Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents (IMPRINT) (IMPRINT)
Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents: a Cluster-randomized Controlled Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hamburg, Germany, 20146
- University of Hamburg
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Nordrhein-Westfalen
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Witten, Nordrhein-Westfalen, Germany, 58448
- Witten/Herdecke University
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Sachsen-Anhalt
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Halle (Saale), Sachsen-Anhalt, Germany, 06112
- Martin-Luther-University Halle-Wittenberg
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23562
- University of Lubeck
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.)
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Experimental: 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.)
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Active Comparator: 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants
Time Frame: 12 Months
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12 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Residents' quality of life (measured by QoL-AD)
Time Frame: 12 Months
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Will be measured by QoL-AD for a randomly selected subgroup of 10% of residents
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12 Months
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Falls and fall-related fractures
Time Frame: 12 Months
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12 Months
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Costs within trial period (cost parameters related to the implementation of the intervention as well as outcome-related cost parameters)
Time Frame: 12 Months
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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
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12 Months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Process evaluation
Time Frame: 12 Months
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Different process parameters will be assessed as e.g.
relatives' experiences, staff experiences, leaders' experiences and organizational culture
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12 Months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sascha Köpke, Prof. Dr., University of Lubeck
Publications and helpful links
General Publications
- Abraham J, Kupfer R, Behncke A, Berger-Hoger B, Icks A, Haastert B, Meyer G, Kopke S, Mohler R. Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial. Int J Nurs Stud. 2019 Aug;96:27-34. doi: 10.1016/j.ijnurstu.2019.03.017. Epub 2019 Apr 4.
- Abraham J, Mohler R, Henkel A, Kupfer R, Icks A, Dintsios CM, Haastert B, Meyer G, Kopke S. Implementation of a Multicomponent intervention to Prevent Physical Restraints In Nursing home residenTs (IMPRINT): study protocol for a cluster-randomised controlled trial. BMC Geriatr. 2015 Jul 21;15:86. doi: 10.1186/s12877-015-0086-0.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMPRINT
- 01GY1336A (Other Grant/Funding Number: German Federal Ministry of Education and Research)
- 01GY1336B (Other Grant/Funding Number: German Federal Ministry of Education and Research)
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