- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07361458
Modex, a Cloud-based, Centralized Health Economic Model Marketplace to Reduce Costs and Enhance Equity in Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Endpoint: Iteratively unit test 4 tasks (A) Revise model platform and back end, (B) Refine the model taxonomy/characterization (i.e., ontology) and search module, (C) Revamp submission module, and (D) Implement paid modules) individually to ascertain 100% pass of common functionality (e.g., searching, uploading, and evaluating models) in the system back end and then iteratively perform integration testing via the front-end user interface until 100% pass using the System Usability Scale (as below). The System Usability Scale yields a single number representing a composite measure of the overall usability of the system being studied. To calculate the System Usability Scale score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7, and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of System Usability Score; scores range from 0 to 100, with higher numbers being better.
Secondary Endpoints: Measure the success of Aim 2 by (1) completion of 80% of tasks in usability testing with scores of ≥68 on the System Usability Scale, a validated questionnaire, and (2) satisfaction with the site. Testing will focus on user interaction with the system, emphasizing effectiveness, efficiency, engagingness, error tolerance, and ease of learning. Specifically, the investigators will assess the ability of the project team and Advisory Panel member participants to log into the platform, configure and manage their modeling projects, and annotate or categorize them in accordance with an ontological index. The investigators will assign participants to interact with at least 2 randomly selected models and associated data files, iterating on this milestone until the investigators achieve 100% success.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami Beach, Florida, United States, 33139
- Arnold Consultancy & Technology, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Expert Advisory Panel member
Exclusion Criteria:
- Non-English-speaker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Advisory Panelist participa will evaluate wireframes and a working prototype of the HModEx® website.
This is a single-arm study that will build and evaluate (via usability testing) an open source health economic model platform prototype using a 9-member expert advisory panel of health economist participants from the US and Europe.
|
open source health economic models
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alpha testing of wireframe usability
Time Frame: 2 months
|
Iteratively unit test 4 tasks (A) Revise model platform and back end, (B) Refine the model taxonomy/characterization (i.e., ontology) and search module, (C) Revamp submission module, and (D) Implement paid modules) individually to ascertain 100% pass of common functionality (e.g., searching, uploading, and evaluating models) in the system back end and then iteratively perform integration testing via the front-end user interface until 100% pass using the System Usability Scale.
The overall value of the System Usability Score ranges from 0 to 100.
The higher the score on the System Usability Scale, the better.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beta testing of prototype usability
Time Frame: 4 months
|
Measure the success of Aim 2 by (1) completion of 80% of tasks in usability testing with scores of ≥68 on the System Usability Scale, a validated questionnaire, and (2) satisfaction with the site.
Testing will focus on user interaction with the system, emphasizing effectiveness, efficiency, engagingness, error tolerance, and ease of learning.
Specifically, the investigators will assess the ability of the project team and Advisory Panel member participants to log into the platform, configure and manage their modeling projects, and annotate or categorize them in accordance with an ontological index.
The investigators will assign panelist participants to interact with at least 2 randomly selected models and associated data files, iterating on this milestone until the investigators achieve 100% success.
The overall value of the System Usability Score ranges from 0 to 100.
The higher the score on the System Usability Scale, the better.
|
4 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Renee JG Arnold, PharmD, Arnold Consultancy & Technology, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R43CA297808-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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