Clinical trial NCT04533230: Prevention of Benzodiazepine Misuse in Primary Care
Official title: Prevention of Benzodiazepine Misuse: A Randomized Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Benzodiazepine Dependence
Benzodiazepine Abuse
Substance Use Disorders
Keywords: Primary Health Care
Benzodiazepines
Substance Use Disorder
Addiction
Prescription Drugs
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prescriptions of benzodiazepines and benzodizepine-like hypnotics
timeFrame: 12 months
Secondary outcomes:
measure: New prescriptions of benzodiazepines and benzodiazepine-like hypnotics
timeFrame: 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm, Academic primary health care center
Study officials:
affiliation: Karolinska Institutet
name: Johan Franck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: