Shared Decision Making in Older Adults With Distal Radius Fractures

January 8, 2019 updated by: Washington University School of Medicine
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University-St Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.
Experimental: Decision Aid
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision Conflict Score
Time Frame: Immediate post appointment
Validated measure for decision conflict
Immediate post appointment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision regret scale
Time Frame: 6 weeks and 6 months post appointment
Validated measure for decision regret
6 weeks and 6 months post appointment
Patient knowledge
Time Frame: immediate post appointment
Knowledge quiz created to evaluate knowledge of distal radius treatment options
immediate post appointment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Study Director: Ryan Calfee, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

May 1, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201512001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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