Public-Academic Partnerships: Integrating State Psychiatric Hospital Treatment and Clinical Research

Rockland Psychiatric Center (RPC) in Orangeburg, New York, is one of 16 hospitals for adults with mental illnesses operated by the New York State Office of Mental Health (OMH). The Nathan S. Kline Institute for Psychiatric Research (NKI), affiliated with the New York University Departments of Psychiatry and Child and Adolescent Psychiatry, is one of two psychiatric research institutes operated by OMH and occupies a separate set of buildings on the same campus as RPC. RPC's main funding source is OMH. NKI receives OMH funding and additional support from grants and contracts administered through a not-for-profit corporation unaffiliated with the university, the Research Foundation for Mental Hygiene, Inc. (RFMH). The Clinical Research and Evaluation Facility (CREF) is a 24-bed inpatient unit located within NKI, created by agreement between the directors of NKI and RPC and in operation since 1998. The clinical staff are RPC employees. The investigators and research staff are NKI or RFMH employees. The university offers opportunities for faculty appointments, research collaboration, and teaching. This column describes the planning and implementation of the CREF.

State-academic collaboration

Collaboration between treatment services and research programs provides new opportunities for research as well as access to assessment modalities that are not always available in state-operated psychiatric hospitals, such as magnetic resonance imaging, neurophysiological measures, and other technologies ( 1 ). Specialized hospital units can serve as vehicles for quality assessment and performance improvement as recommended by accrediting and regulatory bodies, for example by establishing procedures for identifying patients at risk of escalating agitation ( 2 ). Research units within state hospitals allow researchers to study complex disorders under controlled conditions over extended periods. State-academic research collaboration promotes a research focus on severe and persistent mental illness, which is often otherwise neglected. Relevant and compelling research topics include augmentation strategies to treat negative and cognitive symptoms ( 3 ) and persistent aggressive behavior associated with schizophrenia ( 4 ).

Historical context and planning

In 1952 Nathan S. Kline, M.D., came to head a research unit at Rockland State Hospital. Two decades later, the research department became the Rockland Research Institute, an independent New York State OMH research facility. The institute was renamed for Dr. Kline after his death in 1982. In 1993 state governmental approval and funding were given for a major capital improvement project at NKI to include construction of a new building and renovation of another, creation of the Center for Advanced Brain Imaging, and establishment of a new clinical research facility, the CREF. The CREF was designed with two subunits to accommodate a total of 24 patients with separate living spaces, but with a common nursing station that enables direct visual contact with both sets of dayrooms and courtyards. One 12-bed subunit dedicated to the evaluation and study of patients with hostile behavior, poor impulse control, or both was equipped with video-recording equipment in the dayroom and courtyard ( 5 ) and designed with an open architecture. The other 12-bed subunit was designed differently, with several additional program rooms instead of one large dayroom. The two subunits share staffing.

Planning for the CREF involved representatives from both RPC and NKI, because clinical treatment services would be provided by RPC and research would be led by NKI. Staffing ratios were designed to be somewhat richer than is typical for intermediate-stay hospital units in order to allow for supervision of patients during research and clinical appointments while maintaining a safe and therapeutic staff-to-patient ratio within the unit.

Joint training with small-group exercises included all staff, research and clinical, using a preplanned curriculum. Specific training needs included an introduction to research and clinical research ethics for clinical staff and clinical management of aggressive behaviors for all staff. Operational policies were developed for the unit. The CREF director, a psychiatrist-clinical investigator employed by NKI and member of the medical staff organization of RPC, was to work with an administrative unit chief employed by RPC. The CREF director's role was to be an intermediary between NKI principal investigators and their respective teams and CREF clinical services while overseeing the general conduct of research and clinical care.

Staged opening

The CREF opened in stages. On December 15, 1998, the first six patients transferred from a unit at RPC, where they had already been participating in clinical trials, to the CREF at NKI. The full 24 beds became available on May 25, 1999, after public hearings and meetings to assuage community fears and misconceptions that housing "aggressive and violent" patients would pose a public safety risk. The unit was inspected by outside agencies, including the office of the local chief of police. Additional safety enhancements, including personal safety alarms, were implemented.

Protocol review

Before a research protocol can be implemented on the CREF, it must first undergo review by the CREF Protocol Operations Committee before being submitted for standard review by the joint NKI-RPC Institutional Review Board (IRB). The committee includes CREF clinical treatment staff as well as NKI researchers. Its purpose is to assess the feasibility of planned projects, maximize the efficient utilization of staffing resources, and identify potential operational and safety issues. The committee recommendations to investigators have concerned establishing the location of where assessments were to be done and their frequency, minimizing duplicate blood draws by coscheduling with clinical needs, and standardizing the amount and distribution of monetary compensation for research participation.

Recruitment

Most patients come to the CREF from units in the main RPC buildings. Outside research referrals were not actively pursued until 2007. Eligible RPC patients are recruited for research by NKI staff, with direct involvement of RPC clinical staff, who must endorse each transfer and can also refer patients for clinical evaluation, and at times, respite. Referrals are sometimes made through family members of patients as well as by patients themselves. Managing the tension between the hospital's clinical needs and NKI's research mission poses a clinical and administrative challenge. Difficult-to-treat patients are often referred to the CREF, providing added value to the hospital by offering a comprehensive patient assessment and novel treatment approaches. Such patients place additional demands on staff attention, making the conduct of research protocols more difficult. CREF staff also provide clinical consultation for patients in the hospital who may ultimately remain on their home units.

