Shared Decision Making in Older Adults With Distal Radius Fractures
Primary Purpose
Radius Fracture
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
About this trial
This is an interventional treatment trial for Radius Fracture focused on measuring Decision aid, Shared decision making, Older adult patients, Distal radius fracture
Eligibility Criteria
Inclusion Criteria:
- Distal radius fracture within the past 2 weeks
- Initial appointment seeing Attending
- Age 65+
Exclusion Criteria:
- Non english speaker
- Dementia or other mental limitation preventing ability to complete survey
- Other traumatic injuries in extremity that would affect surgical decision
Sites / Locations
- Washington University-St Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Decision Aid
Arm Description
This group will not be exposed to the decision aid. Patients will complete the same surveys, and will be followed for the same length of time.
This group will be exposed to the decision aid before the patients appointment with the surgeon. Patients will also complete the same outcome surveys, and will be followed for the same length of time.
Outcomes
Primary Outcome Measures
Decision Conflict Score
Validated measure for decision conflict
Secondary Outcome Measures
Decision regret scale
Validated measure for decision regret
Patient knowledge
Knowledge quiz created to evaluate knowledge of distal radius treatment options
Full Information
NCT ID
NCT02782299
First Posted
May 1, 2016
Last Updated
January 8, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02782299
Brief Title
Shared Decision Making in Older Adults With Distal Radius Fractures
Official Title
Shared Decision Making in Older Adults With Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
IRB closed project as the continuing review was not submitted. PI has left WU.
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study to investigate the use of a Decision Aid for shared decision making in older adults with distal radius fractures. The goal is to improve patient decisions making, and improve patient knowledge through the use of a validated decision aid.
Detailed Description
Shared decision making has become a increasingly important with the goal of helping patients make decisions that more align with patients values and goals. Decision aids are validated instruments that provide unbiased information and guide patients through questions that allow patients to clarify patients goals.
Older adults with distal radius fractures have increasing evidence of ability to tolerate residual deformity with little to no functional deficits, which has called into question the indications for surgery. In situations where the operative indications are not clear, it is important to engage the patient in the risk and benefits of the decision.
This trial is a prospective trial with two groups, one standard of care, and one with the decision aid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture
Keywords
Decision aid, Shared decision making, Older adult patients, Distal radius fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will not be exposed to the decision aid. Patients will complete the same surveys, and will be followed for the same length of time.
Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
This group will be exposed to the decision aid before the patients appointment with the surgeon. Patients will also complete the same outcome surveys, and will be followed for the same length of time.
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Description
Decision aid which is still under revision will include unbiased information to assist is clarifying values and informing patients with distal radius fractures.
Primary Outcome Measure Information:
Title
Decision Conflict Score
Description
Validated measure for decision conflict
Time Frame
Immediate post appointment
Secondary Outcome Measure Information:
Title
Decision regret scale
Description
Validated measure for decision regret
Time Frame
6 weeks and 6 months post appointment
Title
Patient knowledge
Description
Knowledge quiz created to evaluate knowledge of distal radius treatment options
Time Frame
immediate post appointment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Distal radius fracture within the past 2 weeks
Initial appointment seeing Attending
Age 65+
Exclusion Criteria:
Non english speaker
Dementia or other mental limitation preventing ability to complete survey
Other traumatic injuries in extremity that would affect surgical decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Calfee, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Washington University-St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shared Decision Making in Older Adults With Distal Radius Fractures
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