Identification and Treatment of Alcohol Problems in Primary Care

General Practice Clinical Trial

— iTAPP  

Official title:

iTAPP Study - Identification and Treatment of Alcohol Problems in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05916027
• Other study ID #: iTAPP project
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study protocol with a detailed description of the iTAPP Study is in preparation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Affiliated with the participating general practices

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Alcoholism
• General Practice

Intervention

Behavioral:
• The 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.

Locations

Country	Name	City	State
Denmark	Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark	Odense C	Fynen

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Scholer PN, Sondergaard J, Barfod S, Nielsen AS. Danish feasibility study of a new innovation for treating alcohol disorders in primary care: the 15-method. BMC Prim Care. 2022 Feb 28;23(1):34. doi: 10.1186/s12875-022-01639-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of alcohol related conversations in the clinics	The total number of consultations in which the topic of alcohol has been addressed.; Outcome measure on the level of the practices (i.e. not patients). Alcohol related conversations are continuously registered in the patient filing system throughout the study period.; Comparison of baseline frequency (pre-implementation) to post-implementation frequencies	Up to 19 months
Secondary	Percentage of patients who exceed the Danish national recommendations of alcohol consumption	Data type: survey Level: population Variables: The Alcohol Use Disorder Identification Test Scores (0-40 points) and the Timeline Follow Back one-week version (number of standard drinks, 12g of ethanol, per week) Comparison of baseline (pre-implementation) and post-implementation levels	4 times of 10 minutes
Secondary	Quality of Life 5D-5L scores	Data: Survey Level: population Variable: Quality of life score by The World Health Organization 5D-5L questionnaire.	4 times of 10 minutes
Secondary	Pharmacological Treatment	The use of pharmacological treatment for alcohol problems in the clinics will be analyzed, comparing baseline levels to active (post-implementation) levels.; Data: register based Level: practices Variables: prescription rates of Disulfiram, Naltrexone, Acamprosate, and Nalmefene	0-4 sessions of 15 minutes
Secondary	Use of blood sampling	The use of blood sampling as screening/monitoring for potential alcohol problems in the clinics will be analyzed, comparing baseline levels to active (post-implementation) levels.; Data: register based Level: practices Blood variables: Gamma-Glutamyltransferase (GGT) and Alanine-Aminotransferase (ALAT).	0-4 sessions of 15 minutes

External Links

•   The 15-method material and educational videos (Danish version) for participating healthcare professionals
•   The iTAPP project website at The university of Southern Denmark (in Danish)