BETHESDA, MD—It is not enough to conduct cutting-edge research and create innovative new treatments if those treatments are never utilized by health care systems, according to Dr Robert Heinssen, acting director of NIMH’s Division of Services and Intervention Research.
One of the leading candidates to take over the position full-time, Heinssen has new strategies planned to enhance NIMH’s impact and better connect scientists, policymakers and other stakeholders.
The Barriers From Bench to Bedside
“We are downstream in the research translation process. Our job is to take research knowledge and put it into a form where it can improve everyday clinical practice. We also generate data that is useful for policy-makers.” In this effort, DSIR supports a wide variety of studies, including comparative effectiveness research, personalization studies, dissemination and implementation research, as well as cost-effectiveness studies, which have garnered them recent attention in the debates on health care reform.
The problem for NIMH has been that not all of its research efforts are translated into improved clinical practice. For example, in a national study, researchers found that there are a very large number of adults in the United States who experience periods of mental disorder in their lives. But for those individuals for whom treatment would be warranted, very few of them actually received care. It’s a distinct minority that received evidence-based and high-quality care.
“I think some of the problem is that we don’t integrate our translational research efforts as well as we could. It’s not often the case that issues of implementation and issues of reimbursement are taken into account as interventions are being developed. And when that happens, when we don’t take into account these practical realities along the development pathway, we can very often end up with treatments that make an installment on your bookshelf, but are ignored in terms of actual clinical practice.”
These disconnects between research and practice can lead to an intervention being delayed for many years. For example, when four large clinical trials conducted over a 10-year period showed positive results when patients with chronic schizophrenia were kept in the community rather than in a hospital, health systems could not immediately integrate it. It took another 10 years for states to find a way to pay for this intervention. “These real-world issues need to be taken into account as interventions are being developed,” Heinssen declared.
There are several methods that DSIR can use to help narrow this gap between bench and bedside. The first is to prioritize intervention and research service-research questions. “We put out fewer rewards, but magnify their value and allow people to compete for those things.”
Another is to adopt deployment-focused intervention development, bridging the gap between the basic research scientists and the scientists conducting interventionist research. “We also need to bring the patients and the clinicians into the development process far earlier, so we don’t end up with a very well defined, but a relatively too pure intervention to have immediate applicability.” Feasibility and reimbursement issues also must be included at an earlier stage of the development process.
It is important to collect information on clinical, functional and economic outcomes in a form that is useful to policy makers. Information that is interesting to a researcher may be of no interest to a policy-maker and vice versa.
The RAISE Project
Heinssen pointed out two contemporary examples of research programs he has been involved with since coming to DSIR that utilize this strategy for improving implementation. The first is the RecoveryAfter Initial Schizophrenia Episode (RAISE) project. “This one highlights the value of a deployment intervention development approach and the value of bringing in stake-holders very early in the process.”
Historically, the paradigm for treating schizophrenia has been managing an established illness and entrenched disability. The average length of time between a person’s first episode and the first care they receive is 53 weeks. During those early phases is when the disability associated with the illness accrues. Once it’s entrenched, it becomes difficult to treat. “Because we’re late in treatment, we end up treating individuals for whom the room to recover is much narrower. RAISE’s objective is to test whether early and aggressive prevention can slow or half the deterioration we see in schizophrenia.”
DSIR decided early on that they needed to challenge the field to address this issue a different way. They wanted researchers to focus on optimizing the use of interventions that were already known to be effective individually, but also wanted them put together in a suite of interventions that could be delivered in regular treatment settings. Researchers were also required to partner with end-users in the development process. “They had to come in demonstrating that they had a working relationship with some clinic or health system that treated people with first episode schizophrenia and demonstrate that they had regular input from clinicians and patients and advocacy groups in the vetting of this intervention.”
Ultimately, DSIR went with two applications and included opt-out phases where, if a team did not come through with the agreedupon deliverables, NIMH could opt out and funding would be cut, effectively having the two groups competing against one another.
To increase ultimate transportability of this intervention, NIMH reached out to public and private policy makers, as well as other federal agencies, to get their input and find ways that the results would be meaningful to them. As a result of that effort, HHS has taken RAISE on as a project and developed an ancillary project exploring financing and reimbursement mechanisms that can be implemented to make RAISE a widely available intervention, should the results of the clinical trial endorse that.
Partnering With the Army on Implementation
The other example of a project taking implementation into consideration is the Army Study to Assess Risk and Resilience in Service Members (STARRS)—the largest study on suicide and mental health the military has ever undertaken. “The Army reached out to us. They asked us if we could apply the best science available to help them solve a practical and critically important problem. Our objective is to identify a list of protective and risk factors across a broad range of domains and to use that information to inform the development of empirically derived interventions.”
The application process required not just plans to find risk and protective factors, but ways to identify individuals with those factors and ways for the Army to apply that information. “We built it into the program to connect T1 risk factor scientists with T2 interventionist research so we can rapidly identify and move into conceiving interventions and testing them within this system.”
Heinssen also discovered the benefits of creating an environment of productive urgency with the scientists involved, impressing upon them the knowledge that there were service members in immediate need of their results. “The Army is constantly whipping us asking us, ‘What are you doing? What have you found?’ The way I’ve found to respond is to whip our PIs.” The goal is to foster the sense that this is not business as usual, but not in a way that becomes overwhelming or undermining.
The success of these two projects gives some indication of how DSIR should move forward. “We need to prioritize questions to help focus competition and generate innovative approaches. We also need to develop an ethos of productive urgency among PIs.
“We also need to involve policymakers early on in defining the questions and identifying the data of interest—an important way to ensure that the results will actually influence the people who need the information. The end goal, as always, is to promote deployment-focused intervention development.”
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