A Study to Identify the Needs for and Develop a Communication Tool for Intensive Care Patients and Their Family
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-008732
Sponsor Protocol Number: 13-008732
About this study
The purpose of the study is to identify the daily patient-specific information needs of intensive care unit patients and their families in order to develop an effective communication tool for use on electronic devices.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Aim 1 (Survey information assessment):
- Subject population
- Family members of patients in the ICU (MB 6B/G, MB 7/E, MB 5 B/D, Eisenberg 10-3) (n=160 subjects)
- Providers in the ICU (residents, fellows, consultants, nurse practitioners) (n=50 subjects)
- Inclusion Criteria
- > 18 years old
- give informed consent for participation
- off duty
- Exclusion Criteria
- Minors
- prisoners
- wards of the state
- pregnant women
- non-English speakers
- the visually impaired
- patients receiving comfort measures at the time of the survey
Aim 2a (Simulation testing of AWARE family viewer):
- Subject population
- Family members of patients in the ICU (MB 6B/G, Eisenberg 10-3) (n=40 subjects)
- Providers in the ICU (residents, fellows, consultants, nurse practitioners) (n=20 subjects)
- Inclusion Criteria
- > 18 years old
- give informed consent for participation
- off duty for providers
- Exclusion Criteria
- Minors
- prisoners
- wards of the state
- pregnant women
- non-English speakers
- the visually impaired
- patients receiving comfort measures only
Aim 2b (RCT implementation of AWARE family viewer):
- Subject population:
- Family members of patients in the ICU (MB 6B/G, Eisenberg 10-3) (n=50 subjects, estimate, power calculation to be done once parts 1 and 2 are complete)
- Providers in the ICU (residents, fellows, consultants, nurse practitioners, nurses) (n=50 subjects)
- Inclusion Criteria
- > 18 years old
- give informed consent for participation
- off duty
- Exclusion Criteria:
- Minors
- prisoners
- wards of the state
- pregnant women
- non-English speakers
- the visually impaired
- patients receiving comfort measures only
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available