Clinical trial NCT00618800: Preventing Falls Through Enhanced Pharmaceutical Care
Official title: Preventing Falls Through Enhanced Pharmaceutical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Keywords: Falls
Elderly
Injury
Medication
Pharmacy
Pharmacist
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2008-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first fall
timeFrame: One Year
measure: Proportion of participants who fall
timeFrame: One Year
Secondary outcomes:
measure: Use of high-risk medications
timeFrame: One Year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Injury Prevention Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Susan J. Blalock, PhD
role: PRINCIPAL_INVESTIGATOR
References: