TSA Centers of Excellence. Program Criteria & Blueprint. for Tourette Syndrome & Tic Disorders
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1 0 Tourette Syndrome Association, Inc. TSA Centers of Excellence for Tourette Syndrome & Tic Disorders Program Criteria & Blueprint Medical & Scientific Programs Bell Boulevard Suite 205 Bayside, NY Tel: , ext 222 Fax: Web: tsa-usa.org/cofe.html Seeking to improve the quality of life of people with Tourette Syndrome and Tic Disorders by promoting the highest level of care, research, education/awareness and outreach/advocacy for these conditions 0
2 TSA CENTER OF EXCELLENCE PROGRAM Table of Contents MISSION STATEMENT 2 OBJECTIVES 2 DESIGNATION 2 SERVICES 3 Clinical Care 3 Research 4 Training, Education and Awareness 4 Outreach and Advocacy 5 THERAPIES 5 PERSONNEL 5 APPLICATION PROCESS 6 SELECTION 7 POST-AWARDS 7 MANAGEMENT 7 FUNDING AND SUPPORT 8 1
3 MISSION STATEMENT The Tourette Syndrome Association s Center of Excellence (CofE) program seeks to improve the quality of life of people with Tourette Syndrome and other Tic Disorders by promoting the highest level of care, research, education/awareness and outreach/advocacy for these conditions. OBJECTIVES OF THE TSA CofE PROGRAM The CofE program aims to address the significant variability in the level and quality of care, research on and education about TS and related disorders. In this respect, the development of outstanding interdisciplinary and multidisciplinary care models for the field is a key objective of the program. In addition, the program seeks to advance research in all relevant areas, and improve knowledge of the condition among both affected and unaffected people. Specifically, the CofE program addresses the following problems with TS and Tic disorders: Diagnostic variability, conflicting recommendations and lack of coordination of therapeutic strategies among care providers. Poorly defined care models and uncertain impact of many interventions. Unrecognized, misdiagnosis and/or poor treatment of non-tic features. Need for more scientific and clinical research focused on gaining a better understanding of TS/Tic Disorders and the development of more effective treatments. Lack of training programs and opportunities for medical (e.g., M.D.), allied (e.g., Dr. O.T.) and scientific (e.g., Ph.D.) fellows in multiple subspecialties. These are needed to expand and ensure continuity of expertise in TS/Tic Disorders. Poor awareness and understanding of TS and related conditions among community physicians, allied health professionals, patients, families and the general public. TSA CofE DESIGNATION Existing healthcare facilities or academic institutions (private and public) in the US that already attain or aim to meet qualifying criteria set forth by the TSA, pass the peer-review process, and are approved by the organization s internal processes may receive the designation of TSA Center of Excellence. Prospective Centers of Excellence, which may be constituted from one location or a consortium/network of regional sites, should ideally demonstrate the following before or after designation: Comprehensive care based on the best available evidence and current research findings. A willingness to innovate new approaches for the best care possible. An interdisciplinary team approach for patients and families throughout the life cycle, from very young children to adults. Regular CofE interdisciplinary team meetings and 2
4 regular CofE business meetings are encouraged. While research is not an absolute requirement for a CofE designation, they are strongly encouraged to undertake or collaborate on investigator-initiated, hypothesis-driven, clinical and/or scientific research in areas relevant to the advancement of the understanding, treatment, and dissemination of effective interventions for TS and related disorders. Training and education of clinicians, scientists and other professionals who may become future experts in TS and related disorders. Participation in advocacy and awareness for people touched by TS and other Tic Disorders. CofE SERVICES TSA CofEs are expected to provide excellent clinical care for people with TS and related disorders, encouraged to conduct or collaborate on high quality research in areas relevant to TS, help to train/educate professionals and/or lay people, and engage in outreach/advocacy activities: 1. Clinical Care The TSA CofE should have the capacity to provide evidence-based, multidisciplinary (or interdisciplinary) evaluation and treatment tailored to the complexity of patients seeking assistance for TS, Tic Disorders and their co-morbidities. Initial evaluation by a physician is recommended to ensure that all medical issues are addressed at the outset, but this is not an absolute requirement. Demonstration that all major care areas are covered is essential, although Centers may have latitude in designating different specialists to cover different functions of care. The credentials and training of the specialists, as well as a plan to integrate the team and to have regular care conferences, must be evident. Centers should focus on quality of care rather than quantity of patients seen. In this respect, CofEs are not mandated to see an absolute number of patients in any given time period. We expect that: Patient numbers will vary significantly depending on the geographical location of the Center. Larger volume Centers may justify seeing fewer new patients to focus their resources on the intense treatment of their existing patients. Centers may specialize in one-time consultations and provide integration plans to return patients into the community, while others may specialize in continuing care. Regional Centers may choose to work together to cover sparsely populated (e.g., some parts of the west and mid-west) and densely populated (e.g., New York Metro) areas, for the convenience of the patients. 3
