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

Primary Purpose

Anxiety, Prescription Drug Abuse and Dependency

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
ePrimaPrescribe online educational program
ComunicaSaudeMental online educational program
Sponsored by
Universidade Nova de Lisboa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety focused on measuring Prescribing Patterns, Benzodiazepines, General Practitioners

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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.

Full Information

First Posted
April 10, 2019
Last Updated
June 7, 2021
Sponsor
Universidade Nova de Lisboa
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1. Study Identification

Unique Protocol Identification Number
NCT04925596
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
April 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Nova de Lisboa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Prescription Drug Abuse and Dependency
Keywords
Prescribing Patterns, Benzodiazepines, General Practitioners

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized trial
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
general practitioners randomized to intervention group will be given access to ePrimaPrescribe online program
Arm Title
Control
Arm Type
Active Comparator
Arm Description
general practitioners randomized to control group will be given access to an online program concerning doctor-patient communication
Intervention Type
Behavioral
Intervention Name(s)
ePrimaPrescribe online educational program
Intervention Description
online training program aiming to change general practitioners' benzodiazepine prescription
Intervention Type
Behavioral
Intervention Name(s)
ComunicaSaudeMental online educational program
Intervention Description
online training program aiming to improve general practitioners' communication with mentally ill patients
Primary Outcome Measure Information:
Title
Change in the frequency of BZD prescriptions issued per month
Description
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.
Time Frame
Change from baseline prescription to 6 months after intervention
Secondary Outcome Measure Information:
Title
Change in the frequency of antidepressant prescriptions issued per month
Description
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.
Time Frame
Change from baseline prescription to 6 months after intervention
Title
Change in the diagnosis registration frequency
Description
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).
Time Frame
Change from baseline prescription to 6 months after intervention
Title
Change in the costs with BZD co-payment
Description
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.
Time Frame
Change from baseline prescription to 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Reis, Md
Organizational Affiliation
Universidade Nova de Lisboa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School
City
Lisbon
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
35562695
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.
Results Reference
derived

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

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