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Decision Aids Upper and Lower Extremity

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Upper Extremity Dysfunction
Lower Extremity Problem

Treatments

Other: Decision aid

Study type

Interventional

Funder types

Other

Identifiers

NCT03643978
2018-07-0027

Details and patient eligibility

About

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.

Full description

Patients visiting an orthopeadic surgeon in one of our 4 affiliated offices in a large urban area in the United States are invited to participate over a 4 month period. All English-speaking patients, between 18 and 89 years old, visiting an orthopeadic surgeon with a new problem, for which either invasive or non-invasive treatment is possible and a DA is available are asked to participate in this study. Exclusion criteria are non-English speakers or a clear preference for a treatment option by surgeon or patient. Patients will be randomly assigned to either the intervention or the control group in a 1:1 ratio using an Excel random number generator. Patients in the intervention group go over the DA during the visit, once the surgeon has identified the diagnosis. After the diagnosis is set, the surgeon steps out of the visit and steps back in when the patients has reviewed the DA. The surgeon and the patient go over the treatment options and a decision will be made. After the visit, all patients, both in the intervention and control group, are asked to fill out a survey. Two weeks after enrollment a research assistant calls all patients for a follow up questionnaire.

Enrollment

168 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
  • Carpal tunnel syndrome
  • Scaphoid fracture
  • Thumb arthrosis
  • Trigger finger
  • Mallet fracture
  • de Quervain tendinopathy
  • Wrist ganglion
  • Dupuytren

Knee • Knee arthritis: cortisone injection

Hip

• Hip arthritis: total hip arthroplasty

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

168 participants in 2 patient groups

Decision Aid Group
Experimental group
Description:
These patients review a decision aid.
Treatment:
Other: Decision aid
Control Group
No Intervention group
Description:
These patients do not review a decision aid.

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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