5 CofEs are required to provide information on the practices and services available as well as the care model they adopt. Centers will be asked to specify whether these services are provided in the Center, through collaboration within their host institution, or through partnerships with external entities. CofEs are required to report the number and types of patients they see annually. TSA CofEs are required to detail the processes for evaluation and follow-up for each potential patient cared for, and show how services will be integrated and delivered. Also, Centers should provide details of a plan that includes regular comprehensive care and business meetings. 2. Research Research is not an absolute requirement for a CofE. However, where possible, CofE are encouraged to undertake or collaborate with other institutions and investigators conducting research on TS and related basal ganglia conditions. Such research could be laboratory-based scientific investigations, clinical research, or psychosocial/behavioral studies. Research should not be limited to industry sponsored trials. There should be evidence of scholarly, hypothesis-driven, investigator-initiated, basic and/or clinical research within Centers. CofEs should show collaborations with other investigators and Centers. There are no specific research areas required for Centers. However, research must be relevant to TS or related conditions, and if not immediately obvious, the applicant must explain the link of their research to TS. Research on other Tic related disorders or related co-morbid conditions such as Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Attention Deficit Disorder (ADD), etc. is encouraged. The presence of a database to track potential clinical-research subjects and a system to inform patients of opportunities for research participation during visits to the TSA CofE is highly encouraged. Information will be collected on funded grants, active research studies, areas of research expertise, and publication records where available. 3. Training, Education and Awareness TSA CofEs are required to provide varying levels of training and education for healthcare professionals, including medical students, residents, fellows, graduate students, Ph.D. students and post-doctoral fellows. Rotations through the services, electives with faculty, and opportunities for student mentorship are encouraged. Centers will be encouraged to apply for TSA funding for fellows and graduate students through existing TSA programs. Education and awareness for patients, caregivers and the general public are needed as well. There is no specific requirement for training and education within a CofE, but activities in one or more of the aforementioned areas are important. Centers are required to provide information on 4
6 previous trainees, locations, and links to TS care, research or education. In addition, Centers are required to provide a list of all training and educational programs, including CME s and CE s. 4. Outreach and Advocacy Involvement with and support for the national TSA, local chapters and support groups are a must for each CofE. Centers should seek opportunities for outreach in their communities and promote local TSA-related activities. Centers should have a plan to disseminate TSA educational materials, as well as inform the TSA of any educational materials produced by their team or facility. THERAPIES OFFERED WITHIN TSA CofE A TSA CofE is expected to offer a range of accepted medical, behavioral, surgical (where appropriate) and other therapies for TS and related conditions. There must be a demonstrated expertise with credentials for providers offering these therapies. Although there are no specific guidelines that are widely adopted across the field for TS care, the Center must demonstrate that they are providing excellent care that is based on existing guidelines and recommendations, even if a Center does not adhere to every specific expert recommendation. Comprehensive Behavioral Intervention for Tics (CBIT) and Cognitive Behavior Therapy (CBT) should be available to patients. If these therapies are not available within the Center, there should be a clearly defined collaboration or referral plan to link to experts who have sufficient training and experience in administering these treatments. Deep Brain Stimulation (DBS) is still investigational, but could offer additional treatment options for individuals with severe, drug/behavior therapy-refractory and injurious (e.g., spinal cord injury) tics. The availability of DBS at the site or a plan of consultation/collaboration with other facilities is encouraged. Botulinum toxin therapy can be an effective treatment for some focal tics. Availability of botulinum toxin, or a plan detailing a collaboration to provide these services should be available. CofE PERSONNEL A TSA CofE interdisciplinary team should reflect the Center s clinical, research, educational and other activities. The Center will be led by a Director/Co-Directors or Principal/Co-Investigators who have the responsibility to establish, maintain and run the Center in compliance with the TSA s CofE criteria and all applicable local, state and federal laws. The Director/PI can designate a clinical/research coordinator and define the role of all personnel operating within or collaborating with the Center. Also, the Director can designate Co-Directors or Co-PI s from regional sites if a TSA CofE has a regional strategy or is constituted from a 5
