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

Yale University

Status: Completed

Conditions: Patient Centered Outcomes Research

Treatments: Device: Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)

Study type: Observational

Funder types: Other

Identifiers

NCT02537886

1501015262

R21HSO22319-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Evaluation Group

Description:

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.

Treatment:

Device: Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)