Dementia
Conditions
Keywords
nursing home care, physical restraints, dementia, implementation research, cluster-randomized controlled trial
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.
Interventions
OTHEREducational programme for all nurses
OTHERTraining and structured support for nominated key nurses
OTHERFacultative train-the-trainer module for key nurses
OTHERPrinted study material
OTHERSupportive material (poster, mugs etc.)
Sponsors
Martin-Luther-Universität Halle-Wittenberg
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants | 12 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residents' quality of life (measured by QoL-AD) | 12 Months | Will be measured by QoL-AD for a randomly selected subgroup of 10% of residents |
| 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 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Process evaluation | 12 Months | Different process parameters will be assessed as e.g. relatives' experiences, staff experiences, leaders' experiences and organizational culture |
Countries
Germany
Outcome results
None listed