NCT00298220

Brief 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. 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. 2.to identify predictors of effect
  3. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

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

July 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 22, 2009

Status Verified

August 1, 2009

Enrollment Period

2.8 years

First QC Date

February 21, 2006

Last Update Submit

September 21, 2009

Conditions

Keywords

Family PracticeIntervention StudiesPrevention and Control

Outcome Measures

Primary Outcomes (2)

  • - 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).

Secondary Outcomes (7)

  • - 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).

  • +2 more secondary outcomes

Study Arms (2)

training

ACTIVE COMPARATOR

tailored multi-component implementation program

Behavioral: Feedback about patients at riskBehavioral: Dissemination guideline and patient information lettersBehavioral: Tailored educational trainingBehavioral: Tailored outreach based facilitator supportBehavioral: Facilitation of co-operation with local addiction servicesBehavioral: Patient directed interventionsBehavioral: Reminder-card for GP's deskBehavioral: Personal feedback to patients

control

NO INTERVENTION
Behavioral: Feedback about patients at riskBehavioral: Dissemination guideline and patient information lettersBehavioral: Personal feedback to patients

Interventions

GPTs receive this feedback about their patient population; obtained through premeasurement results

controltraining

for GP(T)s

training

in the practices of the GPTs

training

Like poster for the waiting room, self-help booklets, folders

training
training

Patients receive advise based on their premeasurement answers

controltraining

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (47)

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MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • M. Laurant, PhD

    Centre for Quality for Care Research Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

March 1, 2006

Study Start

July 1, 2005

Primary Completion

May 1, 2008

Study Completion

April 1, 2009

Last Updated

September 22, 2009

Record last verified: 2009-08