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Table 4 Illustrative planning phase trial-specific metrics and deliverables

From: Is this study feasible? Facilitating management of pragmatic trial planning milestones under a phased award funding mechanism

Trial-specific metric Description of deliverable
 Train staff on assessment methods Summary of training with staff
 Train staff on protocol Summary of training with staff on the protocol
 Training sessions completed in intervention settings Table of trainings completed and planned for future
Stakeholders/partner engagement
 Assessment of provider satisfaction with interventions Satisfaction survey items and feedback based on data from five physicians
 Identification of local champions List of local champions and their letters of support
Data management
 Determine feasibility of obtaining baseline and 30-day follow-up data Obtained 30-day follow-up data on 85% of patients enrolled in pilot
 Validate capture of all proposed outcomes in a sample of de-identified patients Description of process to finalize list of outcomes
 Data form development completion Copy of data collection forms
 Create preliminary versions of educational materials Preliminary draft of educational materials
 Final adjustments made to interventions Procedures manual
Recruitment/accrual feasibility
 Enroll (subset) of pilot study cohort Consort diagram summarizing pilot recruitment
 Testing and validation in validation cohort: test candidate model with summary of findings in derivation cohort Application of model for patients with and without an event of concern
Information technology/systems
 Fully functional research recruitment alert in electronic health records Screenshot of pop-up alert as evidence that system is functional
 Online intervention ready for deployment Screen shots of login and modules
 Web-based data collection procedures in place Screen shots to capture screening data
 Electronic health records data pull methods tested and validated Three sample Subject Data Tables
 Web conferencing capabilities for intervention Minimum technical and support requirements
 Development of strategy to automate intervention into electronic medical records Flow diagram illustrating how intervention is integrated with electronic medical records and other clinical data systems
 Develop patient identification and automatic ordering processes in the electronic health records List of patient eligibility criteria screening; specifications for automated order