Reducing Inappropriate Benzodiazepine Use Among Older Adults

Not Applicable

Completed

• Conditions: Long Term Use of Benzodiazepine
• Interventions: Behavioral: Educational Material; Behavioral: Supplemental Collaborative Care

• Registration Number: NCT03405298
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-23
• Study Start: 2018-02-08
• Primary Completion: 2018-09-20
• Study Completion: 2018-09-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Material with Collaborative Care available	Educational Material	In addition to the material described below, these patients are seen in clinics with behavioral health collaborative care (BHCC), which includes a care manager in the primary care provider's office along with a consulting psychiatrist. If a patient receives the brochure and would like to taper their benzodiazepine, their provider can refer them to the BHCC care manager who can provide education and anxiety and insomnia self-management strategies, while the BHCC psychiatrist will make recommendations regarding the medication taper back to the primary care provider.
Educational Material with Collaborative Care available	Supplemental Collaborative Care	In addition to the material described below, these patients are seen in clinics with behavioral health collaborative care (BHCC), which includes a care manager in the primary care provider's office along with a consulting psychiatrist. If a patient receives the brochure and would like to taper their benzodiazepine, their provider can refer them to the BHCC care manager who can provide education and anxiety and insomnia self-management strategies, while the BHCC psychiatrist will make recommendations regarding the medication taper back to the primary care provider.
Educational Material Only	Educational Material	Patients will receive an 8-page educational brochure that presents information about potential harms of these medications and a vignette about a patient that successfully stopped. It does NOT suggest patients to stop on their own, but rather suggests they speak with their provider.

Primary Outcome Measures

Name	Time	Method
Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg	6 months	Compare the average daily dose during month 6 to the baseline average daily dose

Secondary Outcome Measures

Name	Time	Method
Alcohol Use Disorders Identification Test (AUDIT-C)	3 months	Hazardous Alcohol Use will be assessed using the AUDIT-C which assesses average alcohol consumption (quantity and frequency) and binge drinking (6 or more) over the past 3 months on a scale of 0 (none) to 12 (heavy alcohol use).The cut-off scores for hazardous drinking are 3 for women and 4 for men.
Insomnia Severity Index (ISI)	3 months	ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties, ranging from 0-28. Scores of 0-7 are categorized as no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 clinical insomnia (moderate severity), 22-28 clinical insomnia (severe).
PHQ-8	6 months	The PHQ-8 is a self-report instrument assessing 8 DSM-IV symptoms of depression, this measure will be conducted at 6 months, with total scores ranging from 0 (low) to 24 (high); scores ≥10 suggest the presence of Major Depressive Disorder.
GAD-7	6 months	The GAD-7 total score ranges from 0 (low) to 21 (high), with "cut scores" for mild (5), moderate (10), and severe anxiety (15).
Patient Health Questionnaire (PHQ-8)	3 months	The PHQ-8 is a self-report instrument assessing 8 DSM-IV symptoms of depression, this measure will be conducted at 3 months, with total scores ranging from 0 (low) to 24 (high); scores ≥10 suggest the presence of Major Depressive Disorder.
Generalized Anxiety Disorder 7-Item Scale (GAD-7)	3 months	The GAD-7 total score ranges from 0 (low) to 21 (high), with "cut scores" for mild (5), moderate (10), and severe anxiety (15); will be conducted at 3 months.
ISI	6 months	ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties, ranging from 0-28. Scores of 0-7 are categorized as no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 clinical insomnia (moderate severity), 22-28 clinical insomnia (severe).
AUDIT-C	6 months	Hazardous Alcohol Use will be assessed using the AUDIT-C which assesses average alcohol consumption (quantity and frequency) and binge drinking (6 or more), this measure will be conducted at 6 months, on a scale of 0 (none) to 12 (heavy alcohol use).The cut-off scores for hazardous drinking are 3 for women and 4 for men.

Trial Locations

Locations (1)

Department of Psychiatry, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States