Pilot Programs

We are pleased to provide the enclosed application guidance for licensed EMS agencies and Training and Educational Institutions (TEI)s to participate in Kentucky Board of Emergency Medical Services clinical pilot programs. The guidance provides details about the application components that must be submitted in order to be considered for a pilot program.

There is no traditional application form to apply, nor is there an application fee. Instead, applications must be in the form of a proposal that contains the required sections summarized below.

The duration of all pilot programs shall not exceed 12 months.

Please feel free to contact the Kentucky Board of EMS office if you have any questions about the KBEMS Pilot program.

An application will be considered complete when it is submitted to the Kentucky Board of Emergency Medical Services and contains the following sections:

Section 1: Letter of Intent
Section 2: Type of Pilot Project
Section 3: General Project Description
Section 4: Patient Interaction Plan
Section 5: Staffing Plan
Section 6: Training/Educational Plan
Section 7: Medical Direction/ Quality Improvement Plan
Section 8: Data Collection/Quantitative Reporting
Section 9: Human Subjects Review Board (HSRB)
Section 10: Memorandum of Understanding

An application approved by the Board will be assigned a KBEMS Pilot Program number. The Pilot Program number will be assigned prior to any implementation of a pilot program and should be referenced on any and all Pilot Program correspondence. KBEMS may request additional material in support of an application before it makes a decision to approve or deny a request.

Related Forms

Form Name Form Number Form Description
Pilot Program Background KBEMS-PP01 Background and Regulatory Authority for Pilot Programs.
Pilot Program Guidance KBEMS-PP02 Guideance on the Application processs for Pilot Programs.
HSRB Application KCTCS HSRB Human Subjects Review Board Application
Adverse Event Report KBEMS ADVERSE Report used in the case of an Adverse Event

KBEMS Pilot Program Guidance

There is no traditional application form to apply for a KBEMS pilot program, nor is there an application fee. Applications must be in the form of a proposal that contains all ten (10) sections explained below. An application will be considered complete when all required information for all ten (10) sections is submitted to the Kentucky Board of Emergency Medical Services. Incomplete submissions will not be processed. Please feel free to contact the Kentucky Board of EMS office if you have any questions about the KBEMS pilot program.

Section 1: Letter of Intent

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.

Section 2: Type of Pilot Program

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.


Section 3: General Project Description

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.

Section 4: Patient Interaction Plan

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.

Section 5: Staffing Plan

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?

Section 6: Training/Educational Plan

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.

Section 7: Medical Direction/Quality Improvement Plan

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.

Section 8: Data Collection/ Quantitative Reporting

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.

Section 9: Human Subjects Review Board

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.

Section 10: Memorandum of Understanding

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.

Submission Process:

Kentucky Board of Emergency Medical Services
ATTN: Pilot Programs
118 James Ct., Suite 50
Lexington, KY 40505

Any amendment to the original Pilot Project must be submitted as a new project, and will be evaluated independently of any other project of the requesting agency.

A PROJECT MAY ONLY BEGIN AFTER YOU HAVE BEEN NOTIFIED THAT THE BOARD HAS REVIEWED AND APPROVED YOUR RESEARCH. APPROVAL IS EFFECTIVE FOR A MAXIMUM OF ONE YEAR FROM BOARD MEETING DATE.