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Abstract: Clinical trial recruitment and retention of individuals who use substances are challenging in any setting and can be particularly difficult in emergency department (ED) settings. This article discusses strategies for optimizing recruitment and retention in substance use research conducted in EDs. Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED, CTN-0047) was a National Drug Abuse Treatment Clinical Trials Network (CTN) protocol designed to assess the impact of a brief intervention with individuals screening positive for moderate to severe problems related to use of non-alcohol, non-nicotine drugs. We implemented a multisite, randomized clinical trial at six academic EDs in the United States and leveraged a variety of methods to successfully recruit and retain study participants throughout the 12-month study course. Recruitment and retention success is attributed to appropriate site selection, leveraging technology, and gathering adequate contact information from participants at their initial study visit. The SMART-ED recruited 1,285 adult ED patients and attained follow-up rates of 88%, 86%, and 81% at the 3-, 6-, and 12-month follow-up periods, respectively. Participant retention protocols and practices were key tools in this longitudinal study that required continuous monitoring, innovation, and adaptation to ensure strategies remained culturally sensitive and context appropriate through the duration of the study. Conclusions: Tailored strategies that consider the demographic characteristics and region of recruitment and retention are necessary for ED-based longitudinal studies involving patients with substance use disorders. Related protocols: CTN-0047

Abstract:

This is the second of a series of discussions pertaining to CTN collaborations with CSAT. This webinar will consist of two presentations on updates on OUD treatment for youth and updates on screening and interventions in pediatric medical settings.

The webinar’s agenda was as follows:

12:00 – 12:15 pm:
CSAT’s Director, Dr. Kimberly Johnson will speak on the current state of adolescent services at CSAT. [view slides]

12:15 – 12:45 pm:
Dr. Marc Fishman will provide Updates on Opioid Use Disorder (OUD) Treatment for Youth. [view slides]

12:45 – 1:15 pm:
Dr. Sharon Levy will provide Updates on Screening and Interventions in Pediatric Medical Settings. [view slides]

1:15 – 1:30 pm:
Questions and answers.

Abstract:

This is the primary outcomes article for CTN-0047.

Medical treatment settings such as emergency departments (EDs) present important opportunities to address problematic substance use. Currently, EDs do not typically intervene beyond acute medical stabilization. This study aimed to contrast the effects of a brief intervention with telephone boosters (BI-B) with those of screening, assessment, and referral to treatment (SAR) and minimal screening only (MSO) among drug-using ED patients. Between October 2010 and February 2012, 1285 adult ED patients from 6 US academic hospitals, who scored 3 or greater on the 10-item Drug Abuse Screening Test (indicating moderate to severe problems related to drug use) and who were currently using drugs, were randomized to MSO (n=431), SAR (n=427), or BI-B (n=427). Follow-up assessment were conducted at 3, 6, and 12 months by blinded interviewers. Following screening, MSO participants received only an informational pamphlet; SAR participants received assessment plus referral to addiction treatment if indicated, and BI-B participants received assessment and referral as in SAR, plus a manual-guided counseling session based on motivational interviewing principles and up to 2 “booster” sessions by telephone during the month following the ED visit. Outcomes evaluated at follow-up visits included self-reported days using the patient-defined primary problem drug, days using any drug, days of heavy drinking, and drug use based on analysis of hair samples. The primary outcome was self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up.

Follow-up rates were 89%, 86%, and 81% at 3, 6, and 12 months, respectively. There were no significant differences between groups in self-reported days using the primary drug, days using any drug, or heavy drinking days at 3, 6, or 12 months. At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280, 95%) than did participants in the MSO group (253 or 287, 88%) or the BI-B group (244 of 275, 89%). Hair analysis differences between groups at other time points were not significant.

Conclusions: The findings of this study suggest that even a relatively robust brief intervention such as the one implemented in this trial is unlikely to be useful as a general strategy for the population recruited for this trial (ED patients with relatively severe drug problems and other life challenges). Further research will be needed to explore more intensive interventions targeting the most severely affected patients with substance use disorder visiting the ED and to ascertain whether screening and brief interventions play a useful roll in the treatment of ED patients less severely affected by drug use disorders.

