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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02782299
Other study ID # 201512001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date November 2018

Study information

Verified date January 2019
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date November 2018
Est. primary completion date November 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Decision Aid
Decision aid which is still under revision will include unbiased information to assist is clarifying values and informing patients with distal radius fractures.

Locations

Country Name City State
United States Washington University-St Louis Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decision Conflict Score Validated measure for decision conflict Immediate post appointment
Secondary Decision regret scale Validated measure for decision regret 6 weeks and 6 months post appointment
Secondary Patient knowledge Knowledge quiz created to evaluate knowledge of distal radius treatment options immediate post appointment
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