Prevention of physical restraints in the acute care setting: a cluster-randomized controlled pilot study
Not Applicable
- Conditions
- se of physical restraintsFalls, Therapy interruptions, Prescription of psychotropic medication
- Registration Number
- DRKS00027989
- Lead Sponsor
- Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3573
Inclusion Criteria
Cluster level:
Internal medicine, surgery, trauma surgery, neurology, and general acute care hospital units.
Individual level:
Adult patients (18 years and older) treated in participating wards at the time of data collection.
Exclusion Criteria
Cluster level:
Emergency departments, intensive care units, pediatric and psychiatric wards.
Individual level:
Patients who are primarily treated for a psychiatric illness and pediatric patients who are actually assigned to another ward but are treated on the addressed ward (e.g., due to lack of available beds in other wards).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with at least one physical restraint (PR) after six months. <br><br>The frequency and type of PR will be assessed by direct observation using a standardized form during the observation period. Observation occurs on seven consecutive days, three times each day, morning (08:30 to 10:30 am), noon (01:00 to 03:00 pm), and evening (07:00 to 09:00 pm), by blinded trained study staff. <br><br>Examples of PR types: Continuous bed rails on both sides, belts of various types, fixed tables/therapy tables, other PR such as mitts.
- Secondary Outcome Measures
Name Time Method Safety parameters: Falls, therapy interruptions (e.g., removal of medical devices), and prescriptions of psychotropic medication.