Distal Radius FractureNCT04032873
Distal Radius Buckle Fracture RCT
A study testing Monetary Cost of Immobilization Treatments, Physician and Study Team in people with Distal Radius Fracture, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study evaluates the influence of cost information on decision-making for immobilization for treatment of distal radial buckle fractures. Half of the participants will receive cost information from an orthopaedic surgeon prior to making their decision for treatment, while the other half will receive cost… Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Monetary Cost of Immobilization Treatments, Physician and Study Team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2017to 9 Oct 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females ages 4 to 14 years with a buckle fracture for which they will be treated with a cast or a splint.
- Parental/guardian permission (informed consent) and, if appropriate, child assent.
- Parent of a child ages 4 to 14 years with a buckle fracture that requires treatment with either a cast or a splint.
- Parental/guardian permission (informed consent).
Who cannot join
- Non-English speaking subjects.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Influence of Cost Information on Cast vs. Splint Decision-Making After Pediatric Buckle Fractures: A Randomized Controlled Trial
This study evaluates the influence of cost information on decision-making for immobilization for treatment of distal radial buckle fractures. Half of the participants will receive cost information from an orthopaedic surgeon prior to making their decision for treatment, while the other half will receive cost information from another member of the study team after they had made their decision treatment.
Read the detailed description
Research has shown equipoise in treatment outcomes after casting and splinting for pediatric buckle fractures. Despite the similarly favorable treatment outcomes associated with both casting and splinting these fractures, there is wide disparities in cost between the two types of immobilization. However, cost information is not routinely presented to families during the discussion of immobilization types.
The primary objective of this study is to determine if cost information influences family decision-making about immobilization type after pediatric buckle fractures. A secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making.
- Conditions
- Distal Radius Fracture
- Being tested
- Monetary Cost of Immobilization Treatments, Physician, Study Team, Before Initial Treatment Decision, After Initial Treatment Decision
- Keywords
- Distal Radius Fracture, Cost, Buckle Fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monetary Cost of Immobilization TreatmentsOther
Also called Cost Information
Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.
PhysicianOther
The monetary cost information is relayed by the patient's physician
Study TeamOther
The monetary cost information is relayed by a member of the study team
Before Initial Treatment DecisionOther
Also called Initial Consult
Monetary cost information is relayed during the initial consult, before the treatment decision is made.
After Initial Treatment DecisionOther
Also called Post-Consult
Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.
| Study group | Role | What they receive |
|---|---|---|
| Provider Cost | Other | The subject will be given information about the cost of casting and splinting for treatment of the buckle fracture by the orthopaedic surgeon before the decision for immobilization has been made. Receives: Other: Monetary Cost of Immobilization Treatments; Other: Physician; Other: Before Initial Treatment Decision |
| Research Team Cost | Other | The subject will be given information about the cost of casting and splinting for treatment of the buckle fracture by a member of the study team after the decision for immobilization has been made. Receives: Other: Monetary Cost of Immobilization Treatments; Other: Study Team; Other: After Initial Treatment Decision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monetary Cost of Immobilization's Influence on Treatment Decisions
The outcome measure will evaluate whether monetary cost influenced payers' decisions to choose one immobilization treatment over the other (splinting vs. casting).
Measured: 1 to 5 minutes
Secondary outcomes (1)
Timing/Person Effect on Decision-Making
A secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making
Measured: 1 to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start31 May 2017
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Todd R Lawrence, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032873
- Sponsor's protocol ID
- 17-013965
- Status last verified
- Feb 2021
- First submitted
- 23 Jul 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared with researchers outside of the research team for this clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cost Information on Cast vs. Splint Decision-Making After Pediatric Buckle Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04032873
- Acronym / sponsor ID
- 17-013965
- Conditions
- Distal Radius Fracture
- Keywords
- Distal Radius Fracture, Cost, Buckle Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 25 Jul 2019 (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 evaluates the influence of cost information on decision-making for immobilization for treatment of distal radial buckle fractures. Half of the participants will receive cost information from an orthopaedic surgeon prior to making their decision for treatment, while the other half will receive cost information from another member of the study team after they had made their decision treatment.
Detailed description
Research has shown equipoise in treatment outcomes after casting and splinting for pediatric buckle fractures. Despite the similarly favorable treatment outcomes associated with both casting and splinting these fractures, there is wide disparities in cost between the two types of immobilization. However, cost information is not routinely presented to families during the discussion of immobilization types.
The primary objective of this study is to determine if cost information influences family decision-making about immobilization type after pediatric buckle fractures. A secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider Cost | Other | Other: Monetary Cost of Immobilization Treatments, Other: Physician, Other: Before Initial Treatment DecisionThe subject will be given information about the cost of casting and splinting for treatment of the buckle fracture by the orthopaedic surgeon before the decision for immobilization has been made. |
| Research Team Cost | Other | Other: Monetary Cost of Immobilization Treatments, Other: Study Team, Other: After Initial Treatment DecisionThe subject will be given information about the cost of casting and splinting for treatment of the buckle fracture by a member of the study team after the decision for immobilization has been made. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males or females ages 4 to 14 years with a buckle fracture for which they will be treated with a cast or a splint.
- Parental/guardian permission (informed consent) and, if appropriate, child assent.
- Parent of a child ages 4 to 14 years with a buckle fracture that requires treatment with either a cast or a splint.
- Parental/guardian permission (informed consent).
Key exclusion criteria (2 listed)
- Non-English speaking subjects.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
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 |
|---|---|---|
| Monetary Cost of Immobilization TreatmentsAlso: Cost InformationInformation regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer. | Other | Provider Cost, Research Team Cost |
| PhysicianThe monetary cost information is relayed by the patient's physician | Other | Provider Cost |
| Study TeamThe monetary cost information is relayed by a member of the study team | Other | Research Team Cost |
| Before Initial Treatment DecisionAlso: Initial ConsultMonetary cost information is relayed during the initial consult, before the treatment decision is made. | Other | Provider Cost |
| After Initial Treatment DecisionAlso: Post-ConsultMonetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made. | Other | Research Team Cost |
Primary outcome
Monetary Cost of Immobilization's Influence on Treatment Decisions
Time frame: 1 to 5 minutes
The outcome measure will evaluate whether monetary cost influenced payers' decisions to choose one immobilization treatment over the other (splinting vs. casting).
1 secondary outcome
Timing/Person Effect on Decision-Making
Time frame: 1 to 5 minutes
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 3 Feb 2021.
- Individual participant dataSharing planned: No. The IPD will not be shared with researchers outside of the research team for this clinical trial.
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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.
John Todd R Lawrence, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monetary Cost of Immobilization Treatments, Physician and Study Team in people with Distal Radius Fracture, run by Children's Hospital of Philadelphia 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 4 inclusion and 2 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 3 Feb 2021. 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 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?
Monetary Cost of Immobilization's Influence on Treatment Decisions (time frame: 1 to 5 minutes). 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 3 Feb 2021.