Design and management considerations for control groups in hybrid effectiveness-implementation trials: Narrative...

Area of Science:

• Health Services Research
• Implementation Science
• Clinical Trials

Background:

• Hybrid effectiveness-implementation studies integrate intervention effectiveness and implementation research.
• Limited guidance exists for designing and managing hybrid trials, particularly those with differential implementation support for control groups.
• Challenges arise in setting up and managing participating sites in such complex trials.

Purpose of the Study:

• To provide guidance on designing and managing hybrid effectiveness-implementation studies.
• To identify common themes in study design and management through literature review and case studies.
• To address the specific challenges of hybrid trials with comparison/control arms receiving less implementation support.

Main Methods:

• A narrative literature review (Phase 1) was conducted.
• A comparative case study of three hybrid trials (Phase 2) was performed.
• Common themes related to study design and management were identified.

Main Results:

• The study highlights the need to balance fidelity to study design with tailoring to site-specific needs.
• Modifications to implementation strategies require careful consideration and systematic reporting.
• Effective management involves addressing the impact of design choices and modifications on controlled evaluations.

Conclusions:

• Hybrid trial teams must carefully consider design, management, and modification impacts on controlled evaluations.
• Systematic reporting of rationales for design and management decisions is crucial.
• Addressing the guidance gap is essential for successful hybrid trial execution and evidence translation.