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临床试验/NCT04925596
NCT04925596已完成不适用

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

Universidade Nova de Lisboa1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Change in the frequency of BZD prescriptions issued per month

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in the frequency of BZD prescriptions issued per month

时间窗: Change from baseline prescription to 6 months after intervention

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.

次要结局

  • Change in the diagnosis registration frequency(Change from baseline prescription to 6 months after intervention)
  • Change in the frequency of antidepressant prescriptions issued per month(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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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