ACCME Performance in Practice Structured Abstract A tool for preparing and demonstrating compliance through performance in practice

Transcription

1 ACCME Performance in Practice Structured Abstract A tool for preparing and demonstrating compliance through performance in practice Instructions: Complete this form for each activity selected for the ACCME s performance in practice review. Complete all sections applicable for the activity, and assemble attachments, marking each attachment with the appropriate number. If submitting material electronically, assemble a single PDF file that includes this form and the required attachments with each attachment bookmarked. Submit the abstract/attachments to the ACCME as instructed. ACCME Provider ID: Provider Name: ABC Medical Specialty Society Activity Title: Assessment and Management of Patients with Depression in the Primary Care Setting Activity Date (mm/dd/yyyy): 3/9/2013 Activity Type: Course Providership: Direct Commercial Support Received: Yes State the professional practice gap(s) of your learners on which the activity was based (maximum 100 words). (C2) State the educational need(s) that you determined to be the cause of the professional practice gap(s) (maximum 50 words each). (C2) Knowledge need and/or Competence need and/or Performance need and/or State what this CME activity was designed to change in terms of learners competence or performance or patient outcomes (maximum 50 words). (C3) Despite the availability of effective treatments, patients with major depressive disorder often are under treated or inadequately treated resulting in continued distress. Physicians need to refine their screening and assessment of patients who may be at risk for depression by conducting a thorough, individualized depression assessment and an effective interview. This activity was designed to improve physician screening and assessment for depression. Explain why this educational format is appropriate for this activity (maximum 25 words). (C5) This activity will use didactic lectures, interactive cases, and role playing to train physicians to conduct interviews more effectively. Indicate the desirable physician attribute(s) (i.e., competencies) this activity addresses. (C6) ACGME/ABMS Competencies Institute of Medicine Competencies Interprofessional Education Collaborative Competencies Patient Care and Procedural Skills Provide patient centered care Values/Ethics for Interprofessional Practice Medical Knowledge Work in interdisciplinary teams Roles/Responsibilities Practice based Learning and Improvement Employ evidence based practice Interprofessional Communication Interpersonal and Communication Skills Apply quality improvement Teams and Teamwork Professionalism Utilize informatics Systems based Practice Other Competency(ies) (specify): For all INDIVIDUALS IN CONTROL OF CONTENT for the activity Complete the table below. If you have this information already available electronically, then simply include it as part of Attachment 2. For each individual in control of content, list the name of the individual, the individual s role (e.g., planner, editor, content reviewer, faculty) in the activity, the name of the ACCME defined commercial interest with which the individual has a relevant financial relationship (or if the individual has no relevant financial relationships), and the nature of that relationship. (Note: please ensure that when you are collecting this information from individuals, that you are using the most current definitions of what constitutes a relevant financial relationship and ACCME defined commercial interest.) (C7 SCS 2.1, 2.2, 2.3) Name of individual Individual s role in activity Name of commercial interest Nature of relationship Example: Jane Smythe, MD Course Director None Example: Thomas Jones Faculty Pharma Co. US Research grant Sally Jones, MD Faculty XYZ Pharma Incorporated Consultant Paula Smith, PhD Group Facilitator None N/A Jane Doe, MD Chair of CME Review Cmte/Reviewer None N/A Susan Lee, MD Planner None Chief, Primary Care Jack Smith, Ed.M. CME Coordinator None Page 1 of 16

