Pragmatic Trials Study Nonpharmacologic Pain Management Interventions
The NIH Collaboratory is adding two demonstration projects focused on the opioid crisis to its portfolio of pragmatic clinical trials embedded in healthcare systems.
The NIH Collaboratory aims to improve the way clinical trials are conducted by creating an infrastructure for collaborative research with healthcare systems. The Collaboratory has five core working groups of experts that help research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process.
The new projects are funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the Helping to End Addiction Long-Term Initiative (HEAL) Initiative, to address the opioid crisis.
The new PRISM awards total approximately $1.6 million in the initial planning phase and are supported by the HEAL Initiative and administered by two participating NIH institutes:
• BeatPain Utah is a pragmatic trial of nonpharmacologic pain management interventions in primary care clinics of federally qualified health centers in Utah. The interventions will be designed to overcome barriers specific to rural and lower-income communities through innovative use of telehealth resources. The study is administered by the National Institute of Nursing Research and will be conducted by Julie Fritz, Ph.D., of the University of Utah.
• The Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) trial is a hybrid effectiveness–implementation trial of guided relaxation and acupuncture for pain associated with chronic sickle cell disease in three large healthcare systems. The study is administered by the National Center for Complementary and Integrative Health and will be conducted by Ardith Doorenbos, Ph.D., R.N., a professor of biobehavioral nursing science at the University of Illinois at Chicago (UIC).
Researchers at UIC are leading a five-year national study to determine the effectiveness of acupuncture and guided relaxation for people with chronic pain from sickle cell disease, or SCD. “The opioid crisis in the U.S. is very severe, and some states have had more deaths from opioid overdoses than from car accidents,” Doorenbos said in an article posted on the UIC website. “We’re trying to do what we can to reduce opioid use in the sickle cell disease population who have high pain levels and opioid use. If we can find ways to manage their pain and get them off opioids, it’s going to be fabulous,” she added.
Doorenbos and her team will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on people with SCD while observing and gathering information on implementation in three health systems: University of Illinois Hospital & Health Sciences System, University of Florida Health and Duke University Health Systems. Each serves a large population with SCD and uses Epic as their electronic health record, which will facilitate data gathering and analysis. One aim of the study is to discover which non-pharmacological pain management interventions work best for SCD patients and how to make these treatments regular practice at the three research health systems involved in the study.
The NIH HEAL Initiative is a trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management.
Through the HEAL Initiative, NIH has awarded six grants totaling approximately $22 million to fund research aimed at managing pain and reducing opioid prescribing. Each awardee is conducting a pragmatic clinical trial aimed at improving the availability of, effectiveness of, and adherence to evidence-based, non-drug pain management.
The PRISM Resource Coordinating Center at Duke University provides technical support and pragmatic trial expertise for the research that this program funds.
