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Many people with addictions receive health care but never receive specialty addictions treatment. With movement toward integrating addiction treatment into medical care, the National Drug Abuse Treatment Clinical Trials Network (CTN) began conducting protocols in medical settings such as primary care and emergency departments (ED). This poster describes the implementation process of the first CTN trial conducted in medical emergency departments, the six-site “Screening, Motivational Assessment, Referral and Treatment in the Emergency Department (SMART-ED)” protocol (CTN-0047). The SMART-ED trial presented unique challenges because of its ED setting. Several implementation components were particularly important in the SMART-ED trial: 1. Site selection (ED department and staff buy-in was central to decisions on which sites were chosen to participate); 2. Staff selection (interventionists/RAs needed to possess the empathy necessary to deliver an motivational interviewing-based intervention); 3. RA and interventionist training and ongoing coaching (in-person and webinar trainings ensured that research staff understood and were able to follow protocol procedures and be certified to deliver the intervention. Ongoing telephone coaching is successful in preventing drift); 4. Site preparation (prior to beginning the main trial, each site also had real-world practice conducting study procedures through standardized patient visits); 5. Data collection (the screening data is collected using direct entry into tablet computers to facilitate rapid screening and mobility within the ED setting). In conclusion, some of the procedures used in this clinical trial may be useful in the successful implementation of future addiction trials conducted in medical settings.
Related protocols: CTN-0047Download audio (mp3) | Download slides (pdf)
This two-hour webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, discusses the methodology and common findings from recent standard participant/standardized patient (SP) walkthroughs prior to the launch of many CTN trials. Viewers will learn valuable implementation and operational recommendations for improving on-site practices, and gain a better understanding of how SP walkthroughs can improve standard operating procedures by testing them in practice.
The target audience is CTN members and other researchers and clinicians who are interested in the use of standardized participant/patients in their protocols.
Presented by Lynn Kunkel, MS, CCRP and Holly Fussell, PhD, Oregon Health & Science University, WS Node.
Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation. The objective of this study was to examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials. Actors portrayed clients and “walked through” study procedures with protocol research staff (the study completed 57 walkthroughs during implementation of four clinical trials). Observers and walkthrough participants then identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns.
Conclusions: Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership can modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.
Few empirical studies are available to guide best practices for transferring evidence-based treatments to community substance abuse providers. To maximize the learning and maintenance of new clinical skills, this study tested a context-tailored training (CTT) model, which used standardized patient actors in role-plays tailored to agency clinical context, repetitive cycles of practice and feedback, and enhanced organizational support. This study reports the results of a randomized pilot evaluation of CTT for motivational interviewing (MI). Investigators randomly assigned community substance abuse treatment agencies, all of which had previously participated in the National Drug Abuse Treatment Clinical Trials Network (CTN), to receive either CTT or a standard 2-day MI workshop. The study also evaluated the effects of counselor-level and organizational-level variables on the learning of MI. No between-condition differences were observed on the acquisition and maintenance of MI skills despite reported higher satisfaction with the more costly context-tailored model. Analyses revealed that those counselors with more formal education and less endorsement of a disease model of addiction made the greatest gains in MI skills, irrespective of training condition. Similarly, agencies whose individual counselors viewed their organization as being more open to change and less supportive of autonomy showed greater average staff gains in MI skills, again, irrespective of training method. Post-training activities within agencies that supported the ongoing learning and implementation of MI mediated the effects of organizational openness to change.
This pilot study suggests that tailored training methods may not produce better outcomes than traditional workshops for the acquisition of evidence-based practice, and that efforts to enhance skill acquisition can be focused on characteristics of learners and ongoing organizational support of learning.
This article describes a standardized patient (SP) walk-through to facilitate implementation of a clinical trial within the National Drug Abuse Treatment Clinical Trials Network (CTN). SPs are actors trained to portray a set of symptoms consistently across interactions with multiple clinicians. The Oregon/Hawaii Node of the CTN employed one SP to pilot participant screening processes in a study testing a combined pharmacological and behavioral therapy for women and men dependent on prescription opioid analgesics (CTN-0030, Prescription Opiate Addiction Treatment Study (POATS)). The SP mimicked an individual seeking treatment and “walked” through study intake processes. Findings such as study staff members’ inadequacy in describing issues of patient confidentiality and problems explaining the Health Insurance Portability and Accountability Act led to modifications to the clinical implementation of the study. Research coordinators and the staff found the use of an SP to be highly effective, and the Node is now making routine use of SPs in the implementation of CTN protocols.
Related protocols: CTN-0030
Training efforts for evidenced-based treatments require evaluation, yet the value of practitioner self-reports of skills acquisition has been questioned. Thus, a key issue concerns how accurately practitioners assess their own clinical skills. In this CTN platform study, 23 community practitioners that had previously participated in the National Drug Abuse Treatment Clinical Trials Network (CTN) took part in training of Motivational Interviewing (MI), completed standardized patient (SP) interviews before and after training, and provided self-ratings of MI elements after each interview. Interview recordings were later coded independently.
Results suggest training contributed to: 1) reasonable agreement between practitioner and independent ratings; and 2) more effective use of MI, despite a tendency for practitioners to underestimate training gains. This micro-analysis of training documents initials skill gains along with increased practitioner self-awareness. Further, it exemplifies how practitioner self-ratings and objective skill assessment methods may be used in tandem to more fully describe practitioner learning. And, in so doing, perhaps it provides a fuller picture of how the image in the looking glass changes as practitioners consider and explore, understand and appreciate, practice and self-evaluate, and adopt and adapt the spirit and techniques of this therapeutic approach.
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-0029 (“A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers with ADHD”) and CTN-0030 (“Prescription Opioid Addiction Treatment Study (POATS)”). The SP portrayed an individual seeking treatment and “walked” through the study intake process, including being interviewed by research assistants and study medical staff.
The poster describes the SPs and the roles they played in each protocol, then details the observations and suggested procedural changes that emerged as a result. In conclusion, the poster reports that 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, or testing client responsiveness in treatment and prevention services.
Related protocols: CTN-0029, CTN-0030
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-0029 (“A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers with ADHD”). The SP portrayed an individual seeking treatment and “walked” through the study intake process, including being interviewed by research assistants and study medical staff. The poster describes the SP and the role he played in the protocol, then details the modifications made to the protocol as the result of his experiences.
In conclusion, the poster reports that applying SP technology as a pilot of the implementation of clinical trials in substance abuse resulted in positive reactions from research and Node staff. In addition, it 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 the success of this pilot implementation, there is evidence to suggest that SP technology could be applied in other settings such as training in a wide range of human services, or testing client responsiveness in treatment and prevention services.
Related protocols: CTN-0029