USING STANDARDIZED PATIENTS TO PILOT SCREENING VISITS IN CLINICAL TRIALS Lynn E. Kunkel, M.S., Holly...
1
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 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 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. Table 2. Examples of Screening Visit Content for CTN-0030 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. Discussion • 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. • Due to the success of these pilot implementations, there is evidence to suggest that SP technology could be applied in other settings such as: – Training in a wide range of human services – Testing client responsiveness in treatment and prevention services 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. 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 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 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. Screening Visit 1 Screening Visit 2 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, SF-36, physical exam, UA, Risk Behavior Survey, session with counselor Table 3. Examples of SP Contributions to Clinical Implementation
-
Upload
esther-ray -
Category
Documents
-
view
214 -
download
0
Transcript of USING STANDARDIZED PATIENTS TO PILOT SCREENING VISITS IN CLINICAL TRIALS Lynn E. Kunkel, M.S., Holly...
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
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 5Community 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 / ImplementationDue 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
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.
Table 2. Examples of Screening Visit Content for CTN-0030
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.
Discussion• 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.
• Due to the success of these pilot implementations, there is evidence to suggest that SP technology could be applied in other settings such as:
– Training in a wide range of human services
– Testing client responsiveness in treatment and prevention services
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.
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
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
IntroductionStandardized 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.
Screening Visit 1 Screening Visit 2
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, SF-36, physical exam, UA, Risk Behavior Survey, session with counselor
Table 3. Examples of SP Contributions to Clinical Implementation
