Long Term Use of BenzodiazepineNCT03405298
Reducing Inappropriate Benzodiazepine Use Among Older Adults
A study testing Educational Material and Supplemental Collaborative Care in people with Long Term Use of Benzodiazepine, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long Term Use of Benzodiazepine
- What is being tested?
- Educational Material and Supplemental Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 20 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- With a prescription BZD supply covering ≥20% of days in the preceding 12 months ("chronic").
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
Read the 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
- Being tested
- Educational Material, Supplemental Collaborative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational MaterialBehavioural
Educational material is in the form of a brochure
Supplemental Collaborative CareBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start8 Feb 2018
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Use of BenzodiazepineStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Responsible party
- Principal investigator, Donovan Maust, University of Michigan
- Investigators
- Donovan Maust, MS, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405298
- Sponsor's protocol ID
- HUM00133623
- Other IDs
- 20180230-00
- Status last verified
- Oct 2018
- First submitted
- 12 Jan 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Inappropriate Benzodiazepine Use Among Older Adults
- ClinicalTrials.gov ID
- NCT03405298
- Acronym / sponsor ID
- HUM00133623
- Conditions
- Long Term Use of Benzodiazepine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Material with Collaborative Care available | Active comparator | Behavioral: Educational Material, Behavioral: Supplemental Collaborative CareIn 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 | Active comparator | Behavioral: Educational MaterialPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- With a prescription BZD supply covering ≥20% of days in the preceding 12 months ("chronic").
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational MaterialEducational material is in the form of a brochure | Behavioural | Educational Material Only, Educational Material with Collaborative Care available |
| Supplemental Collaborative CareSupplemental 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 | Behavioural | Educational Material with Collaborative Care available |
Primary outcome
Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg
Time frame: 3 months
Compare the average daily dose during month 3 to the baseline average daily dose
Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg
Time frame: 6 months
Compare the average daily dose during month 6 to the baseline average daily dose
8 secondary outcomes
Patient Health Questionnaire (PHQ-8)
Time frame: 3 months
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: 3 months
Insomnia Severity Index (ISI)
Time frame: 3 months
Alcohol Use Disorders Identification Test (AUDIT-C)
Time frame: 3 months
PHQ-8
Time frame: 6 months
GAD-7
Time frame: 6 months
ISI
Time frame: 6 months
AUDIT-C
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Long Term Use of Benzodiazepine
RecruitingObservational study
Benzodiazepine Impact on Cognitive Function: fNIRs and PET/MRI Study
Benzodiazepine Adverse Reaction, Depression, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donovan Maust, MS, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Material and Supplemental Collaborative Care in people with Long Term Use of Benzodiazepine, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.