Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents (IMPRINT)

Summary

Background: Physical restraints as bedrails and belts are still regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent intervention has been shown with a significant reduction in physical restraints use without adverse events. The present study aims to apply different versions of the original intervention in nursing home residents in four different regions throughout Germany in order to evaluate the effectiveness of the programme.

Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention groups ((1) updated original programme and (2) brief version of the updated programme) with a control group (3) receiving printed study materials (optimized usual care). Intervention (1) consists of an information programme for all nurses, additional training and structured support for nominated key nurses, and provision of printed study material and other supportive material. For intervention (2) nurses' training is only optional carried out facultatively by key nurses who have received an additional train-the-trainer module. The control group (3) receives printed study material only. Overall, 120 nursing homes including approximately 10800 residents will be recruited, randomized to one of the three groups and followed up for 12 months. The primary outcome is defined as proportion of residents with at least one physical restraint at 12 months. Physical restraint use will be assessed by direct observation. Secondary outcomes are residents' quality of life as well as safety parameters as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.

Conditions

• Dementia

Interventions

OTHER

Educational programme for all nurses

OTHER

Training and structured support for nominated key nurses

OTHER

Facultative train-the-trainer module for key nurses

OTHER

Printed study material

OTHER

Supportive material (poster, mugs etc.)

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• University of Luebeck

  lead OTHER

Principal Investigators

• Sascha Köpke, Prof. Dr. · University of Lübeck

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2017-03-31

Completion

2017-03-31

Countries

• Germany

Study Locations