Prevention of Benzodiazepine Misuse in Primary Care

Prevention of Benzodiazepine Misuse: A Randomized Trial in Primary Care

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.

Study Overview

• Status: Withdrawn
• Conditions: Substance Use Disorders; Benzodiazepine Dependence; Benzodiazepine Abuse
• Intervention / Treatment: Behavioral: Educational intervention with prescription feedback; Behavioral: Information on treatment guidelines

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 104 31
    • Region Stockholm, Academic primary health care center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational intervention with prescription feedback; 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; Educational intervention and targeted feedback on prescription of benzodiazepines and benzodiazepine-like hypnotics
Active Comparator: Information on guidelines; 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; Written information on treatment guidelines.
No Intervention: No active intervention: standard care; 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?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Johan Franck, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Benzodiazepines; Primary Health Care; Addiction; Substance Use Disorder; Prescription Drugs
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2018/1347-31/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data for this study will be gathered from regional registers and health care databases. For permission to access these data, interested parties should contact the regions.
• IPD Sharing Time Frame: Interested parties can contact the regions to request data from regional registers and databases.
• IPD Sharing Access Criteria: Access criteria for data sharing are determined by the regions and regulated by law.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No