A $13 million research trial that will be conducted with 800 individuals in Philadelphia and Washington, D.C., will seek to determine whether opioid-dependent patients can receive comprehensive and effective care in the same system that fueled their illness: general healthcare.
A funding award from the Patient-Centered Outcomes Research Institute (PCORI) to the Treatment Research Institute (TRI) will result in the first large-scale comparison of evidence-based care delivered in federally qualified health centers (FQHCs) to the standard care that patients with opioid use disorders receive in the community. To the study's principal investigator, those who have been in the latter group have faced long odds for success.
“You take individuals with a disease that disrupts motivation, and you ask them to be super-motivated to navigate fragments of a [specialty] treatment system, and you are setting them up for failure,” says David R. Gastfriend, MD, TRI's scientific adviser.
Unlike in the community, where the range of treatments for opioid use disorders may be available but aren't always accessible, the TRI study will be designed to offer all available treatments to the participants at the four FQHC study sites. Gastfriend tells Addiction Professional that in traditional treatment, some patients may not have access to certain services because the various providers in the community don't communicate, or in some cases are even downright hostile to each other.
In other instances, reimbursement challenges stymie access to care, such as with FQHC funding that does not cover behavioral health services. The $13 million from PCORI eliminates that challenge for the purposes of this study, and Gastfriend hopes that the results ultimately will capture the attention of payers such as Medicaid.
“The reimbursement issue is a huge obstacle to effective patient care,” he says. “There is no room for that obstacle in the midst of an epidemic.”
Details of PATH
The approach that will be evaluated in the main study intervention is called the Personalized Addiction Treatment to Health (PATH) model. Gastfriend says he came up with the concept four years ago, and he considers each of the four letters in the acronym a critical component to the model's potential success:
Treatment will be personalized through use of American Society of Addiction Medicine (ASAM) criteria in order to understand patients' multifaceted needs.
A range of approaches to addressing addiction will be offered, including cognitive-behavioral therapy and all of the approved medications for treating opioid dependence. Gastfriend refers to the medication options as “medication in addiction treatment,” adding that he sees the commonly used “medication-assisted treatment” as a stigmatizing term that fails to acknowledge the biological underpinnings of addiction.
Treatment will be structured along a “contingency management” model in which patients will receive incentives for participation and progress. Gastfriend says that despite the existence of around 40 randomized controlled trials documenting the effectiveness of contingency management, “90% of the treatment programs don't use it.”
The “health” component will encompass a range of supports designed to improve patients' quality of life, in areas such as building coping skills and improving social relationships.
Gastfriend also highlights the significance of the financial award coming from an organization such as PCORI. This independent organization funds comparative “effectiveness” research, he says, which will allow TRI to test a range of real-world treatments and not be constrained to one controlled condition for every patient. If this type of study were funded by the National Institutes of Health (NIH), Gastfriend says, it would be an “efficacy” trial that would carefully constrain the conditions being compared (everyone in each of the two comparison groups would have to receive the exact same treatment designated for that particular group, with no matching of treatment to individual needs).
The population in the TRI study will be made up of adults with an opioid use disorder; their progress will be tracked over 18 months, Gastfriend says. Patients with any form of insurance coverage, or no insurance, will be eligible for inclusion. Details of the contract agreement with PCORI will have to be finalized before a launch date can be set.
Two FQHC sites each in Philadelphia and Washington, D.C., will serve as the study sites. Gastfriend says the two city locations were chosen based on their serious opioid problem as well as a strong presence of both general health and specialty addiction treatment resources.
The study will compare the effectiveness of services delivered in the FQHC settings and those delivered in specialty treatment in the community. Gastfriend suggests that it is unfair for a general health sector that contributes to much of the opioid misuse problem (through poorly controlled prescription drug prescribing) to expect patients to have to search within the community for help. In the majority of cases, the addiction “originated with prescribing,” he says.
How should specialists react?
News of major addiction treatment initatives in general health settings often is met with concern from specialty treatment providers who believe they could be left out in an evolving healthcare system. Gastfriend says of such concerns, “This should not be read as a threat, but rather as an opportunity for specialty addiction providers.”