Identification and Treatment of Alcohol Problems in Primary Care (iTAPP)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: General Practice; Alcohol Abuse Alcoholism; Screening and Brief Intervention
• Intervention / Treatment: Behavioral: The 15-Method

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Fynen
    • Odense C, Fynen, Denmark, 5000
      • Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years or older
• Affiliated with the participating general practices

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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 Comparator: Active; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Study Director: Anette S Nielsen, Professor, Unit of Clinical Alcohol Research, University of Southern Denmark; Principal Investigator: Jens Søgaard, Professor, Research Unit of General Practice Odense, University of Southern Denmark

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Primary Care; Screening; Alcohol Use Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Alcoholism; Alcohol-Related Disorders
• Other Study ID Numbers: iTAPP project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No