The Effectiveness of a Fall Prevention Program

Summary

Phase 1 of the study:

Falls are the leading cause of preventable injury, long term disability, premature institutionalization and mortality in the older adult population. Promising preliminary research suggests that modifications to the home can potentially reduce the incidence of falls in the elderly. The purpose of this study is to gather data necessary to design a definitive trial of a home modification intervention for older adults at risk for fall. The specific aims are to 1) estimate the efficacy of an intensive tailored environmental intervention to reduce functional decline among community-dwelling older adults; 2) gather the data necessary to design a definitive clinical trial of an intensive tailored environmental intervention to reduce the cumulative incidence of falls among community-dwelling older adults; 3) examine the direct cost of intensive tailored home modification. A pilot randomized controlled trial will be conducted with 40 older adults who have experienced a fall resulting in an emergency room visit.

Phase 2 of the study:

Our long-term objective is to prevent falls for these older adults at high risk by removing hazards in their homes. Development of an effective intervention for fall reduction could have an immediate impact for this population and high public health significance. Intensive home hazard removal has been established as an effective environmental intervention for the prevention of falls; however, none of the published studies have been conducted in the US, and no study has adequately controlled for biases. The investigators propose a double-blinded, randomized sham-controlled clinical trial to determine the efficacy of an intensive tailored home hazard removal intervention to reduce the cumulative incidence of falls among 110 community-dwelling older adults who visit the emergency department (ED) because of a fall. This three year study will be the first to utilize a sham control group and a double-blind, randomized study design. The investigators will intervene with a high-risk group of community-dwelling older adults who visit an ED after a fall. The primary hypothesis will be tested by comparing the 12-month cumulative incidence of falls in an intensive tailored home intervention group with falls in a sham control group. Falls will be operationalized as unintentional movements to the floor, ground or object below knee level. The secondary hypothesis will be tested by comparing total number of falls, number of injurious falls, fear of falling and performance in daily activities between the intervention and sham control group.

The primary aim of the proposed study is to:

1. Compare the efficacy of an intensive tailored home hazard reduction intervention to sham treatment on the cumulative incidence of falls over 12 months for older adults who visit the ED after a fall.

Hypothesis 1: The cumulative incidence of falls over 12 months will be lower for the intensive tailored home hazard removal group compared to the sham control group.

The secondary aims of the proposed study are to:
2. Determine if intensive tailored home hazard reduction intervention is superior to sham treatment on secondary outcomes including: total number of falls, number of injurious falls, fear of falling and activities of daily living (ADL) performance.

Hypothesis 2: The investigators hypothesize that the intensive tailored home hazard reduction intervention group will experience fewer total falls, fewer injurious falls, less fear of falling and improved ADL performance compared to the sham control group.
3. Characterize intensive tailored home hazard reduction interventions including the frequency of environmental modification by type and location in the home and its direct costs. The investigators will also conduct subgroup analysis of type, location and cost of home modifications by race and gender.

The proposed study is innovative because it provides intensive, individualized prescriptions of home hazard removal and because it provides a quick response to a fall. It is also the first double-blind trial of the effect of environmental modification on falls and, to our knowledge, is the first collaboration between occupational therapy and emergency medicine on fall reduction strategies in the US.

The results of the proposed study will provide new evidence about the effectiveness of intensive tailored home hazard removal to reduce falls. This study has the potential to provide public health guidelines for the delivery of home hazard removal, decrease the health care costs associated with falls and to provide evidence for guiding public health policy for older adults who have fallen.

Conditions

• Accidental Falls

Interventions

OTHER

Tailored home intervention

The occupational therapist (OT) interventionist will develop a set of environmental modification choices to improve performance in problematic activities identified during the clinical evaluation. A plan for resolving the barriers identified during clinical assessment will be developed. The participant will review the barrier removal options and will make an informed choice resulting in a final treatment plan. Modification installation which will be provided, at no cost to the participant, by a contractor trained by the study PI. The tailored intervention includes training in the use of the new equipment or architectural changes. Photographs of identified barriers, study measures, and intervention plans will be reviewed by the principal investigator during team meetings to ensure treatment fidelity.

OTHER

Sham intervention

We have developed a kit containing 12 standard adaptive equipment (AD) items (e.g., jar opener). The AD kit has been specifically designed to address fine motor function and will not influence fall outcomes. Two pieces of AD will be provided during each session, and the individual will be instructed to use each AD by the OT interventionist

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Susan Stark, PhD, OTR/L · Assistant Professor in Occupational Therapy & Neurology at Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2013-06-30

Completion

2014-06-30

Countries

• United States

Study Locations