Reducing Inappropriate Benzodiazepine Use Among Older Adults

NCT ID: NCT03405298

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2018-09-20

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.

Conditions

Long Term Use of Benzodiazepine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Educational Material

Intervention Type: BEHAVIORAL

Educational material is in the form of a brochure

Supplemental Collaborative Care

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Educational Material

Intervention Type: BEHAVIORAL

Educational material is in the form of a brochure

Interventions

Educational Material

Educational material is in the form of a brochure

Intervention Type: 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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan Department of Health and Human Services

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Donovan Maust

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donovan Maust, MS, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Department of Psychiatry, University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

20180230-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUM00133623

Identifier Type: -

Identifier Source: org_study_id