Clinical trial NCT02537886: Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent
Official title: Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Centered Outcomes Research
Keywords: PCOR
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: VIC Focus Group Feedback
timeFrame: 3-5 weeks following the launch of VIC
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine: Dept of Emergency Medicine
state: Connecticut
Study officials:
affiliation: Yale School of Medicine: Dept of Emergency Medicine
name: Fuad Abujarad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abujarad F, Peduzzi P, Mun S, Carlson K, Edwards C, Dziura J, Brandt C, Alfano S, Chupp G. Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial. JMIR Form Res. 2021 Oct 19;5(10):e20458. doi: 10.2196/20458.