[Effectiveness of a multifactorial intervention to reduce physical restraints in nursing home residents with dementia].

At present, observational studies and expert opinion are the best evidence for the use of physical restraints. Large regional and national disparities are described in acute and long-term care. Epidemiological data demonstrate a prevalence of 3-5% body-fixed or near body restraint devices. The hip fracture rate in Germany are approximately 50 per 1000 resident years. Between 40-50% of the residents in nursing homes are treated with psycho-tropic medication potentially limiting their physical mobility. The presented study protocol was designed to test the effectiveness of a multifactorial intervention to reduce physical restraints in long-term care (LTC) residents particularly with cognitive impairment. The intervention consists of an educational and an organizational part to empower staff members to improve their skills and practice in using restraints. Technical devices to reduce fall related injuries are additionally offered to the LTC facilities. The study population includes 200 LTC residents in 54 facilities in three states in Germany. The sample size calculation was based upon a 5% prevalence rate in the control group and an expected reduction of 50% in the intervention group. The protocol is a waiting-list control design. All waiting facilities will be offered to participate after their waiting period. Primary endpoints are the number of restrained residents and resident time (hours) of being restrained. The use of psychotropics, falls, fall-related injuries and the incidence of residents newly being restrained is being monitored. The study starts with a baseline documentation of all facilities followed by randomization and a three month intervention. Change agents will be responsible for the intervention. Technical devices will include a newly developed soft hip protector and sensor mats which notice the intent of leaving the bed. The aim of the study is to develop an evidence-based model for a knowledge transfer project to implement minimum restraint environments in LTC.