2 (If there are additional individuals in control of content for the activity, please attach a separate page using the same column headings.) If the activity was COMMERCIALLY SUPPORTED Complete the table below. If you have this information already available electronically, then simply include it as part of Attachment 8. List the names of the commercial supporters of this activity and the $ value of any monetary commercial support and/or indicate in kind support (C8 SCS ). Name of commercial supporter Amount of monetary commercial support In kind Example: XYZ Pharma Company $5,000 Example: ABC Medical Device Company XYZ Pharma Incorporated $2, (If there are additional commercial supporters, please attach a separate page using the same column headings.) ATTACHMENTS Attachment 1 Attachment 2 Attachment 3 Attachment 4 Attachment 5 Attachment 6 The activity topics/content, e.g., agenda, brochure, program book, or announcement. (ACCME Definition of CME) The form, tool, or mechanism used to identify relevant financial relationships of all individuals in control of content. (C7 SCS 2.1) (NOTE: See instructions on page 1 include table or attachment with relevant financial relationships of all individuals in control of content for this activity.) Evidence that you implemented your mechanism(s) to resolve conflicts of interest for all individuals in control of content prior to the start of the activity. (C7 SCS 2.3) The disclosure information as provided to learners about the relevant financial relationships (or absence of relevant financial relationships) that each individual in a position to control the content of CME disclosed to the provider. (C7 SCS , 6.5) The data or information generated from this activity about changes achieved in learners competence or performance or patient outcomes. (C11) The ACCME accreditation statement for this activity, as provided to learners. (Appropriate Accreditation Statement) If the activity was COMMERCIALLY SUPPORTED The income and expense statement for this activity that details the receipt and expenditure of all of the commercial Attachment 7 support. (C8 SCS 3.13) Attachment 8 Each executed commercial support agreement for the activity. (C8 SCS ) Attachment 9 The commercial support disclosure information as provided to learners. (C7 SCS ) Page 2 of 16

3 Note: If this activity is an enduring material, journal based CME, or Internet CME, please include the actual CME product (or a URL and access code if applicable) with your performance in practice. Page 3 of 16

4 Attachment 1 Continuing Medical Education ABC Medical Specialty Society Activity Announcement Assessment and Management of Patients with Depression in the Primary Care Setting When: March 9, 2013 Time: 8:30 AM 2:30 PM Location: Our Town Conference Center, 3 rd Floor Conference Room Activity Description: More than 32 million adults in the United States are diagnosed with depression (major depressive disorder, MDD) at some time in their lives. MDD is the leading worldwide cause of disability. Despite the availability of effective treatments, patients with MDD often are under treated or inadequately treated resulting in continued distress. This activity will provide participants with tools and strategies needed to diagnose and manage MDD. Learning Objectives: At the conclusion of this activity, participants should be able to: 1. Discuss the major risk factors for depression 2. Cite the barriers to diagnosing depression in the primary care setting 3. Screen and assess patients who may be at risk for depression. 4. Identify tools to conduct a thorough individualized depression assessment and an effective interview 5. Describe three common medical conditions that may mask the diagnosis of depression Target Audience: Primary care physicians, nurses, nurse practitioners CME Information: ABC Medical Specialty Society designates this live activity for a maximum of 4.75 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity. Accreditation Statement: ABC Medical Specialty Society is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Agenda: 8:30 Check in & Breakfast 9:00 Welcome & Pre Activity Poll (Susan Lee, MD) 9:15 Neurobiology of Depression (James Jones, MD) 9:45 Q & A 10:00 Assessment and Management of Depression in the Primary Care Setting (James Jones, MD) 11:00 Q & A Page 4 of 16

5 11:15 Coffee Break 11:30 Pharmacological & Psychosocial Approaches to the Management of Depression (Jones & Paula Smith, PhD) 12:30 Lunch Break 1:00 Conducting an Individualized Depression Assessment and an Effective Interview: Role Playing Exercise (Smith) 2:00 Q & A 2:15 Post Activity Poll (Lee) 2:30 Program Adjourns Cost: This activity is provided free of charge. Acknowledgment of Commercial Support: This activity has received support in the form of an educational grant from XYZ Pharma Incorporated. Page 5 of 16

6 Name: Content of Activity: Date of Activity: Attachment 2 Disclosure of Relevant Financial Relationships First, list the names of commercial interests (defined in the Glossary of Terms below) with which you or your spouse/partner have, or have had, a relevant financial relationship within the past 12 months. For this purpose we consider the relevant financial relationships of your spouse or partner that you are aware of to be yours. Second, describe what you or your spouse/partner received (ex: salary, fee, research grant, etc). Do NOT list any amounts received. Third, describe your role. Nature of Relevant Financial Relationship (Include all those that apply) Commercial Interest What was received For What Role? Example: Company X Speaker Fee Promotional Speaker I do not have any relevant financial relationships with any commercial interests. Signature Example terminology What was received: Salary, royalty, intellectual property rights, research grant, consulting fee, speaker fee, Role(s): Employment, management position, independent contractor (including contracted research), consulting, ownership interest (e.g., stocks, stock options or other speaking and teaching, membership on advisory ownership interest, excluding diversified mutual funds), or other financial benefit. committees or review panels, board membership, and other activities (please specify). Glossary of Terms Commercial Interest The ACCME defines a commercial interest as any entity producing, marketing, re-selling, or distributing health care goods or services, used on, or consumed by, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests. For more information, visit Financial relationships Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. Relevant financial relationships ACCME focuses on financial relationships with commercial interests in the 12-month period preceding the time that the individual is being asked to assume a role controlling content of the CME activity. ACCME has not set a minimal dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship. The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months that create a conflict of interest. Conflict of Interest Circumstances create a conflict of interest when an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship. Date Page 6 of 16