7 network of facilities. The team should include an experienced neurologist, a psychiatrist and a psychologist (or another credentialed provider, trained in behavior therapy) with qualified experience in child and adult care. The core personnel do not need to include adult and pediatric practitioners as long as there are affiliated providers who can demonstrate a commitment to the Center and an ability to function over a diversity of age ranges. Ideally, there should be a coordinator who could be a nurse, nurse-practitioner, social worker, or other provider who would be available to facilitate care, manage interactions with school personnel (in the case of children), and have the ability to effectively address psychosocial problems. Team members should be experienced and knowledgeable in the evaluation and treatment of patients with TS, OCD, ADHD, and other related disorders such as mood and anxiety problems, trichotillomania, self- injurious behavior, and skin picking. A TSA CofE, in which research, training and educational activities are present, should have suitably qualified and experienced professionals working within or affiliated with the Center. The credentials and relationships should be provided for all such individuals. TSA CofE APPLICATION PROCESS Private or public healthcare facilities, or academic institutions, in the US may apply for designation as a TSA Center of Excellence. The prospective Center Director/PI will be required to complete and submit an application to the TSA using a specific application form. The application will request relevant information as mentioned above, including demographics; historical numbers of patients; innovative programs; collaborations within and outside of the Center; outreach activities; goals and objectives; current structure; changes planned once CofE status is granted; personnel bio-sketches; specific plans for clinical care (evaluation, consultation, treatment, training and education); current research portfolio, including grants under review; faculty publications; and most importantly, justification as to why the applicant should become a TSA CofE, and how their Center will be a model for TS care. Evidence for innovation in combining clinical care and research, or innovation in other areas, such as teaching models for residents, medical students and graduate trainees, will be sought. A willingness to collaborate on research activities occurring elsewhere is encouraged if a Center does not have their own research programs. In addition, the applicant will be required to provide details on what CofE status would mean in terms of added value for the Center, how quality of services will be assessed, and the level of current and future institutional support, financial or otherwise. 6
8 The application can be strengthened by the inclusion of a letter detailing leveraged funds from elsewhere if a TSA CofE designation is obtained. SELECTING TSA CofE All applications for CofE designation will be reviewed by an unbiased, non-conflicted, panel of experts comprising: Clinical and scientific experts in TS and related disorders, as well as experts from other fields TSA Chapter/Support Group and Patient representatives TSA Board of Director (BOD) members TSA s Vice President for Medical and Scientific Programs (Chairperson) Panel members or individuals from their institutions can apply for TSA CofE designation, but such members will not be involved in the review process. Applications from individuals with TSA links will be reviewed by independent, impartial, experts. The panel of experts will review full applications and each will be assigned a score/rank based on their quality. These applications will be presented to the TSA s BOD for consideration. Applicants that receive BOD approval will be notified and will receive the TSA CofE designation which will be granted for 3 years. Existing and prospective Centers may receive site visits as part of the evaluation process. POST-AWARDS After the designation of a TSA CofE, Centers will be required to submit annual progress reports and demonstrate continued adherence to the requirements of the CofE program. Further, Center Directors/PI will be required to participate in an annual TSA CofE meeting. MANAGEMENT OF TSA CofE & LIABILITY The Center Director(s)/PI and the head of his/her institution are responsible for the day-to-day operations of the Center. Also, they required to ensure that the Center complies with all relevant laws, guidelines and standards at all times. They will be required to take steps to prevent and respond to potential misconduct and all unlawful activities. Also, the Center Director/PI is required to receive and address all complaints and inquiries from patients and other parties. The TSA will present, for signature, relevant forms approved by the TSA legal counsel to all CofE facilities and institutional personnel. Terms and conditions of the TSA s award will have to 7
9 be accepted by the institution to receive the TSA CofE designation. The TSA reserves the right to withdraw its CofE designation at any time for violation of its terms and conditions and other requirements of the program. FUNDING & SUPPORT The aim of the TSA is to provide, within its limitations, what is required to assist existing institutions to become excellent with respect to treatment and other activities relevant to TS and related disorders. The type and level of support will be dictated by a needs-assessment during the application review process and will vary from Center to Center. For example, some Centers may require financial support to purchase equipment for a clinic or laboratory; hire or retain personnel; or fund the training of a physician in the latest therapy for TS. Some Centers may require salary support for key members of the care or research team. Other Centers may not require financial support, but may require educational material from the TSA, extensive assistance with conducting clinical trials, and other related programs. Finally, the TSA envisages that some Centers will not require any support from the Association, but seeks the CofE designation as they have met all required criteria. Funded Centers will be awarded up to $50,000 per year for 3 years to be spent on TS relevant activities as set forth in the budgetary component of the application. Centers may strengthen their application by providing institutional or other leveraged support to share/match a commitment from the TSA. It is considered that the TSA CofE program will be a major tool for fundraising for the Center. Therefore, Centers are encouraged to engage in related fundraising and promotional activities for themselves, as well as with and on behalf of the TSA. The proposed application process and timeline are as follows: Fall (December): Announcement and RFA Winter (February): Receive applications and submit for reviews Spring (April): Complete application reviews Summer (June): Present recommendations to the BOD and announce awards 8
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