Alcohol Abuse Alcoholism, General Practice, Screening and Brief Intervention
Conditions
Keywords
Primary Care, Screening, Alcohol Use Disorder
Brief summary
The Identification and Treatment of Alcohol Problems in Primary Care (iTAPP) Study is a pragmatic 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. The 15-Method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems in a primary care setting. The method has shown promising results as a treatment tool in Sweden. A feasibility study of the 15-Method in Denmark suggested that the method can be implemented in Danish general practice. The trial is led by the Unit for Clinical Alcohol Research at The University of Southern Denmark in collaboration with The Research Unit of General Practice Odense at The University of Southern Denmark.
Interventions
BEHAVIORALThe 15-Method
The 15-Method is a Screening and Brief Intervention method for identifying and treating alcohol problems in primary care. The method combines evidence-based approaches from specialized addiction treatment with screening and readily available treatment options in general practice to help identify and treat alcohol problems. The 15-method is based on Motivational Interviewing, Cognitive Behavioral Therapy and utilizes the Alcohol Use Disorder Identification Test (AUDIT) as a screening tool. The 15-Method contains three flexible steps: Identification of clinical problem related to alcohol; feedback and clinical work-up as needed; treatment. Treatment includes structured consultations (maximum of four) with patient home-work assignments, and can be combined with pharmacological treatment for alcohol problems.
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Stepped-wedge cluster randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Affiliated with the participating general practices
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients exceeding the Danish national low-risk alcohol consumption limits | Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024). | Using Timeline Follow Back one-week data from patient surveys. The Danish national low-risk alcohol consumption limit is maximum 10 standard units (1 unit = 12 grams of ethanol) per week and maximum 4 standard units on a single day. Patients are coded 1 (drinking above limits) or 0 (not drinking above limits). |
| Number of heavy drinking days per week in patients | Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024). | The number of heavy drinking days (HDD) per week is derived from the Timeline Follow Back one-week (range 0-7 HDD/week) in patient surveys. A HDD is defined as \>4 standard units (1 unit = 12 grams of ethanol) on the same day. Is a sum of the number of days patients drink \>4 standard units. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likelihood of alcohol use being addressed during a consultation in general practice | Data is collected from enrollment in trial until the end of the trail (January 2023-August 2024). | The likelihood of consultations in which the topic of alcohol has been addressed. Alcohol related consultations are continuously registered in the patient filing system throughout the trial period. An alcohol related consultation is defined as a consultation registered with the ICD-10 code z006 and ICPC-2 code A97. |
| Frequency of use of biomarkers as a screening tool for harmful alcohol use | Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024). | The frequency of use in general practice. Biomarkers as a screening tool for harmful alcohol use comprise Gamma-Glutamyltransferase (GGT) and Alanine-Aminotransferase (ALAT). Data is obtained from Danish registers. The use of biomarkers as screening tool in the practices will be analyzed, comparing baseline levels to active (post-implementation) levels. |
| Prescription rate of pharmacological treatment for alcohol problems | Data is collected 1 year prior to trial start/enrollment (January 2022-December 2023) and from enrollment in trial until the end of the trial (January 2023-August 2024). | The prescription rate in general practice. Pharmacological treatment for alcohol problems comprise Disulfiram, Naltrexone, Acamprosate, and Nalmefene. Data is obtained from Danish registers. The prescription rate in the practices will be analyzed, comparing baseline levels to active (post-implementation) levels. |
Countries
Denmark
Contacts
STUDY_DIRECTORAnette S Nielsen, Professor
Unit of Clinical Alcohol Research, University of Southern Denmark
PRINCIPAL_INVESTIGATORJens Søgaard, Professor
Research Unit of General Practice Odense, University of Southern Denmark
Outcome results
None listed