Alcohol DrinkingNCT00298220
Engaging General Practice in the Prevention of Patients With Alcohol Problems
A study testing Feedback about patients at risk, Dissemination guideline and patient information letters and Tailored educational training in people with Alcohol Drinking, run by Radboud University Medical Center.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Feedback about patients at risk, Dissemination guideline and patient information letters and Tailored educational training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- GP
- all GPs in a GPT have to participate or
- patients should be listed per GP
- There are no exclusion criteria.
Who cannot join
None listed.
About this study
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:
- 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
- to identify predictors of effect
- 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.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- Feedback about patients at risk, Dissemination guideline and patient information letters, Tailored educational training, Tailored outreach based facilitator support, Facilitation of co-operation with local addiction services
- Keywords
- Family Practice, Intervention Studies, Prevention and Control
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback about patients at riskBehavioural
GPTs receive this feedback about their patient population; obtained through premeasurement results
Dissemination guideline and patient information lettersBehavioural
Tailored educational trainingBehavioural
for GP(T)s
Tailored outreach based facilitator supportBehavioural
in the practices of the GPTs
Facilitation of co-operation with local addiction servicesBehavioural
Patient directed interventionsBehavioural
Like poster for the waiting room, self-help booklets, folders
Reminder-card for GP's deskBehavioural
Personal feedback to patientsBehavioural
Patients receive advise based on their premeasurement answers
| Study group | Role | What they receive |
|---|---|---|
| training | Active comparator | tailored multi-component implementation program Receives: 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 |
| control | No intervention | Not described Receives: Behavioral: Feedback about patients at risk; Behavioral: Dissemination guideline and patient information letters; Behavioral: Personal feedback to patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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).
- Average SAAPPQ score.
- Change in SAAPPQ score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startJul 2005
- Primary completionMay 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- M. Laurant, PhD, Principal investigator, Centre for Quality for Care Research Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298220
- Sponsor's protocol ID
- KWAZO/GPA-01
- Other IDs
- 50-50115-98-041
- Status last verified
- Aug 2009
- First submitted
- 21 Feb 2006
- Last updated
- 22 Sep 2009
- Results posted
- No
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, Cremona A, Paton A, Turner C, Wallace P. The risk of alcohol. Addiction. 1993 Nov;88(11):1493-508. doi: 10.1111/j.1360-0443.1993.tb03135.x.
PubMed 8286995Anderson 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
Guilbert JJ. The world health report 2002 - reducing risks, promoting healthy life. Educ Health (Abingdon). 2003 Jul;16(2):230. doi: 10.1080/1357628031000116808. No abstract available.
PubMed 14741909Garretsen HFL, Knibbe RA. Alcohol prevalentie onderzoek Rotterdam/Limburg. Landelijk eindrapport. Rijswijk: Ministerie van WVC. 1983
Volksgezondheid Toekomst Verkenning. Natioaal Kompas Volksgezondheid. Bilthoven: RIVM, http://www.nationaal kompas.nl, versie 2.4, september 2003
Cornel M et al. NHG Standaard M10. Problematisch alcoholgebruik. Huisarts en Wetenschap 1998; 41 (12): 582-90
Ministerie van VWS. Zorgnota 2003
Anderson P. The effectiveness of general practitioners' advice in reducing the risk of alcohol. IN: Neil A et al (eds). Prevention of Cardiovascular Disease: An evidence-based approach. 2nd Ed. Oxford: Oxford University Press. In press
Sutherland G. Smoking cessation: Evidence for counseling efficacy. J of Clinical Psychiatry. In press
Fleming MF, Mundt MP, French MT, Manwell LB, Stauffacher EA, Barry KL. Benefit-cost analysis of brief physician advice with problem drinkers in primary care settings. Med Care. 2000 Jan;38(1):7-18. doi: 10.1097/00005650-200001000-00003.
PubMed 10630716Spandorfer JM, Israel Y, Turner BJ. Primary care physicians' views on screening and management of alcohol abuse: inconsistencies with national guidelines. J Fam Pract. 1999 Nov;48(11):899-902.
PubMed 10907628Anderson P, Laurant M, Kaner E, Wensing M, Grol R. Engaging general practitioners in the management of hazardous and harmful alcohol consumption: results of a meta-analysis. J Stud Alcohol. 2004 Mar;65(2):191-9. doi: 10.15288/jsa.2004.65.191.
