Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents: a Cluster-randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10,800
- Locations
- 8
- Primary Endpoint
- Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Outcomes
Primary Outcomes
Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants
Time Frame: 12 Months
Secondary Outcomes
- Residents' quality of life (measured by QoL-AD)(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)(12 Months)
Investigators
Sascha Köpke
Prof. Dr.
University of Luebeck