Identification and Treatment of Alcohol Problems in Primary Care

NCT05916027 | Active Not Recruiting

• 1 other identifier: iTAPP project
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse Alcoholism; General Practice; Screening and Brief Intervention

Keywords

Primary Care; Screening; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• Proportion of patients exceeding the Danish national low-risk alcohol consumption limits

  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).

  Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).

• Number of heavy drinking days per week in patients

  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.

  Four times during trial: Baseline (spring 2023), summer 2023, winter 2023/spring 2024, follow-up (summer 2024).

Secondary Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (2)

Control

NO INTERVENTION

Each participating clinic serves as its own control and as control for active clinics, in the stepped-wedge design. All clinics are inactive (no intervention) during the baseline period of three months.

Active

ACTIVE COMPARATOR

Active clinics are trained in the intervention object (the 15-method) prior to switching to the active group. Clinics are enrolled as active clinics (intervention) in four steps (4-5 clinics in each step). The intervention is implemented into the clinic, and the staff are free to use the intervention in everyday work.

Behavioral: The 15-Method

Interventions

The 15-Method BEHAVIORAL

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.

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Affiliated with the participating general practices

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark

Odense C, Fynen, 5000, Denmark

Location

Related Publications (2)

• Scholer PN, Volke KH, Andreasson S, Rasmussen S, Sondergaard J, Nielsen AS. The identification and treatment of alcohol problems in primary care (iTAPP) study: protocol for a stepped wedge cluster randomized control trial testing the 15-method in a primary care setting. Addict Sci Clin Pract. 2024 Jun 13;19(1):49. doi: 10.1186/s13722-024-00474-6.

  PMID: 38872214 RESULT

• Olsen CDH, Volke KH, Scholer PN, Sondergaard J, Nielsen AS. Primary health care professionals' documentation and patients' recall of alcohol as a topic in consultations: quality assessment of data collection in the iTAPP study. BMC Res Notes. 2026 Mar 28. doi: 10.1186/s13104-026-07790-x. Online ahead of print.

  PMID: 41904599 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anette S Nielsen, Professor

  Unit of Clinical Alcohol Research, University of Southern Denmark

  STUDY DIRECTOR

• Jens Søgaard, Professor

  Research Unit of General Practice Odense, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster randomized controlled trial.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: June 23, 2023
• Study Start: January 1, 2023
• Primary Completion: August 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)