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

University of Luebeck

Status: Completed

Conditions: Dementia

Treatments: Other: Training and structured support for nominated key nurses; Other: Supportive material (poster, mugs etc.); Other: Facultative train-the-trainer module for key nurses; Other: Printed study material; Other: Educational programme for all nurses

Study type: Interventional

Funder types: Other

Identifiers

NCT02341898

IMPRINT

01GY1336B (Other Grant/Funding Number)

01GY1336A (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 10,800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Cluster level

Inclusion Criteria:

• randomly selected nursing homes in each region; no specific inclusion criteria will be applied

Exclusion Criteria:

• no specific exclusion criteria will be applied

Individual level

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

Exclusion Criteria:

• no specific exclusion criteria will be applied

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10,800 participants in 3 patient groups

Updated original programme

Experimental group

Description:

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.)

Treatment:

Other: Supportive material (poster, mugs etc.)

Other: Training and structured support for nominated key nurses

Other: Printed study material

Other: Educational programme for all nurses

Concise updated programme

Experimental group

Description:

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.)

Treatment:

Other: Supportive material (poster, mugs etc.)

Other: Training and structured support for nominated key nurses

Other: Printed study material

Other: Facultative train-the-trainer module for key nurses

Optimized usual care

Active Comparator group

Description:

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

Treatment:

Other: Printed study material