Using Exploratory Trials to Identify Relevant Contexts and Mechanisms in Complex Electronic Health Interventions:...

Area of Science:

• Health Services Research
• Digital Health
• Implementation Science

Background:

• Evaluating complex interventions, such as electronic health solutions for integrated care, presents methodological challenges.
• Understanding how intervention components link to outcomes is crucial for effective design.
• Exploratory trials can identify key determinants to inform intervention theory before full evaluation.

Purpose of the Study:

• To conduct a multimethod exploratory trial of an electronic patient-reported outcome (ePRO) tool to identify context, process, and outcome variables and their linking mechanisms.
• To provide methodological insights on using exploratory data to define central versus peripheral mechanisms for complex interventions.
• To inform the content theory underpinning the ePRO tool for integrated care.

Main Methods:

• A 4-month multimethod exploratory trial in two primary health care practices.
• Randomized controlled trial comparing ePRO intervention and control groups on quality of life and activation.
• Semistructured interviews with intervention group patients and providers, analyzed using narrative analysis.

Main Results:

• The study identified complex context, process, and outcome variables influencing the ePRO intervention.
• Narrative analysis revealed dominant themes in patient and provider experiences, focusing on integration into daily life and perceived meaningfulness.
• Patient-provider relationships, technology comfort, and research process engagement moderated intervention themes.

Conclusions:

• Narrative analysis effectively identifies critical context and process variables and dominant story lines for complex interventions.
• Normalization Process Theory is valuable for uncovering mechanisms related to the social and technical aspects of implementing new tools.
• Careful attention to central versus peripheral mechanisms, guided by narrative methods, is essential for successful complex intervention evaluation.