NCT04925596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

April 10, 2019

Last Update Submit

June 7, 2021

Conditions

Keywords

Prescribing PatternsBenzodiazepinesGeneral Practitioners

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in the frequency of antidepressant prescriptions issued per month

    Change from baseline prescription to 6 months after intervention

  • Change in the diagnosis registration frequency

    Change from baseline prescription to 6 months after intervention

  • Change in the costs with BZD co-payment

    Change from baseline prescription to 6 months after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: ePrimaPrescribe online educational program

Control

ACTIVE COMPARATOR

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

Behavioral: ComunicaSaudeMental online educational program

Interventions

online training program aiming to change general practitioners' benzodiazepine prescription

Intervention

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

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Primary care units involved in another trial concerning mental health topics directly related with the subject of this thesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School

Lisbon, Portugal

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anxiety DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Mental DisordersChemically-Induced Disorders

Study Officials

  • Teresa Reis, Md

    Universidade Nova de Lisboa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2019

First Posted

June 14, 2021

Study Start

March 1, 2017

Primary Completion

May 15, 2017

Study Completion

April 9, 2019

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations