|- candidate number||11316|
|- NTR Number||NTR3343|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mrt-2012|
|- Secondary IDs||2011/278 METC Radboud University Nijmegen Medical Centre|
|- Public Title||What are the effects of internal audits on quality and safety of hospital care?
|- Scientific Title||The effects of auditing on patient safety in hospital care: Results in a Dutch hospital at ward level.|
|- ACRONYM||APS study = Audit Patient Safety study|
|- hypothesis||The objective of this thesis is to get insight into the effects of internal audits on patient safety and on health care professional’s behavior in an academic hospital at ward level.|
|- Healt Condition(s) or Problem(s) studied||Patient safety, Hospital care, Internal audits|
|- Inclusion criteria||The included departments of the Radboud University Nijmegen Medical Centre are:|
1. Comprehensive and thus recognizable for other hospitals;
2. Delivering clinical care with basic risks for patient safety;
3. Will be audited between October 2011 and February 2013.
|- Exclusion criteria||In this study we exclude the following criteria:|
1. The eight ‘sub audits’ perform by experts (Medication Safety, Hygiene and Infection prevention, ARBO and milieu, Medical Devices, Sterile Medical Aids, Patient-centered, Education and Scientific Research);
2. Departments which facilitating healthcare processes to clinical and outdoor patients, for example Radiotherapy, Operating Rooms and Laboratory Medicine;
3. The safety of outpatients.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-aug-2011|
|- planned closingdate||1-jan-2015|
|- Target number of participants||800|
|- Interventions||Internal audits.|
|- Primary outcome||Complications and adverse events.|
|- Secondary outcome||1. Patient safety culture;|
2. Team Climate;
3. Experiences of patients;
4. Standarized Mortality Rate (SMR);
5. Unintended prolonged hospital stay;
6. Learning effects of health care givers and department leaders.
|- Timepoints||Primary outcome: |
Complications and adverse events in hospital care are measured by structured retrospective patient record review of hospital admissions 3 months before and 15 months after an internal audit.
1. The patient safety culture whitin a team of health care givers is measured by the Dutch Questionnaire COMPaZ 3 months before and 15 months after an internal audit;
2. The team climate is determined by the Team Climate Inventory 3 months before and 15 months after an internal audit;
3. Patients experiences with hospital care are measured with the Consumer Quality Index of Hospital Admission 3 months before, 9 and 15 months after an internal audit;
4.+ 5. The SMR and the data of unintended prolonged hospital stay are derived monthly from the hospital registry database and the national medical registration (LMR);
6. The learning effects of health care givers and department leaders are gathered retrospective by in-depth questionnaires and for this study developed questionnaires.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Mirelle Hanskamp-Sebregts|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Marieke Zegers|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Centre Nijmegen|
|- Brief summary||We examine the current internal audits of the Radboud University Nijmegen Medical Centre; are they a valid, reliable and responsive diagnostic instrument to analyze the safety of patient care? And we want to know what the results of the internal audits of the Radboud University Nijmegen Medical Centre are on the safety of patient care in (academic) hospitals. We use a mix method approach (quantitative and qualitative research methods) to measure the effects of internal audits on different levels: patient, professional and department level. To measure the effects of internal audits on patient safety in clinical hospital care we use a before-and-after design. The null hypothesis is that there is no difference of patient safety of healthcare between the measurement before and after the internal audit and between departments with and without an internal audit. The alternative hypothesis is that internal audits improve the patient safety of healthcare in the Radboud University Nijmegen Medical Centre. In this study we perform a determinant analysis to correct statistical for potential confounders. And we also perform a process analysis to explain certain (un)expected effects of internal audits.
This study takes place in the Netherlands.|
|- Main changes (audit trail)|
|- RECORD||12-mrt-2012 - 17-mrt-2013|