Emory University School of Medicine



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OFFICE OF CONTINUING MEDICAL EDUCATION

A GUIDE TO DEVELOPING AND IMPLEMENTING A QUALITY, NEEDS AND EVIDENCE-BASED CME ACTIVITY

FOR COURSE DIRECTORS, PLANING COMMITTEE MEMBERS

AND STAFF

June 2013; August 2015

This Guide is intended to outline the processes, policies and procedures necessary for the development of a quality continuing medical education activity that is needs driven, evidence based and fully compliant with the ACCME Accreditation Criteria/Policies and Standards for Commercial Support.

AMA DEFINITION OF CME

CME consists of educational activities which serve to maintain, develop, or increase the knowledge, skills and professional performance and relationships that a physician uses to provide services for patients, the public or the profession. The content of CME is the body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine and the provision of health care to the public.

GENERAL REQUIREMENTS

• The activity must not simply be meant to provide “education for education’s sake”. It should be produced in order to increase physician knowledge/competence, change physician performance (influence behavior), and/or improve patient outcomes.

• Therefore, the activity must be planned to address an identified professional practice gap and the educational needs that underlie the gaps.

• The format of the activity should consider appropriate teaching and learning methods that will best achieve the learning objectives.

• There must be an identified target audience and the educational content delivered must be directly related to what the intended audience actually does in their professional practice.

• The activity must be evaluated to determine its effectiveness at closing the educational gap.

• Planning must be independent of commercial influence. All persons, including planning committee members and faculty presenters, who are in a position to control CME content must disclose all relevant financial relationships with a commercial interest. Persons who have been employed by a commercial interest within 12 months of the planned activity or who are currently employed by a commercial interest are prohibited from participation in any capacity, i.e. faculty, moderator, planning committee member, etc.

This Guide contains the following:

I. Steps to Program Planning/Development

II. Responsibilities of Activity Course Director

III. Responsibilities of OCME Program Coordinator

IV. Resources and Examples

V. Forms and Documents

PLANNING AND IMPLEMENTING A CME ACTIVITY

1. Read, sign and return the Activity Planning Agreement to the Office of Continuing Medical Education.

2. Develop the Activity Plan

a. Identify the specific needs the activity will address. Essentially, the activity should focus on the gaps that exist between actual practice/outcome and ideal practice/outcome. This activity (educational intervention) should be designed to address these needs and if effective, will close those gaps. (Resource: List of needs assessment research articles; Activity example)

b. Determine learning objectives, i.e., what should the learner know and/or be able to do in order to close the gaps between what they are doing and what they should be doing based on the best available evidence. They are derived from the educational needs and should be expressed in terms that are measurable and a reflection of desired outcomes. (Resource: Guidelines for Writing Learning Objectives and Summaries)

c. Write a comprehensive program description that delineates who the intended audience is, their educational needs and how participation in this activity will enhance their competence/knowledge, performance and/or patient health outcomes.

d. Choose an educational format that provides the best and most appropriate structure for achieving the stated objectives. The format should match the kinds of change desired; e.g., didactic lectures, discussion groups and panel discussions are appropriate when increasing knowledge is the objective; case studies, simulation labs and standardized patients are options that can impact the learner’s performance and competence. Use a variety of formats to keep the learner engaged and participating.

e. The activity’s effectiveness should be measured in terms of change in competence, performance and/or patient health. When designing the activity, give consideration to the evaluation tools and mechanisms that will the most appropriate results.

3. Complete the Course Activity Planning and Approval Form (CAF)

a. Use the information derived from Step 2 to complete the CAF.

b. Signed by Activity Course Director and Course Director’s Department Chair.

c. Include all documentation including:

▪ Preliminary agenda

▪ Signed Financial Relationship Disclosure Forms for all confirmed speakers and planning committee members.

▪ List of all speakers, their affiliations and contact information

▪ Sources of needs assessment

▪ List of potential commercial supporters (pharmaceutical and medical device companies)

▪ List of other potential financial supporters ( foundations, government, etc)

4. Activity Review and Approval

5. Logistical Planning

Planning the logistical aspects of the activity will commence after the activity has gone through the approval process. An OCME Program Coordinator will be assigned and begin work with the Activity Course Director and/or his/her assistant to implement the activity.

RESPONSIBILITIES OF ACTIVITY COURSE DIRECTOR

1. Select and confirm Program Dates with OCME at least 9 months prior to activity

2. Meet on a regular basis with OCME staff for program planning

3. Disclose his/her financial relationships with commercial pharmaceutical and medical device manufacturers via the Financial Relationship Disclosure Form

4. Select knowledgeable individuals to serve on a planning committee

5. Document the processes and resources that the planning committee used to identify professional practice gaps and to determine the educational needs of the target audience

6. State the identified needs and learner objectives as well as how the educational activity will meet the learners’ needs

7. Identify appropriate, knowledgeable speakers and in the invitation letters to them, identify the content of their presentation. Collect financial disclosure information from each speaker and planning committee member with the assistance of OCME

8. Assist OCME with resolving or managing all identified conflicts of interest

9. Execute the CME Activity Planning and Approval Form and provide the supporting documents, including completed Financial Disclosure Forms from all members of the planning committee and speakers, needs assessment documentation, and Maintenance of Certification/Licensure information

10. Prepare a draft of the program agenda

11. (Optional) Identify potential Commercial Supporters and Exhibitors with the assistance of OCME

12. Review final financial statements

13. Create an evaluation form to assess how well activity met its stated learning objectives, how learners will change their practice as a result of the activity, and whether commercial bias was evident during the activity

RESPONSIBILITIES OF OCME PROGRAM STAFF (these services are optional and require additional fees)

1. Meet with Course Director for program planning

2. Assist with course’s educational design

3. Assist with identifying appropriate audience

4. Block meeting space and execute hotel contract

5. Block lodging space and confirm

6. Prepare/review course budget

7. Prepare planning timeline

8. Contact journals and websites for publicity (if applicable)

9. Design course brochure

10. Prepare marketing plan

11. Select and order mailing lists; send to mailing house

12. Coordinate all mailings of brochure/postcard

13. Place brochure on CME website; link to applicable sites

14. Produce and activate online course registration

15. Process course registrations incl. checks, credit cards.

16. Confirm registrants

17. Contact faculty: obtain W-9 and conflict of interest forms, and A-V and lodging requirements

18. Solicit commercial support and obtain copies of Letters of Agreements from Commercial Supporters

19. Process faculty honoraria

20. Coordinate meeting space specifications with hotel

21. Guarantee banquet event orders

22. Order audiovisual equipment and personnel

23. Coordinate production of syllabus

24. Inform Course Director of audience composition

25. Registrant course packet preparation: name tags, syllabi, etc.

26. Ship registration materials to course site

27. ON-SITE management of course

28. Submit Registrant Roster for University Registrar

29. Maintain course registrant roster for 6 years

30. Process all invoices for payment

31. Produce financial report

32. Produce course evaluation summary

RESOURCES AND EXAMPLES



ama-

Spirit of the ACCME Standards for Commercial Support

Why Are We Doing This Activity?

FORMS AND DOCUMENTS

Activity Planning Agreement

CME Activity Planning and Approval Form

Attestation Statement/Sample Faculty Letter

Financial Relationship Disclosure Form

Resolution of Conflict(s) of Interest

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