A Framework to Decipher and Report Implementation Strategies and Pragmatic Attributes of Trial Design Domains From...

Area of Science:

• Implementation Science
• Health Services Research
• Digital Health

Background:

• Telemedicine shows promise for improving hypertension management but faces limited adoption in routine care.
• Implementation strategies (IS) are crucial for enhancing the use of evidence-based interventions (EBIs).
• Systematically reporting IS and trial designs from pre-implementation studies is challenging for clinical researchers.

Purpose of the Study:

• To develop and describe a systematic approach for reporting IS used in telemedicine trials for hypertension management.
• To assess the pragmatic nature of these trials using the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool.
• To aid clinical researchers in evaluating the real-world readiness of EBIs.

Main Methods:

• A systematic review identified 13 telemedicine trials for hypertension management.
• The Pragmatic Implementation Strategy Reporting tool (PISRT) was used to retrospectively report IS.
• The PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool assessed trial design domains.
• Three clinical researchers trained in implementation science conducted data extraction and analysis with expert consultation.

Main Results:

• A practical manual was developed for systematically reporting IS and trial design attributes.
• The approach facilitates the assessment of telemedicine interventions for hypertension management along the efficacy-effectiveness spectrum.
• Examples of IS implementation in telemedicine for hypertension were elaborated.

Conclusions:

• A step-by-step manual is provided to support clinical researchers in reporting IS and assessing EBI readiness for real-world application.
• The described methods aim to expedite the translation of EBIs into routine care.
• Further evaluation of the effectiveness of these reporting methods is recommended.