Primary Care Faculty Development Fellowship Project Expectations

							      Primary Care Faculty
   Development Fellowship

Project Expectations / Introduction to IRB



                     16 October 2010
                   Jon Temte, MD/PhD

                      University of Wisconsin
                School of Medicine and Public Health
                  Department of Family Medicine
Project Guidelines
 Each Fellow is expected to prepare and
 present a project that integrates the skills
 learned during the Fellowship
    Select a topic of interest from one of the core
     curriculum areas
    Develop a question/identify problem, determine
     the feasibility of the investigation, define your
     audience.
Project Guidelines
    Discuss, discuss, discuss
    Prepare your project plan
    Complete IRB/HIPAA requirements
    Complete your project
    Write an abstract of your findings
    Present your project/findings at the final session
        April 1-2, 2011
Typical Projects
   Quality Improvement Project
       Examining processes
       making them more effective
   Educational Project
       Writing or revising a curriculum
   Research Project
       Systematic investigation of a question or theory
Examples of Projects
   Conscientious Refusal in Family Medicine
    Residency Training
       Jennifer Frank, MD, FAAFP
   Needs Assessment of Residents Regarding Cultural
    Competency
       Lisa Righter, MD
   Evaluation of an Oral Health Intervention in a
    Primary Care Setting
       Graciela Villadóniga, MD
   Predictors of Postpartum Smoking Relapse
       Troy Kleist, MD
Examples of Projects
   Review of the American Board of Internal Medicine
    Diabetes Performance Improvement Module
       Jason Mohror, MD, FAAP
   A Needs Assessment for Staff Training in Geriatric
    Rehabilitation
       George Xakellis, MD and Nancy W. Patterson, BSN, MS
   Improving Patient Flow and Satisfaction at the
    Center for Senior Health and Longevity
       Soryal Soryal, MD
   Comparison between Pharmacists and Physician
    Managed Anti-Coagulation Program
       Imran Sajjad, MD
Project Timeline
   Decide on Project Type and Topic
       November 12, 2010
   Complete IRB/HIPAA trainings on line
       December 17, 2010
   Complete IRB process for your project
       January 14, 2011
   Complete data collection
       February 25, 2011
Project Timeline (cont.)
   Submit draft abstract
       March 4, 2011
   Submit final abstract
       March 18, 2011
   Submit PowerPoint Presentation
       March 25, 2011
   Present Project
       April 2, 2011
Who is Here to Help?
   Fellowship Faculty and Staff
       Jon Temte
       Patricia Kokotailo
       Mae Hla
       Stephanie Berkson
       Patricia Greene
   HS-HSC Staff
   Your colleagues
       Projects
during Practice
           Pearls
               Identifying an
           Appropriate Topic


           Think small...   (or very small)




   small, easily completed projects
   set the stage for success
Nine Essential Questions

   What is the question ?
       ask very simple questions...
   Why is it interesting ?
       is the questions clinically relevant ?
       is there fire in your belly ?
   Has the question been answered by
      somebody else?
       literature review, discussions with “experts”
Nine Essential Questions             (cont.)




   Can the project be done during very
    limited time ?
       limited time, other competing demands
   What data will you need ?
       keep it simple, narrow hypotheses
   How will you collect the data ?
       chart reviews, simple prospective designs
Nine Essential Questions                (cont.)




   How will the data be used to answer the
    question ?
       research design, statistics, analyses
   What help will you need ?
       mentorship, data collection and entry
       analyses, interpretation, writing, review
   Can you find the help you need ?
       support staff, faculty mentors, statisticians
    A question of Risk
           a stepwise approach

   Identify the potential harms posed by the
    proposed intervention
   Categorize the magnitude of the potential harms
       7 continuous levels on a “harm” scale
   Estimate the likelihood of each potential harm
   Compare likelihoods of each harms against a
    comparator activity

        Rid et al., Evaluating the risks of clinical research. JAMA 2010 304:1472-9.
Overview of IRB Process
   Purpose is to provide a systematic way to
    protect human subjects involved in research
   The Health Sciences Human Subject
    Committee serves the Medical School and
    consists of representatives from Law
    Medicine, Pediatrics, Psychiatry and others
       “Health Sciences Institutional Review Boards”
       http://www.medicine.wisc.edu/hsc/
The Big Question
   Will your project need IRB review?
       ONLY the IRB can make this determination
       Depends on the institution where the study will be
        conducted
   Remember HIPAA when planning your project
       “HIPAA Privacy Rule Research Guidance”
       www.wisc.edu/hipaa/ResearchGuide/index.html
   All Fellowship participants should complete
    the IRB and HIPAA Trainings

   IRB Human Subjects Protections Tutorial:
    https://my.gradsch.wisc.edu/citi

   HIPPA Training:
    https://hipaa.wisc.edu/courses/moodle/login/index.php
Where to Go From Here
   Talk with Fellowship faculty, staff and your
    colleagues about your project ideas
   Begin to formulate your project using the
    planning handouts provided
   Complete the IRB and HIPAA Trainings
   Contact Patricia Greene or one of the HS-
    HSC staff with IRB/HIPAA-related questions
Looking Ahead
   Prior to the November session, you will be
    assigned a mentor based on your initial
    project ideas
   A staff person from the HS-HSC will
    participate in our November project time
   By our January meeting you should have
    completed your IRB review and began data
    collection