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Engaging General Practice in the Prevention of Patients With Alcohol Problems

2009年9月21日 更新者:Radboud University Medical Center

The aim of the study is to test whether or not a tailored multi-component intervention program to increase the activity of general practice teams in the prevention of hazardous and harmful alcohol consumption results in increase advice giving rate to patient with hazardous and harmful alcohol consumption and a better patient outcome in terms of hazardous and harmful alcohol consumption.

The primary objectives of the proposed study are:

  1. to test the (cost) effectiveness of a tailored multi-component implementation program to engage general practices (i.e. GPs, nurse practitioners or practice nurses/assistants) in the prevention of hazardous or harmful alcohol consumption, changing both providers' advice giving behaviour and patients' alcohol consumption
  2. to identify predictors of effect
  3. to examine whether or not the implementation of a tailored multi-component implementation program to engage general practice in the prevention of hazardous or harmful alcohol consumption is feasible.

研究概览

详细说明

Hazardous and harmful alcohol consumption is likely to cause damage to health, either physical or mental. The prevention of harmful alcohol consumption results in a reduction of alcohol related diseases, of emergency and hospital use, and of societal related problems, and it results in direct health care savings as well as in non-health care savings. General practice is an important setting to intervene with patients whose drinking is hazardous or harmful to their health. Despite the evidence for the efficacy and cost effectiveness of case finding and brief interventions in general practice, such interventions are rarely integrated into routine practice. Based on the literature it is recommended to develop a tailored multi-component implementation program to engage general practice in the prevention of patients with alcohol consumption.

In our trial such a tailored multi-component intervention program is offered to the general practice team (GPT). The participants in our trial are the GPT, not the patients. The GPTs practising in Mid-West and Mid-South are invited to participate in the trial by an invitational letter, including an information leaflet. Participation is not obligatory, but based on own interest of the GPT. Next, GPTs who are willing to participate in the trial are random allocated to the intervention or control condition. Besides the effect outcome measures described in the 'Outcome measure" part there are process and costs measures described.

Besides measurements at the GPT-level, we also conduct measurements at the patient level. All patients of 18 years or older visiting the GPT during a pre-defined 3-month period are asked to fill in the Alcohol Use Disorders identification Test (AUDIT). This measurement takes place before the intervention starts. Only those patients at risk are asked to fill in the AUDIT after the intervention ended. As described in the 'Outcome part', the AUDIT is used to describe the effects of the intervention program at the patient level. Patients receive individual feedback with personal advice depending on their AUDIT score. Patients are not informed about whether the GPT is allocated to the intervention program or control condition (usual care) (single blind).

Comparison: GPTs participated in the multi-component intervention program (see Interventions; intervention group) are compared to GPTs who didn't participate in the multi-component intervention program (control group). The GPTs in the control group receive the NHG guideline and NHG patient information letters, which can be seen as usual care. In addition the receive feedback about the number of patients at risk because of their alcohol consumption, which can be seen as a minimal intervention.

研究类型

介入性

注册 (实际的)

77

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • GP
  • all GPs in a GPT have to participate or
  • patients should be listed per GP

There are no exclusion criteria.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:控制
GPTs receive this feedback about their patient population; obtained through premeasurement results
Patients receive advise based on their premeasurement answers
有源比较器:training
tailored multi-component implementation program
GPTs receive this feedback about their patient population; obtained through premeasurement results
for GP(T)s
in the practices of the GPTs
Like poster for the waiting room, self-help booklets, folders
Patients receive advise based on their premeasurement answers

研究衡量的是什么?

主要结果指标

结果测量
- Proportion of patients who, with an initial AUDIT score of 16 or more, have an AUDIT score at follow-up (= 18 months) of 15 or less.
- Proportion of patients who, with an initial AUDIT score of 16 or more, have been given advice by the general practitioner or by other staff (e.g. nurse practitioner, practice nurse).

次要结果测量

结果测量
- Average AUDIT score at follow-up (= 18 months).
- Average alcohol consumption as measured by the AUDIT at follow-up (= 18 months).
- Proportion of patients with hazardous or harmful alcohol consumption as measured by the AUDIT at follow-up (= 18 months).
- Proportion of patients with harms from alcohol as measured by the AUDIT at follow-up (= 18 months).
- Proportion of patients with alcohol dependence as measured by the AUDIT at follow-up (= 18 months).
- Average SAAPPQ score.
- Change in SAAPPQ score.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:M. Laurant, PhD、Centre for Quality for Care Research Nijmegen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年7月1日

初级完成 (实际的)

2008年5月1日

研究完成 (实际的)

2009年4月1日

研究注册日期

首次提交

2006年2月21日

首先提交符合 QC 标准的

2006年2月21日

首次发布 (估计)

2006年3月1日

研究记录更新

最后更新发布 (估计)

2009年9月22日

上次提交的符合 QC 标准的更新

2009年9月21日

最后验证

2009年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • KWAZO/GPA-01
  • 50-50115-98-041

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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