Preventing Falls Through Enhanced Pharmaceutical Care

Falls Clinical Trial

Official title:

Preventing Falls Through Enhanced Pharmaceutical Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618800
• Other study ID #: 5-38047/0-401-4974
• Status: Completed
• Phase: N/A
• First received: February 7, 2008
• Last updated: September 16, 2011
• Start date: August 2004
• Est. completion date: September 2009

Study information

• Verified date: September 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Falls

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.

Other:
• Written Materials
Participants receive written information about falls prevention.

Locations

Country	Name	City	State
United States	Injury Prevention Research Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first fall		One Year	No
Primary	Proportion of participants who fall		One Year	No
Secondary	Use of high-risk medications		One Year	No