Skip to content

Prevention of physical restraints in the acute care setting: a cluster-randomized controlled pilot study

Prevention of physical restraints in the acute care setting: a cluster-randomized controlled pilot study - PROTECT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027989
Enrollment
2772
Registered
2022-02-28
Start date
2022-09-05
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use of physical restraints Falls, Therapy interruptions, Prescription of psychotropic medication

Interventions

Group 1: Intervention group: The intervention program is based on an intervention developed in the previous feasibility study (MARAH). The program will be further developed and adapted in a preparator
coordination of all activities for change in practice
support of all stakeholders during decision-making regarding the use of PR
critical review of the PR used and development of an agenda with prevention strategies • Interdisciplinary short information sessions (45-minute with the following target groups: nurses, medical staf

Sponsors

Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Proportion of patients with at least one physical restraint (PR) after six months. 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. Examples of PR types: Continuous bed rails on both sides, belts of various types, fixed tables/therapy tables, other PR such as mitts.

Secondary

MeasureTime frame
Safety parameters: Falls, therapy interruptions (e.g., removal of medical devices), and prescriptions of psychotropic medication.

Countries

Germany

Contacts

Public ContactSusan;Jens Gottschalk;Abraham

Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät, Institut für Gesundheits- und Pflegewissenschaft;Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät, Institut für Gesundheits- und Pflegewissenschaft

susan.gottschalk@medizin.uni-halle.de;jens.abraham@medizin.uni-halle.de+49 345 557 4139;+49 345 557 5411

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026