|- candidate number||23458|
|- NTR Number||NTR5539|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2015|
|- Secondary IDs||(METC 15-4-161) METC azM/UM Maastricht|
|- Public Title||A theory-based implementation program of alcohol screening and brief interventions (ASBI) in general practices in The Netherlands.|
|- Scientific Title||A theory-based implementation program of alcohol screening and brief interventions (ASBI) in general practices in The Netherlands.|
|- hypothesis||We hypothesize that:|
(1) GPs who receive the ASBI implementation
program will increase screening and brief intervention delivery rates relative to GPs in the
(2) GPs involved in the ASBI implementation program will have a higher proportion of patients with problematic alcohol use who reduce their alcohol consumption to low-risk levels compared with GPs in the control group.
|- Healt Condition(s) or Problem(s) studied||Alcohol, Screening, Intervention|
|- Inclusion criteria||In order to be eligible to participate in this study, general practitioners must meet the following criteria: |
- Working in general practice.
- Working in co-operation with a practice nurse mental health.
- Situated in the Netherlands.
In order to be eligible to participate in this study, patients must meet the following criteria:
- Being over 18 years of age.
- Registered with the practice.
- Having an AUDIT-C score of ¡Ý 4, as assessed and registered by the GP during a consultation.
|- Exclusion criteria||GP exclusion criteria |
A potential patient who meets any of the following criteria will be excluded from participation in this study:
- Patients with a DSM diagnosis of alcohol abuse or dependence, or those for whom the primary care team consider it would be clinically inappropriate to participate in this study (e.g., complex psychiatric or physical comorbidity).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2016|
|- planned closingdate||30-okt-2016|
|- Target number of participants||58|
|- Interventions||The ASBI implementation program consists of
three parts, targeting previously found barriers: lack of knowledge, lack of skills, negative
attitude and a lack of a supportive environment. GPs in the implementation program condition, will be referred to a 2-hour accredited E-learning module ¡°Learning how to discuss alcohol use with patients¡± to address lack of knowledge and/or skill concerning alcohol assessment. The 2-hour accredited E-learning module is an acknowledged
product consistent with the Dutch ¡®NHG Standaard¡¯ guideline recommendations for problematic alcohol use. An additional short feedback module will be given to general practitioners to address motivational factors such as attitude and beliefs about discussing alcohol use with patients. The third component of the ASBI implementation program consists of supportive environmental materials such as screening questionnaires, a referral scheme, reminder cards as well as contact information of local addiction prevention centres for support for GPs. |
GPs in the control condition will not receive the ASBI implementation program and will
continue to deliver care as usual.
|- Primary outcome||Screening rate: The screening rate will be expressed as the proportion: patients
screened divided by the total amount of patient consultations involving patients with
early signs with respect to risky alcohol use. |
Rate of brief intervention delivery: The brief intervention rate is expressed as the
proportion patients who receive a brief advice or referral to another provider for brief
intervention divided by the total amount of screen positives.
Patient alcohol consumption is expressed as the following proportion: patients who score ¡Ý 5 for men or ¡Ý 4 for women on the AUDIT-C who reduced their levels of alcohol consumption to low-risk level divided by the total amount of patients who score ¡Ý 5 for men or ¡Ý 4 for women on the AUDIT-C.
|- Secondary outcome||Knowledge: about the Dutch ¡®NHG Standaard¡¯ guideline recommendations, early signs, risk groups, ASBI methodology and referral possibilities. |
Cognitive and interpersonal skills: knowing how to address the topic in a neutral manner.
Attitude: beliefs about consequences of ASBI (e.g. effectiveness, antagonizing the patient, difficulty in working with problem drinkers) .
Self-efficacy: beliefs about personal ASBI capabilities (e.g. confidence in performing ASBI).
Environmental context & resources: are the facilities/resources available to facilitate ASBI?
|- Timepoints||Screening rate, rate of brief intervention delivery and secondary outcomes will be measured at the following timepoints: week 1, 2, 6, 7. Patient alcohol consumption will be measured at the following timepoints: week 8 (baseline measurement), week 13 (one-month post-measurement) & week 21 (three-month follow-up).|
|- Trial web site||www.ask-studie.nl|
|- CONTACT FOR PUBLIC QUERIES||MSc Latifa Abidi|
|- CONTACT for SCIENTIFIC QUERIES||MSc Latifa Abidi|
|- Sponsor/Initiator ||Maastricht University|
(Source(s) of Monetary or Material Support)
|Mondriaan Zorggroep, CAPHRI School for public health and primary care|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||7-dec-2015 - 22-mei-2016|