Impact of using routine healthcare data on the efficiency of implementation trials: a qualitative comparative case study

BACKGROUND: Randomised implementation trials evaluate the effects of implementation strategies on implementation outcomes and may also monitor clinical effectiveness. Routine healthcare data are used in implementation trials for participant identification, intervention delivery, and/or outcome ascertainment. Trial efficiency (scientific, operational, statistical, and economic) is operationalised across trial design, processes, superstructure, infrastructure, and stakeholder engagement (the Trial Efficiency Pentagon). Despite frequent usage, the contribution of routine data to implementation trial efficiency remains underexplored. We aimed to investigate how the use of routine healthcare data affects trial efficiency in two implementation trials. METHODS: We conducted a qualitative comparative case study of two implementation trials, one UK-based and one US-based. Participants were purposively sampled from trial teams involved in the use and management of routine healthcare data. Data were collected through semi-structured interviews, document analysis, and feedback workshops. Framework analysis guided by the Trial Efficiency Pentagon was used to analyse the data, and data flow diagrams were developed to visualise routine data pathways within each trial. RESULTS: ART trial, managing a larger national sample, employed an external research database to integrate data from various EHR systems but faced challenges such as legacy systems, diverse coding practices and site-specific approvals. Data quality can act as either a facilitator or a barrier. CONCLUSIONS: Routine data has an impact on implementation trial efficiency across trial design, processes, superstructure, infrastructure, and stakeholder engagement. To improve trial efficiency in public healthcare systems, researchers must address technological and regulatory barriers to accessing data. In private healthcare systems, data use and access hinges on investing in robust IT infrastructure and ensuring comprehensive organisational commitment. TRIAL REGISTRATION: ART trial registration: ISRCTN15448074; DIGITS trial Clinicaltrials.gov Identifier: NCT05160233.