Decision Aids Upper and Lower Extremity

NCT ID: NCT03643978

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-02-01

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.

Detailed 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.

Conditions

Upper Extremity Dysfunction; Lower Extremity Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decision Aid Group

These patients review a decision aid.

Group Type: EXPERIMENTAL

Decision aid

Intervention Type: OTHER

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.

Control Group

These patients do not review a decision aid.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Decision aid

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

David Ring

Associate Dean for Comprehensive Care and Professor, Department of Surgery and Perioperative Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Austin Regional Clinic

Austin, Texas, United States

Texas Orthopedics

Austin, Texas, United States

HTB Musculoskeletal Institute

Austin, Texas, United States

Seton Institute for Plastic and Reconstructive Surgery

Austin, Texas, United States

Orthopedic Specialists of Austin

Austin, Texas, United States

ATX Ortho

Austin, Texas, United States

Countries

United States

Other Identifiers

2018-07-0027

Identifier Type: -

Identifier Source: org_study_id