Accidental Falls Care Bundle

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Accidental Falls

Treatments: Other: Care bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT03147521

76/2014/O/Sper

Details and patient eligibility

About

Accidental falls represents an elderly very important health problem, both in the community and within the hospital. The aim of this research project is to evaluate the effectiveness of accidental falls prevention care bundle in geriatrics, internal medicine, post acute, and rehabilitation wards, in terms of incidence and outcome reduction. It will be also investigated the cost effectiveness ratio, in terms of falls avoided, care bundle implementation costs, and falls related healthcare costs. The study will permit to evaluate the implementation feasibleness in time, considering the study will last for 20 months.

Enrollment: 10,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ≥ 75 years of age with or without documented fall risk and patients with < 75 years of age, but ≥ 18, only at documented fall risk, admitted at participant wards. The risk assessment will be performed with Conley scale and/or on the base of some specific fall risk characteristics (previous falls, cognitive impairment, neuropsychological damage, increased need to go to the bathroom for increased evacuative needs, neuroleptic or cardiovascular drugs assumption);
• Patients (or legal guardian for those incapable of giving their consent) that give their consent to the study participation .

Exclusion criteria

• Patients or legal guardian that don't give their consent to study participation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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10,000 participants in 2 patient groups

Accidental falls care bundle

Experimental group

Description:

Care Bundle Implementation Arm

Treatment:

Other: Care bundle

Accidental falls standard care

Active Comparator group

Description:

Standard Care Implementation Arm (Universal strategy application for the environmental and patient)

Treatment:

Other: Care bundle