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STANDARDIZED PATIENTS AS PARTICIPANTS IN CLINICAL TRIALS PROTOCOL IMPLEMENTATION Holly Fussell, Ph.D., Lynn E. Kunkel, M.S., Colleen Shannon-Lewy, Ph.D., & Bentson McFarland, M.D., Ph.D. Oregon Health & Science University Introduction This poster is a qualitative report on the innovative approach of using a standardized patient (SP) to pilot patient screening processes in implementing a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study on attention deficit hyperactivity disorder and smoking (CTN-0029). For this approach, an SP “walked” through all intake processes that would take place for “real” patients in the ADHD and smoking study, including being interviewed by a research assistant and study nurse. Standardized Patients • Standardized patients are individuals who are coached to simulate physical and psychological symptoms in order to train and assess provider clinical skills. • Beginning in 2005, graduation requirements for medical students across the US include passing an exam based on interacting with SPs. • Most commonly, SPs are used in medical school settings for clinical interactions. • SP scripts, therefore, typically include only enough information to fulfill 15 minutes of client portrayal. • This CTN application of SP technology used one SP role successfully developed through previous NIDA funded efforts R03 DA016958 toward creating SPs as realistic substance abuse clients. Methods Results Methods include a brief description of the original SP role (“Mike Langsley”) and study modifications that made the role more appropriate as a pilot tool for research staff on the study on attention deficit hyperactivity disorder and smoking. Applying SP technology to a CTN Study on ADHD and smoking resulted in training opportunities and modifications to the clinical implementation. See Table 2 for example opportunities and modifications. Table 2. SP Contributions to Clinical Implementation Original SP Role Topics “Mike Langsley’s” script was written to include detail satisfactory for up to 2 hours of substance abuse assessment interviews by multiple practitioners. What follows is a brief summary of Mike’s original case. Case summary. Mike is a 36 year-old unemployed male who has been using heroin for approximately six months. He first started after he had a fight with his wife, Jen. Jen has been increasingly suspicious that Mike was on something, but has been out of town. However, three days ago, she discovered that their savings account was almost completely depleted (Mike spent it on heroin) and then she found a syringe in his sock drawer. Upon being confronted with the syringe and the bank statement, Mike confessed. Jen was very angry about the money and drugs and kicked Mike out of the house. She told Mike that she isn’t sure she’ll let him come home. Mike is adamant about entering detoxification immediately and is vaguely aware of possibilities for subsequent rehabilitation. Mike’s co-morbidity is dysthymia. • The SP role was originally written, applied and refined as a heroin abusing adult male with a history of chronic depression. Key Modifications for CTN-0029 Protocol • In addition to general descriptions of this application of SPs, this poster describes the original SP role, reports on original authenticity ratings of that role, and describes adaptations to the role which resulted in high satisfaction ratings of participating coordinators and research staff in the Oregon/Hawaii Node of the CTN. Exclusion criteria of CTN-0029: The following aspects of the SP role were deleted: - Drug use / abuse – All behaviors and symptoms of drug use / abuse - Depression / Anxiety – All behaviors and symptoms related to major depression Clinical Trials Network • The mission of the CTN is to improve the quality of drug abuse treatment throughout the country using science as the vehicle. • CTN-0029 is designed to test whether a medication that has proven effective in treating ADHD—the medication Concerta® (methylphenidate)—will also help people with ADHD to stop smoking. • CTN-0029 is being implemented in approximately 6 Nodes throughout the US. • Participating patients in the CTN-0029 protocol go through a rigorous screening process to determine eligibility for the trial. • Once eligibility is confirmed, the participants are randomized and followed for approximately 12 visits to assess such variables as medication effects, ADHD symptoms and smoking frequency. SP Recommendations/Findings Scheduling/Organizing Coordinate participant schedule w/ research staff schedule Allow for more flexibility in scheduling (early morning / late evenings) Consent Pilot the consent form for comprehensibility Develop a summary sheet highlighting the important aspects of the study Case Report Forms (CRFs) Real time data collection Prepare for longer visits than originally planned Protocol “Flow” Streamlining of process (e.g., location of activities, 1) Provide a calendar for recall adequacy of rooms, whether all materials that were 2) Do not locate computer monitor between the needed were present, staff group coordination, timing staff and participant of visits) 3) Improve timing of the completion of the locator form Discussion Inclusion criteria of CTN-0029: The following aspects of the SP role were added: - DSM-IV diagnosis of ADHD – The SP reviewed literature of ADHD behaviors and symptoms - Smoked cigarettes for a least 3 months, currently smoking > 10 cigarettes / day - Desire to quit smoking • The CTN is made up of 17 awardees (Nodes), each collaborate with 5-10 Community Treatment Programs. • There are currently over 30 multi-site clinical trial protocols in the CTN. Complexities • Applying SP technology as a pilot of the implementation in CTN-0029 study on attention deficit hyperactivity disorder and smoking resulted in positive reactions from research and Node staff. • This successful approach to using SPs in a clinical application beyond medical settings and even beyond substance abuse counseling offered a concrete example of possibilities for SPs and clinical trials. • The success of brief adaptations to an SP role designed for clinical purposes beyond the CTN-0029 study also suggests a range of possibilities exist for utilizing SPs in multiple clinical domains in which human clients interact with practitioners for multiple purposes. • Overall, applying SP to the implementation of the CTN-0029 provided staff confidence in the participant flow and a better understanding of how the data collection would occur when faced with “real’ study participants. Implementation Due to the number of participant visits in the study, only the screening visits were piloted using the SP. Table 1 lists examples contents of the screening visits. • Due to this experience, the Oregon / Hawaii Node has decided to use SP’s to pilot all future clinical trials. Limitations / Future Direction Table 1. Example Screening Visit Contents Screening Visit 1 Screening Visit 2 Screening Visit 3 Consent, locator, demographics, medical & smoking history, depression & anxiety scales, pregnancy / birth control, prior & con meds, vital signs, study eligibility, UA Fagerstrom, prior / con meds, vital signs, study eligibility, adverse events, ECG, various psychological & behavioral scales (e.g., thoughts on abstinence, suicidal / homicidal intent, ASRS ADHD self screen, withdrawal from tobacco etc. Vital signs, CIDI, ASPD, study eligibility, adverse events, Adult ADHD Diagnostic scale, CIDI • One major limitation of the process was the inability to pilot all phases of the research study. In order to fully pilot the process, the SP would have been required to complete over 16 visits and been randomized to one of the drug arms of the study. • The SP role used in this study was originally designed for substance abuse counseling assessment interviews not for the CTN-0029 project. Although the role was modified to include factors specific to CTN-0029, the success of this project indicates that future SP roles could be created specifically for the clinical trials and related purposes. Awards from the National Institute on Drug Abuse (U10 DA 013036 & R03 DA016958) supported these activities. Contacts: Holly Fussell, 503-381-2730, [email protected] Lynn Kunkel, 503-494-2562, [email protected]