Radius FractureNCT02782299
Shared Decision Making in Older Adults With Distal Radius Fractures
A study testing Decision Aid in people with Radius Fracture, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a study to investigate the use of a Decision Aid for shared decision making in older adults with distal radius fractures. The goal is to improve patient decisions making, and improve patient knowledge through the use of a validated decision aid. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radius Fracture
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Nov 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Distal radius fracture within the past 2 weeks
- Initial appointment seeing Attending
- Age 65+
Who cannot join
- Non english speaker
- Dementia or other mental limitation preventing ability to complete survey
- Other traumatic injuries in extremity that would affect surgical decision
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University-St Louis
St Louis, Missouri, 63110
About this study
This is a study to investigate the use of a Decision Aid for shared decision making in older adults with distal radius fractures. The goal is to improve patient decisions making, and improve patient knowledge through the use of a validated decision aid.
Read the detailed description
Shared decision making has become a increasingly important with the goal of helping patients make decisions that more align with patients values and goals. Decision aids are validated instruments that provide unbiased information and guide patients through questions that allow patients to clarify patients goals.
Older adults with distal radius fractures have increasing evidence of ability to tolerate residual deformity with little to no functional deficits, which has called into question the indications for surgery. In situations where the operative indications are not clear, it is important to engage the patient in the risk and benefits of the decision.
This trial is a prospective trial with two groups, one standard of care, and one with the decision aid.
- Conditions
- Radius Fracture
- Being tested
- Decision Aid
- Keywords
- Decision aid, Shared decision making, Older adult patients, Distal radius fracture
- Medical subject headings
- Radius Fractures, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
Decision aid which is still under revision will include unbiased information to assist is clarifying values and informing patients with distal radius fractures.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will not be exposed to the decision aid. Patients will complete the same surveys, and will be followed for the same length of time. |
| Decision Aid | Experimental | This group will be exposed to the decision aid before the patients appointment with the surgeon. Patients will also complete the same outcome surveys, and will be followed for the same length of time. Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Conflict Score
Validated measure for decision conflict
Measured: Immediate post appointment
Secondary outcomes (2)
Decision regret scale
Validated measure for decision regret
Measured: 6 weeks and 6 months post appointment
Patient knowledge
Knowledge quiz created to evaluate knowledge of distal radius treatment options
Measured: immediate post appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startDec 2015
- Primary completionNov 2018
- Study completionNov 2018
Why it stopped: IRB closed project as the continuing review was not submitted. PI has left WU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius FractureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Calfee, MD, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782299
- Sponsor's protocol ID
- 201512001
- Status last verified
- Jan 2019
- First submitted
- 1 May 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Older Adults With Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT02782299
- Acronym / sponsor ID
- 201512001
- Conditions
- Radius Fracture
- Keywords
- Decision aid, Shared decision making, Older adult patients, Distal radius fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB closed project as the continuing review was not submitted. PI has left WU.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 25 May 2016 (estimated)
- 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 is a study to investigate the use of a Decision Aid for shared decision making in older adults with distal radius fractures. The goal is to improve patient decisions making, and improve patient knowledge through the use of a validated decision aid.
Detailed description
Shared decision making has become a increasingly important with the goal of helping patients make decisions that more align with patients values and goals. Decision aids are validated instruments that provide unbiased information and guide patients through questions that allow patients to clarify patients goals.
Older adults with distal radius fractures have increasing evidence of ability to tolerate residual deformity with little to no functional deficits, which has called into question the indications for surgery. In situations where the operative indications are not clear, it is important to engage the patient in the risk and benefits of the decision.
This trial is a prospective trial with two groups, one standard of care, and one with the decision aid.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will not be exposed to the decision aid. Patients will complete the same surveys, and will be followed for the same length of time. |
| Decision Aid | Experimental | Other: Decision AidThis group will be exposed to the decision aid before the patients appointment with the surgeon. Patients will also complete the same outcome surveys, and will be followed for the same length of time. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Distal radius fracture within the past 2 weeks
- Initial appointment seeing Attending
- Age 65+
Key exclusion criteria (3 listed)
- Non english speaker
- Dementia or other mental limitation preventing ability to complete survey
- Other traumatic injuries in extremity that would affect surgical decision
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 AidDecision aid which is still under revision will include unbiased information to assist is clarifying values and informing patients with distal radius fractures. | Other | Decision Aid |
Primary outcome
Decision Conflict Score
Time frame: Immediate post appointment
Validated measure for decision conflict
2 secondary outcomes
Decision regret scale
Time frame: 6 weeks and 6 months post appointment
Patient knowledge
Time frame: immediate post appointment
Results and safety
The study was stopped early (reason given: IRB closed project as the continuing review was not submitted. PI has left WU.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Radius Fracture
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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.
Ryan Calfee, MD study director
Washington University School of Medicine
1 site 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 Radius Fracture, run by Washington University School of Medicine at 1 site 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 3 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: stopped early, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: IRB closed project as the continuing review was not submitted. PI has left WU.). Results are not available in the source record.
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?
Decision Conflict Score (time frame: Immediate post appointment). 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 10 Jan 2019.