A Randomized Controlled Trial of Decision Aids for Upper and Lower Extremity Conditions.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Upper Extremity Dysfunction
- Sponsor
- University of Texas at Austin
- Enrollment
- 168
- Locations
- 6
- Primary Endpoint
- Patient satisfaction on a 11-point ordinal scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
David Ring
Associate Dean for Comprehensive Care and Professor, Department of Surgery and Perioperative Care
University of Texas at Austin
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:
- •Clavicle fracture in the middle
- •Clavicle fracture close to the shoulder
- •Proximal humerus fracture
- •Humerus shaft fracture
- •Distal humerus fracture
- •Lateral epicondylitis
- •Ruptured biceps at the elbow
- •Olecranon fracture
- •Radial head fracture
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.
Outcomes
Primary Outcomes
Patient satisfaction on a 11-point ordinal scale
Time Frame: From enrollment till follow-up after two weeks
On a scale of 0-10 how satisfied were you with this visit 0 being totally dissatisfied and 10 being totally satisfied.
Secondary Outcomes
- 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)
- Choice of treatment (invasive/non-invasive)(Day of enrollment)
- Decision regret scale (O'Connor '96)(One time measurement, two weeks after the visit.)