Accidental Falls Care Bundle

Stepped Wedge Cluster Randomized Controlled Trial for the Evaluation of Effectiveness of a Accidental Falls Care Bundle Implementation in Elderly Hospital Patients.

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.

Study Overview

• Status: Completed
• Conditions: Accidental Falls
• Intervention / Treatment: Other: Care bundle

• Study Type: Interventional
• Enrollment (Actual): 10000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accidental falls care bundle; Care Bundle Implementation Arm	Other: Care bundle; Risk fall assessment at hospital admission with Conley scale or with findings of specific risk characteristics (previous falls, cognitive impairment, neuropsychological damage, increased need to go to the bathroom for increased evacuative needs, neuroleptic or cardiovascular drugs assumption); if risk is found shear the information with the team, writing it in patient chart, and positioning a specific symbol on patient bed. Inform patient and family about fall risk and ask, if possible, a continuous caregiver presence. Universal strategy application for the environmental safety and patient safety. Periodic assessment of drugs therapy, with the aim of reduce those that acts on central nervous system and cardiovascular system. If patient is at risk and alone, verify each 2 hours the need to go to the bathroom, change position or drink.
Active Comparator: Accidental falls standard care; Standard Care Implementation Arm (Universal strategy application for the environmental and patient)	Other: Care bundle; Risk fall assessment at hospital admission with Conley scale or with findings of specific risk characteristics (previous falls, cognitive impairment, neuropsychological damage, increased need to go to the bathroom for increased evacuative needs, neuroleptic or cardiovascular drugs assumption); if risk is found shear the information with the team, writing it in patient chart, and positioning a specific symbol on patient bed. Inform patient and family about fall risk and ask, if possible, a continuous caregiver presence. Universal strategy application for the environmental safety and patient safety. Periodic assessment of drugs therapy, with the aim of reduce those that acts on central nervous system and cardiovascular system. If patient is at risk and alone, verify each 2 hours the need to go to the bathroom, change position or drink.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2015
• Primary Completion (Actual): December 28, 2016
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 76/2014/O/Sper

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No