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SMART-ED Study Design to Examine the Potential Role of Assessment Reactivity in SBIRT

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. SMART-ED Study Design to Examine the Potential Role of Assessment Reactivity in SBIRT . INEBRIA Conference Boston, MA

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SMART-ED Study Design to Examine the Potential Role of Assessment Reactivity in SBIRT

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  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. SMART-ED Study Design to Examine the Potential Role of Assessment Reactivity in SBIRT 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

  6. Findings Concerning the Impact of Assessment Reactivity: Individuals in Alcohol Treatment 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 Screen Randomization Randomization Assessment + Intervention Assessment Control Assessment + Intervention Assessment Control Screen-Only Control

  9. Findings Concerning the Impact of Assessment Reactivity: At-Risk Drinkers in EDs

  10. Findings Concerning the Impact of Assessment Reactivity: Young Heavy Marijuana Users in EDs • Compared a screen+assessmentcondition 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 MSO Info only Consent if screen positive 3-month follow-up (Primary outcome) SAR Assessment +/- Referral Demographics, locator, hair sample BI-B Assessment +/- Referral 6-month follow-up 12-month follow-up Two-stage randomization (MSO – Yes/No; if No, then SAR or BI-B) Brief Intervention Two telephone Booster sessions

  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.

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