The last issue of Mental Health News was devoted to the science, research, treatment and understanding of schizophrenia. As a follow-up to this important area of study and understanding, I had the opportunity to speak with John Kane, MD, one of the principal investigators and leaders of the nationwide RAISE (Recovery After an Initial Schizophrenia Episode) project. Dr. Kane is Vice President of Behavioral Health Services at North Shore-LIJ Health System, and Chairman of Psychiatry of The Zucker Hillside Hospital in Glen Oaks, New York. I asked Dr. Kane to give us a comprehensive look at the RAISE project and why it holds such promise for the future of schizophrenia research and treatment as well as for the lives of consumers in recovery and their families.
Q: Dr. Kane, give us an overview of the RAISE project.
A: We have all come to realize that despite the progress we have made in the treatment of schizophrenia, many patients are still left with considerable residual disability or functional impairment. Some of the work that we have done here at The Zucker Hillside Hospital suggests that if we apply strict recovery criteria to a population of first episode patients with schizophrenia, we found that after five years of follow-up that only about 14% of the patients had met full recovery criteria. Our full recovery criteria means that the patient was either working part-time, going to school or functioning as a homemaker, as well as being able to do day-to-day living tasks without supervision, having social relationships with people outside the family, etc. All of these criteria had to have been sustained for two years. Unfortunately, we found a small proportion of patients who met these criteria.
The RAISE project is really a landmark effort on the part of The National Institute of Mental Health (NIMH) to see if we can bring about better outcomes in the treatment and recovery of patients with schizophrenia. By better outcomes, we mean that the outcomes are not simply the measure of the signs and symptoms that are associated with schizophrenia like delusions and hallucinations, but involve people’s ability to function in the community. That’s really the goal of RAISE.
We have a team of experts around the country who have been developing a state-of-the-art intervention package that includes: psychopharmacology – the cutting edge use of medications, psycho-social interventions, psycho-education, supported employment, and supported education. All of these components will be administered together by a team of specially trained people who will work with our patient population that have recently had an initial episode of schizophrenia. The team’s impact on patient outcome will be compared to a control group of individuals who are being treated in community clinics around the country in the usual way. These groups of patients will be followed and assessed, and we will compare the “quality of life” in these two groups after two years of follow-up. We will be looking for good outcomes among the people receiving the enhanced interventions in relation to the group that is only receiving traditional treatment.
Q: Are there any requirements of patients to be invited to join the RAISE study?
A: The criteria are quite liberal. However, we are looking for people who are still in the early phase of illness. One of the assumptions of the study is that we want to try to get people as close to the onset of the illness as possible, because we think that if we can apply very state-of-the-art comprehensive care at that phase of the illness, we have a better chance of significantly impacting the trajectory of the illness. We are looking for people between the ages of 16 and 40 who have one of the following diagnoses included in the differential, and that would be, Schizophreniform Disorder, Schizophrenia, Schizoaffective Disorder, Psychotic Disorder NOS, or Brief Psychotic Disorder. Patients will have to have one of these diagnoses included in the differential – although we are not insisting that they have a definite diagnosis of schizophrenia at the point when they enter the study since we want to catch patients very early in the process of their illness. We are also requiring that they have less than four months of treatment with anti-psychotic medications in the past. That is another way of the study ensuring that we have people who are in the early phase of their illness.
Q: Can you provide our lay readership with a brief general description of the various schizophrenia diagnoses that you just mentioned?
A: The critical issue is that sometimes a person is in the very early stages of a schizophrenia illness. At that time, we aren’t quite sure of the specific diagnosis. One factor is determining how long the person’s symptoms have been present. That is the differential between Schizophreniform Disorder and Schizophrenia for example; or between Schizophrenia and Psychotic Disorder NOS (not otherwise specified); or Brief Psychotic Disorder (implying that the disorder is too brief to be certain that it is schizophrenia). Schizoaffective Disorder indicates that there is an affective (mood) component, and sometimes we may not be sure if this is really schizophrenia or the early stages of a Manic Depressive or Bipolar illness. Sometimes, it takes a while to sort all that out and the best diagnosis may not become obvious for many months. That is why our study is taking people initially with a range of diagnoses and patients will be evaluated at various intervals by the study’s panel of researchers. We can then see if the patient’s diagnosis changed. Often it doesn’t change, but sometimes it does.
Q: Has the pharmacology in the treatment of schizophrenia become more specific and targeted in the past number of years, or do clinicians generally find the right medication for a particular patient through a process of trial and error?
