Clinical trial NCT04925596: Prescription of Benzodiazepines by General Practitioners: Characteristics of Prescribing Trend and Implementation of an Online Educational Program
Official title: Prescription of Benzodiazepines by General Practitioners: Characteristics of Prescribing Trend and Implementation of an Online Educational Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Prescription Drug Abuse and Dependency
Keywords: Prescribing Patterns
Benzodiazepines
General Practitioners
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the frequency of BZD prescriptions issued per month
timeFrame: Change from baseline prescription to 6 months after intervention
Secondary outcomes:
measure: Change in the frequency of antidepressant prescriptions issued per month
timeFrame: Change from baseline prescription to 6 months after intervention
measure: Change in the diagnosis registration frequency
timeFrame: Change from baseline prescription to 6 months after intervention
measure: Change in the costs with BZD co-payment
timeFrame: Change from baseline prescription to 6 months after intervention
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School
Study officials:
affiliation: Universidade Nova de Lisboa
name: Teresa Reis, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.