Impact of Patient Education on Benzodiazepine Use in the Elderly

September 28, 2021 updated by: Charles MacLean, MD, University of Vermont
The overall goal of this research is to develop and test strategies to decrease potentially inappropriate medication use among the elderly.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Specifically, the purpose of the study is to determine whether direct patient education is effective in decreasing benzodiazepine use in seniors.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women
  • Full benefit members living in a SASH facility
  • 60 years old or older
  • Using at least 1 active short/medium/long acting benzodiazepine at time of recruitment

Exclusion Criteria:

  • Inability to provide consent
  • Inability to communicate in English
  • Diagnosis of severe mental illness, dementia, seizure disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Group to receive educational booklet regarding risk/benefits of Benzodiazepine.
Behavioral: Educational booklet
Participants in the intervention group will receive an 8-page booklet that includes a list of generic and brand benzodiazepine names, benzodiazepine medication knowledge test, information about the associated risks of benzodiazepine use, and a list of safe alternative to their potentially inappropriate medication, as well as a stepwise tapering method. Recommendations to discuss decreasing use of benzodiazepines with physicians as well as to consult physicians before stopping any medication are also advised in the booklet. Participants in the control group will receive a booklet, produced by the Centers for Disease Control and Prevention, containing information regarding the important of exercise for seniors.
No Intervention: Control group
Group to receive educational booklet regarding risk/benefits of exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benzodiazepine or non-benzodiazepine hypnotic medication use
Time Frame: Baseline and 6 months post-intervention
Proportion of subjects using benzodiazepine or non-benzodiazepine hypnotic medication (such as zolpidem)
Baseline and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient attempt to discontinuing benzodiazepine
Time Frame: 1 month and 6 months post-intervention
Novel patient reported measure regarding attempts to discontinue medication
1 month and 6 months post-intervention
Patient knowledge regarding benzodiazepines
Time Frame: Baseline and 6 months post-intervention
Novel patient reported measure regarding knowledge of the potential risks and benefits of benzodiazepines
Baseline and 6 months post-intervention
Belief about Medicines Questionnaire (BMQ)
Time Frame: Baseline and 6 months post-intervention
This is a validated instrument assessing patient beliefs regarding medication efficacy and safety
Baseline and 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Charles MacLean, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00000485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on Educational booklet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe