A Study to Evaluate Complete Cochlear Implant Care (CCIC) Requiring a Single On-Site Visit
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: 20-008144
About this study
The purpose of this study is to evaluate the feasibility of highly coordinated care model in cochlear implantation (CI), to determine the impact of new care delivery model on the patient care experience, and to evaluate financial and implementation implications of highly coordinated care in cochlear implantation.
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.
Inclusion Criteria:
- Post-lingually deafened adults (age ≥ 18 years).
- < 10 years duration of deafness.
- Likely to meet audiologic candidacy criteria for cochlear implant (CI) (based on screening of audiologic testing performed locally).
- Normal inner ear anatomy.
- Access to appropriate technology (computer, tablet or mobile phone) for videoconference.
- All patients who do not require prior written authorization from their insurers for this procedure.
Exclusion Criteria:
- Individuals < 18 years of age.
- Comorbidities or cognitive deficits that prevent participation in the telehealth component and preference for non-Cochlear brand devices, non-English speaking, or deafness caused by pathology that would significantly impact outcomes such as significant head trauma, certain brain tumors, revision CI. Those patients who continue to undergo CI through the traditional care delivery model will serve as the “control” group for comparison purposes.
- Additional exclusion criteria for the traditional control group include non-English speaking, a revision CI, deafness due to a tumor, single-sided deafness, or any patients that have a cause of hearing loss that the study staff consider “non-traditional”, as this would not be a good patient to compare to the subjects in the other study arm.
Eligibility last updated 9/3/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Matthew Carlson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available