Engaging General Practice in the Prevention of Patients With Alcohol Problems

NCT ID: NCT00298220

Last Updated: 2009-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-04-30

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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: NONE

Study Groups

training

tailored multi-component implementation program

Group Type: ACTIVE_COMPARATOR

Feedback about patients at risk

Intervention Type: BEHAVIORAL

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

Dissemination guideline and patient information letters

Intervention Type: BEHAVIORAL

Tailored educational training

Intervention Type: BEHAVIORAL

for GP(T)s

Tailored outreach based facilitator support

Intervention Type: BEHAVIORAL

in the practices of the GPTs

Facilitation of co-operation with local addiction services

Intervention Type: BEHAVIORAL

Patient directed interventions

Intervention Type: BEHAVIORAL

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

Reminder-card for GP's desk

Intervention Type: BEHAVIORAL

Personal feedback to patients

Intervention Type: BEHAVIORAL

Patients receive advise based on their premeasurement answers

control

Group Type: NO_INTERVENTION

Feedback about patients at risk

Intervention Type: BEHAVIORAL

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

Dissemination guideline and patient information letters

Intervention Type: BEHAVIORAL

Personal feedback to patients

Intervention Type: BEHAVIORAL

Patients receive advise based on their premeasurement answers

Interventions

Feedback about patients at risk

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

Intervention Type: BEHAVIORAL

Dissemination guideline and patient information letters

Intervention Type: BEHAVIORAL

Tailored educational training

for GP(T)s

Intervention Type: BEHAVIORAL

Tailored outreach based facilitator support

in the practices of the GPTs

Intervention Type: BEHAVIORAL

Facilitation of co-operation with local addiction services

Intervention Type: BEHAVIORAL

Patient directed interventions

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

Intervention Type: BEHAVIORAL

Reminder-card for GP's desk

Intervention Type: BEHAVIORAL

Personal feedback to patients

Patients receive advise based on their premeasurement answers

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

M. Laurant, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Quality for Care Research Nijmegen

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 8286995 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 14741909 (View on PubMed)

Garretsen HFL, Knibbe RA. Alcohol prevalentie onderzoek Rotterdam/Limburg. Landelijk eindrapport. Rijswijk: Ministerie van WVC. 1983

Reference Type: BACKGROUND

Volksgezondheid Toekomst Verkenning. Natioaal Kompas Volksgezondheid. Bilthoven: RIVM, http://www.nationaal kompas.nl, versie 2.4, september 2003

Reference Type: BACKGROUND

Cornel M et al. NHG Standaard M10. Problematisch alcoholgebruik. Huisarts en Wetenschap 1998; 41 (12): 582-90

Reference Type: BACKGROUND

Ministerie van VWS. Zorgnota 2003

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Sutherland G. Smoking cessation: Evidence for counseling efficacy. J of Clinical Psychiatry. In press

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 10630716 (View on PubMed)

Spandorfer 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.

Reference Type: BACKGROUND

PMID: 10907628 (View on PubMed)

Anderson 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.

Reference Type: BACKGROUND

PMID: 15151349 (View on PubMed)

Murphy 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.

Reference Type: BACKGROUND

PMID: 7412295 (View on PubMed)

Skinner HA, Holt S. Early intervention for alcohol problems. J R Coll Gen Pract. 1983 Dec;33(257):787-91.

Reference Type: BACKGROUND

PMID: 6361249 (View on PubMed)

Hulscher ME, Wensing M, Grol RP, van der Weijden T, van Weel C. Interventions to improve the delivery of preventive services in primary care. Am J Public Health. 1999 May;89(5):737-46. doi: 10.2105/ajph.89.5.737.

Reference Type: BACKGROUND

PMID: 10224987 (View on PubMed)

Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. The Cochrane Effective Practice and Organization of Care Review Group. BMJ. 1998 Aug 15;317(7156):465-8. doi: 10.1136/bmj.317.7156.465. No abstract available.

Reference Type: BACKGROUND

PMID: 9703533 (View on PubMed)

Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care. 2003 Feb;12(1):47-52. doi: 10.1136/qhc.12.1.47.

