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NCT00365430 Clinical Trial

SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes

Pressure Ulcer Clinical Trial

Official title:
SAFE or SORRY? Development and Testing of an Evidence Based Inpatient Safety Program for the Prevention of Common Complications.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00365430
Other study ID # SoS245119
Secondary ID 54010002
Status Completed
Phase N/A
First received August 16, 2006
Last updated January 22, 2009
Start date September 2006
Est. completion date December 2008

Study information
Verified date January 2009
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3000
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients on participating wards admitted for more than three days

- all nurses on participating wards

Exclusion Criteria:

- students on participating wards

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• safety program
Education, patient involvement, tailored implementation and a computerized registration system

Locations
Country Name City State
Netherlands Alysis Zorggroep lokatie Rijnstate Arnhem Gelderland
Netherlands Zorggroep Maas en Waal Beneden-Leeuwen Gelderland
Netherlands Stichting SVVE De Archipel Eindhoven Noord-Brabant
Netherlands Stichting De Riethorst Stromenland Geertruidenberg Noord-Brabant
Netherlands Canisius Wilhelmina Ziekenhuis Nijmegen Gelderland
Netherlands Radboud University Nijmegen Medical Center Nijmegen Gelderland
Netherlands Stichting De Waalboog Nijmegen Gelderland
Netherlands Universitair Longcentrum Dekkerswald Nijmegen Gelderland
Netherlands Zorggroep Zuid-Gelderland Nijmegen Gelderland
Netherlands Zorggroep Noord-Limburg Venlo Venlo Noord-Limburg

Sponsors (2)
Lead Sponsor Collaborator
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (count incidence of Pressure Ulcers, Urinary Tract Infections, and Falls nine months Yes
Secondary Utilization of preventive interventions and knowledge of nurses and caregivers nine months Yes
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Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
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Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Not yet recruiting NCT06421454 - Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers N/A
Terminated NCT05547191 - Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement N/A
Completed NCT05458050 - An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers N/A
Active, not recruiting NCT03048357 - Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury. N/A
Completed NCT06025370 - Pressures During Prone Positions in Healthy Volunteers N/A
Recruiting NCT05033470 - A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers N/A
Terminated NCT04023981 - Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers N/A

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