Prevention of Benzodiazepine Misuse in Primary Care

Study Overview
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Brief Summary
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Benzodiazepines and benzodiazepine-like hypnotics (z-drugs) are prevalent and addictive narcotics. Guidelines recommend restricted prescription of these drugs for anxiety and insomnia. The majority of benzodiazepine prescriptions are written for these disorders by physicians (GPs) in primary health care. Primary health care is thus an important arena for efforts to reduce access to benzodiazepines in order to lower the number of new users and users at risk of dependency. This trial evaluates whether a brief educational intervention in primary health care followed by 12 months of feedback on prescription data changes the prescription of benzodiazepines and benzodiazepine-like hypnotics.

Detailed Description
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Background: Benzodiazepines and the benzodiazepine-like hypnotics, often called z-drugs (hereafter benzodiazepines) are common and addictive narcotic drugs that can be obtained by prescription. Even short-term prescription can become a long-term problem, leading to tolerance and dependency, as well as adverse effects, including cognitive disturbance and decline, behavioral problems, emergency visits, accidents, suicide, and drug-related mortality. Guidelines restrict prescription of these drugs for anxiety and insomnia. The majority of benzodiazepine prescriptions are written for these disorders by physicians in primary health care. Primary health care is thus an important arena for efforts to reduce access to benzodiazepines in order to lower the number of new users and users at risk of dependency. Aim: This randomized controlled trial tests whether a brief educational intervention in primary health care followed by 12 months of feedback on prescription data changes prescriptions of benzodiazepines and benzodiazepine-like hypnotics. Methods: Primary health care centers will be invited to participate in the study. Centers that express interest in participating, meet the inclusion criteria, and do not meet the exclusion criteria will be randomized to the intervention or the control group. Personnel at the intervention centers will participate in a brief educational intervention followed by 12 months of regular feedback on benzodiazepine prescriptions that are written at the center. Personnel in an active control group will receive written information on treatment guidelines but will not receive the onsite educational intervention or prescription feedback. Data on characteristics of participating primary health care centers, as well as on prescriptions before the intervention and during and after the 12-month follow-up period, will be gathered from regional health care registers and databases and statistically analyzed.

Official Title
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Prevention of Benzodiazepine Misuse: A Randomized Trial in Primary Care

Conditions
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Benzodiazepine Dependence, Benzodiazepine Abuse, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Educational intervention with prescription feedback
* Behavioral: Information on treatment guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for primary health care centers: Employs at least two full-time physicians Has at least 3000 patients Has a regional care agreement (contract) Exclusion criteria for primary health care centers: In operation for less than 12 months Participated in an intervention to reduce benzodiazepine prescriptions in the last 12 months
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational intervention with prescription feedback<br>The manager and physicians at each intervention center will participate in a brief educational intervention about benzodiazepines and benzodiazepine-like hypnotics and receive 12 months of targeted feedback on prescription of these drugs. The education will cover national and regional treatment guidelines for anxiety, depression, and insomnia, which include guidelines on prescription of benzodiazepines and benzodiazepine-like hypnotics. | Behavioral: Educational intervention with prescription feedback<br>* Educational intervention and targeted feedback on prescription of benzodiazepines and benzodiazepine-like hypnotics<br>|
| Active Comparator: Information on guidelines<br>The manager and physicians at each center in the active control group will receive written information on national and regional treatment guidelines for anxiety, depression, and insomnia, which include guidelines on prescription of benzodiazepines and benzodiazepine-like hypnotics. These centers will not receive the onsite educational intervention or 12 months of targeted prescription feedback. | Behavioral: Information on treatment guidelines<br>* Written information on treatment guidelines.<br>|
| No Intervention: No active intervention: standard care<br>The manager and physicians at each primary health care center in the passive control group will receive no active intervention. The passive control group will consist of primary health care centers that are not actively participating in the study. Data will be gathered from regional registers and databases. Thus, there will be no need to contact or communicate directly with the centers. This arm will be used only if the General Data Protection Regulation continues to allow access to regional registers and databases in primary health care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescriptions of benzodiazepines and benzodizepine-like hypnotics | Change in total prescriptions | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New prescriptions of benzodiazepines and benzodiazepine-like hypnotics | Change in new prescriptions | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Health Care, Benzodiazepines, Substance Use Disorder, Addiction, Prescription Drugs