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OpenTrials
Completed

NCT Number: NCT03147521

Accidental Falls Care Bundle

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Falls Incidence rate

    Time frame: 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 outcomes

  1. Falls outcome

    Time frame: 5 monts

    Numbers falls from wich a fractures or a brain haemorrhage has been generated

  2. Cost-effectiveness

    Time frame: 20 months

    Cost effectiveness ratio in terms of costs and avoided falls. Cost Implementation costs: costs for education and staff meeting; printed material costs.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 10, 2017
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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