Engaging General Practice in the Prevention of Patients With Alcohol Problems

Alcohol Drinking Clinical Trial

Official title:

Engaging General Practice in the Prevention of Patients With Alcohol Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298220
• Other study ID #: KWAZO/GPA-01
• Secondary ID: 50-50115-98-041
• Status: Completed
• Phase: N/A
• First received: February 21, 2006
• Last updated: September 21, 2009
• Start date: July 2005
• Est. completion date: April 2009

Study information

• Verified date: August 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• GP

• all GPs in a GPT have to participate or

• patients should be listed per GP

There are no exclusion criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Feedback about patients at risk
GPTs receive this feedback about their patient population; obtained through premeasurement results
• Dissemination guideline and patient information letters

• Tailored educational training
for GP(T)s
• Tailored outreach based facilitator support
in the practices of the GPTs
• Facilitation of co-operation with local addiction services

• Patient directed interventions
Like poster for the waiting room, self-help booklets, folders
• Reminder-card for GP's desk

• Personal feedback to patients
Patients receive advise based on their premeasurement answers

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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.
Primary	- 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).
Secondary	- Average AUDIT score at follow-up (= 18 months).
Secondary	- Average alcohol consumption as measured by the AUDIT at follow-up (= 18 months).
Secondary	- Proportion of patients with hazardous or harmful alcohol consumption as measured by the AUDIT at follow-up (= 18 months).
Secondary	- Proportion of patients with harms from alcohol as measured by the AUDIT at follow-up (= 18 months).
Secondary	- Proportion of patients with alcohol dependence as measured by the AUDIT at follow-up (= 18 months).
Secondary	- Average SAAPPQ score.
Secondary	- Change in SAAPPQ score.