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.

INEBRIA ConferenceBoston, MA

September 23, 2011

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.

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.

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)

Findings Concerning the Impact of Assessment Reactivity:

Heavy Drinking College Students

Studies Reactivity Observed

Reactivity Not

Observed

Kypri, et al., 2006 +

Walters, et al., 2009 +

McCambridge & Day, 2007 +

Findings Concerning the Impact of Assessment Reactivity:

Individuals in Alcohol Treatment

Studies Reactivity 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.

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.

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

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

Studies Reactivity Observed

Reactivity Not

Observed

Daeppen,et al., 2007 +Cherpitel, et al., 2010 +

Findings Concerning the Impact of Assessment Reactivity:

Young Heavy Marijuana Users in EDs

Studies Reactivity 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.

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).

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

SARAssessment +/- Referral

BI-B

Assessment +/- Referral

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 < SARBI-B < MSOSAR < MSO

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).

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.

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.