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

Not Applicable

Completed

• Conditions: Anxiety; Prescription Drug Abuse and Dependency
• Interventions: Behavioral: ComunicaSaudeMental online educational program; Behavioral: ePrimaPrescribe online educational program

• Registration Number: NCT04925596
• Lead Sponsor: Universidade Nova de Lisboa

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-05-15
• Study Completion: 2019-04-09
• Study First Submitted: 2019-04-10
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-07
• Last Update Submitted: 2021-06-07
• Study First Posted: 2021-06-14
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	ComunicaSaudeMental online educational program	general practitioners randomized to control group will be given access to an online program concerning doctor-patient communication
Intervention	ePrimaPrescribe online educational program	general practitioners randomized to intervention group will be given access to ePrimaPrescribe online program

Primary Outcome Measures

Name	Time	Method
Change in the frequency of BZD prescriptions issued per month	Change from baseline prescription to 6 months after intervention	Each prescription data was coded using an individual GP and patient numerical identification, in a secured and validated electronic database, directly extracted by the central Shared Services of the Portuguese Ministry of Health.

Secondary Outcome Measures

Name	Time	Method
Change in the diagnosis registration frequency	Change from baseline prescription to 6 months after intervention	Monthly registration distribution of psychological symptoms, complaints, and diagnoses coded at the same month as BZD and antidepressant prescriptions. The GP's diagnosis registration used the International Classification of Primary Care, second edition (ICPC-2) developed and updated by the World Organization of Family Doctors' (WONCA) International Classification Committee (WICC).
Change in the frequency of antidepressant prescriptions issued per month	Change from baseline prescription to 6 months after intervention	Each prescription data was coded using an individual GP and patient numerical identification, in a secured and validated electronic database, directly extracted by the central Shared Services of the Portuguese Ministry of Health.
Change in the costs with BZD co-payment	Change from baseline prescription to 6 months after intervention	Cost analysis considering the monthly National Health Service spending with BZD co-payment. This cost was compared with the amount that would need to be spent to comply with needs and solutions suggested when evaluating GP's perceptions of the feasibility and implementation.

Trial Locations

Locations (1)

Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School; 🇵🇹 Lisbon, Portugal