| - candidate number | 4604 |
| - NTR Number | NTR1562 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 26-nov-2008 |
| - Secondary IDs | 80-81600-98-2-003 ZonMw |
| - Public Title | Patient Safety and Complex Care. |
| - Scientific Title | Research 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. |
| - ACRONYM | Patient Safety and Complex Care |
| - hypothesis | The 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) studied | Safety, Hip fractures, Mobility, Avoidable harm |
| - Inclusion criteria | 1. Acute hip fracture patient 2. 65 years and older |
| - Exclusion criteria | 1. 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 received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 13-jun-2008 |
| - planned closingdate | 31-dec-2009 |
| - Target number of participants | 500 |
| - Interventions | Interventions - 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 site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | MSc. H. Merten |
| - CONTACT for SCIENTIFIC QUERIES | PhD. 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 |
| - Publications | N/A |
| - Brief summary | Elderly 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) | |
| - RECORD | 26-nov-2008 - 30-sep-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl