Reducing Inappropriate Benzodiazepine Use Among Older Adults

NCT03405298 | Completed

• 2 other identifiers: HUM0013362320180230-00
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Long Term Use of Benzodiazepine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Patient Health Questionnaire (PHQ-8)

  3 months

• Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  3 months

• Insomnia Severity Index (ISI)

  3 months

• Alcohol Use Disorders Identification Test (AUDIT-C)

  3 months

• PHQ-8

  6 months

Study Arms (2)

Educational Material with Collaborative Care available

ACTIVE COMPARATOR

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; Behavioral: Supplemental Collaborative Care

Educational Material Only

ACTIVE COMPARATOR

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

Interventions

Educational Material BEHAVIORAL

Educational material is in the form of a brochure

Educational Material Only; Educational Material with Collaborative Care available

Supplemental Collaborative Care 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 with Collaborative Care available

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• Michigan Department of Health and Human Services: collaborator

Study Sites (1)

Department of Psychiatry, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Donovan Maust, MS, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: February 8, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)