Upper Extremity DysfunctionNCT03643978
Decision Aids Upper and Lower Extremity
A study testing Decision aid in people with Upper Extremity Dysfunction and Lower Extremity Problem, run by University of Texas at Austin at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Upper Extremity Dysfunction, Lower Extremity Problem
- What is being tested?
- Decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Mar 2018to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 26Show fewer
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Austin Regional Clinic
Austin, Texas, 78705
Texas Orthopedics
Austin, Texas, 78705
HTB Musculoskeletal Institute
Austin, Texas, 78712
Seton Institute for Plastic and Reconstructive Surgery
Austin, Texas, 78731
Orthopedic Specialists of Austin
Austin, Texas, 78751
ATX Ortho
Austin, Texas, 78756
About this study
Official title: 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.
Read the 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.
- Being tested
- Decision aid
- Keywords
- Decision aids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid Group | Experimental | These patients review a decision aid. Receives: Other: Decision aid |
| Control Group | No intervention | These patients do not review a decision aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment till follow-up after two weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Mar 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in an intervention group that reviews a decision aid and a control group that does not.
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ring, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643978
- Sponsor's protocol ID
- 2018-07-0027
- Status last verified
- Mar 2019
- First submitted
- 18 Aug 2018
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Decision Aids for Upper and Lower Extremity Conditions.
- ClinicalTrials.gov ID
- NCT03643978
- Acronym / sponsor ID
- 2018-07-0027
- Keywords
- Decision aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in an intervention group that reviews a decision aid and a control group that does not.
| Arm | Type | Receives |
|---|---|---|
| Decision Aid Group | Experimental | Other: Decision aidThese patients review a decision aid. |
| Control Group | No intervention | –These patients do not review a decision aid. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidThe 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. | Other | Decision Aid Group |
Primary outcome
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.
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System Physical Function Computer Adaptive Test (directly after visit)
Time frame: From enrollment till two weeks after visit
Pain intensity on an 11-point ordinal scale
Time frame: From enrollment till two weeks after visit
Decision regret scale (O'Connor '96)
Time frame: One time measurement, two weeks after the visit.
Choice of treatment (invasive/non-invasive)
Time frame: Day of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Upper Extremity Dysfunction and Lower Extremity Problem, run by University of Texas at Austin at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction on a 11-point ordinal scale (time frame: From enrollment till follow-up after two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.