Decision Aids Upper and Lower Extremity

A Randomized Controlled Trial of Decision Aids for Upper and Lower Extremity Conditions.

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.

Study Overview

• Status: Completed
• Conditions: Upper Extremity Dysfunction; Lower Extremity Problem
• Intervention / Treatment: Other: Decision aid

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Regional Clinic
    • Austin, Texas, United States, 78712
      • HTB Musculoskeletal Institute
    • Austin, Texas, United States, 78751
      • Orthopedic Specialists of Austin
    • Austin, Texas, United States, 78705
      • Texas Orthopedics
    • Austin, Texas, United States, 78731
      • Seton Institute for Plastic and Reconstructive Surgery
    • Austin, Texas, United States, 78756
      • ATX Ortho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision Aid Group; These patients review a decision aid.	Other: 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.
No Intervention: Control Group; These patients do not review a decision aid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System Physical Function Computer Adaptive Test (directly after visit)	Questionnaire that measures patients self-reported capability of physical activities. This Questionnaire is a CAT: Computerized Adaptive Test. Participant responses guide the system's choice of subsequent items from the full item bank (121 items in total in adult bank). Although items differ across respondents taking CAT, scores are comparable across participants. CAT will continue until either the standard error drops below a specified level, or the participant has answered the maximum number of questions (12), whichever occurs first. A score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. Range scores 19-76. Higher scores is better physical function.	From enrollment till two weeks after visit
Pain intensity on an 11-point ordinal scale	Can you rate your pain on a scale of 0-10, 0 meaning no pain and 10 meaning the worst possible pain.	From enrollment till two weeks after visit
Decision regret scale (O'Connor '96)	Measures 'distress' or 'remorse' after a (health care) decision. Scale from 1-5, 1 being strongly agree, 5 being stongly disagree; it was the right decision; I regret the choice that was made; I would go for the same chice if I had to do it over again; The choice did me a lot of harm; The decision was a wise one	One time measurement, two weeks after the visit.
Choice of treatment (invasive/non-invasive)	Patients have to fill out if they either chose invasive treatment (surgery) or non-invasive treatment (no surgery)	Day of enrollment

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: August 18, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Decision aids
• Other Study ID Numbers: 2018-07-0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No