iTAPP: Identification and Treatment of Alcohol Problems in Primary Care

Sponsor

University of Southern Denmark (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05916027

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Abuse Alcoholism General Practice Screening and Brief Intervention	Behavioral: The 15-Method	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Stepped-wedge cluster randomized controlled trial.Stepped-wedge cluster randomized controlled trial.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Frequency of alcohol related conversations in the clinics [Up to 19 months]
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

Secondary Outcome Measures

Percentage of patients who exceed the Danish national recommendations of alcohol consumption [4 times of 10 minutes]
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
Quality of Life 5D-5L scores [4 times of 10 minutes]
Data: Survey Level: population Variable: Quality of life score by The World Health Organization 5D-5L questionnaire.
Pharmacological Treatment [0-4 sessions of 15 minutes]
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
Use of blood sampling [0-4 sessions of 15 minutes]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years or older
Affiliated with the participating general practices

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark	Odense C	Fynen	Denmark	5000

Sponsors and Collaborators

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