Preventing Falls Through Enhanced Pharmaceutical Care

University of North Carolina (UNC)

Status: Completed

Conditions: Falls

Treatments: Behavioral: Pharmaceutical Care; Other: Written Materials

Study type: Interventional

Funder types: Other

Identifiers

NCT00618800

5-38047/0-401-4974

Details and patient eligibility

About

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.

Full description

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.

1. 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.
2. 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Pharmacist Care

Experimental group

Description:

Pharmacist Intervention

Treatment:

Behavioral: Pharmaceutical Care

Control

Active Comparator group

Description:

Written information only group

Treatment:

Other: Written Materials