Description: Overview
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 administrative details.
- Most common uses as a Subject Data Entry 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. These reports can information that is tied directly to the collection schedule. Any one subject report can output text and multimedia, based on logic driven form data entry.
Post-Study
1. Utilized for feedback questionnaires, followup tracking and additional non-study related inquires.
Things to consider: A standard "Patient Portal" template should be designed that is best suited for the cohort that will utilize it. While several components of the portal are set by the system by default, there are sections on the portal that can be manipulated, to further assist the visitors experience. Keep in mind, that the customizable regions of the portal can be modified at each data collection interval.
See Examples: (link to examples of layout)
- Branding of portal- Since display space is limited horizontally for institution branded images, visitor instructions and alternative Non-CRF documentation, how much information needs to be included prior to filling out study related forms? What is the technical experience, age of the subject? Are there visual or hearing impairments involved? (Font size, tutorial needed to explain portal environment)
- Form Design - How many forms need to be filled out by the visitor at each collection interval? How much time should be spent by the subject at any one visit to the portal? (e.g. Will impact vertical depth of middle panel, as well as impact the patients time availablity for any one collection period). Will the visitor be able to modify the form data at any time, or should it be limited to a collection period? Is there a need for supportive multimedia in the forms to be completed?
- Reports and educational materials - This section can be reserved for static documentation, or, reports specifically designed to make use of the subjects study data. Much like a clinic note or subject level report is customized for the staff, these same reports can be customized to fit the subject as well.
- Limitations:
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"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:
- Completely configurable layout using HTML editor
- Multi-media (charts, graphs, video, sound, pictures), hyperlinks, etc.
- Access to all data elements, within one visit or across multiple visits
- Automatically build text (e.g., logic driven, conditional text)
- Coordinate same subject enrolled in multiple studies
- Automatically send email to subject for schedule study events (e.g., year 1 follow-up)
- Configurable email templates and automated "mail-merge" tags
- Embed login link, choose whether require username and password
- Configurable look and feel, able to personalize and brand as needed
- Able to allow subjects to create study events (e.g., click an "Adverse Event" link whenever needed, which turn automatically delivers associated forms and reports)
- Able to allow subjects to view and/or edit previously completed forms
- Completely customizable programming logic using Javascript
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:
- Branding – How much do you want to emphasize your organization / message in the look and feel of the portal? Three areas:
- Home page – See image for configurable areas
i. Note: can be different across study events (e.g., baseline vs. 3 month follow-up)
- Forms – Incorporate brand in layout
- Reports – Deliver brand specific content
- Form Design – What accommodations should be made for the target cohort?
- Level of computer expertise
- Age
- Reading level
- Visual impairment (e.g., use of large fonts)
- 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:
- Data –
i. What data values should be displayed?
ii. What data-driven clinical events will trigger specific information (e.g., if BMI over 25, show video on weight management)?
iii. How can the report content be customized to fit the specific needs of a subject and provide the greatest incentive for participation?
- Other Content
i. Videos, educational materials (tutorials)
ii. Links to websites, podcasts, files, and other web information sources
iii. Data driven, conditional text
Examples