Table 4 Illustrative planning phase trial-specific metrics and deliverables
Trial-specific metric | Description of deliverable |
|---|---|
Training | |
 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 |
Intervention | |
 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 |