Preventing Falls Through Enhanced Pharmaceutical Care

Study Overview
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Brief Summary
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The objective of the proposed study is to reduce the incidence of falls and fall-related injuries among community-dwelling older adults by better utilizing community pharmacists to advise patients and physicians on medication management.

Detailed Description
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Falls are the leading cause of both fatal and nonfatal injuries among older adults in the United States. Past research suggests that individuals taking four or more prescription medications are at increased risk for falls. CNS-active drugs (e.g., benzodiazepines), in particular, have been associated with increased risk. Research also suggests that interventions to reduce inappropriate medications can reduce the risk of falls. This finding comes primarily from multifaceted interventions, however, and the impact of medication modification, by itself, remains largely unknown. This study is using a a randomized controlled clinical trial design to evaluate a falls prevention program targeting community-dwelling older adults through community pharmacies. The study focuses on individuals at high risk for future falls. Individuals in the intervention group receive an in-depth consultation concerning their current medications, conducted by a community pharmacist. The consultation is designed to elicit medication-related problems (e.g., orthostatic hypotension, daytime sedation). Problems identified during the consultation, and therapeutic recommendations designed to address these problems, are communicated to the prescribing physician. With physician approval, appropriate modifications are made to the patient's medication regimen. The primary study endpoints are: time to first fall and proportion of individuals who fall during the one-year follow-up period. Two primary hypotheses will be tested. Compared to individuals in the control group, individuals in the intervention group will experience a 30% reduction in the hazard of falling (hazard ratio=0.70) for time to first fall following randomization. Compared to individuals in the control group, 25% fewer people in the intervention group will experience a fall during the one-year follow-up period. If the intervention is effective in reducing falls, these effects should be mediated by improvements in the overall quality of medication use. Thus, we will also assess effects of the intervention on: change in the number of inappropriate medications prescribed and change in the number of CNS-active medications prescribed. One secondary hypotheses will be tested. 1. Compared to individuals in the control group, individuals in the intervention group will experience a 40% reduction in the use of high-risk medications during the one-year follow-up period.

Official Title
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Preventing Falls Through Enhanced Pharmaceutical Care

Conditions
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Falls

Intervention / Treatment
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* Behavioral: Pharmaceutical Care
* Other: Written Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently taking at least four prescription medications Currently taking at least one high risk medication At least one fall during 12 month period before study entry Able to speak and read English Exclusion Criteria: Resident of a long-term care facility Cognitive impairment Housebound

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Care<br>Pharmacist Intervention | Behavioral: Pharmaceutical Care<br>* Participants receive written information about falls prevention and a personal consultation from a community pharmacist concerning their medication regimen. The pharmacist follows up, as required, with participants' physicians to coordinate any recommended medication changes.<br>|
| Active Comparator: Control<br>Written information only group | Other: Written Materials<br>* Participants receive written information about falls prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first fall |  | One Year | 
| Proportion of participants who fall |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of high-risk medications |  | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, Elderly, Injury, Medication, Pharmacy, Pharmacist