A: We certainly do not have personalized medicine yet. We cannot examine a patient and immediately say that this individual will respond to drug X and not drug Y. We are not at that point yet. All of the medications we use are efficacious; however, some drugs will work better with one patient versus another. One of the things we will be doing in this study is collecting DNA from the patients (with their consent) who participate. We will be trying to advance our understanding of why one patient responds to one drug and another patient does not. By the same token, we want to understand why one patient develops a particular side-effect to a drug while another patient doesn’t develop that side-effect at all. We think that genetics plays a role in our understanding of that. As of today, there is still a certain amount of trial and error that goes into our choice of medications. We try to choose medicines that we know are efficacious and that we know are well tolerated, which is important in first episode patients, who often are particularly ambivalent about taking medication at all. Some patients do respond differently and some patients will develop side-effects. Part of what I think is critical about our effort in this study is that we will be providing the psychiatrists with a computerized decision-support system which we are developing. This will give the clinicians a lot of guidance in terms of how to think about the choice of medication, the dose of the medication, when and if to change the medication – if so, how do they monitor side-effects, and what do they do if certain side-effects occur. Using this computerized support system, we are trying to emphasize “evidence-based” decision making. We want to make sure that the clinicians have the evidence they need to help them make the best-informed decisions. We are also going to be training the clinicians (and particularly the doctors) to work with the patients to make “shared” decisions about things like the medications that they are taking. We want the patients to participate in that discussion. In this respect, we have to understand what the patient wants; because we shouldn’t assume that our goals are their goals. This mindset also applies to the issue of medication side-effects. Some patients may be really troubled by feeling sleepy while other patients might not be bothered by that at all. People have different vulnerabilities and they react differently to things. The patient has to really be a stakeholder in the therapeutic process.
Q: Besides the psychiatric aspects of the study will you also be looking at some of the other critical factors for a successful overall recovery process, such as housing and vocational issues?
A: Yes, we are going to be looking at that and are trying to provide as much supportive services as we can to help the patient in their recovery. We want the patient to participate in determining the goals within this process. If they get a job, we want to provide the supports necessary so that they can keep it. We also want to make sure they are getting the benefits such as SSD, SSI, housing, etc. that they are entitled to. We will work with the patients with regard to resiliency, wellness management, managing stress, reducing substance abuse, smoking cessation, improving social relationships, goal setting and so forth. We will have very concrete targets for each patient, and we will work very closely with them. We will also provide family psychoeducation in order to get family members involved with what’s going on. Families need to know what this disorder means, what the treatment entails, reducing stigma, helping them communicate and solve problems within the family and with the patient and the treatment team. We also will work to help family members process their own personal experience of the patient’s illness which can be very frightening for some family members.
Q: Since the study is being conducted on a nationwide basis are you going to take into account the cultural aspects of the patient and their illness.
A: That’s an excellent question. We actually have an anthropologist who is on our steering committee and we are going to try to be sensitive to cultural differences that we encounter in the study. We are also going to try to get a lot of feedback from the patients about what they like and dislike about the treatment. We are going to try to take advantage of everything that we know about the things that influence patient’s behavior, attitudes, and acceptance of treatment. As you know, one of the huge issues, particularly in this early stage of illness are when patients think about, “Am I going to stay in treatment?” or “I am feeling better now – I only had one psychotic episode – it’s not going to happen again – and I am not going to take this medicine anymore.” We have to work very hard to try to minimize that to the extent possible, to help our patients accept the need for treatment, for them to feel that the treatment is being helpful to them, etc. All of the cultural sensitivity issues comes into play there.
Q: Are the studies being conducted in an outpatient setting or while they are in the hospital?
A: We are going to try to identify people in either setting, but the bulk of their treatment will take place in a community clinic. We are partnering with 25-30 real-world clinics across the United States, not special academic settings or special programs for first episode patients, but average community clinics in different geographic regions across the country. The clinicians who work in these clinics will be trained to deliver the interventions of the study. Clinicians will receive special training sessions, training manuals, and they will receive ongoing supervision as the study progresses. They will become a cohesive team and will follow the study patients in their community.
Q: How will the clinicians report their findings to the study’s leaders?
