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Sponsored by: |
University of North Carolina |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00618800 |
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.
Condition | Intervention |
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Falls |
Behavioral: Pharmaceutical Care Other: Written Materials |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Preventing Falls Through Enhanced Pharmaceutical Care |
Estimated Enrollment: | 200 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Pharmacist Care: Experimental
Pharmacist Intervention
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Behavioral: Pharmaceutical Care
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.
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Control: Active Comparator
Written information only group
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Other: Written Materials
Participants receive written information about falls prevention.
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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.
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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Injury Prevention Research Center | |
Chapel Hill, North Carolina, United States, 27599-7505 |
Principal Investigator: | Susan J. Blalock, PhD | The University of North Carolina, Chapel Hill |
Responsible Party: | UNC Injury Prevention Research Center ( Susan J. Blalock, Ph.D/Principal Investigator ) |
Study ID Numbers: | 5-38047/0-401-4974 |
Study First Received: | February 7, 2008 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00618800 History of Changes |
Health Authority: | United States: Institutional Review Board |
Falls Elderly Injury |
Medication Pharmacy Pharmacist |