Reducing Inappropriate Benzodiazepine Use Among Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Long Term Use of Benzodiazepine
• Intervention / Treatment: Behavioral: Educational Material; Behavioral: Supplemental Collaborative Care

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Department of Psychiatry, University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Educational Material with Collaborative Care available; 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.	Behavioral: Educational Material; Educational material is in the form of a brochure; Behavioral: Supplemental Collaborative Care; Supplemental care management consist of meeting with a behavioral health care manager over five sessions in-person or via phone call; the care manager will review patient information with the consulting psychiatrist, who can then make recommendations back to the primary care provider
Active Comparator: Educational Material Only; 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.	Behavioral: Educational Material; Educational material is in the form of a brochure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg	Compare the average daily dose during month 3 to the baseline average daily dose	3 months
Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg	Compare the average daily dose during month 6 to the baseline average daily dose	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-8)	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.	3 months
Generalized Anxiety Disorder 7-Item Scale (GAD-7)	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.	3 months
Insomnia Severity Index (ISI)	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).	3 months
Alcohol Use Disorders Identification Test (AUDIT-C)	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.	3 months
PHQ-8	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.	6 months
GAD-7	The GAD-7 total score ranges from 0 (low) to 21 (high), with "cut scores" for mild (5), moderate (10), and severe anxiety (15).	6 months
ISI	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).	6 months
AUDIT-C	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.	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Michigan Department of Health and Human Services
• Investigators: Principal Investigator: Donovan Maust, MS, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): September 20, 2018

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HUM00133623; 20180230-00 (Other Grant/Funding Number: Michigan, State of, Health and Human Services, Department of Health and Human Services)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No