NCT03643978

Brief Summary

This study aims to assess differences in choice of treatment (and the rationale behind it), physical function, pain intensity, satisfaction, and decision regret between orthopedic patients who review a decision aid during their visit and those that do not. Decision aids for 23 different conditions are included.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

August 18, 2018

Last Update Submit

March 6, 2019

Conditions

Upper Extremity DysfunctionLower Extremity Problem

Keywords

Decision aids

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction on a 11-point ordinal scale

    On a scale of 0-10 how satisfied were you with this visit 0 being totally dissatisfied and 10 being totally satisfied.

    From enrollment till follow-up after two weeks

Secondary Outcomes (4)

  • Patient-Reported Outcomes Measurement Information System Physical Function Computer Adaptive Test (directly after visit)

    From enrollment till two weeks after visit

  • Pain intensity on an 11-point ordinal scale

    From enrollment till two weeks after visit

  • Decision regret scale (O'Connor '96)

    One time measurement, two weeks after the visit.

  • Choice of treatment (invasive/non-invasive)

    Day of enrollment

Study Arms (2)

Decision Aid Group

EXPERIMENTAL

These patients review a decision aid.

Other: Decision aid

Control Group

NO INTERVENTION

These patients do not review a decision aid.

Interventions

Decision aidOTHER

The decision aids aim to inform the patients about the diagnosis and the treatment options. They aim to help the patient prioritize and make an informed decision.

Decision Aid Group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking, adult patients seeing an upper or lower extremity surgeon for a new visit regarding diagnoses that can be treated invasively and non-invasively:
  • Shoulder
  • Clavicle fracture in the middle
  • Clavicle fracture close to the shoulder
  • Proximal humerus fracture
  • Humerus shaft fracture
  • Distal humerus fracture
  • Elbow
  • Lateral epicondylitis
  • Ruptured biceps at the elbow
  • Olecranon fracture
  • Radial head fracture
  • Olecranon bursitis
  • Hand/wrist
  • Distal radius fracture
  • +11 more criteria

You may not qualify if:

  • Obvious indication for one treatment approach, either from the surgeon or the patient perspective.
  • Patients who do not want to be contacted for follow-up.
  • Non-English speaking patients, because the decision aids used in this study are not currently validated to non-English language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Austin Regional Clinic

Austin, Texas, 78705, United States

Location

Texas Orthopedics

Austin, Texas, 78705, United States

Location

HTB Musculoskeletal Institute

Austin, Texas, 78712, United States

Location

Seton Institute for Plastic and Reconstructive Surgery

Austin, Texas, 78731, United States

Location

Orthopedic Specialists of Austin

Austin, Texas, 78751, United States

Location

ATX Ortho

Austin, Texas, 78756, United States

Location

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized in an intervention group that reviews a decision aid and a control group that does not.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean for Comprehensive Care and Professor, Department of Surgery and Perioperative Care

Study Record Dates

First Submitted

August 18, 2018

First Posted

August 23, 2018

Study Start

March 1, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(6)