While there is plenty of straightforward research on the efficacy of treatments and drug therapies for mental illness and substance abuse, head-to-head studies that compare discrete treatments or medications to each other are rare. Even more rare are studies that take individual patient responses or subpopulations into account.
Yet, the industry needs exactly this type of best-practice data now more than ever. Clinicians must be able to discern what works and for whom.
“There's very little or no information comparing the treatments that are currently approved by the FDA for bipolar depression, for instance,” says Andrew Nierenberg, MD, director of the Bipolar Clinic and Research Program at Massachusetts General Hospital. “There are also large, unanswered questions about the best way to help people with suicidal thoughts and behaviors.”
Armed with nearly $1 million in funding from the federal Patient-Centered Outcomes Research Institute (PCORI), Nierenberg is launching a Mood Patient Powered Research Network (Mood PPRN) that will provide opportunities for patients to participate in comparative effectiveness research for the treatment of mood disorders. The goal: to help patients and clinicians determine the best interventions that lead to the best outcomes as defined by the patients.
Comparative effectiveness research is increasingly more important as the country moves toward provider accountability to use evidence-based practices (EBPs) and financial incentives for improved outcomes. However, disseminating intelligence gained from comparative studies and then properly implementing it at the practice level remain a challenge. PCORI has allocated 8% of its $500 million budget to communication of results.
It’s a longstanding fact that it takes more than a decade for newly discovered evidence-based best practices to turn into everyday care.
"There is a lot of research documenting these practices in both the treatment of behavioral health and substance abuse disorders," says Annette Crisanti, PhD, research associate professor at the University of New Mexico. Crisanti is leading another PCORI-funded study on the use of peer-delivered PTSD and substance abuse therapy in under-served rural areas. "What seems to be lagging behind is the extent to which they are implemented in the real world."
The adoption of proven EBPs can have an impact on the bottom line as well as patient outcomes. There have already been clashes in Idaho and Illinois over Medicaid reimbursement for treatments, where the sticking point was the treatments’ EBP status.
PCORI was established in 2010 as part of the Affordable Care Act to fund and disseminate research that can give patients a better understanding about their treatment and care options. It has funded 60 comparative effectiveness research projects that focus on mental health conditions and substance abuse treatments, including everything from talk therapy, peer and community-based treatments, medication therapy, integration and other interventions. Measures are designed to focus solely on clinical efficacy, rather than cost.
“Many of the projects we’ve funded address more than one condition and often involve more than one treatment modality," says PCORI spokesperson Christine Stencel. "For some projects, multiple modalities are compared to study effectiveness. These designs may provide more useful information about how to deliver treatment in real world settings, where populations and conditions cannot be easily categorized.”
Crisanti's project in New Mexico will evaluate whether Seeking Safety (SS) treatment can be as effective when delivered by trained peers instead of clinicians in provider-scarce rural counties.
“Peers are involved in delivery of services in various ways,” Crisanti says. “The important thing is to develop an evidence base of their effectiveness in delivering those services. Then it will be important to look at ways in which the services of peers can be funded through Medicaid. Some services already are.”
In Massachusetts, Nierenberg says the impetus for the Mood PPRN was that outcomes for mood disorders like major depression simply aren't good enough with the best available treatments.
“It's essential that we understand what's working, what's not working, and why, and that we move the whole field forward in a way that's never been done before with close collaboration with patients,” he says.
The goal is to gather 50,000 participants through online and other channels in order to access patient-reported outcomes and EHR information. Patients will help prioritize research questions, which will cover a broad range of treatment topics.
From paper to practice
Moving these EBPs from journal publication into actual practice can still be a slow process. In addition to funding the comparative studies, PCORI has launched a number of projects to determine the most effective way to communicate study results and speed up implementation. PCORI also is developing a blueprint for a dissemination and implementation action plan.
“One of the great things about PCORI is that right from the beginning, we had to have a dissemination plan,” Crisanti says. “We had to plan how we were going to get the findings into practice at the beginning, rather than waiting until after the study is over.”