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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