|- candidate number||10910|
|- NTR Number||NTR3277|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jan-2012|
|- Secondary IDs||319934 Assigned by Ministry of Health, Welfare and Sports|
|- Public Title||Patient safety interventions in General Practice.|
|- Scientific Title||SCOPE Intervention Study. Comparison of patient safety interventions in General Practice.|
|- hypothesis||The purpose of this study is to compare two patient safety culture interventions (a questionnaire and a workshop) with each other and to a control group.|
|- Healt Condition(s) or Problem(s) studied||Safety, Behaviour, Health care workers|
|- Inclusion criteria||Data is obtained from general practices in the Netherlands.|
We will include practices that consist of at least three employees.
|- Exclusion criteria||The practice did not complete the SCOPE patient safety culture questionnaire in the two previous years.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2011|
|- planned closingdate||31-dec-2013|
|- Target number of participants||30|
|- Interventions||There are two interventions: The SCOPE questionnaire and a workshop.
The SCOPE questionnaire measures patient safety culture in seven dimensions.
The workshop is tailored to the results of the SCOPE questionnaire for that particular practice. The workshop is aimed at learning and discussing about patient safety culture and finishes with an action plan.
Intervention group 1: Staff of these practices complete the SCOPE questionnaire.
Intervention group 2: The staff also completes the SCOPE questionnaire and in addition receives a tailored workshop about patient safety culture.
The control group continues work as usual.
|- Primary outcome||The number of incident reporting by staff in general practice, measured by a beforehand composed form. |
|- Secondary outcome||Patient safety culture, measured by the SCOPE questionnaire.
Several quality and safety issues in the general practice such as ‘team meetings’, ‘incident reporting' 'safety management’, ‘education’, measured by a beforehand composed form.
|- Timepoints||1. Incident reporting is measured by a beforehand composed form;|
2. Patient safety culture is measured by the SCOPE questionnaire;
3. Quality and safety issuas are measured by a beforehand composed form.
Timepoints: One year.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| N.J. Verbakel|
|- CONTACT for SCIENTIFIC QUERIES|| N.J. Verbakel|
|- Sponsor/Initiator ||Julius Center for Health Sciences and Primary Care, NIVEL|
(Source(s) of Monetary or Material Support)
|Ministry of Health, Welfare and Sports|
|- Brief summary||In this research we want to investigate the effect of two cultural interventions on patient safety culture in General Practice in the Netherlands.
The first intervention will be the completion of the SCOPE questionnaire by all staff members of the general practice. The second intervention will also consist of the completion of the SCOPE questionnaire but complemented with a tailored training about patient safety culture. In this training the results of the questionnaire of the particular practice will be discussed. Furthermore, staff will be learned about patient safety culture and develop a concrete action plan.
The study will be conducted in 30 general practices in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||11-jan-2012 - 14-feb-2012|