7 Attachment 3 Western Regional Medical Center Continuing Education Resolution of Conflict(s) of Interest Form For staff only: Please complete this form for each individual in control of content who has disclosed relevant financial relationship(s) 1 with ACCME-defined commercial interest(s) 2. NB: This resolution form does not need to be completed for individuals for whom no relevant financial relationships to ACCME-defined commercial interests have been identified. Name of Individual with Relevant Financial Relationship: Sally Jones, MD Activity Title: Assessment and Management of Patients with Depression in the Primary Care Setting Session Name and Date: 3/9/14 Neurobiology of Depression: Pharmacological and Psychosocial Approaches to the Treatment of Depression Please indicate which of the following approaches were implemented to resolve the individual s Conflict(s) of Interest: 1. Regarding the Content of the Activity Content changed so that commercial products/services no longer discussed during activity Conducted peer review of activity materials Staff Note: The peer review found that clinical recommendations are based on the best available evidence and met the expectations of CME content validation. Other: 2. Regarding the Individual s Role in the Activity Individual will not present clinical recommendations about the use of commercial products/services for which s/he has a conflict of interest Staff Note: Dr. Jones will limit her presentation to a discussion of the pathophysiology of depression. Clinical recommendations regarding treatment options will be given by a different speaker without financial relationships to the manufacturer of the therapy. Staff corresponded with individual to review and revise materials to ensure independence Changes made: Review completed by: Jane Doe, DME Date: 2/16/13 1 Relevant Financial Relationship A relevant financial relationship exists when an individual is able to control the content of a CME activity and has a financial relationship of any amount within the past 12 months with an ACCME defined commercial interest. The ACCME considers the financial relationships of the individual s spouse or partner to be considered as their own. 2 Commercial Interest ACCME defines a commercial interest as any entity producing, marketing, re selling, or distributing health care goods or services, used on, or consumed by, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests. For more information, visit Page 7 of 16

8 Attachment 4 ABC Medical Specialty Society Continuing Medical Education SUMMARY OF DISCLOSURE INFORMATION FOR ALL INDIVIDUALS IN A POSITION TO CONTROL THE CME ACTIVITY MEETING TITLE: Assessment and Management of Patients with Depression in the Primary Care Setting Meeting Date: March 9, 2013 The following is disclosure information of relevant (or no) financial relationships with an ACCME defined commercial interest for all individuals in a position to control the content of the CME activity including planners, CME Review Committee members, faculty presenters, moderators, panelists, and reviewers. The current definition of a commercial interest per the ACCME is any entity producing, marketing, re selling, or distributing health care goods or services consumed by, or used on, patients." Name James Jones, MD Name of Commercial Interest XYZ Pharma Incorporated Nature of Relationship Consultant None of the other individuals in a position to control the content of this activity including planners, CME Review Committee members, faculty presenters, moderators/facilitators, panelists, and reviewers have any relevant financial relationships with an ACCME defined commercial interest to disclose. Page 8 of 16

9 Attachment 5 Assessment and Management of Patients with Depression in the Primary Care Setting March 9, 2012 Evaluation Question: (Competence) Evaluation Summary Relative to where you were prior to participating in this activity, please rate how well this activity has affected your ability to: Discuss the major risk factors for depression No Effect Modest Effect Significant Effect Discuss the major risk factors for depression 8 Cite the barriers to diagnosing depression in the primary care setting Cite the barriers to diagnosing depression in the primary care setting 0 No Effect Modest Effect Significant Effect Page 9 of 16

