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Trial record 3 of 232 for:    Recruiting, Not yet recruiting, Available Studies | "informed consent"

Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent

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ClinicalTrials.gov Identifier: NCT02537886
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) will be developed as a patient-centered web-based mobile application and will be able to run on mobile devices. The development of VIC is to create a reusable infrastructure for integrating the informed consent process into clinical care and the clinical workflow in a way that enhances patient comprehension while improving the efficiency of obtaining patient consent.

Condition or disease Intervention/treatment
Patient Centered Outcomes Research Device: Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)

Detailed Description:

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
Estimated Enrollment : 6 participants
Observational Model: Other
Time Perspective: Other
Official Title: Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent
Study Start Date : June 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Group/Cohort Intervention/treatment
Evaluation Group
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population for this study includes patients from the Yale Center for Asthma and Airway Disease (YCAAD) clinic. Participants for the VIC study will be recruited from the large and diverse asthma population that the YCAAD GenEx 2.0 trial accesses for enrollment.
Criteria

Inclusion Criteria:

  • Clinician diagnosis of asthma based on National Asthma Education and Prevention Program (NAEPP) guidelines.
  • Historical evidence of variable airflow obstruction.
  • Subjects are required to speak English.

Exclusion Criteria:

  • >10 pack-year smoking history.
  • Active smoking within the past year.
  • Other chronic lung disease or asthma variant.
  • Patients will be excluded if they cannot safely undergo the studies required for participation.
  • Patient or clinician refusal to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537886


Contacts
Contact: Caitlin Johnson 203 737 6152 Caitlin.johnson@yale.edu

Locations
United States, Connecticut
Yale School of Medicine: Dept of Emergency Medicine Recruiting
New Haven, Connecticut, United States, 06511
Contact: Caitlin Johnson    203-737-5187    Caitlin.johnson@yale.edu   
Principal Investigator: Fuad Abujarad, MD         
Sub-Investigator: Sandra Alfano, PharmD         
Sub-Investigator: Peter Peduzzi, PhD         
Sub-Investigator: Geoffrey Chupp, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Fuad Abujarad, MD Yale School of Medicine: Dept of Emergency Medicine

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02537886     History of Changes
Other Study ID Numbers: 1501015262
R21HSO22319-01A1 ( Other Grant/Funding Number: AHRQ )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Yale University:
PCOR