Identification and Treatment of Alcohol Problems in Primary Care

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Alcohol Abuse Alcoholism, General Practice, Screening and Brief Intervention

Intervention / Treatment
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* Behavioral: The 15-Method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Affiliated with the participating general practices Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped-wedge cluster randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Care, Screening, Alcohol Use Disorder