Response to AHCPR on CERTs:

Julian D. Ford, et. al., University of Connecticut, School of Medicine and Department of Psychiatry
December 18, 1998

By way of brief background, the University of Connecticut School of Medicine's Department of Psychiatry is developing a Neuropsychopharmacological Treatment, Research and Training Center (NTRTC) based upon a model for integrating laboratory and clinical research related to psychopharmacotherapy with systematic dissemination and training. The NTRTC is developing in collaboration with the State of Connecticut's Departments of Public Health, Mental Health and Addictions Services, Children and Families, and Corrections, and with the University of Connecticut School of Medicine's Alcohol Research Center (ARC), Center for the Study of High Utilizers of Health Care (CSHUHC), and Health Promotion and Clinical Intervention Center (HPCIC), under the auspices of a coordinating council empowered to shape the agendas for the collaborating agencies.

The NTRTC is designed to conduct and disseminate research aimed at improving the quality and reducing the costs of health care (targeting high utilizers of both mental health and medical care) and increasing practitioner and systemic use of psychotropic drugs with the best outcomes and most limited adverse effects (targeting new drug development and the study of drug-drug and drug-psychotherapy interactions in the laboratory and in clinical trials and cost-effectiveness studies to advance the development and dissemination of evidence-based practice guidelines).

Because the core group for the NTRTC (including Drs. Huey, Winokur, Ford, and several colleagues) has just arrived at the University of Connecticut this September, we are still very much in a startup phase—however, our investigators have strong backgrounds in the research and clinical areas targeted by the NTRTC, and we felt that the concept and model for the NTRTC is extremely congruent with the general concepts described for the CERTs. So we would like to offer the following specific comments:

1. How the CERTs centers should be organized.

Each center should be both a national and regional resource for laboratory research, clinical trials, clinical effectiveness studies, and the dissemination and evaluation of training and both professional continuing education and community education concerning evidence-based practice guidelines for the safe and cost-effective application of biological interventions.

As such, each center should be organized with a leadership core comprised of a small number of highly experienced and nationally recognized (a) laboratory and clinical scientists specializing in psychopharmacology and (b) clinical and public health educators specializing in curriculum development and evaluation for both professional and community education. The core leadership group should be responsible for establishing and ensuring the realization of a coherent agenda linking all center projects in a longitudinal framework progressing from laboratory to clinical trial to clinic and community effectiveness studies to teaching and community education of evidence-based guidelines. This concept parallels the growing emergence of continuous quality initiatives as they are being applied to health care.

The core leadership group also should develop comprehensive ongoing linkages with (a) scientists within and outside the center pursuing complementary studies, (b) academic clinical training programs within and outside the primary site(s), (c) public and private sector organizations responsible for public health, mental health, addictions, children and families, and corrections, (d) organizations developing and promulgating guidelines for evidence-based practice and quality assurance in the mental and medical health care system, (e) organizations representing consumers of psychopharmacotherapies (e.g., NAMI), and (f) pharmaceutical companies developing psychotropic drugs.

The center core group should be established within a single academic center, but should be a consortium involving several related Schools (e.g., Public Health, Medicine, Social Work) and departments. Core group principal investigators should develop scientific and educational projects in collaboration with experts from other academic and service-delivery sites, in order to draw upon the full range of expertise available in the field and to produce findings of regional or national generalizability.

2. The appropriateness of AHCPR or these centers seeking additional funding partners to increase the resources available for research.

We feel that it is incumbent upon each center to develop several additional funding partners in order to achieve a breadth of study and dissemination sufficient to genuinely influence practice in the field. We would encourage the FDA/AHCPR to fund two or three core study projects at the outset for each center, in order to clearly establish a clear focused agenda and center of gravity—however, the center investigators must then obtain additional funding in order to create an integrated set of projects spanning the laboratory/clinical practice/education spectrum. Funding partners might logically include include federal, state, foundation, and commercial sponsors of investigator-initiated research, treatment development, and dissemination/education projects.

