Clinical trial NCT03405298: Reducing Inappropriate Benzodiazepine Use Among Older Adults
Official title: Reducing Inappropriate Benzodiazepine Use Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long Term Use of Benzodiazepine
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
First posted: 2018-01-23
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this project is to reduce chronic benzodiazepine use through two approaches: direct patient education or direct patient education paired with additional support and encouragement from a behavioral health care manager.

Detailed description: This is a State of Michigan/Medicaid Match project proposal. These proposed projects are developed to address specific goals for Medicaid policies, procedures, and model programs for Medicaid Recipients in Michigan.

Benzodiazepine use in the United States is common and increases with age, used by 8.7% of patients aged 65-80 years. Benzodiazepines-which include well-known medications such as Xanax, Ativan, and Klonopin-are most commonly used for anxiety and insomnia, even though psychotherapy and alternative medications are now recommended preferentially over benzodiazepines. Use is a particular concern among older adults, given the links between benzodiazepine prescribing and a variety of adverse outcomes including falls, fractures and motor vehicle accidents.

Attempts to reduce benzodiazepine use have met with limited success in the real world, as patients are reluctant to consider the possibility of stopping them and providers are reluctant to even suggest the possibility. In the course of a brief return visit in primary care, providers simply do not have the time or incentive to engage in a potentially difficult, lengthy discussion with patients about reducing or stopping their benzodiazepine.

The goal of this project is to evaluate direct patient education compared to direct patient education paired with additional support and encouragement from a care manager in order to reduce chronic benzodiazepine use. Strategies to help reduce benzodiazepine use are of great interest to providers and our findings would have significance for all providers, and may even conceivably improve the care of patient both inside and outside the Medicaid program.

Eligibility criteria: Inclusion Criteria:

* With a prescription BZD supply covering ≥20% of days in the preceding 12 months ("chronic").

Exclusion Criteria:

* Patients with BZD supply \<20% days in past 12 months
* Patients with ICD-10 codes for dementia (derived from encounter diagnosis codes)
* long-term care residents (ICD-10 codes Z59.3 and Y92.199)

Primary outcomes:
measure: Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg
timeFrame: 3 months
measure: Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg
timeFrame: 6 months
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 3 months
measure: Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: 3 months
measure: Insomnia Severity Index (ISI)
timeFrame: 3 months
measure: Alcohol Use Disorders Identification Test (AUDIT-C)
timeFrame: 3 months
measure: PHQ-8
timeFrame: 6 months
measure: GAD-7
timeFrame: 6 months
measure: ISI
timeFrame: 6 months
measure: AUDIT-C
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Department of Psychiatry, University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Donovan Maust, MS, MD
role: PRINCIPAL_INVESTIGATOR
References: