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

Primary Purpose

Alcohol Abuse Alcoholism, General Practice, Screening and Brief Intervention

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
The 15-Method
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Alcohol Abuse Alcoholism focused on measuring Primary Care, Screening, Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Active

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Quality of Life 5D-5L scores
Data: Survey Level: population Variable: Quality of life score by The World Health Organization 5D-5L questionnaire.
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
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).

Full Information

First Posted
October 5, 2022
Last Updated
June 22, 2023
Sponsor
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05916027
Brief Title
Identification and Treatment of Alcohol Problems in Primary Care
Acronym
iTAPP
Official Title
iTAPP Study - Identification and Treatment of Alcohol Problems in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
Detailed Description
The study protocol with a detailed description of the iTAPP Study is in preparation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse Alcoholism, General Practice, Screening and Brief Intervention
Keywords
Primary Care, Screening, Alcohol Use Disorder

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped-wedge cluster randomized controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Active
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The 15-Method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of alcohol related conversations in the clinics
Description
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
Time Frame
Up to 19 months
Secondary Outcome Measure Information:
Title
Percentage of patients who exceed the Danish national recommendations of alcohol consumption
Description
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
Time Frame
4 times of 10 minutes
Title
Quality of Life 5D-5L scores
Description
Data: Survey Level: population Variable: Quality of life score by The World Health Organization 5D-5L questionnaire.
Time Frame
4 times of 10 minutes
Title
Pharmacological Treatment
Description
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
Time Frame
0-4 sessions of 15 minutes
Title
Use of blood sampling
Description
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).
Time Frame
0-4 sessions of 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older Affiliated with the participating general practices Exclusion Criteria: - None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anette S Nielsen, Professor
Organizational Affiliation
Unit of Clinical Alcohol Research, University of Southern Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jens Søgaard, Professor
Organizational Affiliation
Research Unit of General Practice Odense, University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit for Clinical Alcohol Research, Clinical Institute, University of Southern Denmark
City
Odense C
State/Province
Fynen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35227207
Citation
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.
Results Reference
result
Links:
URL
http://www.sdu.dk/itapp-study
Description
The iTAPP project website at The university of Southern Denmark (in Danish)
URL
http://www.sdu.dk/15-metoden
Description
The 15-method material and educational videos (Danish version) for participating healthcare professionals

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Identification and Treatment of Alcohol Problems in Primary Care

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