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Preventing Falls Through Enhanced Pharmaceutical Care
This study is ongoing, but not recruiting participants.
First Received: February 7, 2008   No Changes Posted
Sponsored by: University of North Carolina
Information provided by: The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00618800
  Purpose

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
Falls
Behavioral: Pharmaceutical Care
Other: Written Materials

U.S. FDA Resources
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

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Time to first fall [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Proportion of participants who fall [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of high-risk medications [ Time Frame: One Year ] [ Designated as safety issue: No ]

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
Pharmacist Care: Experimental
Pharmacist Intervention
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.
Control: Active Comparator
Written information only group
Other: Written Materials
Participants receive written information about falls prevention.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618800

Locations
United States, North Carolina
Injury Prevention Research Center
Chapel Hill, North Carolina, United States, 27599-7505
Sponsors and Collaborators
University of North Carolina
Investigators
Principal Investigator: Susan J. Blalock, PhD The University of North Carolina, Chapel Hill
  More Information

No publications provided

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

Keywords provided by The University of North Carolina, Chapel Hill:
Falls
Elderly
Injury
Medication
Pharmacy
Pharmacist

ClinicalTrials.gov processed this record on May 07, 2009