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

Study Overview
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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.

Official Title
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Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents: a Cluster-randomized Controlled Trial

Conditions
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Dementia

Intervention / Treatment
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* 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.)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Updated original programme<br>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.) | Other: Educational programme for all nurses<br> <br> Other: Training and structured support for nominated key nurses<br> <br> Other: Printed study material<br> <br> Other: Supportive material (poster, mugs etc.)<br> <br> |
| Experimental: Concise updated programme<br>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.) | Other: Training and structured support for nominated key nurses<br> <br> Other: Facultative train-the-trainer module for key nurses<br> <br> Other: Printed study material<br> <br> Other: Supportive material (poster, mugs etc.)<br> <br> |
| Active Comparator: Optimized usual care<br>Provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives) only | Other: Printed study material<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residents' quality of life (measured by QoL-AD) | Will be measured by QoL-AD for a randomly selected subgroup of 10% of residents | 12 Months | 
| Falls and fall-related fractures |  | 12 Months | 
| Costs within trial period (cost parameters related to the implementation of the intervention as well as outcome-related cost parameters) | For economic evaluation cost parameters related to the implementation of the intervention will be collected as well as outcome-related costparameters; explicit trial-associated will not be taken into account | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nursing home care, physical restraints, dementia, implementation research, cluster-randomized controlled trial