Think Results First!!

Traditionally, patient registry design centered around discussions of data content (e.g., "Form Y should have X fields that capture...."). However, advances in web-based information technology, communication, and multi-media tools have dramatically changed the process. In fact, it's best to start with the desired "Results First" and then work back to data content. The KEY consideration is transforming data into information and delivering this information to three primary stakeholders:

1. Patients
2. Health care staff
3. Academic community

This website is designed as a big-picture guide to setting up a patient registry in StudyTRAX. Please send any questions or feedback to support ( support@sciencetrax.com).

Subjects

Subject Portal

Engage patient in the process through an easy to use on-line portal.

• Key Features
  1. Web-based multi-media tools for:
     • Subject data entry
     • Delivery of reports dynamically linked to data
  2. Completely customizable layout, content and look and feel for secure and public pages
  3. Automated email communication
  4. Scheduling
• Examples
  1. Data entry forms with video, sounds, pictures, etc.
  2. Clinic-specific look, images, content menus and pages, etc.
  3. Reports driven by data (e.g., progress toward clinical goals, chart of prognosis, list of support groups / other services, etc.)
  4. Automated email reminders of data collection events
• What To Consider
  1. What proportion of targeted cohort is able to use / access a computer?
  2. What information would be helpful to patients (e.g, disease FAQs, brochures, charts, graphs, feedback on goals, prognostic chart, treatment video, educational materials etc.), and how can this information be customized to a specific patient?
  3. What information could a patient provide that would facilitate or improve clinical care?
  4. How do you want to brand your clinic?

Healthcare and Research Staff

Automated Clinic Notes And Reports

Enhance clinical decison making and workflow via single subject and group-level reports.

• Key Features
  1. Integrated word-processor for layout design, formatting, etc.
  2. Automated clinic notes / reports (single subject-level)
     • Boilerplate and conditional logic driven text
     • Within or across visit summaries and analysis
     • All data elements completely accessible and configurable
  3. Group-level Reports
     • Aggregation across subjects, within or across visits
     • Dynamically linked charts, graphs, tables
     • Combine data across patient registries and/or studies
• Examples
  1. Across specialty consolidated case-conference note
  2. Color coded matrix of clinical parameters over time
  3. Outcome comparisons across groups using charts, tables and graphs
• What To Consider
  1. What data driven tasks (e.g., clinic notes, group reporting, patient summaries, etc.) can be automated?
  2. What components of the clinic note best fit standardization or target an important research aim?
  3. What information (e.g., tends, cut-points, goals, seminal events, risk-factors, standardized scores, event date timing, etc.) would help staff improve care and/or facilitate workflow?

Academic Community

Organize And Plan Publications, Abstracts, Etc.

Complete integration of data collection and the creation of all types of academic output (e.g., manuscripts, posters, grants, etc.)

• Key Features
  1. Dynamically link together data collection efforts with all associated academic output.
  2. Manage generation of academic output using the Workbench
     • Create and organize data sets
       • Include raw, recoded, transformed, and calculated variables within or across visits
       • Utilize integrated data cleaning / scrubbing routines
       • Seamlessly transfer data to statistical packages
     • Create reports with charts, graphs, and tables dynamically linked to study data
     • Integrated word-processor for report layout design and formatting
  3. File and task management
     • Coordinate tasks across staff using a centralized calendar
     • Upload and track all associated files
• Examples
  1. Plan, create and instantly update study safety monitoring board reports
  2. Departmental or institutional-level report of enrollment and research activities
  3. Consolidated report of all patient surveys and quality of metrics
• What To Consider
  1. What academic output (e.g., manuscripts, abstracts) is planned and what would make the process of creating this output faster?
  2. How should data sets be set up so as to facilitate data analysis?
  3. What are the planned research productivity and quality of care administrative reports?

Laying The Foundation

Preparing To Capture Data

After the information output has been planned (see above), there are a number of practical and theoretical issues that will need to be addressed before capturing data. The link below provides an outline designed to help sort through these issues. This is not a detailed 'cookbook', but instead briefly covers the content- and design-related steps to ensure the various issues are addressed. Contact us for questions ( support@sciencetrax.com ).

Patient Registry Setup Outline (pdf)

Final Steps

As your group gets close to implementing the new registry, the following helps expedite the process:

To Finish Up Before Going "Live"
- Have everyone involved provide "Actionable Feedback" (i.e., can be directly translated into a task) of anything left to be done before going "Live".
- Take an initial pass at outlining how the success of the registry will be evaluated (helpful for ensuring everything is in place and planning future changes).
- Put together a "Wish-List" of functionality and prioritize (helps focus ongoing modifications).
- Plan a "Kick-off"-oriented meeting to talk through any final details and plan the start-up process.