Prescription of Benzodiazepines by General Practitioners: Characteristics of Prescribing Trend and Implementation of an Online Educational Program

NCT ID: NCT04925596

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-04-09

Brief Summary

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Portugal has the highest benzodiazepine utilization compared to other European countries. The high utilization of benzodiazepines has been a concern due to reported side effects of long-term use and dependence. Also, these data demonstrate that doctors are possibly choosing an inadequate treatment to manage anxious and depressive syndromes.

This research aims to develop and implement in primary health care units an online educational program, following a cluster randomized study design; to study the impact of this educational program for changing general practitioner's benzodiazepine prescription pattern; to analyze of barriers and facilitators to the implementation of the e-PrimaPrescribe program.

Detailed Description

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BZD excessive prescription has long been considered a serious mental health concern in many countries. A large number of interventions using different methodologies have been implemented to change BZD prescription pattern at primary health care settings, with limited positive results.

The investigators propose the implementation of an effectiveness-implementation hybrid type 1 intervention. In the study it was developed an online platform, named ePrimaPrescribe, which was delivered using a Digital Behavior Change Intervention(DBCI).

The investigators included all primary health care units from one region in Portugal which were randomly allocated to receive a Digital Behavior Change Intervention (DBCI) in the format of an online platform to reduce BZD prescription (ePrimaPrescribe) or an online platform concerning communication techniques (control).

The investigators primarily aimed to evaluate the effectiveness of the Digital Behavior Change Intervention (DBCI) using as outcome measure the frequency of BZD prescriptions issued per month. Secondarily the investigators aimed to analyze the effect of ePrimaprescribe on antidepressant prescriptions, to study the effect of ePrimaprescribe on diagnosis definition associated with BZD and antidepressant prescription; to perform a cost analysis considering the monthly National Health Service spending with BZD co-payment. The investigators finally aim to analyze the implementation process using quantitative and qualitative methods.

Conditions

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Anxiety Prescription Drug Abuse and Dependency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

general practitioners randomized to intervention group will be given access to ePrimaPrescribe online program

Group Type EXPERIMENTAL

ePrimaPrescribe online educational program

Intervention Type BEHAVIORAL

online training program aiming to change general practitioners' benzodiazepine prescription

Control

general practitioners randomized to control group will be given access to an online program concerning doctor-patient communication

Group Type ACTIVE_COMPARATOR

ComunicaSaudeMental online educational program

Intervention Type BEHAVIORAL

online training program aiming to improve general practitioners' communication with mentally ill patients

Interventions

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ePrimaPrescribe online educational program

online training program aiming to change general practitioners' benzodiazepine prescription

Intervention Type BEHAVIORAL

ComunicaSaudeMental online educational program

online training program aiming to improve general practitioners' communication with mentally ill patients

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Primary care units using the Portuguese online prescription tool (created by the Portuguese Shared Services of the Ministry of Health and Finance - SPMS)

Exclusion Criteria

* Primary care units involved in another trial concerning mental health topics directly related with the subject of this thesis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Nova de Lisboa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teresa Reis, Md

Role: PRINCIPAL_INVESTIGATOR

Universidade Nova de Lisboa

Locations

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Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School

Lisbon, , Portugal

Site Status

Countries

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Portugal

References

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Reis T, Faria I, Serra H, Xavier M. Barriers and facilitators to implementing a continuing medical education intervention in a primary health care setting. BMC Health Serv Res. 2022 May 13;22(1):638. doi: 10.1186/s12913-022-08019-w.

Reference Type DERIVED
PMID: 35562695 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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47/2016/CEFCM

Identifier Type: -

Identifier Source: org_study_id

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