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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925596
• Other study ID #: 47/2016/CEFCM
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: April 9, 2019

Study information

• Verified date: June 2021
• Source: Universidade Nova de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 9, 2019
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Prescription Drug Abuse and Dependency
• Substance-Related Disorders

Intervention

Behavioral:
• ePrimaPrescribe online educational program
online training program aiming to change general practitioners' benzodiazepine prescription
• ComunicaSaudeMental online educational program
online training program aiming to improve general practitioners' communication with mentally ill patients

Locations

Country	Name	City	State
Portugal	Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the frequency of BZD prescriptions issued per month	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 from baseline prescription to 6 months after intervention
Secondary	Change in the frequency of antidepressant prescriptions issued per month	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 from baseline prescription to 6 months after intervention
Secondary	Change in the diagnosis registration frequency	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 from baseline prescription to 6 months after intervention
Secondary	Change in the costs with BZD co-payment	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.	Change from baseline prescription to 6 months after intervention