Transcript Open slide - CTN Dissemination Library

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]