Identifying and Managing Alcohol-related Health Problems in General Practice

Study Overview
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Brief Summary
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The overall purpose of the proposed research is to increase patients' and general practitioners' (GPs') awareness of alcohol as a relevant factor for a wide variety of health problems in general practice, and enable earlier help and treatment. To achieve this, the investigators aim to test the feasibility of a pragmatic strategy for identification of alcohol-related health problems, and the feasibility of a web-based intervention between consultations, as a supplement to usual care in general practice.

Detailed Description
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Alcohol use is a major health problem, and there is a strong need for improved identification of and interventions for alcohol-related health problems. These constitute somatic and neuropsychiatric health problems, caused, precipitated, or complicated by alcohol use. The investigators will especially recruit patients in late adulthood (60+), as this group may experience more barriers with digital interventions, and will have more health problems potentially affected by alcohol. The investigators have developed the identification strategy and the interventions in close collaboration with key stakeholders: patients and health care professionals. The aim is to test the feasibility of interventions for hazardous (a quantity or pattern placing patients at risk for adverse health events) and harmful alcohol consumption (consumption resulting in adverse events), with two distinct components, namely pragmatic case finding and a digital self-administered intervention (called Endre) for use between consultations. The study will focus mainly on aspects related to acceptability, demand, implementation and practicality. The results from this feasibility study may give valuable knowledge on how this treatment approach should be adapted and implemented, and will indicate whether a full-scale RCT is warranted. This study is testing the feasibility of interventions intended to facilitate change for both patients (reduced alcohol consumption) and for physicians (improved addressing of alcohol and improved intervention delivery).

Official Title
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Testing the Feasibility of Pragmatic Case Finding and a Supplemental Digital Intervention for Alcohol-related Health Problems in General Practice

Conditions
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Alcohol-Related Disorders, Alcohol Problem, Alcohol Drug Interaction, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: 'Change' - an e-health intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered patient with participating clinic, accepting that alcohol may be relevant for his/her health problem and wanting to participate Exclusion Criteria: None, except age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study of a digital intervention supporting change in alcohol consumption for patients in general practice. The digital intervention is a supplement to usual care.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: 'Change' - an e-health intervention|The aim of the e-health intervention is to support the patient's change process and facilitate the doctor's ability to help. We plan for a web-application instead of a native application. A web-application enables use from mobile devices and from computers and is thus not dependent on a specific mode or system. Before including patients (postponed to September 2020 because of the Corona-virus pandemic), about 30 members of the general public have tested the e-health intervention.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients offered the web-based intervention |  | Three months from start date | 
| The number of patients completing baseline registration |  | Six months from start date | 
| The number of patients using the intervention for at least one week |  | Six months from start date | 
| The number of patients using the intervention for at least four weeks |  | Six months from start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes alcohol consumption (AUDIT-C) | Changes in weekly alcohol consumption and binge drinking between baseline and 3 months | Three months from completed baseline registration | 
| Changes in quality of life (RAND12) | Changes in quality of life between baseline and 3 months | Three months from completed baseline registration | 
| Changes in mental distress (SCL5) | Changes in mental distress between baseline and 3 months | Three months from completed baseline registration | 
| Changes in sleeping (Bergen Insomnia Scale) | Changes in sleeping between baseline and 3 months | Three months from completed baseline registration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General practice, Feasibility, Implementation