- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00298220
Engaging General Practice in the Prevention of Patients With Alcohol Problems
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Conductual: Feedback about patients at risk
- Conductual: Dissemination guideline and patient information letters
- Conductual: Tailored educational training
- Conductual: Tailored outreach based facilitator support
- Conductual: Facilitation of co-operation with local addiction services
- Conductual: Patient directed interventions
- Conductual: Reminder-card for GP's desk
- Conductual: Personal feedback to patients
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- GP
- all GPs in a GPT have to participate or
- patients should be listed per GP
There are no exclusion criteria.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: control
|
GPTs receive this feedback about their patient population; obtained through premeasurement results
Patients receive advise based on their premeasurement answers
|
Comparador activo: training
tailored multi-component implementation program
|
GPTs receive this feedback about their patient population; obtained through premeasurement results
for GP(T)s
in the practices of the GPTs
Like poster for the waiting room, self-help booklets, folders
Patients receive advise based on their premeasurement answers
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
---|
- 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).
|
Medidas de resultado secundarias
Medida de resultado |
---|
- 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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: M. Laurant, PhD, Centre for Quality for Care Research Nijmegen
Publicaciones y enlaces útiles
Publicaciones Generales
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- Volksgezondheid Toekomst Verkenning. Natioaal Kompas Volksgezondheid. Bilthoven: RIVM, http://www.nationaal kompas.nl, versie 2.4, september 2003
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- Ministerie van VWS. Zorgnota 2003
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- Sutherland G. Smoking cessation: Evidence for counseling efficacy. J of Clinical Psychiatry. In press
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- 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.
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- Skinner HA, Holt S. Early intervention for alcohol problems. J R Coll Gen Pract. 1983 Dec;33(257):787-91.
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- 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.
- 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.
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- 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.
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- 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.
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- 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.
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- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- Astrop P. Facilitator--the birth of a new profession. Health Visit. 1988 Oct;61(10):311-2. No abstract available.
- Hulscher MEJL. Implementing prevention in general practice: a study on cardiovascular disease. Doctoral thesis. Nijmegen: 1998
- Huiberts A, Boon B. Alcoholadvies op maat online. G: vakblad over gezondheid en maatschappij 2003; 1: 28-9
- Riper H, Kramer, J Effectiviteit van een zelfhulpboekje voor probleemdrinkers. Utrecht: Trimbos-instituut. In preparation
- Hermens R. Cervical cancer screening. Quality improvement interventions in general practice. Doctoral thesis. Nijmegen: 2003
- 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).
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KWAZO/GPA-01
- 50-50115-98-041
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