Section 3: Understanding Effectiveness and Implementation Research

3.1 Introduction

Will my study be focused on effectiveness only, implementation only, or both effectiveness and implementation outcomes (suggesting a hybrid trial may be appropriate)?

  • Clinical effectiveness trials only (no implementation outcomes)
  • Implementation trial only (no health outcomes)
  • Hybrid Type 1: Primary aim: clinical effectiveness. Secondary aim: context for implementation, acceptability, and feasibility
  • Hybrid Type 2: Coprimary aims: clinical effectiveness and implementation (adoption, fidelity)
  • Hybrid Type 3: Primary aim: utility of an implementation strategy. Secondary aim: clinical outcomes

3.2 Effectiveness and Implementation – Key Questions

Will my study be focused on effectiveness only, implementation only, or both effectiveness and implementation outcomes (suggesting a hybrid trial may be appropriate)?

  • Clinical effectiveness trials only (no implementation outcomes)
  • Implementation trial only (no health outcomes)
  • Hybrid Type 1: Primary aim: clinical effectiveness. Secondary aim: context for implementation, acceptability, and feasibility
  • Hybrid Type 2: Coprimary aims: clinical effectiveness and implementation (adoption, fidelity)
  • Hybrid Type 3: Primary aim: utility of an implementation strategy. Secondary aim: clinical outcomes