Short summary

Alcohol problems have immense health consequences and a large treatment gap with sufficient treatment often delayed several years. General practice is an opportune place to identify and treat alcohol-related problems. The iTAPP Study is a pragmatic stepped-wedge cluster randomized controlled intervention trial evaluating the effectiveness of the 15-Method as an identification and treatment tool for alcohol-related problems in Danish general practice.

Rationale

Every year, more than 5% of deaths in Denmark are related to alcohol. One in six Danes exceed the nationally recommended limits for weekly alcohol consumption and approximately 15% have a harmful consumption. The cost of alcohol related problems sums up to 40.000 life-years lost, 13 billion DKK per year and 160.000 additional contacts in general practice related to alcohol. Persons with mild to moderate alcohol use disorder are currently overlooked or difficult to reach with the existing interventions in primary healthcare. General practice is in contact with a large part of the population, including many patients with alcohol problems, but alcohol problems can be challenging to identify and are often found difficult to address. The 15-method is developed in Sweden, translated and feasibility-tested in Denmark. For mild and moderate alcohol use disorders, the 15-method in general practice has been found equal to specialist treatment (Wallhed, Hammarberg, Andreasson 2018). The method is an evidence based, stepped care approach to alcohol problems. The 15-method has not yet been tested on a non-randomized population. The overall aim of the iTAPP-study is to evaluate the effectiveness of the 15-method in Danish general practice. This will be done by evaluating the 15-Methods effectiveness in:

a) Lowering the proportion of patients in general practice, who exceed the Danish low-risk alcohol consumption levels.

b) Increasing the proportion of alcohol related consultations in general practice.

Description of the cohort

The study will take place in 16 general practices in the Region of Southern Denmark. All patients aged 18 years or older, affiliated with the participating general practices, are included in the study.

Data and biological material

Questionnaire data on alcohol consumption, lifestyle and quality of life, will be collected by means of E-Boks and sent as a survey to all patients affiliated with the participating practices four times during the study period.

Registration of alcohol-related conversations in general practice: Healthcare professionals will be trained and encouraged to register any event of alcohol-related conversations and register it in their patient filing system by a predefined code. By the time of study completion, journals matching the inclusion criteria will be searched for the code linked to alcohol-related conversations.

Any conversation regarding alcohol consumption and/or alcohol-related problems will count as an observation.

Register data: Pharmacological treatment of alcohol problems will include prescriptions of Disulfiram, Naltrexone, Acamprosate and Nalmefene. Data on prescriptions will be collected from the Danish National Prescription Registry.

Biomarkers include Gamma-Glutamyltransferase (GGT) and Alanine-Aminotransferase (ALAT) and will be collected via the National Laboratory Database.

Collaborating researchers and departments

The Research Unit of General Practice Odense, Department of Public Health, University of Southern Denmark

• Jens Søndergaard, prof., ph.d., MD, GP, clin.pharm.

The Unit for Clinical Alcohol Research, Clinical Institute

• Peter Næsborg Schøler, MD, ph.d.-student