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Comparison between care as usual and a comprehensive care pathway for the treatment of hip fractures.


- candidate number10607
- NTR NumberNTR3171
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2011
- Secondary IDs2011/164 METC UMCG
- Public TitleComparison between care as usual and a comprehensive care pathway for the treatment of hip fractures.
- Scientific TitleA comprehensive care pathway for the treatment of hip fractures: A prospective observational study into its clinical and cost effectiveness compared to care as usual.
- ACRONYM
- hypothesisThe hypothesis is that 15% more patients in the comprehensive care pathway compared with patients in the care as usual condition will recover at least as well at 6 months follow-up as before the fracture in Activities of Daily Living.
- Healt Condition(s) or Problem(s) studiedHip fractures, Comprehensive care pathway
- Inclusion criteriaPatients aged 60 and older with a hip or pertrochanteric femur fracture.
- Exclusion criteriaHigh energetic trauma.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2012
- planned closingdate31-dec-2012
- Target number of participants390
- InterventionsIn the new comprehensive care pathway at UMCG the treatment and the role of every participant is described from the arrival at the emergency room until discharge from the nursing home. Main features of this new treatment protocol are multidisciplinary cooperation between trauma surgeon, orthopedic surgeon, geriatrician and anesthesiologist, a preoperative workup protocol, a clearly defined moment of surgery and a postoperative protocol together with the physiotherapist and nursing home physician. The comprehensive care pathway doesn’t end with discharge from the hospital.
- Primary outcomeKatz index at 6 months follow-up.
- Secondary outcome1. Health-related quality of life as measured with the EQ-5D at 6 months follow-up;
2. Living situation at 6 months follow-up.
- TimepointsMeasurements will be taken perioperatively, and at 6 weeks and 3 and 6 months after surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES E.R. Flikweert
- CONTACT for SCIENTIFIC QUERIESDr. M. Stevens
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Biomet Nederland, Dordrecht
- PublicationsN/A
- Brief summaryHip fractures constitute an economic burden on healthcare resources. Most persons with a fracture have surgery. However, perioperative care leaves much room for improvement. It can be improved if it is organized in comprehensive care pathways but these pathways have never been studied in randomized controlled trials (RCT). The main reason for this is that RCT´s are difficult to execute in this patient group. To overcome this dilemma a prospective observational study will be conducted in which by means of the application of Propensity Score Matching (PSM)* a RCT will be simulated. The objective of this study is to determine the clinical effectiveness of a new comprehensive care pathway for the treatment of hip fractures compared with care as usual. A prospective observational study will be conducted in which the new comprehensive care pathway of UMCG Groningen will be compared with care as usual at Martini Hospital Groningen and at Ommelander Ziekenhuis Groep. The hypothesis is that 15% more patients at the UMCG compared with patients in the care as usual condition will recover at least as well at 6 months follow-up as before the fracture in Activities of Daily Living. Patients aged 60 and older will be included.
- Main changes (audit trail)
- RECORD1-dec-2011 - 17-dec-2011


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