10 Screen and assess patients who may be at risk for depression. No Effect Modest Effect Significant Effect Screen and assess patients who may be at risk for depression Describe three common medical conditions that may mask the diagnosis of depression No Effect Modest Effect Significant Effect Describe three common medical conditions that may mask the diagnosis of depression Summary of participants anwers regarding the following question: What questions will you ask your patients now to screen for depression that you were not asking before the activity? Fatigue & energy level change (7) Unexpected weight gain or loss (3) Insomnia or excessive sleep almost every day (5) Feelings of apathy, agitation, or irritability (8) Page 10 of 16

11 Attachment 6 Continuing Medical Education Western Regional Medical Center Activity Announcement Assessment and Management of Patients with Depression in the Primary Care Setting When: March 9, 2013 Time: 8:30 AM 2:30 PM Location: Our Town Conference Center, 3 rd Floor Conference Room Activity Description: More than 32 million adults in the United States are diagnosed with depression (major depressive disorder, MDD) at some time in their lives. MDD is the leading worldwide cause of disability. Despite the availability of effective treatments, patients with MDD often are under treated or inadequately treated resulting in continued distress. This activity will provide participants with tools and strategies needed to diagnose and manage MDD. Learning Objectives: At the conclusion of this activity, participants should be able to: 1. Discuss the major risk factors for depression 2. Cite the barriers to diagnosing depression in the primary care setting 3. Screen and assess patients who may be at risk for depression. 4. Identify tools to conduct a thorough individualized depression assessment and an effective interview 5. Describe three common medical conditions that may mask the diagnosis of depression Target Audience: Primary care physicians, nurses, nurse practitioners CME Information: ABC Medical Specialty Society designates this live activity for a maximum of 4.75 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity. Accreditation Statement: ABC Medical Specialty Society is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Agenda: 8:30 Check in & Breakfast 9:00 Welcome & Pre Activity Poll (Susan Lee, MD) 9:15 Neurobiology of Depression (James Jones, MD) 9:45 Q & A 10:00 Assessment and Management of Depression in the Primary Care Setting (James Jones, MD) 11:00 Q & A Page 11 of 16

12 11:15 Coffee Break 11:30 Pharmacological & Psychosocial Approaches to the Management of Depression (Jones & Paula Smith, PhD) 12:30 Lunch Break 1:00 Conducting an Individualized Depression Assessment and an Effective Interview: Role Playing Exercise (Smith) 2:00 Q & A 2:15 Post Activity Poll (Lee) 2:30 Program Adjourns Cost: This activity is provided free of charge. Acknowledgment of Commercial Support: This activity has received support in the form of an educational grant from XYZ Pharma Incorporated. For more information about this activity and to register, please visit Page 12 of 16

13 Attachment 7 Assessment and Management of Patients with Depression in the Primary Care Setting March 9, 2013 Income and Expense Statement Income Category Projected Actual Variance Description/Comments Registration Fees 20 Participants ( $ Ten attended Subtotal - Registration Fees 0.00 $ 0.00 $ 0.00 Commercial Support (unrestricted educational grants) XYZ Pharma Incorporated $ 3, $ 2, $(1,000.00) Subtotal Commercial Support $ 3, $ 2, $(1,000.00) Exhibits Other, specify $ - Subtotal - Other $ - $ - $ - Total Income $ $ $ Expense Category Projected Actual Variance Description/Comments Marketing Mailing lists $ - Brochure $ $ $ Postage, bulk mail charge $ Other, specify $ - Subtotal - Marketing $ $ $ Meeting Space and Logistics Meeting room charge Meals for attendees, faculty $600 $ $ $ A/V $ - Registration Supplies $ - Internet Hosting charges $ - Other, specify $ - Subtotal - Meeting Space/Logistics $ $ Faculty Honoraria and Travel Expenses James Jones, MD $ $ $ - Paula Smith, MD $ $ $ - Subtotal - Honoraria/Travel $ $ $ - Western Regional Medical Center CME Certification Expenses CME Administrative Fee $ $ $ - CME Operational Expenses Subtotal -CME Expenses $ $ $ Total Expenses $ $ $ Net Gain (Loss): $ (50.00) Page 13 of 16

