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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Updated original programme

Educational programme for all nurses (90 min. single information session); training and structured support for nominated key nurses (one-day training workshop); provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.)

Group Type EXPERIMENTAL

Educational programme for all nurses

Intervention Type OTHER

Training and structured support for nominated key nurses

Intervention Type OTHER

Printed study material

Intervention Type OTHER

Supportive material (poster, mugs etc.)

Intervention Type OTHER

Concise updated programme

Training and structured support for nominated key nurses (one-day training workshop); nurses' training will be carried out by key nurses as facultative option; key nurses receive an additional train-the-trainer module to apply the educational programme; provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.)

Group Type EXPERIMENTAL

Training and structured support for nominated key nurses

Intervention Type OTHER

Facultative train-the-trainer module for key nurses

Intervention Type OTHER

Printed study material

Intervention Type OTHER

Supportive material (poster, mugs etc.)

Intervention Type OTHER

Optimized usual care

Provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives) only

Group Type ACTIVE_COMPARATOR

Printed study material

Intervention Type OTHER

Interventions

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Educational programme for all nurses

Intervention Type OTHER

Training and structured support for nominated key nurses

Intervention Type OTHER

Facultative train-the-trainer module for key nurses

Intervention Type OTHER

Printed study material

Intervention Type OTHER

Supportive material (poster, mugs etc.)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* all residents within the cluster present on the day of data collection
* all residents newly admitted to clusters during follow-up and present on the day of follow-up data collection