Related protocols: CTN-0047

Abstract:

Post-visit “booster” sessions have been recommended to augment the impact of brief interventions delivered in the emergency department (ED). This paper, which focuses on implementation issues, presents descriptive information and interventionists’ qualitative perspectives on providing brief motivational interviewing-based interventions over the phone, challenges, “lessons learned,” and recommendations for others attempting to implement adjunctive booster calls.

In the National Drug Abuse Treatment Clinical Trials Network study, “Screening Motivational Assessment and Referral to Treatment in Emergency Departments” (SMART-ED), attempts were made to complete two 20-minute telephone “booster” calls within a week following a patient’s ED discharge with 425 patients who screened positive for and had recent problematic substance use other than alcohol or nicotine. Over half (56.2%) of participants completed the initial call; 66.9% of those who received the initial call also completed the second call. Median number of attempts to successfully contact participants for the first and second calls was 4 and 3, respectively. Each completed call lasted an average of about 22 minutes. Common challenges/barriers identified by booster callers included unstable housing, limited phone access, unavailability due to additional treatment, lack of compensation for booster calls, and booster calls coming from an area code different than the participants’ locale and from someone other than ED staff, which some participants found confusing and suspicious.

Conclusions: The results of this inquiry demonstrate that a team of booster interventionists and supporting staff can overcome the challenges in implementing a remotely located, centralized booster call center. Specific recommendations are presented with respect to implementing a successful system. Future use of booster calls might be informed by research on contingency management (e.g., incentivizing call completions, which could help address the barrier related to lack of remuneration), smoking cessation quitlines, and phone-based continuing care for substance abuse patients. Future research needs to evaluate the incremental benefit of adjunctive booster calls on outcomes over and above that of brief motivational interventions delivered in the emergency department setting.

Related protocols: CTN-0047

Abstract:

Drug-related emergency department (ED) visits have steadily increased, with substance users relying heavily on the ED for medical care. This secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0047 (Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)) aimed to identify clinical correlates of problematic drug use that would facilitate identification of ED patients in need of substance use treatment.

Using previously validated tests, 15,224 adult ED patients across 6 academic institutions were prescreened for drug use as part of a large randomized prospective trial. Data for 3,240 participants who reported drug use in the past 30 days were included. Self-reported variables related to demographics, substance use, and ED visit were examined to determine their correlative value for problematic drug use. Of the 3,240 patients, 2,084 (64.3%) met criteria for problematic drug use (Drug Abuse Screening Test score >= 3). Age greater than or equal to 30 years, tobacco smoking, daily or binge alcohol drinking, daily drug use, primary noncannabis drug use, resource-intense ED triage level, and perceived drug-relatedness of ED visit were highly correlated with problematic drug use. Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use. A brief clinical decision tool, developed as part of this study, demonstrated an 88% positive predictive value and would allow clinicians to more rapidly determine whether detailed assessment for a drug problem is indicated in a patient who has used any drug in the past 30 days.

Conclusions: The higher emergency department utilization and hospital admission rates among ED patients with unmet substance abuse treatment needs argue for greater attention to the development of multidisciplinary, cost-effective ways to support ED-based substance use screening, intervention, and referral to treatment. The correlation between problematic drug use and resource-intense ED triage levels in this analysis offers further evidence that ED patients with unmet substance abuse treatment needs incur higher health care costs than their counterparts, and highlights the potential opportunity for decreasing overall health care cost by identifying those patients who are at highest risk of problematic drug use and referring them to treatment. The screening and clinical decision rule proposed here provides a rapid and simple method of identifying patients on whom more comprehensive ED-based SBIRT should be focused as part of emergency care practice. This research and future cost-effectiveness research could inform policy and resource allocation for the advancement of ED-based drug abuse mitigating-activities.

Related protocols: CTN-0047

Abstract:

The prevalence of alcohol, tobacco, and other drug (ATOD) use among emergency department (ED) patients is high and many of these patients have unrecognized and unmet substance use treatment needs. Identification of patients in the ED with problem substance use is not routine at this time. In this study, investigators examined screening data, including standardized measures of ATOD use (HSI, AUDIT-C, DAST-10), from 14,866 ED patients in six hospitals across the United States participating in the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0047 (“Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)”). Younger age, male gender, higher triage acuity, and other substance use severity were expected to be associated both with use versus abstinence and with severity of each substance use type. Negative binomial hurdle models were used to examine the association between covariates and these two elements.

