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Table 3 Intervention vs. Implementation Trial Design Perspectives: A Hypothetical Example of the Use of Motivational Interviewing (MI) for Substance Use Disorders in the Homeless Population

From: An introduction to implementation science for the non-specialist

  Efficacy Design Principles Effectiveness Design Principles Implementation Design Principles
Hypothesis MI beats control MI beats control MI will be adopted and sustained
Population & setting Exclude psychosis, bipolar, anxiety; any setting with cooperative patients Include most comorbidities; typical setting is nonspecialized practice sites Unit of observation may be patients, providers, or clinics; typical setting is nonspecialized practice sites
Outcome measures Health outcomes, many: "just in case…" Health outcomes, short & sweet Emphasize MI adoption measures
Intervention: clinicians PhDs, MSWs hired & trained by PI Addiction counselors hired as study staff Endogenous addiction counselors
Intervention: fidelity Trained to criterion, audiotaped for fidelity Trained to criterion, QI-type monitoring as in clinical system Formative evaluation the focus
Context Make sure that the trial is successful, at all costs Work within “typical” conditions Maintain typical conditions
Research support Crypto-case management Research support, but “firewalled” Research support limited; e.g., only for training
Validity emphasis Internal > > external External > internal Plan to optimize protocol in real time using formative evaluation, in violation of “traditional” considerations of internal validity, while systematically documenting adaptations