A Study of Shared Decision Making in Barrett’s Esophagus with Low Grade Dysplasia
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: 14-004384
Sponsor Protocol Number: 14-004384
About this study
The purpose of this study is to develop an evidence-based management decision aid for patients who have Barrett's Esophagus with low grade dysplasia, called BE Choice. To evaluate the impact of the developed decision aid (BE Choice) on patient-centered outcomes, assessments will be made of patient knowledge, decision conflict, patient involvement in decision-making, treatment choice, and outcomes when compared to ‘usual specialist care’.
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
- Observations of Clinical Encounters and Field Testing & Iterative Development
- Clinicians
- Gastroenterologist at Mayo Clinic, Rochester
- Patient
- Adults ≥ 18 years
- Diagnosis of BE with LGD
- Appointment with Gastroenterologist to discuss treatment options for BE with LGD
- Initial Prototype Focus Group Input
- Patients
- Adults ≥ 18 years
- Diagnosis of BE with LGD receiving ongoing care with Mayo Clinic Gastroenterologist
- Patient Advisory Group Member
- Adults ≥ 18 years
- Member of the Diabetes Advisory Group at Mayo Clinic, Rochester
- Clinician
- Gastroenterologist at Mayo Clinic, Rochester
Exclusion Criteria
- Observations of Clinical Encounters and Field Testing & Iterative Development
- Clinicians
- Patients
- Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)
- Initial Prototype Focus Group Input
- Patients
- Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)
- Patient Advisory Group Member
- Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)
- Clinician
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 Prasad Iyer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available