RCT to Reduce Further Falls and Injuries for Older Fallers Presenting to an Emergency Department

RCT to Evaluate the Effectiveness of a Targeted and Personalised Multifactorial Program to Reduce Further Falls and Injuries for Community-Dwelling Older Fallers Presenting to and Being Discharged Directly From an Emergency Department.

This project is called "Falls Aren't Us" and aimed at evaluating the effectiveness of a customised falls prevention program for people aged 60 and over who were presented to the hospital Emergency Department following a fall and being discharged home. Recruitment for this randomized controlled trial has commenced in late December 2002 from several major public hospitals in the western, southern, and northern parts of Melbourne Metropolitan Region. Consented participants will receive a comprehensive falls risk assessment within one week of being discharged home from the Emergency Department and at twelve month following this initial assessment. Their falls risks will be monitored for twelve months through a falls diary. Following randomization, participants in the intervention group will receive a customised falls prevention program in addition to the usual care being put in place from the hospital Emergency Department.

Study Overview

• Status: Unknown
• Conditions: Accidental Falls
• Intervention / Treatment: Behavioral: a customised multifactorial falls prevention program

Detailed Description

Older people presenting to an Emergency Department (ED) following a fall have high injury and hospitalisation rates. They are also at high risk of further falls and other adverse outcomes. However, there is currently limited available evidence to inform best practice.

The primary aim of this project is to evaluate the effectiveness of a targeted multi-factor intervention in improving health and well being of older people who present to an ED after a fall. It also aims to identify those within this high-risk population most likely to benefit from the intervention program.

Approximately 800 people aged 60 years and over will be invited to participate at the Emergency Department from the end of September 2002. Those who are eligible to participate will have a falls risk assessment in their own home and will be required to complete a falls diary for 12 months. There is a 50/50 chance (random allocation) that participants will receive an individualised falls prevention program.

The duration of a falls risk assessment is up to 2 hours and there is no cost involved. Participation in the research program will not affect routine management from the Emergency Department.

Becoming a participant may lessen the risk of having another fall and help others as well.

• Study Type: Interventional
• Enrollment: 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Blackberry, MB, PhD; Phone Number: 83872614; Email: i.blackberry@nari.unimelb.edu.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3052
      • Recruiting
      • National Ageing Research Institute
      • Contact: John Barlow, PhD; Phone Number: 83872305; Email: j.barlow@nari.unimelb.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• presenting to the Emergency Department with the primary cause of presentation being a fall; aged 60 years or older;
• discharged directly home following emergency care; living in the community or a retirement village; willing to take part in the study;
• able to provide informed consent or has consent provided by a third party; able to comply with simple instructions;
• able to walk independently indoors with or without a gait aid.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the effectiveness of a customised multifactorial intervention in reducing falls and falls related injury rates, compared to "usual care".

Secondary Outcome Measures

Outcome Measure
To accurately identify the circumstances, contributory factors and consequences of falls for older people presenting to Emergency Departments following a fall.
To evaluate the effectiveness of the intervention program in improving secondary health and well-being measures, including physical, psychological (fear of falling, depression), and quality of life indices.
To identify the physical, functional, and cognitive (executive function) parameters most strongly associated with good outcomeTo conduct an economic evaluation of the interventions and outcomes.
To provide guidelines for future management of high risk older people presenting to Emergency departments.

Collaborators and Investigators

• Sponsor: National Ageing Research Institute, Australia
• Investigators: Principal Investigator: Keith D Hill, PhD, National Ageing Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Study Completion: December 1, 2006

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): October 4, 2006
• Last Update Submitted That Met QC Criteria: October 3, 2006
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: HREC 2001.034