Engaging General Practice in the Prevention of Patients With Alcohol Problems
21 september 2009 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
- Gedragsmatig: Feedback about patients at risk
- Gedragsmatig: Dissemination guideline and patient information letters
- Gedragsmatig: Tailored educational training
- Gedragsmatig: Tailored outreach based facilitator support
- Gedragsmatig: Facilitation of co-operation with local addiction services
- Gedragsmatig: Patient directed interventions
- Gedragsmatig: Reminder-card for GP's desk
- Gedragsmatig: Personal feedback to patients
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
77
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- GP
- all GPs in a GPT have to participate or
- patients should be listed per GP
There are no exclusion criteria.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: controle
|
GPTs receive this feedback about their patient population; obtained through premeasurement results
Patients receive advise based on their premeasurement answers
|
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
|---|
|
- 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).
|
Secundaire uitkomstmaten
Uitkomstmaat |
|---|
|
- Average AUDIT score at follow-up (= 18 months).
|
|
- Average alcohol consumption as measured by the AUDIT at follow-up (= 18 months).
|
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- 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.
|
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- Change in SAAPPQ score.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: M. Laurant, PhD, Centre for Quality for Care Research Nijmegen
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2005
Primaire voltooiing (Werkelijk)
1 mei 2008
Studie voltooiing (Werkelijk)
1 april 2009
Studieregistratiedata
Eerst ingediend
21 februari 2006
Eerst ingediend dat voldeed aan de QC-criteria
21 februari 2006
Eerst geplaatst (Schatting)
1 maart 2006
Updates van studierecords
Laatste update geplaatst (Schatting)
22 september 2009
Laatste update ingediend die voldeed aan QC-criteria
21 september 2009
Laatst geverifieerd
1 augustus 2009
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KWAZO/GPA-01
- 50-50115-98-041
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