Transcript Document

IMPLEMENTING ADDICTION TREATMENT TRIALS IN MEDICAL SETTINGS IN (NIDA’S)
NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK
A.A. Forcehimes1, M.P. Bogenschutz.1, D.M. Donovan2, C. Crandall1, R. Lindblad3 , R. Mandler4, H.I Perl4, R. Walker5
UNIVERSITY of WASHINGTON
ADAI
________
Alcohol &
Drug
Abuse
Institute_
INTRODUCTION
1University
of New Mexico Center on Alcoholism, Substance Abuse, & Addictions
2University of Washington
3EMMES
4National Institute on Drug Abuse
5 UT Southwestern Medical Center
2. Staff selection
4. Site preparation
A recent National Institute on Drug Abuse (NIDA) Clinical Trials
We suggested hiring interventionists/research assistants who:
• Were capable of being flexible and adaptable in a fast-paced setting where
Network (CTN) priority is to integrate addiction treatment into medical
interruptions are common and unavoidable.
care to reach many who would otherwise never receive attention. In
• Possessed the empathy necessary to deliver an MI based intervention and the
these environments, where need far exceeds availability of services,
research skills necessary for protocol adherence.
implementing addiction treatment allows more opportunistic case
finding and intervention and decreases the burden on the medical system 3. RA and interventionist training and ongoing coaching
Here we describe the implementation process of the first CTN trial
•Protocol Training
conducted in a health care setting.
We utilized pre-training webinars, a 2-day in person centralized training that
included didactic presentation, demonstrations, and opportunities to practice key
METHOD
skills; post-training webinars; role plays at the site level; and weekly calls with
The CTN Screening, Motivational Assessment, Referral and Treatment
the lead team to discuss operational issues.
in the Emergency Department protocol (SMART-ED) is examining
substance use and substance-related outcomes among patients (N=1285) •Brief/Booster Intervention Training
endorsing, but not explicitly seeking treatment for, problematic drug use Interventionists attended a local 2-day pre-training in patient-centered
during an emergency department (ED) visit who are randomly assigned counseling skills as well as a centralized 2-day training in the specific content of
to one of three treatment conditions: 1) minimal screening only (MSO); the motivational enhancement therapy intervention, conducted by trainers who
2) screening, assessment, and referral to treatment (if indicated) (SAR); are part of the Motivational Interviewing Network of Trainers (MINT).These inand 3) screening, assessment, and referral plus a brief intervention (BI) person trainings included didactic presentation and role-playing. Interventionists
completed role-plays with other RAs/Interventionists at their sites, and then
with two telephone follow-up booster sessions (BI-B).
completed two pilot sessions with ED patients who met criteria for enrollment.
Six EDs across the United States served as recruitment/brief
These sessions were coded (Motivational Interviewing Treatment Integrity
intervention sites for this protocol. The SMART-ED trial presented
(MITI) Code v3.1.1) and scores of 4 or better on the MITI global scores resulted
unique challenges because of the fast pace and competing urgent and
in interventionist certification. Interventionists also participated in two postemergent priorities in an ED setting. This was a shift from other CTN
training webinars.
trials, which have been conducted in traditional addiction treatment
•Ongoing Coaching
settings.
Because counselors who attend only a 2-day motivational interviewing training
RESULTS
without ongoing coaching and training often drift, it was important to implement
Five implementation components were of central importance.
ongoing fidelity monitoring and coding. The diagram below offers a visual
1. Site Selection
representation of the roles and interaction between the fidelity monitoring center
and supervision center used in this trial.
Prior to distributing the site selection survey, we developed list of
desirable characteristics of participating EDs, including
• Large volume of patients who use drugs
• Prior research experience
• Ability to present a convincing plan for patient flow and space utilization
• Have/Able to hire appropriate staff to conduct the study (in conjunction
with the CTN-affiliated university research center)
• Have an ED physician who can serve as protocol PI or otherwise be
actively involved in the protocol
Certification and Monitoring Center
Lead Node (LN)-Albuquerque, NM
1. Certification of BI-B interventionists
2. Monitored 14% of interventionists’ sessions during trial
(MITI and content) and uploaded scores for clinical
As needed,
supervisor review
the supervisor of the
3. Red-lined interventionists with significant drift
Centralized Monitoring
We received 17 survey responses from 14 CTN nodes
• Nodes made connections with EDs in their region (usually through
university departmental contacts) and described what the CTN is,
possibility of participating in a study, and expectations of participating
sites.
• Most were large EDs with academic affiliation and research experience.
• Sites reported an average of 447 patients potentially eligible per month.
• There was variability with regard to department and ED staff buy-in, ED
physician involvement, and commitment of leadership.
Evaluations were completed by executive committee members and
telephone interviews were conducted with the 11 contender sites.
The team conducted site visits at 8 highly evaluated EDs.
Site visit information was brought back to the executive committee, and
final decisions on site selection were made.
Brief
Interventionists
Housed at 6
participating EDs
Centralized Clinical Supervision Center
Co-Lead Node (Co-LN)-Seattle, WA
1. Reviewed 1 session per interventionist per week
(content coding only)
2. Reviewed uploaded MITI scores completed by
Monitoring Center
to use during supervision sessions
3. Conducted bi-weekly telephone supervision
with all BI-B interventionists
Center communicated
directly with Centralized
Clinical Supervisors to
provide feedback with
regard to a specific
interventionist.
Prior to beginning the main trial, each site had practice conducting
study procedures through standardized patient (SP) visits.
• This practice improved RA/Interventionist confidence and allowed sites to
troubleshoot any problems in conducting the protocol procedures.
• At the end of the visit, the SP team debriefed with the team and discussed
areas in need of improvement.
• Detailed written feedback was then sent to the lead team as evidence that
the site was prepared to begin main trial recruitment.
5. Data collection
Screening data were collected by the RA and by participant self-report.
• A centralized web-based system allowed direct data entry into tablet
computers. No data were stored on the tablets.
• This facilitated rapid screening and mobility in the ED setting and
enhanced privacy for study participants.
• This data capture system also allowed remote booster interventionists to
access baseline questionnaires and session documentation.
DISCUSSION
The CTN has successfully implemented its first trial in an ED setting.
Factors associated with the effective implementation of SMART-ED:
• ED physician and staff buy-in was central to decisions on which sites were
chosen to participate.
• Interventionists/RAs needed to possess the empathy necessary to deliver
an MI based intervention, research abilities necessary for protocol
adherence and the ability to navigate busy EDs.
• 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 successfully prevented drift.
• Prior to beginning the main trial, each site also had real-world practice
conducting study procedures through standardized patient visits.
• The screening data are collected using direct entry into tablet computers
to facilitate rapid screening and mobility within the ED setting.
More general recommendations for successfully implementing SBIRT
in an ED setting are:
• Ensure that there are leadership champions and buy-in at all
organizational levels.
• Well trained staff are critical: they must be able to follow protocol
procedures and “fit” in the ED setting.
• Devote substantial attention and necessary resources to training and other
pre-implementation efforts.
• Use ongoing coaching to prevent drift in delivery of the brief
intervention/booster interventions.
• Effective use of technology can be very beneficial.
Finally, we note that some of the procedures used in this clinical trial
may be useful in the successful implementation of future addiction trials
conducted in medical settings.
Booster Telephone
Interventionists
Housed at Co-LN
ACKNOWLEDGEMENTS
This research was supported by National Drug Abuse Treatment
Clinical Trials Network.