Clinical trial NCT02341898: Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents (IMPRINT)
Official title: Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents: a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: nursing home care
physical restraints
dementia
implementation research
cluster-randomized controlled trial
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Martin-Luther-Universität Halle-Wittenberg
First posted: 2015-01-19
Enrollment: 10800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants
timeFrame: 12 Months
Secondary outcomes:
measure: Residents' quality of life (measured by QoL-AD)
timeFrame: 12 Months
measure: Falls and fall-related fractures
timeFrame: 12 Months
measure: Costs within trial period (cost parameters related to the implementation of the intervention as well as outcome-related cost parameters)
timeFrame: 12 Months
Other outcomes:
measure: Process evaluation
timeFrame: 12 Months
Locations:
city: Witten
country: Germany
facility: Witten/Herdecke University
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: Martin-Luther-University Halle-Wittenberg
state: Sachsen-Anhalt
city: Lübeck
country: Germany
facility: University of Lübeck
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: University of Hamburg
Study officials:
affiliation: University of Lübeck
name: Sascha Köpke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.