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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04925596
Enrollment
110
Registered
2021-06-14
Start date
2017-03-01
Completion date
2019-04-09
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Prescription Drug Abuse and Dependency

Keywords

Prescribing Patterns, Benzodiazepines, General Practitioners

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.

Interventions

BEHAVIORALePrimaPrescribe online educational program

online training program aiming to change general practitioners' benzodiazepine prescription

BEHAVIORALComunicaSaudeMental online educational program

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

Sponsors

Universidade Nova de Lisboa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Cluster randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the frequency of BZD prescriptions issued per monthChange from baseline prescription to 6 months after interventionEach 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

MeasureTime frameDescription
Change in the frequency of antidepressant prescriptions issued per monthChange from baseline prescription to 6 months after interventionEach 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 diagnosis registration frequencyChange from baseline prescription to 6 months after interventionMonthly 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 costs with BZD co-paymentChange from baseline prescription to 6 months after interventionCost 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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026