The implementation of the perioperative safety guidelines.|
|- candidate number||13197|
|- NTR Number||NTR3568|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-aug-2012|
|- Secondary IDs||80-82315-97-11019 ZonMw|
|- Public Title||The implementation of the perioperative safety guidelines.|
|- Scientific Title||The implementation of the perioperative safety guidelines.|
|- hypothesis||The aim is to investigate the effects, costs, and feasibility of an evidence-based professional-directed implementation strategy to implement the Dutch peri-operative guidelines, i.e. to achieve a higher adherence to these guidelines. It is hypothesized that a higher adherence to these guidelines leads to a higher patient safety in terms of less morbidity, less mortality, and less unplanned care.|
|- Healt Condition(s) or Problem(s) studied||Elective operations, Abdominal and vascular procedures|
|- Inclusion criteria||1. Adult patients (aged 18 years or older) undergoing an elective abdominal or vascular operation;|
2. Surgical procedure with a mortality risk ≥ 1%.
|- Exclusion criteria||1. Patients < 18 years;|
2. Acute operations;
3. Surgical procedures other than abdominal or vascular;
4. Surgical procedures with a mortality risk < 1%.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2012|
|- planned closingdate||1-jun-2015|
|- Target number of participants||1800|
|- Interventions||The intervention consists of an evidence-based professional-directed multi-faceted implementation strategy to implement the Dutch peri-operative safety guidelines, in order to achieve a higher adherence to these guidelines. The implementation strategy consists of several components, such as educational activities with regard to the guidelines, feedback activities based on the indicator scores and a total scan of the perioperative process, and patient-related activities based on the use of patient safety cards. The implementation activities will be tailored to the local situation in the hospital.|
|- Primary outcome||Adherence to the guideline. Adherence is measured by a set of quality indicators for perioperative care. These indicators have been developed by the same professionals in the peri-operative care who developed the guidelines. An example of a quality indicator is the percentage of patients who received antibiotic prophylaxes in time. The numerator include the number of patients that received antibiotic prophylaxes in time; the denominator consists of the total included patient population (n=50 per measurement point per hospital).
Data collection takes place in the hospital.|
|- Secondary outcome||Patient safety, in terms of:|
1. Reduction perioperative morbidity;
2. Reduction perioperative mortality;
3. Reduction unplanned care: Length of stay, e-operation, admission to intensive care.
Data collection takes place in the hospital.
|- Timepoints||3 time points within a stepped wedge cluster randomized trial design.
The basic measurement (T0) in all nine hospitals has just been started (June 1, 2012). This takes 3 months. Subsequently, the intervention, i.e. the implementation strategy will be performed in the first group of three hospitals that cross over from the control situation (=usual care) into the intervention situation (=implemetation activities take place). This takes 5 months. After this, the first effect measurement (T1) takes place, again in all nine hospitals.
Then, the 2nd group of three hospitals cross over from the control situation into the intervention sitiuuation. Followed by measurement T2. And so on, until the final measurement T3.
|- Trial web site||www.iqhealthcare.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.P. Wolff|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.P. Wolff|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Calsbeek H. Emond Y, Stienen J, Wolff A. Performance measurement in perioperative care: development of indicators and insight in current practice and patient safety. Abstract for ISQua. Geneva, October 2012.
Emond Y, Stienen J, Calsbeek H, Oron A, Damen J, Dekkers W, Ouwens M, Wollersheim H, Wolff A. Development of quality indicators for monitoring perioperative care. Abstract for European Care Pathway Conference. Amsterdam, May/June 2012.
Emond Y, Stienen J, Calsbeek H, Oron A, Damen J, Dekkers W, Ouwens M, Wollersheim H, Wolff A. Development of quality indicators for monitoring perioperative care. Abstract for International Forum on Quality and Safety in Healthcare. Paris, April 2012.
|- Brief summary||Background: |
Peri-operative unsafety causes high rates of incidents and complications, leading to considerable death, injured and disabled patients and high costs. The Dutch national safety study showed that 65% of adverse events are associated with surgical care. Recently, the Dutch evidence-based pre- and per-operative guidelines have been published. The guideline on post-operative care will follow in 2012. These guidelines have to be actively implemented in Dutch hospitals, as guidelines are not adequately used after only dissemination.
To investigate the effects, costs, and feasibility of an evidence-based professional-directed implementation strategy to implement the Dutch peri-operative guidelines.
The peri-operative guidelines have to be implemented in the Dutch hospitals. Based on current scientific knowledge and expected barriers, a mix of implementation activities has been selected. It is expected that a higher adherence to the guidelines leads to smaller risks on avoidable harm and its consequences in surgical patients.
Stepped wedge cluster randomized trial design.
1800 elective abdominal and vascular surgery patients, including procedures with a mortality risk ≥ 1%.
Evidence-based professional-directed multifaceted strategy, including audit and feedback (indicator measurements, total scan), educational materials (guideline distribution), reminders (posters, ICT-tools, patient empowerment tool), and tailoring (refining the implementation activities according to local barriers).
Guideline adherence (measured with indicator set).
Patient safety (reduction in peri-operative morbidity (complications), mortality, and unplanned care in terms of length of stay, re-operation, admission to intensive care). In addition, the study consists of a process and economic evaluation.
Sample size calculation/data analysis:
4 measurements including 50 operations per hospital are needed, based on: availability of 9 hospitals, baseline adherence 50%, effect intervention: 15% increase, alpha 0.05, intraclass correlation coefficient (ICC) between 0.1-0.3, power 80%. To measure the effectiveness of the implementation strategy and to identify success factors, data will be analyzed using multilevel regression analyses with age, sex, and cultural background as covariates.
Cost-effectiveness of the implementation strategy will be measured by comparing costs of the implementation process (using an Activity Based Costing approach) with improvement on guideline adherence and reduction in harm and unplanned care, expressed in cost savings.
|- Main changes (audit trail)|
|- RECORD||2-aug-2012 - 28-aug-2012|
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