Accidental Falls Care Bundle

NCT03147521 | Completed

• 1 other identifier: 76/2014/O/Sper
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Accidental Falls

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Falls outcome

  5 monts

• Cost-effectiveness

  20 months

Study Arms (2)

Accidental falls care bundle

EXPERIMENTAL

Care Bundle Implementation Arm

Other: Care bundle

Accidental falls standard care

ACTIVE COMPARATOR

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

Other: Care bundle

Interventions

Care bundle OTHER

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.

Accidental falls care bundle; Accidental falls standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Related Publications (1)

• Di Gennaro G, Chamitava L, Pertile P, Ambrosi E, Mosci D, Fila A, Alemayohu MA, Cazzoletti L, Tardivo S, Zanolin ME. A stepped-wedge randomised controlled trial to assess efficacy and cost-effectiveness of a care-bundle to prevent falls in older hospitalised patients. Age Ageing. 2024 Jan 2;53(1):afad244. doi: 10.1093/ageing/afad244.

  PMID: 38251740 DERIVED

MeSH Terms

Interventions

Patient Care Bundles

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 10, 2017
• Study Start: April 28, 2015
• Primary Completion: December 28, 2016
• Study Completion: January 31, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share