Transcript Open slide - CTN Dissemination Library

USING STANDARDIZED PATIENTS TO PILOT SCREENING VISITS IN CLINICAL TRIALS
Lynn E. Kunkel, M.S., Holly Fussell, Ph.D., Colleen Shannon-Lewy, Ph.D., & Bentson McFarland, M.D., Ph.D.
Oregon Health & Science University
Introduction
Standardized patients (SPs) are used in medical education to assist in training
and evaluating clinical skills. This poster summarizes the use of an SP to test
patient screening and intake processes for two clinical trials conducted in the
National Drug Abuse Treatment Clinical Trials Network (CTN). The SP
portrayed an individual seeking treatment and “walked” through the study
intake process, including being interviewed by research assistants and study
medical staff. Roles were modified to meet study inclusion / exclusion criteria.
CTN-0029: Compares Concerta® (methylphenidate) versus placebo in a
smoking cessation treatment for adults with ADHD.
• Implemented in 6 treatment centers throughout the US.
• Participants are randomized and followed for 12 visits to assess ADHD
symptoms and smoking frequency.
CTN-0030: Tests the use of Suboxone ® (buprenorphine/naloxone) with
adults dependent on prescription opiates.
• Implemented in 11 treatment centers throughout the US.
• Participants are followed for 3 to 9 months in two phases that vary in
duration.
Standardized Patients
• SPs are actors trained to simulate physical and psychological symptoms
in order to train and assess clinical skills.
• A NIDA award (R03 DA016958) created, trained and implemented SPs as
drug dependent individuals. Two scripts were modified for use in these
clinical trials and provided sufficient detail for two hours of study intake
interviews.
Clinical Trials Network
• The mission of the CTN is to improve the quality of drug abuse treatment
using science as the vehicle.
• The CTN includes 17 research centers, each collaborating with 5
Community Treatment Programs.
• Participants in CTN protocols complete a rigorous screening to document
eligibility.
Awards from the National Institute on Drug Abuse (U10 DA 013036 & R03 DA 016958) supported these activities.
Contact: Lynn Kunkel, 503-494-2562, [email protected]
Methods / Implementation
Due to the number of participant visits in CTN protocols, only the screening visits
were tested. Table 1 & 2 provide examples of data forms and procedures that are
completed during the screening visits.
CTN-0029 Original SP Role
“Mike Langsley” is a 35-year-old unemployed convenience store clerk using two
balloons of heroin a day.
Table 1. Examples of Screening Visit Content for CTN-0029
Screening Visit 1
Screening Visit 2
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 Vital signs, CIDI, ASPD, study
signs, study eligibility, adverse
eligibility, adverse events, Adult
events, ECG, various
ADHD Diagnostic scale, CIDI
psychological & behavioral scales
(e.g., thoughts on abstinence,
suicidal / homicidal intent, ASRS
ADHD self screen, withdrawal from
tobacco etc)
Table 3. Examples of SP Contributions to Clinical Implementation
Topics
Observations
SP Recommendations/Findings
Scheduling /
Organizing
Need to coordinate participant schedule with
research staff schedule
Allow for more flexibility in scheduling (early
morning / late evenings)
Consent
Study staff had difficulty explaining the consent
form to the SP
1) Develop a summary sheet highlighting the
important aspects of the study
2) Provide additional staff training on issues
related to confidentiality, HIPAA & mandatory
reporting
Case Report
Forms (CRFs)
Data collection required more time than
anticipated
Prepare for longer visits than originally planned
Protocol “Flow”
Organization of study procedures was
awkward: (e.g., location of activities, adequacy
of rooms, whether all materials that were
needed were present, staff group coordination,
timing of visits)
1) Provide a calendar for recall
2) Do not locate computer monitor between the
staff and participant
3) Improve timing of the completion of the locator
form
Participant
Comfort
The research setting was uncomfortable for
individuals in withdrawal that may have
attention difficulties or other co-morbidities
1) Reduce lighting and make room less “sterile”
2) Provide more comfortable chairs
3) Provide “lap desks” or trays so participants can
complete the CRF’s in comfort & with ease
Screening Visit 3
Discussion
CTN-0030 Original SP Role
“Ted Franks” is a 30-year-old unemployed construction worker using 8-9 20 mg
doses of Oxycontin a day without a prescription.
• Applying SP technology as a pilot of the implementation of clinical trials in substance
abuse resulted in positive reactions from research staff. In addition, it provided staff
confidence in the study flow and a better understanding of how the data collection would
occur when faced with “real” study participants.
Table 2. Examples of Screening Visit Content for CTN-0030
• Due to the success of these pilot implementations, there is evidence to suggest that SP
technology could be applied in other settings such as:
Screening Visit 1
Screening Visit 2
–
Training in a wide range of human services
Consent, locator, demographics, medical & smoking
history, depression & anxiety scales, pregnancy / birth
control, prior & con meds, study eligibility, various
psychological & behavioral scales (e.g., thoughts on
abstinence, suicidal / homicidal intent), Clinical
Withdrawal Scale, Brief Pain Inventory etc.
Vital signs, CIDI modules E & K, Fagerstrom for
nicotine dependence, Beck Depression Inventory, SF36, physical exam, UA, Risk Behavior Survey,
session with counselor
–
Testing client responsiveness in treatment and prevention services
Results
Applying SP technology to two CTN studies resulted in training opportunities and
modifications to the clinical implementation. Table 3 summarizes observations and
suggested procedural changes.
Limitations / Future Direction
• One major limitation of the process was the inability to pilot all phases of the research
studies. 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 studies.
• The SP roles used in these studies were originally designed for substance abuse
counseling assessment interviews, not for the CTN. Although the roles were modified to
include factors specific to the studies, the success of this project indicates that future SP
roles could be created specifically for clinical trials and related purposes.