This is a letter, on the letterhead of the KBEMS licensed service(s) or TEI applying for approval of a pilot program, formally requesting consideration. It should state the service s intent to support and staff the project for a maximum of one (1) year as described in the remainder of the attached guidance. The letter should be signed by the Chief Executive Officer/ Director of the agency whose name is on file in the KBEMS office.

The KBEMS licensed EMS agency shall submit a proposal for the clinical pilot program that addresses the following:

a.) Background/Significance: Describe the rationale for the pilot program, citing relevant research. Identify what questions remain and how the proposed pilot program will address these questions. Specify how the Pilot program may improve the quality of care in the EMS System.

b.) Objectives: List the objectives upon which the outcome of the pilot program will be based. Identify the predictor and outcome variables and the expected outcome of the pilot program.

c.) Design/Methods: Identify the type of study, describe the project design and the methods used to collect data and avoid bias.

d.) Evaluation: Describe the data management and statistical methods that will be used to evaluate the data. Include standards or benchmarks proposed.

e.) References: Attach copies of references cited in the protocol.

Describe the community/communities to be served, the Service base location(s) to be employed, the community health need being addressed, and the methodology for addressing the need (including any enhancements of the EMS response system that will result.) It is not required that all pilot program operations be initiated simultaneously at all locations, but a general plan for implementation should be described with specific geographical service area for the project well defined within the description.

Describe the nature of anticipated patient care and diagnostic interactions. Specify how the patient population may be positively affected by changes to accepted scope of practice or training curriculum. Address concerns of any possible adverse patient outcomes associated with implementation of the program.

Who will be providing clinical services and how will these services fit within the normal EMS staffing of the Service? On what type of schedule will these services be made available? Will the program require more or fewer staff than normally appropriate?

What training and/or educational methods will be provided to enable providers to deliver the services described above? Who will be responsible for training oversight and coordination and what are the qualifications of this educator? Curriculum and training outlines, as well as a resume/CV for instructors must be included. All investigators or clinicians practicing within the scope of the pilot program must complete training in Human Subjects Research at http://phrp.nihtraining.com/users/login.php and present evidence of completion for all staff participating in the project prior to initiation of the Pilot Program.

Describe the agency Medical Director(s) involvement in the service s operation and its quality improvement program. Identify any specialty physician that will provide specialized medical oversight for pilot programs, and define and document specific clinical protocols that will be utilized during the program, as well as any specialized credentialing processes for participating staff.

Describe what data demonstrates the need for this project, if any. Collect and reference data to demonstrate the impact of this project on the population served. Describe the data reporting plan, and what quantitative data will be reported to the Board during the program. Quarterly reporting is required for all projects. This information will be presented to the Medical Oversight Committee.

A formal request for review must be made to the KCTCS Human Subjects Review Board. The KCTCS HSRB Expedited or Full Review document must be completed and submitted with the Pilot Program application package. The requesting agency/TEI will be notified of the meeting date of the HSRB and attendance at the HSRB meeting will be required for continued project consideration.

• EXPEDITED REVIEW is conducted by the HSRB for protocols involving a normal population of

subjects who are exposed to no more than minimal risk.

• MINIMAL RISK means that the probability and magnitude of harm or discomfort anticipated in the research is not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical psychological examinations or tests.

A formal memorandum of understanding must be executed between the KBEMS licensed EMS agency and the Kentucky Community and Technical College System & Kentucky Board of Emergency Medical Services. 202 KAR 7:601 Section 15 (5) should be addressed within the memorandum of understanding.

The MOU will be executed following complete approval of the program and processes by the Kentucky Board of Emergency Medical Services.