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Treatment decisions in collarbone fractures


- candidate number21203
- NTR NumberNTR4957
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-dec-2014
- Secondary IDsP14.287 MEC LEIDEN
- Public TitleTreatment decisions in collarbone fractures
- Scientific TitleShared decision making in the treatment of clavicular fractures: daily practice or goal for the future?
- ACRONYM
- hypothesisGoal: To investigate what the perceived role in treatment decision making is in patients with a displaced midshaft clavicular fracture. Do patients prefer a more/less active role in making this decision?
- Healt Condition(s) or Problem(s) studiedClavicula, Fracture , Shared decision making
- Inclusion criteria- midshaft, displaced clavicular fracture type Robinson 2A2 or 2B - age between 18 and 70 years - able to understand dutch
- Exclusion criteria- absolute operation indication (e.g. neurovascular damage, compromised skin). - reasons that rule out shared decision making (e.g. follow up in other hospital, inoperability)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-dec-2014
- planned closingdate31-dec-2015
- Target number of participants50
- InterventionsAll patients fill out a questionnaire once (SDM-Q-9-NL, Control Preferences Scale and additional questions).
- Primary outcomeDegree of perceived participation in treatment decision making in patients with midshaft, displaced clavicular fractures (measured with SDM-Q-9-NL)
- Secondary outcome- Satisfaction of patients with their role in treatment decision making (measured with Control Preferences Scale) - Awareness of the treatment options at the start of the consultation. Do patients have a clear preference for one treatment option before the start of the consultation and if so, has it changed after the consultation? (measured with additional questions)
- TimepointsPatients fill out the questionnaire once, directly (or max. a week) after the consultation at the outpatient clinic where the treatment decsion was made.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Sarah Woltz
- CONTACT for SCIENTIFIC QUERIES Sarah Woltz
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryObservational study in The Netherlands to assess the degree of perceived participation in treatment decision making in patients with a midshaft, displaced clavicular fracture, and to investigate whether patients prefer a more/less active role in decison making than the one they have now.
- Main changes (audit trail)
- RECORD31-dec-2014 - 27-feb-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl