Prevention of Benzodiazepine Misuse in Primary Care

NCT04533230 | Withdrawn DMC

• 1 other identifier: 2018/1347-31/2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Benzodiazepine Dependence; Benzodiazepine Abuse; Substance Use Disorders

Keywords

Primary Health Care; Benzodiazepines; Substance Use Disorder; Addiction; Prescription Drugs

Outcome Measures

Primary Outcomes (1)

• Prescriptions of benzodiazepines and benzodizepine-like hypnotics

  Change in total prescriptions

  12 months

Secondary Outcomes (1)

• New prescriptions of benzodiazepines and benzodiazepine-like hypnotics

  12 months

Study Arms (3)

Educational intervention with prescription feedback

EXPERIMENTAL

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

Information on guidelines

ACTIVE COMPARATOR

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

No active intervention: standard care

NO INTERVENTION

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.

Interventions

Educational intervention with prescription feedback BEHAVIORAL

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

Educational intervention with prescription feedback

Information on treatment guidelines BEHAVIORAL

Written information on treatment guidelines.

Information on guidelines

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Region Stockholm, Academic primary health care center

Stockholm, 104 31, Sweden

Location

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Johan Franck, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Karolinska Trial Alliance (KTA) will conduct the randomization. The administrator at KTA who conducts the randomization will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Interested parties can contact the regions to request data from regional registers and databases.
• Access Criteria: Access criteria for data sharing are determined by the regions and regulated by law.

Locations

SE (1)