Drawing upon their experience and expertise in telehealth, collaborative care models, substance use disorders, depression and health information technology, Indiana University School of Medicine and Regenstrief Institute faculty have been awarded $3.9 million over four years to collaborate with Kaiser Permanente Washington Health Research Institute scientists on a trial to optimize treatment for opioid use disorder.
They will test whether a scalable, telehealth-delivered collaborative care model can motivate primary care patients who are dependent on opioids and also have depression to increase engagement in evidence-based treatments for pain and opioid-use disorder, while simultaneously improving depression symptoms.
The trial, MI-CARE (short for More Individualized Care: Assessment and Recovery through Engagement), is supported by the National Institute of Health's (NIH) National Institute of Mental Health, through The Helping to End Addiction Long-term, or the NIH HEAL Initiative, to address the national opioid crisis.
A patient coming into the doctor's office with a heart problem typically doesn't have to be motivated to follow a treatment regimen, but for mental health issues, in part because of stigma associated with these disorders, patients often need support to become engaged and motivated to adhere to medications and other recommendations from their primary care physician."
Kurt Kroenke, M.D, Chancellor's Professor of Medicine, IU School of Medicine, Research Scientist, Regenstrief Institute
Kroenke is also a co-principal investigator for the Indiana site.
"In studies that we have conducted and in real world situations during the COVID-19 pandemic, telehealth has shown real potential in supporting patients and families. The MI-CARE trial will evaluate telehealth's value, coupled with collaborative care, in the fight against opioid use."
Opioid use and depression frequently occur simultaneously and reinforce each other. Motivating individuals with opioid use disorder and depression to seek and continue to take evidence-based treatments for their conditions has been an unmet challenge.
These patients are suffering from multiple problems and are in need of pragmatic clinical approaches that work.
"Most doctors are called to medicine by a desire to relieve human suffering. For decades, prescribing opioid medications to treat chronic pain was seen as a way to ease suffering.
That well-intentioned practice has unfortunately contributed to an epidemic of opioid dependence and overdose deaths," said Regenstrief Institute Affiliated Scientist and IU School of Medicine Assistant Professor of Psychiatry Michael Bushey M.D., PhD, principal investigator for the Indianapolis site.
"Providing services for opioid use disorder in primary care is the quickest way to reach the most patients, but we need to provide our primary care providers with the resources they need to be successful. We hope that MI-CARE will allow many more patients in primary care to gain access to evidence-based treatments for opioid use disorder and depression."
The Indiana site of the randomized, controlled MI-CARE trial will evaluate 400 individuals with opioid dependence and depression. Half will receive usual care from their primary care physicians.
The other 200 will be contacted by phone by a behavioral health care nurse and offered the opportunity to receive a nurse-supported telehealth program in collaboration with their primary care team.
This will typically include evidence-based medications for opioid use disorder such as buprenorphine or long-acting naltrexone along with treatment aimed at improving their depression.
Outcomes for both the treatment and usual care groups will be determined from the patients' electronic medical records, which will include clinical, laboratory and other information. Regenstrief Institute Research Scientists David Haggstrom, M.D., and Titus Schleyer, DMD, PhD, lead the data team for the Indiana site of the study.
"We will use cutting edge tools of data science developed at Regenstrief Institute to measure -- with a high degree of accuracy -- opioid use and depression care delivery," said Dr. Haggstrom, interim director of Regenstrief's Center for Health Services Research.
Caring for complex patients, such as patients with co-occurring opioid use disorder and depression can be challenging.
Although treating opioid use disorder in primary care (where most adults receive their medical care) is a public health priority, clinical experience and resources in this area lag behind depression, which, in turn, trails behind the treatment of physical ailments.
Among its goals, the MI-CARE trial is designed to determine if the promises of telehealth and coordinated care can help primary care physicians provide the care that opioid users with depression so clearly need.