14 Attachment 8 ABC Medical Specialty Society WRITTEN AGREEMENT FOR COMMERCIAL SUPPORT ABC Medical Specialty Society is committed to presenting CME activities that promote improvements or quality in healthcare and are independent of the control of commercial interests. As part of this commitment, we have outlined in this written agreement the terms, conditions, and purposes of commercial support for its CME activities. Commercial Support is defined as financial, or in-kind, contributions given by a commercial interest i, which is used to pay all or part of the costs of a CME activity. Assessment and Management of Patients with Depression in the Primary Title of CME Activity Care Setting Activity Location Our Town Conference Center, 3rd Activity Date March 9, 2013 Floor Conference Room, City, ST Name of Commercial Interest XYZ Pharma Incorporated Amount of Educational Grant $2, Description of In Kind Support N/A Grant will be used for the following: Speaker Honoraria: Speaker Expenses (itemize) Honoraria: 2 faculty at $800 each ($ in Total) Meeting Expenses (itemize) Terms, Conditions, and Purposes Other (list) Meals: $ CME Fee: $ Independence 1. This activity is for scientific and educational purposes only and will not promote any specific proprietary business interest of the Commercial Interest. 2. The Accredited Provider is responsible for all decisions regarding the identification of educational needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content of the CME, selection of education methods, and the evaluation of the activity. Appropriate Use of Commercial Support 3. The Accredited Provider will make all decisions regarding the disposition and disbursement of the funds from the Commercial Interest. 4. The Commercial Interest will not require the Accredited Provider to accept advice or services concerning teachers, authors, or participants or other education matters, including content, as conditions of receiving this grant. 5. All commercial support associated with this activity will be given with the full knowledge and approval of the Accredited Provider. No other payments shall be given to the director of the activity, planning committee members, teachers or authors, joint sponsor, or any others involved with the supported activity. 6. The Accredited Provider will upon request, furnish the Commercial Interest documentation detailing the receipt and expenditure of the commercial support. Commercial Promotion 7. Product-promotion material or product-specific advertisement of any type is prohibited in or during the CME activity. The juxtaposition of editorial and advertising material on the same products or subjects is not allowed. Live or enduring promotional activities must be kept separate from the CME activity. Promotional materials cannot be displayed or distributed in the education space immediately before, during or after a CME activity. Commercial Interests may not engage in sales or promotional activities while in the space or place of the CME activity. 8. The Commercial Interest may not be the agent providing the CME activity to the learners. Disclosure 9. The Accredited Provider will ensure that the source of support from the Commercial Interest, either direct or inkind, is disclosed to the participants, in program brochures, syllabi, and other program materials, and at the time of the activity. The acknowledgment of commercial support may state the name, mission, and areas of clinical involvement of an ACCME-defined commercial interest but may not include corporate logos or slogans. Page 14 of 16

15 The Commercial Supporter and < ABC Medical Specialty Society > agree to abide by all requirements of the ACCME Standards for Commercial Support SM (appended). Name of Accredited Provider Western Regional Medical Center Tax ID Number Contact Person Mr. Joe Public, CFO Address Phone Number Fax Number Educational Partner (if applicable) Contact Person Phone Number Tax ID Number N/A Address Fax Number Name of Commercial Interest XYZ Pharma Incorporated Address 123 Business Lane City, State, Zip Anytown, ST Contact Person Jane Smith Address Phone Number Fax Number Commercial Interest Agreed by Authorized Representatives Accredited Provider Jane Smith 1/14/12 Mr. Joe Public, CFO January 20, 2012 Signature and Date Signature and Date Jane Smith Print Name Mr. Joe Public Print Name Director, IME Division Title Title CFO Educational Partner (If applicable) Signature and Date Print Name Title i The ACCME defines a Commercial Interest as any entity producing, marketing, re-selling, or distributing health care goods or services, consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests. For more information, visit Page 15 of 16

16 Attachment 9 Assessment & Management of Patients with Depression in the Primary Care Setting ABC MEDICAL SPECIALTY SOCIETY ACKNOWLEDGES XYZ PHARMA INCORPORATED FOR PROVIDING AN EDUCATIONAL GRANT TO SUPPORT THIS ACTIVITY. Page 16 of 16