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Description:  The Subject Data Entry component of a StudyTRAX project is commonly referred to as the "Patient Portal".  It is an inclusive entity of the StudyTRAX database which enables the subject to actively participate in the study process remotely.  This component can be enabled on a per study basis, by selecting the "Subject Login" feature, from within the Project Overview page. 

See "Subject Data Entry SETUP" wiki page for more details. (Link which provides specific how-to instructions on feature setup)

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Overview: Subject Data Entry is utilized for various reasons.  For practical purposes, it is utilized to collect study information from the subject/patient.  However, it has also been utilized as a mechanism to collect in-house study information itself.  This can include information that staff may enter from various sites in order to keep up-to-date on study details. 

When utilized as a SUBJECT PORTAL...

Pre-study
1. Remotely capture demographic and/or screening information from study candidates to determine eligibility only.

2. Provide consent and documentation to remotely enroll study candidates for inclusion on one or multiple studies.

In-Study

1. Utilize email reminders to remotely provide forms and capture study information, which can be filled out per study collection schedule...Both retrospectively or longitudinally.

2. Deliver reports to subjects regarding study progress, or, educational documentation involving any aspect of the study.

Post-Study

1. Utilized for feedback questionarries, stipend tracking...etc...

                                                                

                                            Things to consider

                                            Examples

                                            Limitations

Subject data entry (portal)

                Branding

                                How important is this to your group (will take up a lot of space vs. little)

                Form design

...

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Overview

The "Subject Portal" allows subjects to enter data online (via forms), and receive automated, data-driven reports that can contain a broad range of content (e.g., charts, multi-media, educational materials, etc.).
 

Feature Summary

  • Subjects can fill out forms
  • Automatically deliver to subjects dynamic reports:
    • Configurable layout using HTML editor
      • Include multi-media (charts, graphs, video, sound, pictures),  hyperlinks, etc.
    • Access to all data elements
    • Automatically build text and utilize boilerplates
  • Coordinate same subject enrolled in multiple studies
  • Automatic reminder emails to subjects
    • Templates and "mail-merge" utilities
    • Embed login link
  • Configurable look and feel
  • Allow subjects to; initiate an events, view and/or edit previously completed forms
  • Leverage Javascript for programmable logic

What to Consider

The subject portal can be set up in a number of different ways depending on the project aim and target cohort (i.e., level of computer expertise).  Consider the following:

  1. Branding – How much do you want to emphasize your organization / message in the look and feel of the portal? Three areas:
    1. Home page – See image for configurable areas Image Added
       
      1. Note: can be different across study events (e.g., baseline vs. 3 month follow-up)
    2. Forms – Incorporate brand in layout
    3. Reports – Deliver brand specific content
  2. Form Design – What accommodations should be made for the target cohort?
    1. Level of computer expertise
    2. Age
    3. Reading level
    4. Visual impairment (e.g., use of large fonts)
  3. Reports (or Educational Materials) - What data-driven information would help subjects? That is, answer how the report content be customized to fit the specific needs of a subject and provide the greatest incentive to participate. Consider the following:
    1. Data
      1. What data values should be displayed?
      2. What data-driven clinical events will trigger specific information (e.g., if BMI over 25, show video on weight management)?
      3. How can the report content be customized to fit the specific needs of a subject and provide the greatest incentive for participation?
    2. Other Content
      1. Videos, educational materials (tutorials)
      2. Links to websites, podcasts, files, and  other web information sources
      3. Data driven, conditional text

Setup Steps

In big-picture terms, to utilize the subject portal:

  1. Enable the feature
  2. Indicate which forms are to be completed by subjects and when
  3. Create subject login account

More detailed information can be found here.

Examples

  • A color coded chart of progress toward clinical goals over time
  • Prognostic chart based on the subject's specific clinical characteristics (e.g., a tumor's T, N, M status)
  • Patient driven requests for information and/or educational materials (e.g., video on upcoming procedure, list of support groups in the area, referral resources, disease overview pdf file, prognostic chart, table of links to recommended websites, etc.)
  • Report of participation points (e.g., provide total points score based on number of forms completed and the points, in turn, can be redeemed for items of interest)

 See Examples