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Operationalizing implementation science frameworks to plan a hybrid effectiveness-implementation study of a digital
Jacqueline Hodges1, Wendy Cohn2, Amanda D Castel3
1Duke University.
Research Square
|November 28, 2024
Summary
Planning digital health intervention implementation in hybrid trials requires careful consideration of real-world applicability and rigorous evaluation methods. This study outlines a framework for capturing implementation determinants and outcomes in complex healthcare settings.
Area of Science:
- Implementation Science
- Digital Health Interventions
- Public Health
Background:
- Evaluating digital health interventions (DHIs) in practice is complex due to diverse users and multistep processes.
- Operational guidance for DHI implementation studies, especially hybrid trials, is limited.
- Proactive planning is crucial for capturing implementation determinants and outcomes in hybrid studies.
Purpose of the Study:
- To describe the planning process for evaluating the implementation of a DHI within a hybrid effectiveness-implementation trial.
- To outline methods for capturing implementation determinants and outcomes in a real-world setting.
- To identify challenges and opportunities in planning DHI implementation evaluations for hybrid trials.
Main Methods:
- A cluster randomized, type II hybrid trial tested the PositiveLinks smartphone application for HIV care.
- The study involved defining DHI components, selecting implementation science frameworks (RE-AIM), and mapping them to evaluation aims.
- Instruments were modified/created to collect data on implementation outcomes and determinants, with a compatible data collection plan.
Main Results:
- Specification of DHI components and strategy informed measurement of program reach and adoption.
- The RE-AIM framework guided data collection for implementation strategy steps and outcomes.
- Existing and new instruments captured representativeness, reach, adoption, provider adaptations, dose, and fidelity.
- Challenges included mirroring real-world implementation and modifying aspects to preserve internal validity.
Conclusions:
- Planning DHI implementation evaluations in hybrid trials presents challenges and opportunities.
- Hybrid trial planning must balance generalizability with rigorous procedures for effectiveness measurement.
- Further study of rapid, scalable tools is needed for large, multi-site hybrid studies.
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