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| ID | Type | Description | Link |
|---|---|---|---|
| 20180230-00 | Other Grant/Funding Number | Michigan, State of, Health and Human Services, Department of Health and Human Services |
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| Name | Class |
|---|---|
| Michigan Department of Health and Human Services | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Material | Behavioral | Educational material is in the form of a brochure |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donovan Maust, MS, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| 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 |
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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 |