Standardized Patients

1
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

• Results
• 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

• Methods
• 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.
• Original SP Role
• Mike Langsleys 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
  Mikes 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 isnt sure
  shell let him come home. Mike is adamant about
  entering detoxification immediately and is
  vaguely aware of possibilities for subsequent
  rehabilitation. Mikes co-morbidity is dysthymia.
  
• Key Modifications for CTN-0029 Protocol
• 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
• 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 gt 10 cigarettes / day

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.
• The SP role was originally written, applied and
  refined as a heroin abusing adult male with a
  history of chronic depression.
• 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.
• 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.
• 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.
• CTN-0029 is designed to test whether a medication
  that has proven effective in treating ADHDthe
  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.

• Discussion
• 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.
• Due to this experience, the Oregon / Hawaii Node
  has decided to use SPs to pilot all future
  clinical trials.
• Limitations / Future Direction
• 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,
  fussellh_at_comcast.net
• 
  Lynn Kunkel,
  503-494-2562, kunkell_at_ohsu.edu