Research staff use a coordinated approach and a common form to screen for potential research participants, and the staff meets weekly to share this information. Before transferring to the CREF, patients must provide written informed consent for an IRB-approved general evaluative protocol that specifies that structured assessments will be done, that clinical information can be used for research, and that a video-recording system is in place. The patient's treating psychiatrist on the originating unit assesses the patient's capacity to provide consent. Consent requirements are the same for patients referred for clinical evaluation or respite. Assignment to either CREF subunit is determined by both clinical treatment and research requirements and can change during a patient's stay.

Programming

The requirements of "active psychiatric treatment" for state and federal certification are met by a comprehensive set of therapeutic activities. These include community meetings and other group meetings, and they are attended and conducted by both RPC and NKI personnel. CREF's physical separation from the main hospital prevents access to RPC's well-established treatment mall ( 6 ), necessitating the creation of self-contained and often innovative programming. For example, research and clinical staff have sustained a variety of specialized groups, including spirituality ( 7 ), anger management, gardening, and computer skills groups. Trainees and volunteers from different disciplines, including social work, psychology, and psychiatry, also participate in unit activities. Involvement of clinical trainees varies from one-day orientations by nursing students to placements for social work externs that last several months.

Clinical and research staff attend daily morning rounds at which all patients are discussed, with emphasis on clinical status, clinical and research plans for each patient, outside clinic appointments, and research procedures to be scheduled. Research staff has organized a daily rotation of responsibility for attending morning rounds and preparing a written summary for e-mail distribution to all staff conducting research on the CREF.

Trained, certified research personnel administer a Structured Clinical Diagnostic Interview ( 8 ) to each CREF patient. The results are available to all investigators. Standard operating procedures have been developed for common practices and tasks, such as writing orders and progress notes for research procedures.

Integration of clinical and research staff in the day-to-day functioning of the CREF permits open communication between both groups, which promotes faster resolution of problems. Patient safety issues, particularly with research protocols, can be quickly addressed. The therapeutic milieu has led to relatively lower rates of seclusion and restraint than other RPC units that serve similar patients. The synergy between treatment and research receives favorable comments whenever the unit is surveyed by external agencies.

Lengths of stay and discharges

Lengths of stay can vary from a few weeks to many months, depending on the research protocol and needs of the patient. We originally anticipated very few discharges to the community directly from the CREF; most patients were expected to return to their originating units at RPC after completing research participation. However, from January 2006 through January 2008, 81 patients were admitted to the CREF, 49 were discharged to placements outside of RPC, and only 32 returned to inpatient units at RPC. This has been made possible by the therapeutic structure of the unit, the extended length of stay available to work on discharge plans, as well as the services of a full-time social worker, who conducts a weekly supportive and clinically oriented discharge group that focuses on discharge readiness and community reintegration.

Research

The CREF is a shared "common resource" available to all NKI investigators engaged in evaluative and assessment, observational, and interventional research with psychiatric inpatients. Most studies are funded by Public Health Service grants (such as from the National Institute of Mental Health), foundations, or pharmaceutical companies, but the existing clinical research infrastructure has also enabled unfunded pilot projects. Completed studies include double-blind studies of first- and second-generation antipsychotics for aggression ( 4 ), pharmacokinetic studies of medication combinations ( 9 ), a new rating scale for negative symptoms of schizophrenia ( 10 ), and a double-blind study of adjunctive agents affecting glutamate neurotransmission for reducing negative symptoms ( 3 ).

Incremental changes

Since the CREF opened, new investigators have joined NKI, expanding the number and type of studies conducted. Some new research procedures require specialized equipment (neurophysiological measures and brain imaging) that cannot be located within the CREF. The necessity for clinical staff to accompany patients when they leave the unit for research assessments creates an extra burden for clinical staff and for research staff, whose scheduling must accommodate the availability of clinical staff (and sometimes safety officers). There is an increased need for cooperation among research staff to avoid conflicts over limited resources, such as examination and interview rooms, and shared personnel, such as phlebotomists and electrocardiography technicians.

In 2003, during economic hard times, a proposal was made to close NKI. Because of overwhelming support for the institute, including from family advocacy groups, this plan was reversed. NKI now enjoys an unprecedented level of activity, with plans for capital improvements and program expansion, especially in the area of child and adolescent disorders.

Summary and recommendations

In summary, the key elements of our treatment-research collaboration are joint planning of the unit endorsed by top management of the state psychiatric hospital and the research institute; joint training of all directly involved clinical treatment and research staff before the unit opened and periodic refreshers to maintain the team collaboration and to integrate new staff; joint clinical-research review of all protocols being proposed; involvement of research staff in routine clinical programming, such as community meetings and morning rounds; involvement of clinical treatment staff in routine research meetings; fostering interest among research staff to provide unique clinical services; and fostering interest among clinical staff to initiate or to participate in research activities, or both.

Others contemplating the formation of such a unit should strive to seamlessly integrate research and treatment staff to avoid any obstacles to either research or clinical missions. Treatment and research staff need shared values in order to achieve day-to-day success, optimal patient care, and a productive research enterprise.