3. Initial areas of emphasis.

We recommend that each center address the following issues within the context of specific target populations/disorder(s) that are particularly refractory to treatment and often involve costly high utilization of services, which might include (a) severe and chronic mental illness; (b) mental illness or psychological factors affecting medical health care; (c) dual diagnoses involving addiction and comorbid psychiatric disorder(s); (d) comorbid Axis I and Axis II disorders; (e) trauma-related psychiatric disorders. Logical areas of emphasis might be addressed by such questions as:

• What drug interventions are indicated by the most recent advances in laboratory science or results of laboratory neurobiological studies?
• What open label pilot studies and controlled clinical trials of new or recent drugs or drug combinations best enhance the efficacy of pharmacotherapy for highly refractory conditions or with individuals who experience adverse reactions to existing drugs or drug combinations?
• What drugs or combinations best address not only the target psychiatric symptoms but also can be demonstrated in effectiveness studies to enhance (a) psychosocial functioning and (b) physical health (e.g., sleep, weight maintenance, other cardiovascular risk prevention)?
• What cost effective psychoeducational or psychotherapeutic interventions best enhance adherence to and outcome in pharmacotherapy?
• What biological or psychological markers best identify subgroups of patients whose responses to target pharmacotherapies are divergent, and how can these markers best be used to match patients to optimal treatment(s) in clinical trials and pharmacotherapy or combined pharmacotherapy-psychotherapy effectiveness research?
• How can evidence-based critical pathway algorithms and best practice guides best be revised (or if not in existence, developed) to integrate laboratory and clinical research findings in protocols for careful clinical evaluation to accurately characterize patients and to guide the application (and effectiveness studies) of pharmacotherapies and pharmacotherapy-psychotherapy combinations?
• What approaches to screening and community/provider education best identify individuals at risk or in need of target pharmacotherapies?
• What core elements (such as evidence-based practice guidelines) and teaching approaches are necessary for a psychopharmacotherapy curriculum that effectively establishes a high level of knowledge and skills in psychiatric providers and in allied mental health providers?
• What ongoing consultation, mentoring, and refresher education are necessary to maintain a high level of current knowledge and skills in pharmacotherapy?
• What incentives and consultation, mentoring, and refresher education optimize pharmacotherapy practice patterns , and does adherence to evidence-based practice patterns have demonstrable and lasting effects on patient outcomes, provider and patient satisfaction, medical and mental health care utilization patterns, and recidivism?

4. High-priority research topics.

• Identification and evaluation of pharmacotherapy regimens which combine antipsychotic, antidepressant, and anxiolytic effects to address treatment-refractory and poor-adherence conditions involving complex chronic Axis I (including addictions) and Axis II conditions.
• Identification and evaluation of pharmacotherapy regimens which provide simultaneous psychiatric and public health benefit by reducing adverse physical health consequences such as weight gain, irritability/aggression, sleep loss, and immunosuppression.
• Identification and evaluation of pharmacotherapy regimens which provide timely palliative effects that have additional secondary prevention benefit for acute (e.g., post-traumatic) or subthreshold psychiatric disorders, primarily with nonpsychiatric medical patients.
• Identification of biological and psychological markers that can detect and distinguish particularly treatment-refractory high utilizers of health care.

5. Whether AHCPR should include a list of specific research topics in the RFA, to which applicants would respond, or whether the RFA should focus primarily on the infrastructure and capacity of applicants and identify specific research issues to be addressed following selection of the centers.

As noted above, we recommend that each center be selected based upon both a core infrastructure and the proposal of 2-3 core study projects that define its ability to achieve a coherent mission (and to collaborate nonredundantly with other centers and research/education programs).

Julian D. Ford, Ph.D.
Director of Behavioral Healthcare Outcomes Research
Director of Outpatient Services
Department of Psychiatry 6410
University of Connecticut School of Medicine
University of Connecticut Health Center
10 Talcott Notch Road
Farmington, CT 06032
Telephone: (860) 679-6709/6732
Fax: (860) 679-6736
ford@PSYCHIATRY.UCHC.EDU

In collaboration with:

Peter Deckers, M.D., Dean, School of Medicine
Leighton Y. Huey, M.D., Chair, Department of Psychiatry
Andrew Winokur, M.D., Ph.D., Vice Chair (Research), Director of Pharmacotherapy Clinical Trials
Victor Hesselbrock, Ph.D., Vice Chair (Research) and Director, Alcohol Research Center

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