NCT02782299

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

May 1, 2016

Last Update Submit

January 8, 2019

Conditions

Radius Fracture

Keywords

Decision aidShared decision makingOlder adult patientsDistal radius fracture

Outcome Measures

Primary Outcomes (1)

  • Decision Conflict Score

    Validated measure for decision conflict

    Immediate post appointment

Secondary Outcomes (2)

  • Decision regret scale

    6 weeks and 6 months post appointment

  • Patient knowledge

    immediate post appointment

Study Arms (2)

Control

NO INTERVENTION

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.

Decision Aid

EXPERIMENTAL

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

Interventions

Decision AidOTHER

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

Decision Aid

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Distal radius fracture within the past 2 weeks
  • Initial appointment seeing Attending
  • Age 65+

You may not qualify if:

  • Non english speaker
  • Dementia or other mental limitation preventing ability to complete survey
  • Other traumatic injuries in extremity that would affect surgical decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University-St Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Radius FracturesWrist Fractures

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, BoneWrist Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ryan Calfee, MD

    Washington University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2016

First Posted

May 25, 2016

Study Start

December 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)