PubMed 15151349Murphy HB. Hidden barriers to the diagnosis and treatment of alcoholism and other alcohol misuse. J Stud Alcohol. 1980 May;41(5):417-28. doi: 10.15288/jsa.1980.41.417.
PubMed 7412295Skinner HA, Holt S. Early intervention for alcohol problems. J R Coll Gen Pract. 1983 Dec;33(257):787-91.
PubMed 6361249
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging General Practice in the Prevention of Patients With Alcohol Problems
- ClinicalTrials.gov ID
- NCT00298220
- Acronym / sponsor ID
- KWAZO/GPA-01
- Conditions
- Alcohol Drinking
- Keywords
- Family Practice, Intervention Studies, Prevention and Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jul 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- to identify predictors of effect
- 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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training | Active comparator | 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 patientstailored multi-component implementation program |
| control | No intervention | Behavioral: Feedback about patients at risk, Behavioral: Dissemination guideline and patient information letters, Behavioral: Personal feedback to patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- GP
- all GPs in a GPT have to participate or
- patients should be listed per GP
- There are no exclusion criteria.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback about patients at riskGPTs receive this feedback about their patient population; obtained through premeasurement results | Behavioural | control, training |
| Dissemination guideline and patient information letters | Behavioural | control, training |
| Tailored educational trainingfor GP(T)s | Behavioural | training |
| Tailored outreach based facilitator supportin the practices of the GPTs | Behavioural | training |
| Facilitation of co-operation with local addiction services | Behavioural | training |
| Patient directed interventionsLike poster for the waiting room, self-help booklets, folders | Behavioural | training |
| Reminder-card for GP's desk | Behavioural | training |
| Personal feedback to patientsPatients receive advise based on their premeasurement answers | Behavioural | control, training |
Primary outcome
- 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).
7 secondary outcomes
- 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
- BackgroundLemmens 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
- Background: PubMed 8286995Anderson P, Cremona A, Paton A, Turner C, Wallace P. The risk of alcohol. Addiction. 1993 Nov;88(11):1493-508. doi: 10.1111/j.1360-0443.1993.tb03135.x.
- BackgroundAnderson 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
- Background: PubMed 14741909Guilbert JJ. The world health report 2002 - reducing risks, promoting healthy life. Educ Health (Abingdon). 2003 Jul;16(2):230. doi: 10.1080/1357628031000116808. No abstract available.
- BackgroundGarretsen HFL, Knibbe RA. Alcohol prevalentie onderzoek Rotterdam/Limburg. Landelijk eindrapport. Rijswijk: Ministerie van WVC. 1983
- BackgroundVolksgezondheid Toekomst Verkenning. Natioaal Kompas Volksgezondheid. Bilthoven: RIVM, http://www.nationaal kompas.nl, versie 2.4, september 2003
- BackgroundCornel M et al. NHG Standaard M10. Problematisch alcoholgebruik. Huisarts en Wetenschap 1998; 41 (12): 582-90
- BackgroundMinisterie van VWS. Zorgnota 2003
- BackgroundAnderson P. The effectiveness of general practitioners' advice in reducing the risk of alcohol. IN: Neil A et al (eds). Prevention of Cardiovascular Disease: An evidence-based approach. 2nd Ed. Oxford: Oxford University Press. In press
- BackgroundSutherland G. Smoking cessation: Evidence for counseling efficacy. J of Clinical Psychiatry. In press
- Background: PubMed 10630716Fleming MF, Mundt MP, French MT, Manwell LB, Stauffacher EA, Barry KL. Benefit-cost analysis of brief physician advice with problem drinkers in primary care settings. Med Care. 2000 Jan;38(1):7-18. doi: 10.1097/00005650-200001000-00003.
- Background: PubMed 10907628Spandorfer JM, Israel Y, Turner BJ. Primary care physicians' views on screening and management of alcohol abuse: inconsistencies with national guidelines. J Fam Pract. 1999 Nov;48(11):899-902.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Laurant, PhD principal investigator
Centre for Quality for Care Research Nijmegen
Questions about this trial
What is this clinical trial studying?
A study testing Feedback about patients at risk, Dissemination guideline and patient information letters and Tailored educational training in people with Alcohol Drinking, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- 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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298220, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2009.