Use of a simplified protocol to increase academic clinical faculty research productivity Leigh E. Tenkku, PhD, MPH Department of Family and Community Medicine Saint Louis University STFM Annual Conference Denver, CO May 2, 2009

What is the Problem The expectations of Family Medicine academic clinical faculty to conduct research has been clearly stated, however, the ability to conduct feasible, relevant, and fundable research studies remains difficult to achieve.

A possible solution We created a protocol process using the FINER (feasible, interesting, novel, ethical, relevant) model and one-on-one consults with faculty who have a limited amount of time to devote to research. Hulley et al 2007, Designing Clinical Research

FINER Interesting Feasibility Relevant Novelty Ethical A Good Adequate number of studies and technical expertise Affordable in time and money Manageable in scope Getting the answer intrigues the investigator and others Feasibility Interesting A Good Research Study Relevant Novelty Confirms, refutes or extends previous findings, or provides new findings Relevant to scientific knowledge, clinical and health policy, and future research Ethical Amenable to a study that institutional review board will approve

Department Research Protocol 1. Designing the Study: 2. Post-Study Design: 3. Post-Data Collection:

Designing the Study Inclusion criteria Identify question/hypotheses Exclusion criteria Recruitment of participants- Discuss challenges in recruiting the study population Analysis Plan- outcomes defined, identify data points, statistical analyses and tables Barriers- Discuss potential obstacles to completion of study. How will they be addressed? Measurement instruments Identify question/hypotheses Literature review Study design Discuss HOW to implement idea with strong scientific design Is this study the next step in what has been done previously? Identify key variables and outcomes Mechanisms needed to implement study (website, email, survey, etc) Sample – Define the study population

Who, Where, When Personnel (assign roles to those assisting with implementation of the study) Logistics – Location, staff involvement, etc Consent process – who will oversee the informed consent process Data collection process - Who will collect data, how, and when will data collection begin Set overall timeframe for study – create timeline Identify first author, second author, i.e. who will write manuscript sections

Post-Study Design Synthesizing the literature Recruitment Letter/Statement (this should essentially be an outline of the study) IRB forms – type (exempt, full, expedited) criteria for each is reviewed

Post-Data Collection Analyze data –define tables, report results in tables, write results (interpretation of data) Publication (where can you submit this paper, get guidelines, read sample articles) Prepare manuscript for journal submission Set date for manuscript completion Submit manuscript and get published! Yay! Present poster at applicable conference

Outcomes Using the study design protocol, five studies were designed and implemented within a period of three months. Four of the studies were education-based, one with a clinical component, and one study was set in the clinic. Three additional studies have been added since June 08.

Departmental Research Protocol Study Subject (1) Designing the Study (2) Post-Study Design (3) Post-Data Collection Dissemination Musculoskeletal and Injection Workshop for Medical Students Evidence-Based Exercise Prescription Preceptor Training Methods (Traditional vs Online Module) Efficacy of self-administered assessment tool for diabetic patients to improve treatment plan adherence Pilot study of the use of a FAS recognition protocol Perception of Healthcare by LBGT Population and their Healthcare providers Clerkship workshop on provision of care for the LGBT population Effect of Summer Preceptorship Program on Student Interviewing Skills Article Submission Data Collection Data Collection In Enrollment In Enrollment In Design Data Collection In Design

Implications A simplified study design protocol process has the potential of increasing the interest and ability of academic clinical faculty to conduct research.

Acknowledgements My research team: Jesse Walls, MSW, Sr. Research Asst. Joanne Salas, BS, Data Manager Liz Bolhofner, BS, Research Asst. tenkku@slu.edu