Prevention of Benzodiazepine Misuse in Primary Care

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT04533230
Collaborator
(none)
30
1
3
76
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational intervention with prescription feedback
  • Behavioral: Information on treatment guidelines
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
Single (Outcomes Assessor)
Masking Description:
Karolinska Trial Alliance (KTA) will conduct the randomization. The administrator at KTA who conducts the randomization will be blinded to the intervention.
Primary Purpose:
Treatment
Official Title:
Prevention of Benzodiazepine Misuse: A Randomized Trial in Primary Care
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Prescriptions of benzodiazepines and benzodizepine-like hypnotics [12 months]

    Change in total prescriptions

Secondary Outcome Measures

  1. New prescriptions of benzodiazepines and benzodiazepine-like hypnotics [12 months]

    Change in new prescriptions

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Region Stockholm, Academic primary health care center Stockholm Sweden 104 31

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johan Franck, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04533230
Other Study ID Numbers:
  • 2018/1347-31/2
First Posted:
Aug 31, 2020
Last Update Posted:
Sep 21, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johan Franck, Professor, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2020