Accidental Falls Care Bundle

Not Applicable

Completed

• Conditions: Accidental Falls
• Interventions: Other: Care bundle

• Registration Number: NCT03147521
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-28
• Primary Completion: 2016-12-28
• Study Completion: 2017-01-31
• Status Verified: 2017-05
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Study First Posted: 2017-05-10
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Accidental falls standard care	Care bundle	Standard Care Implementation Arm (Universal strategy application for the environmental and patient)
Accidental falls care bundle	Care bundle	Care Bundle Implementation Arm

Primary Outcome Measures

Name	Time	Method
Falls Incidence rate	5 months	Number of accidental falls respect number of hospital days of stay in elderly hospital patients at the end of a 5 months step.

Secondary Outcome Measures

Name	Time	Method
Falls outcome	5 monts	Numbers falls from wich a fractures or a brain haemorrhage has been generated
Cost-effectiveness	20 months	Cost effectiveness ratio in terms of costs and avoided falls. Cost Implementation costs: costs for education and staff meeting; printed material costs.