Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent
|ClinicalTrials.gov Identifier: NCT02537886|
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment|
|Patient Centered Outcomes Research||Device: Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)|
The informed consent process protects patients and ensures ethical conduct of research. For patients to fully understand the content of the informed consent process, it should clearly explain the purpose, process, risks, benefits and alternatives to medical procedures or clinical research as well as a patient's rights and responsibilities. Patient safety and quality of care are at risk if the informed consent process is not delivered in a way that assures patient comprehension.
Adoption of methods that allow researchers to conduct brief and virtual interviews with participants to complete the informed consent process using tablet computers (e.g. iPads) with a comprehensive multimedia library (e.g. video clips, animations, presentations, etc.) to explains the risks, benefits, and alternatives of the clinical care will enhance patient comprehension.
The goal of this project is to help make the conduct of patient centered outcomes research (PCOR) more efficient and more widely implemented by engaging key stakeholders, including patients, through the development and evaluation of a new mobile health (mHealth) informed consent tool to disseminate PCOR findings in informed consent research.
This study will be conducted over a 15 month period and will consist of 6 parts: (1) Front-End Focus Groups, (2) User Requirements Analysis, (3) Screen Prototypes Usability Focus Groups, (4) Design and Implementation, (5) Before Launch Usability Evaluation, (6) After Launch Usability Evaluation. Given the steps in the process and the changing (i.e. different) subjects/participants in each component of the development process, this study registration record primarily summarizes the final step in the development of VIC.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||April 30, 2018|
Researchers will conduct a focus group to evaluate VIC after it has been developed and used by patients. Six asthma patients will comprise this post-launch focus group, with the goal of gathering opinions, beliefs, and attitudes about VIC. We will use this information to enhance the generalizability of the VIC approach.
Device: Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)
Six asthma patients will comprise this post-launch focus group, with the goal of gathering opinions, beliefs, and attitudes about VIC.
- VIC Focus Group Feedback [ Time Frame: 3-5 weeks following the launch of VIC ]Asthma Patients will use the VIC to complete the informed consent on an iPad. Following 3-5 weeks of use, 8-10 users will be selected to take part in a focus group to evaluate the usability of VIC. The intent of this post-launch focus group, will be to gather opinions, beliefs, and attitudes about VIC. The focus group data will be used to arrive at themes that are common among the focus group participants. This feedback will be used to assess the completed VIC tool and inform further development of such tools.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537886
|United States, Connecticut|
|Yale School of Medicine: Dept of Emergency Medicine|
|New Haven, Connecticut, United States, 06511|
|Principal Investigator:||Fuad Abujarad, MD||Yale School of Medicine: Dept of Emergency Medicine|