Clinical trial NCT03643978: Decision Aids Upper and Lower Extremity
Official title: A Randomized Controlled Trial of Decision Aids for Upper and Lower Extremity Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Dysfunction
Lower Extremity Problem
Keywords: Decision aids
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in an intervention group that reviews a decision aid and a control group that does not.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient satisfaction on a 11-point ordinal scale
timeFrame: From enrollment till follow-up after two weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Physical Function Computer Adaptive Test (directly after visit)
timeFrame: From enrollment till two weeks after visit
measure: Pain intensity on an 11-point ordinal scale
timeFrame: From enrollment till two weeks after visit
measure: Decision regret scale (O'Connor '96)
timeFrame: One time measurement, two weeks after the visit.
measure: Choice of treatment (invasive/non-invasive)
timeFrame: Day of enrollment
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
city: Austin
country: United States
facility: HTB Musculoskeletal Institute
state: Texas
city: Austin
country: United States
facility: Seton Institute for Plastic and Reconstructive Surgery
state: Texas
city: Austin
country: United States
facility: Orthopedic Specialists of Austin
state: Texas
city: Austin
country: United States
facility: ATX Ortho
state: Texas
Study officials:
References: