Engaging General Practice in the Prevention of Patients With Alcohol Problems

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00298220
First received: February 21, 2006
Last updated: September 21, 2009
Last verified: August 2009
  Purpose

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.

Condition Intervention
Alcohol Drinking
Behavioral: Feedback about patients at risk
Behavioral: Dissemination guideline and patient information letters
Behavioral: Tailored educational training
Behavioral: Tailored outreach based facilitator support
Behavioral: Facilitation of co-operation with local addiction services
Behavioral: Patient directed interventions
Behavioral: Reminder-card for GP's desk
Behavioral: Personal feedback to patients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Engaging General Practice in the Prevention of Patients With Alcohol Problems

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • - 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 Outcome Measures:
  • - 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.

Enrollment: 77
Study Start Date: July 2005
Study Completion Date: April 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: training
tailored multi-component implementation program
Behavioral: Feedback about patients at risk
GPTs receive this feedback about their patient population; obtained through premeasurement results
Behavioral: Dissemination guideline and patient information letters Behavioral: Tailored educational training
for GP(T)s
Behavioral: Tailored outreach based facilitator support
in the practices of the GPTs
Behavioral: Facilitation of co-operation with local addiction services Behavioral: Patient directed interventions
Like poster for the waiting room, self-help booklets, folders
Behavioral: Reminder-card for GP's desk Behavioral: Personal feedback to patients
Patients receive advise based on their premeasurement answers
No Intervention: control Behavioral: Feedback about patients at risk
GPTs receive this feedback about their patient population; obtained through premeasurement results
Behavioral: Dissemination guideline and patient information letters Behavioral: Personal feedback to patients
Patients receive advise based on their premeasurement answers

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

There are no exclusion criteria.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298220

Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: M. Laurant, PhD Centre for Quality for Care Research Nijmegen
  More Information

Publications:
Lemmens PH. Relationship of alcohol consumption and alcohol problems at the population level. In Heather N, Peters TJ, Stockwell T (eds). International handbook of alcohol dependence and problems. Chischester: John Wiley & Sons, Ltd. 2001
Anderson P et al. The risk of alcohol. Addiction 1993; 88: 1493-1508
Anderson P. Alcohol and risk of physical harm. In Holder HD & Edwards G (eds). Alcohol and public policy: evidence and issues. Oxford: Oxford Medical Publications. 1995
WHO. The World Health Report 2002. Reducing risks, promoting healthy life. Geneva: WHO. 2002
Garretsen HFL, Knibbe RA. Alcohol prevalentie onderzoek Rotterdam/Limburg. Landelijk eindrapport. Rijswijk: Ministerie van WVC. 1983
Skinner HA et al. Early interventions for alcohol problems. J R Coll Gen Pract 1983; 33: 787-01
Prochaska JO, Di Clemente CC. The transtheoretical approach: crossing traditional boundaries of therapy. Homewood, IL: Dow Jones-Irwin. 1984
Rogers EM. Diffusion of innovations. 4th ed. New York: Free Press. 1995
Fishbein M, Ajzen I. Belief, attitude, intentention and behavior: an introduction to therory and research. Reading, MA: Addison Wesley, 1975
Mc Guire WJ. Attitudes an attitude change. In: Lindzey G, Aronson E (eds). The handbook of social psychology. New York: Random House, 1985; 233-346
Whitfield JB. Diagnostic and monitoring investigations. In: Heather N, et al (eds.) International handbook of alcohol dependence and problems. Chichester: John Wiley & Sons, Ltd., (2001).

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00298220     History of Changes
Other Study ID Numbers: KWAZO/GPA-01, 50-50115-98-041
Study First Received: February 21, 2006
Last Updated: September 21, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Family Practice
Intervention Studies
Prevention and Control

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on October 23, 2014