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| Sponsor: | Radboud University |
|---|---|
| Collaborator: |
ZonMw: The Netherlands Organisation for Health Research and Development |
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00365430 |
Purpose
The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.
| Condition | Intervention |
|---|---|
|
Pressure Ulcer Urinary Tract Infection Accidental Falls |
Behavioral: safety program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications. |
| Enrollment: | 3000 |
| Study Start Date: | September 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Background Patients in hospitals and nursing homes are at risk for the development of, often preventable, somatic complications. However, preventive care is not always optimal. Although guidelines are available for many complications, compliance with the guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is also associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, organisations can never implement all available guidelines. Another problem is lack of feedback about performance using clear quality indicators and lack of a recognizable, unambiguous system for implementation.
Aim The aim of SAFE or SORRY? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.
Participants Patients and nurses will be recruited from ten hospital wards and ten nursing home wards in the Netherlands. All nurses and all adult patients who are admitted for more than three days, will be asked for informed consent.
Method This study consists of two phases. In the first phase the program will be developed. The content of the program is based on the evidence based guidelines on pressure ulcers, urinary tract infections and falls. The program consists of a computerized registration and feedback system, an educational program for nurses and caregivers, and educational material for the patients.
In the second phase the program will be tested in a cluster randomised clinical trial. The program will be implemented on ten wards (5 hospital wards and 5 nursing home wards), i.e. the intervention group. The control group will continue to give care as usual.
Outcome measures Primary outcome measure: incidence of pressure ulcers, urinary tract infections and falls Secondary outcome measures: Utilization of preventive interventions and knowledge of nurses and caregivers regarding the complications and their prevention.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| Alysis Zorggroep lokatie Rijnstate | |
| Arnhem, Gelderland, Netherlands, 6800 TA | |
| Zorggroep Maas en Waal | |
| Beneden-Leeuwen, Gelderland, Netherlands, 6658EK | |
| Radboud University Nijmegen Medical Center | |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Canisius Wilhelmina Ziekenhuis | |
| Nijmegen, Gelderland, Netherlands, 6500 GS | |
| Stichting De Waalboog | |
| Nijmegen, Gelderland, Netherlands, 6503 CB | |
| Zorggroep Zuid-Gelderland | |
| Nijmegen, Gelderland, Netherlands, 6522 AS | |
| Universitair Longcentrum Dekkerswald | |
| Nijmegen, Gelderland, Netherlands, 6560 AB | |
| Stichting SVVE De Archipel | |
| Eindhoven, Noord-Brabant, Netherlands, 5616 PZ | |
| Stichting De Riethorst Stromenland | |
| Geertruidenberg, Noord-Brabant, Netherlands, 4931 BP | |
| Zorggroep Noord-Limburg Venlo | |
| Venlo, Noord-Limburg, Netherlands, 5900 AR | |
| Study Director: | Theo van Achterberg, PhD | Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Nijmegen Medical Center |
More Information
| Responsible Party: | Theo van Achterberg, Radboud University Nijmegen Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00365430 History of Changes |
| Other Study ID Numbers: | SoS245119, 54010002 |
| Study First Received: | August 16, 2006 |
| Last Updated: | January 22, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Patient safety Adverse event Prevention Knowledge Inpatient |
Hospital Nursing home Long term care Nurse |
|
Pressure Ulcer Ulcer Urinary Tract Infections Skin Ulcer |
Skin Diseases Pathologic Processes Infection Urologic Diseases |