Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04533230 |
| Other study ID # |
2018/1347-31/2 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
February 2023 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