Reference Type: BACKGROUND

PMID: 12571345 (View on PubMed)

Moyer A, Finney JW, Swearingen CE, Vergun P. Brief interventions for alcohol problems: a meta-analytic review of controlled investigations in treatment-seeking and non-treatment-seeking populations. Addiction. 2002 Mar;97(3):279-92. doi: 10.1046/j.1360-0443.2002.00018.x.

Reference Type: BACKGROUND

PMID: 11964101 (View on PubMed)

Babor TF, et al. The Alcohol Use Disorders Identification Test Guidelines for Use in Primary Care. Geneva: World Health Organization WHO/MSD/MSB/01.6a.

Reference Type: BACKGROUND

Anderson P, Kaner E, Wutzke S, Wensing M, Grol R, Heather N, Saunders J; World Health Organization Brief Intervention Study Group. Attitudes and management of alcohol problems in general practice: descriptive analysis based on findings of a World Health Organization international collaborative survey. Alcohol Alcohol. 2003 Nov-Dec;38(6):597-601. doi: 10.1093/alcalc/agg119.

Reference Type: BACKGROUND

PMID: 14633648 (View on PubMed)

Anderson P, Clement S. The AAPPQ revisited: the measurement of general practitioners' attitudes to alcohol problems. Br J Addict. 1987 Jul;82(7):753-9. doi: 10.1111/j.1360-0443.1987.tb01542.x. No abstract available.

Reference Type: BACKGROUND

PMID: 3478065 (View on PubMed)

Fiellin DA, Reid MC, O'Connor PG. Screening for alcohol problems in primary care: a systematic review. Arch Intern Med. 2000 Jul 10;160(13):1977-89. doi: 10.1001/archinte.160.13.1977.

Reference Type: BACKGROUND

PMID: 10888972 (View on PubMed)

Bohn MJ, Babor TF, Kranzler HR. The Alcohol Use Disorders Identification Test (AUDIT): validation of a screening instrument for use in medical settings. J Stud Alcohol. 1995 Jul;56(4):423-32. doi: 10.15288/jsa.1995.56.423.

Reference Type: BACKGROUND

PMID: 7674678 (View on PubMed)

Babor TF, Grant M, Acuda W, Burns FH, Campillo C, Del Boca FK, Hodgson R, Ivanets NN, Lukomskya M, Machona M, et al. A randomized clinical trial of brief interventions in primary care: summary of a WHO project. Addiction. 1994 Jun;89(6):657-60; discussion 660-78. doi: 10.1111/j.1360-0443.1994.tb00944.x. No abstract available.

Reference Type: BACKGROUND

PMID: 8069168 (View on PubMed)

Kaner E, Lock C, Heather N, McNamee P, Bond S. Promoting brief alcohol intervention by nurses in primary care: a cluster randomised controlled trial. Patient Educ Couns. 2003 Nov;51(3):277-84. doi: 10.1016/s0738-3991(02)00242-2.

Reference Type: BACKGROUND

PMID: 14630384 (View on PubMed)

Gross PA, Greenfield S, Cretin S, Ferguson J, Grimshaw J, Grol R, Klazinga N, Lorenz W, Meyer GS, Riccobono C, Schoenbaum SC, Schyve P, Shaw C. Optimal methods for guideline implementation: conclusions from Leeds Castle meeting. Med Care. 2001 Aug;39(8 Suppl 2):II85-92.

Reference Type: BACKGROUND

PMID: 11583124 (View on PubMed)

Grol R, Jones R. Twenty years of implementation research. Fam Pract. 2000 Feb;17 Suppl 1:S32-5. doi: 10.1093/fampra/17.suppl_1.s32. No abstract available.

Reference Type: BACKGROUND

PMID: 10735266 (View on PubMed)

Grol R. Successes and failures in the implementation of evidence-based guidelines for clinical practice. Med Care. 2001 Aug;39(8 Suppl 2):II46-54. doi: 10.1097/00005650-200108002-00003.

Reference Type: BACKGROUND

PMID: 11583121 (View on PubMed)

van Bokhoven MA, Kok G, van der Weijden T. Designing a quality improvement intervention: a systematic approach. Qual Saf Health Care. 2003 Jun;12(3):215-20. doi: 10.1136/qhc.12.3.215.

