1. Dennis M. Donovan, Ph.D., Michael P. Bogenschutz, M.D., Harold Perl, Ph.D., Alyssa Forcehimes, Ph.D., Bryon Adinoff, M.D., Raul Mandler, M.D., Neal Oden, Ph.D. INEBRIA Conference Boston, MA September 23, 2011

2. Background  Questions have been raised in screening and brief intervention research concerning the potential role that the assessment process may serve as an active form of intervention that contributes to behavior change.

3. Background  Assessment Reactivity (AR) is a process by which increasing an individual’s awareness of potential problem areas by targeted and extensive assessment may initiate behavior change in the absence of feedback or intervention.

4. Background  Assessment may have a positive therapeutic effect and contribute to the change process (Shrimsher & Filtz, 2011).  However, assessment reactivity may reduce the effect between active interventions and “inactive” control conditions and conceal therapeutic benefit (Kypri, et al., 2006).  “AR should be considered in any analysis targeting treatment outcomes” (Kaminer, et al., 2008)

5. Findings Concerning the Impact of Assessment Reactivity: Heavy Drinking College Students StudiesReactivity Observed Reactivity Not Observed Kypri, et al., 2006 + Walters, et al., 2009 + McCambridge & Day, 2007 +

6. Findings Concerning the Impact of Assessment Reactivity: Individuals in Alcohol Treatment StudiesReactivity Observed Reactivity Not Observed Epstein, et al., 2005 + Kaminer, et al., 2008 + In addition, both studies found that reductions in drinking/drug use between intake assessment and first therapy session predicted better treatment outcomes.

7. Prior Designs in ED SBIRT Studies  Most previous SBIRT trials have not been designed in such a way to disaggregate the impact of assessment versus the combined effect of assessment plus brief intervention.

8. Prior and More Recent Emergency Department SBIRT Designs Prior Designs in ED SBIRT Studies Recent Designs in ED SBIRT Studies Screen Randomization Assessment Control Assessment + Intervention Screen Randomization Assessment Control Screen-Only Control Assessment + Intervention

9. Findings Concerning the Impact of Assessment Reactivity: At-Risk Drinkers in EDs StudiesReactivity Observed Reactivity Not Observed Daeppen,et al., 2007 + Cherpitel, et al., 2010 +

10. Findings Concerning the Impact of Assessment Reactivity: Young Heavy Marijuana Users in EDs StudiesReactivity Observed Reactivity Not Observed Bernstein, et al., 2009 + Compared a screen+assessment condition to a screen-only condition at 12-month follow-up. No significant differences found, although the screen-only group was smoking 4 fewer days per month than the screen+assessment group.

11. SMART-ED Primary Objective  To contrast substance use and related outcomes among substance abusing ED patients randomly assigned to  1) minimal screening 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).

12. SMART-ED Design Overview Screen with TAD Consent if screen positive Two-stage randomization (MSO – Yes/No; if No, then SAR or BI-B) Brief Intervention MSO Info only Two telephone Booster sessions 6-month follow-up 12-month follow-up 3-month follow-up (Primary outcome) Demographics, locator, hair sample SAR Assessment +/- Referral BI-B Assessment +/- Referral

13. SMART-ED Primary Hypothesis  Primary outcome is days of use of the primary substance in the 30 days prior to the 3-month follow-up.  Hypotheses:  BI-B < SAR  BI-B < MSO  SAR < MSO

14. Benefits of SMART-ED Design  Screening and assessment measures are relatively brief in order to minimize participant burden and assessment reactivity.  Allows evaluation of the impact of assessment as an independent factor over and above minimal screening (SAR versus MSO)  Allows evaluation of the incremental benefit of the brief intervention with booster calls over and above assessment without the brief intervention (BI-B versus SAR).

15. Conclusion  Assessment reactivity is of concern, especially in studies of brief interventions, because it may reduce the effect size and conceal therapeutic benefit.  On the other hand, if found to contribute independently to the change process, assessments could be designed to maximize the therapeutic benefit they provide.

16. Conclusion  The influence of assessment reactivity in ED SBIRT studies, especially those targeting drug use rather than alcohol, is still in need of further investigation.  The design used in the SMART-ED trial will allow an evaluation of the independent and incremental contribution of the assessment process to behavior change.

18. Findings Concerning the Impact of Assessment Reactivity  Epstein, et al., 2005: Alcoholic women received a brief telephone screen, a 90-minute intake assessment with their spouses, and then a 3- to 4-hour baseline research interview. Reductions in drinking frequency occurred at all four points in the pretreatment assessment process, resulting in 44% of the participants becoming abstinent before the first session of treatment.  Kaminer, et al., 2008: Adolescent substance abusers had a significant shift from alcohol and drug use to non-use status between an initial intake assessment and an initial therapy session.  Both studies found that reductions in drinking/drug use between intake assessment and first therapy session predicted better treatment outcomes.

19. Findings Concerning the Impact of Assessment Reactivity  Kypri, et al, 2006, found that heavy drinking college students who received an alcohol facts and effects leaflet followed by a more thorough assessment 4 weeks later had lower levels of total consumption, heavy episodic drinking, personal problems, and AUDIT scores at 12- month follow-up compared to a group receiving the leaflet without subsequent assessment.  Walters, et al., 2009, found that heavy drinking college students who received an alcohol assessment immediately following screening and at 3,6, and 12- month follow-ups had better drinking-related outcomes than students who were only assessed at the 12-month post-screening follow-up.

20. Recent Designs in ED SBIRT Studies  Daeppen,et al., 2007: No differences in reduction to low- risk drinking or in other parameters of drinking behavior among hazardous drinkers randomized to a 10-15 brief alcohol intervention, screen+assessment, or screen-only control conditions at a 12-month follow-up  Cherpitel, et al., 2010: No differences between screen- only, screen+assessment, and brief intervention conditions on primary outcome variables (at-risk drinking, number of drinks per drinking day). The intervention group had significantly better outcomes on a number of drinking-related outcomes  Assessment reactivity did not appear to account for the improvement in the screen+assessment group, since both the screen-only control and intervention conditions demonstrated greater (although nonsignificant) improvement than the assessed condition.

21. Recent Designs in ED SBIRT Studies  Bernstein, et al., 2009: Found brief intervention led to significantly greater reductions in marijuana use compared to an screen+assessment control among heavy using adolescent and young adult ED patients.  Compared the screen+assessment condition to a screen-only condition at 12-month follow-up. No significant differences found, although the screen- only group was smoking 4 fewer days per month than the screen+assessment group.

22. Conclusion  “Changes in alcohol consumption during the assessment process in treatment outcome studies should be examined in future studies, as implications abound for interpretation of results from clinical trials” (Epstein, et al., 2005).  “AR should be considered in any analysis targeting treatment outcomes” (Kaminer, et al., 2008)