Rates of use and problem use in the study sample were similar to or higher than in other ED samples. Younger patients and males were more likely to use ATOD, but the association of age and gender with severity varied across substances. Triage level was a poor predictor of substance use severity. Alcohol, tobacco, and drug use were significantly associated with using other substances and severity of other substance use.

Conclusions: Better understanding of the demographic correlates of ATOD use and severity and the patterns of comorbidity among classes of substance can inform the design of optimal screening and brief intervention procedures addressing ATOD use among ED patients. Tobacco may be an especially useful predictor.

Related protocols: CTN-0047

Abstract:

Interventionists (N=30, 11 male, 19 female) involved in the six-site National Drug Abuse Treatment Clinical Trials Network Screening, Motivational Assessment, Referral and Treatment in Emergency Departments (SMART-ED) protocol (CTN-0047) delivered 30-minute motivational enhancement therapy-based brief interventions (BI) to patients presenting with problematic substance use during an ED visit. Following the treatment phase of this study, we gathered information on themes in session content that interventionists identified as recurrent. This poster presents descriptive information regarding BI session content. Interventionists completed a survey that included questions on demographics, affiliated ED, and estimates of the number of interventions delivered. Respondents were asked to describe themes that stood out to them during their sessions as well as to list themes they noticed across different domains (e.g., gender differences). A qualitative approach was used to code and analyze responses. Twenty-one interventionists (70%) completed the survey. Respondents reported completing an average of 16-20 sessions during the trial. Five interventionists responded that patients seemed highly ambivalent about making a change in their substance use. Eight reported that most patients did not see their ED visit as related to their substance use. Fifteen interventionists found that patients viewed opioid and IV drug use as more severe/in need of change than marijuana use, although severity and consequences scores were roughly equivalent for these drugs classes. Four interventionists noted that females tended to be more aware of and affected by consequences related to their substance use, despite having lower rates of consumption. Finally, six interventionists reported that patients who had previous exposure to treatment were more open to discussions about their substance use.

Conclusions: Interventionists identified recurrent themes noticed during the delivery of the brief intervention. Knowledge of these themes may be useful to those providing substance use interventions in an ED setting.

Related protocols: CTN-0047

Abstract:

Implementation of a complex clinical trial in the emergency department (ED) is challenging, as the value of rigorous assessment and internal validity must be balanced against practical constraints of the setting. This presentation describes key features of implementation in the ED for the National Drug Abuse Treatment Clinical Trials Network’s “Screening Motivational Assessment and Referral to Treatment in Emergency Departments” (SMART-ED, CTN-0047) study, including staffing, timing of assessments, integration with the ED, screening procedures and data collection, and provides baseline data on the screened and randomized samples, including drug and alcohol use data and demographic characteristics. Participants were screened using a composite measure including items from the Heavy Smoking Index, the AUDIT-C, and the DAST-10. Participants were excluded unless they had a DAST score of 3 or more and reported use of their self-identified primary problem substance in the past 30 days. Participants in the SAR and BI-B groups received further assessment using the NM-ASSIST and time-line follow-back. Hair testing was used as an objective measure of substance use. 14,972 participants completed the screening instrument, of whom 4005 (27%) reported past 30-day drug use and 1285 (8.6%) were randomized. Within the randomized sample, primary problem substances were cannabis (44%), cocaine (27%), opioids (22%), methamphetamine (4%), sedatives-hypnotics (2%), and hallucinogens (1%). These frequencies varied markedly among the six sites. Participants used their primary substance an average of 16 out of the past 30 days. Of the randomized participants, 70% were male, and mean age was 36 +/- 12. Fifty-percent where white, 35% were black, and 24% were Hispanic. Educational level was low, with 32% having 1-11 years of schooling and only 9% being college graduates. Only 9% were married, 19% had full-time jobs, and 42% were unemployed. 63% had household incomes below $15,000.

Conclusions: Study procedures identified a sample that was diverse with respect to substance of abuse and ethnicity, used drugs frequently, and had very low socioeconomic status.

