Table 2.
Explanatory Trial | Primary aim of determining how an intervention performs under ideal conditions (i.e. efficacy). |
Pragmatic Trial | Primary aim of determining how an intervention performs in real world conditions (i.e. effectiveness). |
Embedded Trial | Performed in clinical setting with interventions delivered by health care providers as part of routine care. |
Cluster Randomized Trial | Unit of randomization is at a level other than individual (e.g., clinic or hospital). |
Type 1 Hybrid Effectiveness-Implementation Trial | Primary aim is to determine intervention effectiveness and secondary aim is to gain better understanding of implementation of intervention. Example Primary Aim: Determine if mindfulness-based stress reduction improves physical function for those with chronic low back, when compared to usual medical care. Example Secondary Aim: Determine what percentage of individuals with chronic low back pain completed the entire mindfulness-based stress reduction program. |
Type 2 Hybrid Effectiveness-Implementation Trial | Co-primary aims to simultaneously determine intervention effectiveness and impact of implementation strategies. Example Primary Aim: Determine if mindfulness-based stress reduction improves physical function for those with chronic low back, when compared to usual medical care. Example Primary Aim: Determine best method of mindfulness-based stress reduction program training (in-person vs. on-line vs. hybrid) for improving provider competence. |
Type 3 Hybrid Effectiveness-Implementation Trial | Primary aim is to test implementation strategy and secondary aim is to describe associated clinical outcomes. Example Primary Aim: Determine best method of mindfulness-based stress reduction program training (in-person vs. on-line vs. hybrid) for improving provider competence. Example Secondary Aim: Compare clinical outcomes for patients seeking care from providers that completed in-person training vs. on-line training. |