Table 2 Trial measures
Data collected | Method | |
|---|---|---|
Screening measures | Demographic information Structured questions | Standard demographic characteristics (e.g. age, gender, education level) |
Problem alcohol use AUDIT | Assessed by the Alcohol Use Disorders Identification Test (AUDIT) [33]. A score of > 6 for women and > 7 for men warrants inclusion in the study | |
Severity of alcohol dependence SADQ-C | Assessed by the Severity of Alcohol Dependence Questionnaire (SADQ-C) [54]. A score of 31 or higher indicates “severe alcohol dependence” and warrants exclusion from the study | |
Presence/severity of suicidal thoughts SIDAS | Assessed by the Suicidal Ideation Attributes Scale (SIDAS) [55]. A score of 21+ indicates high risk of suicidal behaviour and warrants exclusion from the study | |
Other inclusion/exclusion Structured questions | Structured questions querying self-reported information pertaining to the study’s inclusion/exclusion criteria (e.g. history of psychosis) | |
Outcome measures | ||
Primary outcome | Alcohol problem severity AUDIT | The primary outcome is alcohol problem severity at 3 months, assessed by the AUDIT. The time frame has been adapted to cover month prior to assessment (rather than year), so that planned follow-up assessments at 3, 6 and 12 months can be performed. Five short items from the recent Australian Institute of Health and Welfare (AIHW) National Drug Strategy Household Survey have been included to provide additional information on self-reported change in alcohol use and alcohol literacy |
Secondary outcomes | Alcohol use patterns TLFB | Past-month (30 days) alcohol consumption and heavy drinking days, assessed by the Alcohol Timeline Follow-back (TLFB) [35]. Heavy drinking days are measured as > 40/60 g of alcohol (4/6 standard drinks) |
Substance use AOD Self-Completion Form | Assessed using items from the Victorian Department of Health and Human Services (DHHS) Victorian AOD Self-Completion Form [56], recording recent use of other drugs and frequency of use in the past 28 days | |
Psychological distress K10 | Assessed by the Kessler Psychological Distress Scale (K10) [36] | |
Quality of life EUROHIS-QOL 8-item index AQoL-6D | Assessed by the EUROHIS-QOL 8-item index [37, 57] and Assessment of Quality of Life (AQoL-6D) [38] | |
Cost effectiveness AQoL-6D WHO HPQ Health-care Resource Use Questionnaire | The incremental cost of treatment will be compared to the incremental benefits of treatment in terms of the primary outcomes and the difference in quality-adjusted life years (QALYs; assessed by the AQoL-6D). Work performance and productivity will be assessed by items from the WHO Health and Work Performance Questionnaire short form (WHO HPQ) [40]. Healthcare resource use is assessed using items from the 3Mg trial’s Health-care Resource Use Questionnaire [41] | |
Adverse events Structured questions | During baseline, scheduled intervention/control calls, and follow-up calls, participants will be asked general questions: “Have you had any health concerns recently (baseline)/since the last time you had telephone contact for this study?”, “Have you felt unwell or different since the last time you had telephone contact for this study?” and “Do you have any specific worries or complaints about your health in general?”, as well as more specific questions: “Has your alcohol use changed?” and “Has your mood changed?” | |
Additional measures/participant feedback | Barriers to help-seeking Structured questions | Perceived barriers to treatment-seeking for alcohol problems will be identified through an open-ended question (“What are the reasons that you have not sought treatment for your alcohol use in the past?”) and from a list of 15 barriers (e.g. financial, stigma, readiness for change) developed by Schuler et al. [58] |
Treatment participation and satisfaction CEST TCU ENG | Assessed by the Client Evaluation of Self and Treatment (CEST) short form (TCU ENG) [39] (approximately 20% of the R2C intervention group) | |
Qualitative feedback Structured questions | Questions asked will include: “Which parts, if any, of the telephone intervention sessions were most helpful to you? How were these most helpful?” and “What did you think about the delivery, format and duration of the telephone intervention sessions?” (approximately 20% of the R2C intervention group) | |
Additional treatment enquiry Structured questions | Engagement in any additional treatment (e.g. inpatient/outpatient treatment) or mutual aid group attendance (AA, SMART Recovery) will be queried and recorded for all participants (exclusion criterion at screening only) | |