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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03147521
Enrollment
10000
Registered
2017-05-10
Start date
2015-04-28
Completion date
2017-01-31
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls

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.

Interventions

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.

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Falls Incidence rate5 monthsNumber of accidental falls respect number of hospital days of stay in elderly hospital patients at the end of a 5 months step.

Secondary

MeasureTime frameDescription
Falls outcome5 montsNumbers falls from wich a fractures or a brain haemorrhage has been generated
Cost-effectiveness20 monthsCost effectiveness ratio in terms of costs and avoided falls. Cost Implementation costs: costs for education and staff meeting; printed material costs.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026