Prevention of Benzodiazepine Misuse in Primary Care

NCT ID: NCT04533230

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2026-12-31

Brief Summary

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

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.

Conditions

Benzodiazepine Dependence; Benzodiazepine Abuse; Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational intervention with prescription feedback

Intervention Type: BEHAVIORAL

Educational intervention and targeted feedback on prescription of benzodiazepines and benzodiazepine-like hypnotics

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.

Group Type: ACTIVE_COMPARATOR

Information on treatment guidelines

Intervention Type: BEHAVIORAL

Written information on treatment guidelines.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational intervention with prescription feedback

Educational intervention and targeted feedback on prescription of benzodiazepines and benzodiazepine-like hypnotics

Intervention Type: BEHAVIORAL

Information on treatment guidelines

Written information on treatment guidelines.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Employs at least two full-time physicians
• Has at least 3000 patients
• Has a regional care agreement (contract)

Exclusion Criteria

• In operation for less than 12 months
• Participated in an intervention to reduce benzodiazepine prescriptions in the last 12 months

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Johan Franck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan Franck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Region Stockholm, Academic primary health care center

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2018/1347-31/2

Identifier Type: -

Identifier Source: org_study_id