Pressure UlcerNCT00365430
SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
A study testing safety program in people with Pressure Ulcer and Urinary Tract Infection, run by Radboud University Medical Center at 10 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Urinary Tract Infection, Accidental Falls
- What is being tested?
- safety program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,000 participants
- Where
- 10 sitesNetherlands
- Study dates
- Sep 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients on participating wards admitted for more than three days
- all nurses on participating wards
Who cannot join
- students on participating wards
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Alysis Zorggroep lokatie Rijnstate
Arnhem, Gelderland, 6800 TA
Zorggroep Maas en Waal
Beneden-Leeuwen, Gelderland, 6658EK
Stichting SVVE De Archipel
Eindhoven, North Brabant, 5616 PZ
Stichting De Riethorst Stromenland
Geertruidenberg, North Brabant, 4931 BP
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6500 GS
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6500 HB
Stichting De Waalboog
Nijmegen, Gelderland, 6503 CB
Zorggroep Zuid-Gelderland
Nijmegen, Gelderland, 6522 AS
Universitair Longcentrum Dekkerswald
Nijmegen, Gelderland, 6560 AB
Zorggroep Noord-Limburg Venlo
Venlo, Noord-Limburg, 5900 AR
About this study
Official title: SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
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.
Read the detailed description
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.
- Conditions
- Pressure Ulcer, Urinary Tract Infection, Accidental Falls
- Being tested
- safety program
- Keywords
- Patient safety, Adverse event, Prevention, Knowledge, Inpatient, Hospital, Nursing home, Long term care, Nurse
- Medical subject headings
- Pressure Ulcer, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safety programBehavioural
Education, patient involvement, tailored implementation and a computerized registration system
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls
Measured: nine months
Secondary outcomes (1)
Utilization of preventive interventions and knowledge of nurses and caregivers
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Theo van Achterberg, PhD, Study director, Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365430
- Sponsor's protocol ID
- SoS245119
- Other IDs
- 54010002
- Status last verified
- Jan 2009
- First submitted
- 16 Aug 2006
- Last updated
- 23 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Gaal BG, Schoonhoven L, Mintjes JA, Borm GF, Hulscher ME, Defloor T, Habets H, Voss A, Vloet LC, Koopmans RT, van Achterberg T. Fewer adverse events as a result of the SAFE or SORRY? programme in hospitals and nursing homes. part i: primary outcome of a cluster randomised trial. Int J Nurs Stud. 2011 Sep;48(9):1040-8. doi: 10.1016/j.ijnurstu.2011.02.017. Epub 2011 Mar 17.
PubMed 21419411van Gaal BG, Schoonhoven L, Vloet LC, Mintjes JA, Borm GF, Koopmans RT, van Achterberg T. The effect of the SAFE or SORRY? programme on patient safety knowledge of nurses in hospitals and nursing homes: a cluster randomised trial. Int J Nurs Stud. 2010 Sep;47(9):1117-25. doi: 10.1016/j.ijnurstu.2010.02.001. Epub 2010 Mar 3.
PubMed 20202633van Gaal BG, Schoonhoven L, Hulscher ME, Mintjes JA, Borm GF, Koopmans RT, van Achterberg T. The design of the SAFE or SORRY? study: a cluster randomised trial on the development and testing of an evidence based inpatient safety program for the prevention of adverse events. BMC Health Serv Res. 2009 Apr 1;9:58. doi: 10.1186/1472-6963-9-58.
PubMed 19338655
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.
- ClinicalTrials.gov ID
- NCT00365430
- Acronym / sponsor ID
- SoS245119
- Conditions
- Pressure Ulcer, Urinary Tract Infection, Accidental Falls
- Keywords
- Patient safety, Adverse event, Prevention, Knowledge, Inpatient, Hospital, Nursing home, Long term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients on participating wards admitted for more than three days
- all nurses on participating wards
Key exclusion criteria (1 listed)
- students on participating wards
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| safety programEducation, patient involvement, tailored implementation and a computerized registration system | Behavioural | – |
Primary outcome
Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls
Time frame: nine months
1 secondary outcome
Utilization of preventive interventions and knowledge of nurses and caregivers
Time frame: nine months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
- Derived from this study: PubMed 21419411van Gaal BG, Schoonhoven L, Mintjes JA, Borm GF, Hulscher ME, Defloor T, Habets H, Voss A, Vloet LC, Koopmans RT, van Achterberg T. Fewer adverse events as a result of the SAFE or SORRY? programme in hospitals and nursing homes. part i: primary outcome of a cluster randomised trial. Int J Nurs Stud. 2011 Sep;48(9):1040-8. doi: 10.1016/j.ijnurstu.2011.02.017. Epub 2011 Mar 17.
- Derived from this study: PubMed 20202633van Gaal BG, Schoonhoven L, Vloet LC, Mintjes JA, Borm GF, Koopmans RT, van Achterberg T. The effect of the SAFE or SORRY? programme on patient safety knowledge of nurses in hospitals and nursing homes: a cluster randomised trial. Int J Nurs Stud. 2010 Sep;47(9):1117-25. doi: 10.1016/j.ijnurstu.2010.02.001. Epub 2010 Mar 3.
- Derived from this study: PubMed 19338655van Gaal BG, Schoonhoven L, Hulscher ME, Mintjes JA, Borm GF, Koopmans RT, van Achterberg T. The design of the SAFE or SORRY? study: a cluster randomised trial on the development and testing of an evidence based inpatient safety program for the prevention of adverse events. BMC Health Serv Res. 2009 Apr 1;9:58. doi: 10.1186/1472-6963-9-58.
- Guideline prevention urinary tract infection (The Netherlands)Link provided by the sponsor.
- Guideline Urinary Tracts Infections (The Netherlands)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theo van Achterberg, PhD study director
Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Nijmegen Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing safety program in people with Pressure Ulcer and Urinary Tract Infection, run by Radboud University Medical Center at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls (time frame: nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365430, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2009.