A: The local clinicians will do some of the assessments, but the bulk of the major outcome assessments will be conducted using live two-way video conferencing, by a group of trained professional researchers who will be centrally located. We have subcontracted with a company that facilitates this process, which lends several advantages to the study. One is that most of the community clinics across the country do not have people who are trained to do the study’s careful research assessments. In addition, the local treatment team will know what treatment the patient is getting – whereas our centralized researchers can be kept “blind” to the location of the patient, what treatment they are getting, etc. The major outcome assessments will be done using live two-way video by the study researchers in a different location. This centralized panel of researchers will actually interview the patients. The patient will be brought into a room at the clinic near where they live and using teleconferencing they will see and speak to the researcher who will be located in another city and state. They will carry on a conversation, and the researcher will assess how the patient is doing on a whole host of variables.
Q: What is the expected timeline of the study?
A: We have been working very hard to finalize the study manuals for the participating clinicians, and we are still in the process of recruiting a good geographic distribution of study sites including, suburban, urban, semi-rural, and so forth. We expect to enroll the first patients sometime in the late spring of this year. The study will go on for at least another four and a half to five years.
Q: From everything you have spoken about this study seems to be putting together all the best components of psychiatric assessment, treatment and long-term care. If anyone will be helped, it certainly would be by following the model that you describe. Are you looking to have the study’s results and experiences serve as a blueprint for psychiatric care in general throughout the country?
A: Yes, if we can demonstrate that the model we are using in the RAISE study is helpful we are hopeful that our results can have an impact on the practice of psychiatric treatment in the future. One of the things we have designed into the study is that almost everything we are doing is going to be done under real-world reimbursement constraints. The only area where we are kicking in a little extra money is where the treatment site has limited resources in the availability of supportive employment or supportive education. We will give those sites some financial support to make sure they can address those services if they do not have them available in-house or in that community. Our hope is that if the study proves to be much more successful in bringing about recovery, then we can have a serious discussion with the states, the federal government and other payers. We can say to them that this is a model that works and a model that does not cost significantly more, and that we want to make sure that our model gets implemented across the country.
Q: As you know, supportive housing can be a very critical aspect of a patient’s survival throughout the treatment process, and that in some communities there are limited supportive housing beds available. In some communities there is a waiting list for a bed that can take several years. How are you going to address this problem within the study?
A: That is something we can’t address in the context of this study. All we can do is to make sure that we help patients gain access to whatever services are available to them in the community that they live in. Certainly, if we find that the patients who happen to live in communities that have good supportive housing end up doing better than the patients who live in communities that don’t, we’ll be able to say something about that in the final results of the study, and say that this is an issue of vital importance to patient’s recovery. The same constraints would apply to us not being able to control the unemployment rate in a particular community and to the extent that that affects our patient’s ability to go out and find a job. We are going to do the best we can under those limited circumstances.
We are very thankful that the NIMH has funded this exciting project, we have assembled a terrific team of clinicians around the country, and I look forward to giving the readers of Mental Health News future updates about our progress with the study. (Another RAISE project, with a somewhat different approach is being led simultaneously by Jeffrey Lieberman and colleagues at Columbia).
In addition to having oversight for system-wide behavioral health services as well as academic, research and clinical programs in psychiatry at NorthShore-LIJ’s psychiatric hospital, Dr. Kane directs the NIMH-funded Research Center for the Study of Schizophrenia at The Zucker Hillside.
Dr. Kane has been a member of the Board of Scientific Counselors for NIMH. He has served on the council of the American College of Neuropsychopharmacology, and chaired the American Psychiatric Association Committee on Research on Psychiatric Treatments. He is president of the American Society of Clinical Psychopharmacology and the Schizophrenia International Research Society.
Dr. Kane has chaired the NIMH Psychopathology and Psychobiology Review Committee as well as the Psychopharmacologic Drugs Advisory Committee of the Food and Drug Administration. He has served as a consultant to the Veterans Administration and the U.S. Department of Justice.
Dr. Kane is professor of psychiatry, neurology, and neuroscience, and holds the Dr. E. Richard Feinberg Chair in Schizophrenia Research at the Albert Einstein College of Medicine. He has published over 300 papers in scientific journals and is one of the most highly cited researchers in psychiatry.
He is a recipient of the Arthur P. Noyes Award in Schizophrenia, the NAPPH Presidential Award for Research, the American Psychiatric Association Foundations’ Fund Prize for Research, the Kempf Fund Award for Research Development in Psychobiological Psychiatry, the Lieber Prize for Outstanding Research in Schizophrenia, the Heinz E. Lehmann Research Award from New York State, and the Dean Award from the American College of Psychiatrists.
Dr. Kane received his medical degree from New York University School of Medicine.