Reference Type: BACKGROUND

PMID: 12792013 (View on PubMed)

Prochaska JO, Di Clemente CC. The transtheoretical approach: crossing traditional boundaries of therapy. Homewood, IL: Dow Jones-Irwin. 1984

Reference Type: BACKGROUND

Rogers EM. Diffusion of innovations. 4th ed. New York: Free Press. 1995

Reference Type: BACKGROUND

Fishbein M, Ajzen I. Belief, attitude, intentention and behavior: an introduction to therory and research. Reading, MA: Addison Wesley, 1975

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Anderson P, Jane-Llopis E. How can we increase the involvement of primary health care in the treatment of tobacco dependence? A meta-analysis. Addiction. 2004 Mar;99(3):299-312. doi: 10.1111/j.1360-0443.2003.00672.x.

Reference Type: BACKGROUND

PMID: 14982543 (View on PubMed)

Davis D, O'Brien MA, Freemantle N, Wolf FM, Mazmanian P, Taylor-Vaisey A. Impact of formal continuing medical education: do conferences, workshops, rounds, and other traditional continuing education activities change physician behavior or health care outcomes? JAMA. 1999 Sep 1;282(9):867-74. doi: 10.1001/jama.282.9.867.

Reference Type: BACKGROUND

PMID: 10478694 (View on PubMed)

Hulscher ME, van Drenth BB, van der Wouden JC, Mokkink HG, van Weel C, Grol RP. Changing preventive practice: a controlled trial on the effects of outreach visits to organise prevention of cardiovascular disease. Qual Health Care. 1997 Mar;6(1):19-24. doi: 10.1136/qshc.6.1.19.

Reference Type: BACKGROUND

PMID: 10166597 (View on PubMed)

Lobo CM, Frijling BD, Hulscher ME, Bernsen RM, Braspenning JC, Grol RP, Prins A, van der Wouden JC. Improving quality of organizing cardiovascular preventive care in general practice by outreach visitors: a randomized controlled trial. Prev Med. 2002 Nov;35(5):422-9. doi: 10.1006/pmed.2002.1095.

Reference Type: BACKGROUND

PMID: 12431890 (View on PubMed)

Fullard E, Fowler G, Gray M. Promoting prevention in primary care: controlled trial of low technology, low cost approach. Br Med J (Clin Res Ed). 1987 Apr 25;294(6579):1080-2. doi: 10.1136/bmj.294.6579.1080.

Reference Type: BACKGROUND

PMID: 3107700 (View on PubMed)

Astrop P. Facilitator--the birth of a new profession. Health Visit. 1988 Oct;61(10):311-2. No abstract available.

Reference Type: BACKGROUND

PMID: 3198412 (View on PubMed)

Hulscher MEJL. Implementing prevention in general practice: a study on cardiovascular disease. Doctoral thesis. Nijmegen: 1998

Reference Type: BACKGROUND

Huiberts A, Boon B. Alcoholadvies op maat online. G: vakblad over gezondheid en maatschappij 2003; 1: 28-9

Reference Type: BACKGROUND

Riper H, Kramer, J Effectiviteit van een zelfhulpboekje voor probleemdrinkers. Utrecht: Trimbos-instituut. In preparation

Reference Type: BACKGROUND

Hermens R. Cervical cancer screening. Quality improvement interventions in general practice. Doctoral thesis. Nijmegen: 2003

Reference Type: BACKGROUND

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).

Reference Type: BACKGROUND

Keurhorst M, van Beurden I, Anderson P, Heinen M, Akkermans R, Wensing M, Laurant M. GPs' role security and therapeutic commitment in managing alcohol problems: a randomised controlled trial of a tailored improvement programme. BMC Fam Pract. 2014 Apr 17;15:70. doi: 10.1186/1471-2296-15-70.

Reference Type: DERIVED

PMID: 24742032 (View on PubMed)

van Beurden I, Anderson P, Akkermans RP, Grol RP, Wensing M, Laurant MG. Involvement of general practitioners in managing alcohol problems: a randomized controlled trial of a tailored improvement programme. Addiction. 2012 Sep;107(9):1601-11. doi: 10.1111/j.1360-0443.2012.03868.x. Epub 2012 May 8.

Reference Type: DERIVED

PMID: 22372573 (View on PubMed)

Other Identifiers

50-50115-98-041

Identifier Type: -

Identifier Source: secondary_id

KWAZO/GPA-01

Identifier Type: -

Identifier Source: org_study_id