symptomatology on the GAD-7 generalized anxiety disorder assessment tool.
“This has the opportunity to impact a large population of patients we see in the emergency department,” said Musey. “We want to get patients to where they need to be within the health care system, and that doesn’t need to be the emergency department every time.”
The team of principal investigators includes dual-PI Kurt Kroenke, MD, MACP; co-PI Jill Connors, PhD; co-PI Patrick Monahan, PhD; and Yelena Chernyak, PhD, all of whom are instrumental collaborators. Kroenke, professor of medicine and Chancellor’s Professor at IUPUI, is an internationally renowned expert in physical and psychological symptoms who has developed multiple patient assessment tools, including the generalized anxiety disorder assessment (GAD-7) and the Patient Health Questionnaire to evaluate the severity of depression (PHQ-9).
“He is a senior trialist. It’s going to be a big study, and he brings the requisite experience and mentorship to the team,” Musey said.
The research team plans to enroll 375 subjects into the clinical trial. This group will be split into three with each subset receiving a different level of treatment intensity.
Low intensity: Enhanced care coordination with referral to primary care for anxiety treatment.
Medium intensity: Online cognitive behavioral therapy (CBT) completed over six-to-10 weeks with support from a certified peer recovery specialist.
High intensity: Telehealth CBT sessions with an IU Health therapist for eight-to-10 weeks.
All of these levels go beyond the treatment a patient would typically receive in the emergency department, Musey said. Most patients with low-risk chest pain are assured their heart is fine and given a general recommendation to see their primary care physician if symptoms persist. Patients often leave confused about the cause of symptoms, and many return to the emergency department when symptoms re-occur for further testing that is likely not beneficial to the patient.
“A lot of these patients get lost in the shuffle because when they come to the emergency department, our primary concern is, ‘Is this something that’s going to kill you?’” Musey said.
Anxiety disorders are common and are likely to respond to treatment. The study will compare the effectiveness of the three levels of enhanced care with patient assessments at three, six, nine and 12 months. The findings will inform future patient and provider decisions about the best treatment options for patients with low-risk chest pain exhibiting signs of anxiety. It also could extend to patients experiencing other anxiety-induced symptoms such as abdominal or back pain, Musey said.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “We look forward to following the study’s progress and working with Indiana University to share the results.”
Musey’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions.
IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.