Related protocols: CTN-0047

Abstract:

Effective training and ongoing coaching in psychosocial treatment modalities is critical to maintaining fidelity in both research and practice. Maintaining fidelity may be particularly challenging in emergency department settings due to the fast pace and competing urgent and emergent priorities. This presentation describes intervention training, certification, supervision and fidelity monitoring procedures used in the NIDA CTN six-site “Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)” study. Interventionists received a 2-day training in basic motivational interviewing skills, followed 1 month later by a 2-day training in the specific intervention used in this trial. Practice sessions with consenting ED patients were reviewed by expert raters, using the Motivational Interviewing Treatment Integrity scale (MITI, v.3.1.1), to determine if interventionists had reached benchmark scores and were therefore certifiable. Clinical supervision of interventionists was conducted independently of fidelity monitoring; centralized fidelity monitors reviewed 12% (n=96) of interventionists’ sessions and reported MITI scores to clinical supervisors to offer objective feedback regarding their supervisee’s performance. Clinical supervisors conducted bi-weekly phone supervision, discussing MI fidelity and clinical issues. Following completion of the trial, 20% of the interventionist sessions (n=161), of which 30% (n=55) were coded by two independent raters to assess inter-rater reliability, were randomly selected and coded for overall trial fidelity. Participating interventionists were 21 females and 12 males with little experience in addiction counseling (M=1.58 +/- 2.5 years). Fidelity monitoring during the trial successfully prevented drift and identified only one interventionist in need of remedial supervision. Bi-weekly coaching continued throughout the trial and interventionists found these sessions useful in maintaining their skills. Results from fidelity monitoring indicate above average performance on MITI scores.

Conclusions: The two-stage interventionist training, bi-weekly supervision, and ongoing monitoring produced excellent results and prevented drift. This model may bestow an advantage for learning and implementing brief interventions based on an MI approach.

Related protocols: CTN-0047

Abstract:

Medical settings such as emergency departments (EDs) present an opportunity to identify and provide services for individuals with substance use problems who might otherwise never receive any form of assessment, referral, or intervention. Although Screening, Brief Intervention, and Referral to Treatment (SBIRT) models have been extensively studied and are considered effective for individuals with alcohol problems presenting in emergency departments and other medical settings, there is much less evidence concerning the efficacy of such interventions for drug users presenting in EDs. This presentation describes the design of the National Drug Abuse Treatment Clinical Trials Network protocol “Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)” (CTN-0047), with a focus on the screening, assessment, treatment conditions, and follow-up procedures. 1285 patients who screened positive for current problematic substance use were randomly assigned to: (1) Minimal screen only (MSO), (2) Screening, assessment, and referral to treatment (if indicated) (SAR); or (3) Screening, assessment, and referral plus a brief intervention (BI) with two telephone follow-up booster calls (BI-B). BI-B therapists received considerable training, ongoing supervision and formal fidelity monitoring. The three-arm design was implemented to control for assessment reactivity. Sites recruited an average of approximately 21 participants per site per month. Treatment exposure was nearly universal for the initial BI, but a significant number of participants could not be reached for one or both of the booster sessions. Although follow-up is ongoing, current rates of follow-up exceed those specified in the analysis plan.

Conclusions: The study was completed on time, with good treatment exposure, strong attention to treatment fidelity, and excellent follow-up rates. Study outcomes should provide strong evidence regarding the efficacy of this brief intervention strategy for drug users presenting in medical EDs.

Related protocols: CTN-0047

Abstract:

Hospital emergency departments (EDs) are receiving increased attention as venues for addiction treatment (Cherpitel et al., 2010; Vaca et al., 2011). Brief interventions in the ED may be effective and economical and reach those who might not seek treatment in traditional addiction treatment settings. However, provision of brief intervention in the ED requires consideration of several factors in order to be implemented successfully. This poster offers the interventionists’ perspectives on the complexities of providing a brief intervention in a medical ED setting. The University of New Mexico Hospital Emergency Department served as one of six sites in the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) Screening, Motivational Assessment, Referral and Treatment (SMART-ED) (protocol CTN-0047). Following completion of the active phase of treatment, the interventionists described the unique challenges and lessons learned. Three themes emerged in our exploration of the challenges involved in conducting screening, assessment, and brief intervention using motivational interviewing (MI). (1) Challenges inherent in the nature of the emergency department including patient flow, availability of space, frequent interruptions, privacy and confidentiality, and patient acuity. (2) Maintaining focus on addictions in the face of competing priorities, including medical reasons for ED visit and other psychosocial/ mental health needs. (3) Using MI techniques appropriately during intervention, and not using them during screening and assessment. There are many complexities involved in providing brief addiction intervention in the ED. Understanding and preparing for these challenges is critical to the successful implementation of addiction treatment programs or research aiming to implement brief interventions in this environment.

