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Patient Safety and Complex Care.


- candidate number4604
- NTR NumberNTR1562
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-nov-2008
- Secondary IDs80-81600-98-2-003 ZonMw
- Public TitlePatient Safety and Complex Care.
- Scientific TitleResearch Program on Patient Safety and Complex Care: An intervention program with the aim to reduce unintended events and avoidable harm in elderly hip fracture patients by introducing instruments to structure the handover process, involve patients more in their treatment and provide patients with evidence based information for the period after discharge.
- ACRONYMPatient Safety and Complex Care
- hypothesisThe rate of unintended events and avoidable harm for elderly hip fracture patients can be reduced by the introduction of three integrated interventions directed at the structure of the handover process, the role of the patient in the care process and evidence based information for the period after discharge.
- Healt Condition(s) or Problem(s) studiedSafety, Hip fractures, Mobility, Avoidable harm
- Inclusion criteria1. Acute hip fracture patient
2. 65 years and older
- Exclusion criteria1. Pathological fractures
2. Patient receives no surgery for the hip fracture
3. Patient is participating in another intervention study that interferes with this research
4. Suffering from dementia
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-jun-2008
- planned closingdate31-dec-2009
- Target number of participants500
- InterventionsInterventions
- SBAR communication tool to structure handover process
- Patient safety card
- Bundles with evidence based recommendations for the period after discharge

There are four different intervention groups (the patients will be randomly assigned to one of the four intervention groups):
Group 1: SBAR
Group 2: SBAR and patient safety card
Group 3: SBAR and bundles
Group 4: SBAR, patient safety card and bundles

Control group: receives no interventions

At least 100 patients per group will be included
- Primary outcome- Avoidable harm
- Mortality rate within 6 months after discharge
- Unintended events
- Functional mobility

Methods: Patient record review and interviews with the patient two weeks and six months after discharge
- Secondary outcome- Length of hospital stay
- Operative delay
- Quality of hand over
- Quality of patient record

Methods: Patient record review and observations
- Timepoints- Baseline measurement
- Final measurements (record review six months after discharge, interview with patients (by telephone) two weeks and six months after discharge
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc. H. Merten
- CONTACT for SCIENTIFIC QUERIESPhD. C. Wagner
- Sponsor/Initiator Nederlands instituut voor onderzoek van de gezondheidszorg (NIVEL), VU University Medical Center, EMGO-Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryElderly patients with a hip fracture are the focus of the research program ‘Patient Safety and Complex Care’. It is hypothesized that an improvement in the handover process, a more active role for the patient in the care process and evidence based information for the period after discharge can reduce the rate of unintended events and avoidable harm in this patient group. Patients will be randomly assigned to one of four intervention groups, the control group will receive no interventions. During one year a maximum of 500 patients will be included in the study, the patients have to be 65 years or older and have an acute hip fracture. Pathological fractures, patients who receive no surgery for the fracture, patients participating in other (interfering) intervention studies and patients suffering from dementia will be excluded from the study. The effectiveness of the intervention program will be measured through observations, patient record review and interviews with patients. Primary outcome measures are avoidable harm, mortality rate, unintended events and functional mobility.
- Main changes (audit trail)
- RECORD26-nov-2008 - 30-sep-2009


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