Engaging General Practice in the Prevention of Patients With Alcohol Problems
21 septembre 2009 mis à jour par: Radboud University Medical Center
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
- Comportemental: Feedback about patients at risk
- Comportemental: Dissemination guideline and patient information letters
- Comportemental: Tailored educational training
- Comportemental: Tailored outreach based facilitator support
- Comportemental: Facilitation of co-operation with local addiction services
- Comportemental: Patient directed interventions
- Comportemental: Reminder-card for GP's desk
- Comportemental: Personal feedback to patients
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
77
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- GP
- all GPs in a GPT have to participate or
- patients should be listed per GP
There are no exclusion criteria.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: contrôler
|
GPTs receive this feedback about their patient population; obtained through premeasurement results
Patients receive advise based on their premeasurement answers
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
|---|
|
- 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).
|
Mesures de résultats secondaires
Mesure des résultats |
|---|
|
- 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: M. Laurant, PhD, Centre for Quality for Care Research Nijmegen
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2005
Achèvement primaire (Réel)
1 mai 2008
Achèvement de l'étude (Réel)
1 avril 2009
Dates d'inscription aux études
Première soumission
21 février 2006
Première soumission répondant aux critères de contrôle qualité
21 février 2006
Première publication (Estimation)
1 mars 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
22 septembre 2009
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 septembre 2009
Dernière vérification
1 août 2009
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KWAZO/GPA-01
- 50-50115-98-041
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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