Related protocols: CTN-0047

Abstract:

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-0047

Abstract:

Screening, brief intervention, and referral to treatment (SBIRT) approaches to reducing hazardous alcohol and illicit drug use have been assessed in a variety of health care settings, including primary care, trauma centers, and emergency departments. A major methodological concern in these trials, however, is “assessment reactivity,” the hypothesized impact of intensive research assessments to reduce alcohol and drug use and thus mask the purported efficacy of the interventions under scrutiny. Thus, it has been recommended that prospective research designs take assessment reactivity into account. This article describes the design of the National Drug Abuse Treatment Clinical Trials Network (CTN) protocol, “Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED, CTN-0047), which addresses the potential bias of assessment reactivity using a 3-arm design. Following an initial brief screening, individuals identified as positive cases are consented, asked to provide demographic and locator information, and randomly assigned to one of the three conditions: minimal screening only, screening + assessment, or screening + assessment + brief intervention. In a two-stage process, the randomization procedure first reveals whether or not the participant will bein the minimal-screening-only condition. Participants in the other two groups receive a more extensive baseline assessment before it is revealed whether they have been randomized to also receive a brief intervention. Comparing the screening only and screening + assessment conditions will allow determination of the incremental effect of assessment reactivity.

Assessment reactivity is a potential source of bias that may reduce and/or lead to an underestimation of the purported effectiveness of brief interventions. From a methodological perspective, it needs to be accounted for in research design. The SMART-ED design offers an approach to minimize assessment reactivity as a potential source of bias. Elucidating the role of assessment reactivity may offer insights into the mechanisms underlying SBIRT as well as suggest clinical options incorporating assessment reactivity as a treatment adjunct.

Related protocols: CTN-0047

Abstract:

For reasons of safety and effectiveness, many forces in health care, especially the Affordable Care Act of 2010, are pressing for improved identification and management of substance use disorders within mainstream health care. Thus, standard information about patient substance use will have to be collected and used by providers within the electronic health record systems (EHRS). Although there are many important technical, legal, and patient confidentiality issues that must be dealt with to achieve integration, this article focuses upon efforts by the National Institute on Drug Abuse and other federal agencies to develop a common set of core questions to screen, diagnose, and initiate treatment for substance use disorders as part of national EHRS. As part of this effort, NIDA tasked its Clinical Trials Network (CTN) to lead the initiative to develop a set of standard common data elements (CDEs) that could become part of the EHRS, with the goal of helping to foster research on, and advance the practice of, screening, brief intervention, and referral to treatment (SBIRT) for patients with substance use problems. This article discusses the background and rationale for these efforts and presents the work to date to identify the questions and to promote information sharing among health care providers.

An article summarizing this paper, “Substance use must be included in electronic patient records: Study,” was published in the January 23 issue of Alcohol & Drug Abuse Weekly (vol. 24, issue 4). A response to that piece, “Commentary: CSAT’S Clark rebuts McLellan-Tai article,” was published the following week in ADAW, vol. 24, issue 5. To request these pieces, please email the Library at info@ctndisseminationlibrary.org.

Abstract:

This collection of presentations from the 8th International Network on Brief Interventions for Alcohol Problems (INEBRIA) conference begins with an introduction by Harold Perl of the Center for the Clinical Trials Network at NIDA, providing an overview of the mission of the CTN and information on how to access the CTN Dissemination Library.

Dan Fischer’s presentation follows, with a review of the research on Screening, Brief Intervention, Referral to Treatment (SBIRT) intervention design, outcomes, implementation, and cost benefits.

Next, Dennis Donovan’s slides describe the study design for SMART-ED (Screening, Motivational Assessment and Referral to Treatment in Emergency Departments), the CTN’s protocol evaluating the use of SBIRT for drug use patients presenting for treatment in the emergency department.

Alyssa Forcehimes’s presentation looks at factors associated with effective implementation of SBIRT delivered in an emergency room setting.

And closing out the symposium is Michael Bogenschutz, reviewing the screening tools and procedures used in SMART-ED to identify problematic substance users in medical emergency departments.

Related protocols: CTN-0047