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Prevention of Benzodiazepine Misuse in Primary Care

Primary Purpose

Benzodiazepine Dependence, Benzodiazepine Abuse, Substance Use Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Educational intervention with prescription feedback
Information on treatment guidelines
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benzodiazepine Dependence focused on measuring Primary Health Care, Benzodiazepines, Substance Use Disorder, Addiction, Prescription Drugs

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Region Stockholm, Academic primary health care center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Educational intervention with prescription feedback

Information on guidelines

No active intervention: standard care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Prescriptions of benzodiazepines and benzodizepine-like hypnotics
Change in total prescriptions

Secondary Outcome Measures

New prescriptions of benzodiazepines and benzodiazepine-like hypnotics
Change in new prescriptions

Full Information

First Posted
August 26, 2020
Last Updated
February 20, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04533230
Brief Title
Prevention of Benzodiazepine Misuse in Primary Care
Official Title
Prevention of Benzodiazepine Misuse: A Randomized Trial in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped due to the COVID-19 pandemic restricting access to primary healthcare clinics.
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benzodiazepine Dependence, Benzodiazepine Abuse, Substance Use Disorders
Keywords
Primary Health Care, Benzodiazepines, Substance Use Disorder, Addiction, Prescription Drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention with prescription feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Information on guidelines
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No active intervention: standard care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention with prescription feedback
Intervention Description
Educational intervention and targeted feedback on prescription of benzodiazepines and benzodiazepine-like hypnotics
Intervention Type
Behavioral
Intervention Name(s)
Information on treatment guidelines
Intervention Description
Written information on treatment guidelines.
Primary Outcome Measure Information:
Title
Prescriptions of benzodiazepines and benzodizepine-like hypnotics
Description
Change in total prescriptions
Time Frame
12 months
Secondary Outcome Measure Information:
Title
New prescriptions of benzodiazepines and benzodiazepine-like hypnotics
Description
Change in new prescriptions
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Franck, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Stockholm, Academic primary health care center
City
Stockholm
ZIP/Postal Code
104 31
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://skr.se/

Learn more about this trial

Prevention of Benzodiazepine Misuse in Primary Care

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