Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments

Study Overview
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Brief Summary
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This study aims to assess the effectiveness of chat-based intervention on reducing risky alcohol consumption to inform clinical practice for providing ABI to risky drinkers attending AED in Hong Kong.

Detailed Description
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Alcohol use is a major risk factor for non-communicable diseases and 6th leading cause of death and disability-adjusted life years. The prevalence of alcohol consumption has increased since 2008 after introduction of zero tax on alcohol with strength <30% (e.g., wine and beer) and due to promoting the city as Asia's wine hub. ABI reduced alcohol intake by about 20g/week at 12-month follow-up in primary healthcare populations. Given the relatively low prevalence of risky alcohol drinkers in Hong Kong, testing ABI in clinics may face difficulties in recruitment. Alcohol use is associated with problems such as injury and violence requiring accident and emergency department (AED) services, thus AEDs in Hong Kong are more feasible places to recruit subjects for delivering ABI. Primary hypothesis: The Intervention group has significantly larger reduction of weekly alcohol consumption compared with the Control group at 12-month follow-up Secondary hypotheses: Compared with the Control group, the Intervention group has lower AUDIT scores, fewer episodes of heavy/binge drinking, lower re-attendence at AED and reduced alcohol-related harms at 6-month and 12-month follow-up.

Official Title
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Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments: a Pragmatic Randomised Controlled Trial

Conditions
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Alcohol Misuse

Intervention / Treatment
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* Behavioral: Alcohol brief intervention
* Behavioral: 12-page health warning leaflet
* Behavioral: Regular messages through Instant Messaging (IM)
* Behavioral: Real-time chat-based support through IM Apps
* Behavioral: General health through IM Apps
* Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HK resident able to read/communicate in Cantonese/Putonghua. This may exclude potential subjects from other countries with higher alcohol consumption than local Chinese, but quality of the chat-based intervention is important for the research hypothesis, and it will not be feasible to recruit other language speakers (e.g., English) in the present study. Aged ≥18 with proficiency in using IM Apps (e.g., WhatsApp, WeChat). Those aged <18 are excluded as other studies suggest they have different patterns of alcohol drinking and reduction from adult drinkers. Exclusion Criteria: Those unable to understand or receive face-to-face ABI due to severe traumatic injury, unconscious, or drunk patients unable to follow commands Anticipated to be admitted to in-patient department for >1 week, which will interfere with the chat-based intervention Having psychiatric/psychological diseases or receiving regular psychotropic medication Participating in other alcohol reduction or abstinence programmes

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps | Behavioral: Alcohol brief intervention<br>* At baseline, subjects will receive face-to-face or online alcohol brief intervention developed based on the guideline by the World Health Organisation in 5-10 minutes<br>Behavioral: 12-page health warning leaflet<br>* Nurses will provide information about the consequences of drinking using a 12-page health warning booklet. Benefits of reducing and quit drinking will be emphasized by focusing on improving their perception towards the impacts on health, social problems, risky behaviors, academic performance and financial issues.<br>Behavioral: Regular messages through Instant Messaging (IM)<br>* A total of 26 e-messages will be scheduled: once daily for the first week, 3 time/week for subsequent 4 weeks and 1 time/week for the remaining 7 weeks. The frequency will be adjusted according to IM Apps conversation and subject's requests.<br>Behavioral: Real-time chat-based support through IM Apps<br>* The chat-based IM support is the extension of baseline ABI and regular e-messages, which aims to provide real-time behavioral and psychosocial support to reduce or quit drinking. It will be personalized according to the subjects' characteristics (gender, drinking pattern and alcoholic drinks preferences), intention to drink and specific questions regarding drinking. Through real-time chatting (text and/or voice), drinkers can acquire information on consequences of drinking and gain social support immediately to reduce intention to drink and alcohol consumption.<br>Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong<br>* a diagram explaining drinking behaviour and potential health risks, definitions of alcohol unit and binge drinking, and advise on limiting daily drinking to 2 alcohol units for men and 1 unit for women<br>|
| Active Comparator: control group<br>Alcohol brief intervention, leaflets, regular messages on general health through IM Apps | Behavioral: Alcohol brief intervention<br>* At baseline, subjects will receive face-to-face or online alcohol brief intervention developed based on the guideline by the World Health Organisation in 5-10 minutes<br>Behavioral: 12-page health warning leaflet<br>* Nurses will provide information about the consequences of drinking using a 12-page health warning booklet. Benefits of reducing and quit drinking will be emphasized by focusing on improving their perception towards the impacts on health, social problems, risky behaviors, academic performance and financial issues.<br>Behavioral: General health through IM Apps<br>* After baseline, they will receive regular e-message through IM Apps with similar frequency to Intervention group with content on general health and the reminding the importance of participating in the follow-up surveys.<br>Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong<br>* a diagram explaining drinking behaviour and potential health risks, definitions of alcohol unit and binge drinking, and advise on limiting daily drinking to 2 alcohol units for men and 1 unit for women<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of alcohol consumption per week (gram/week) at 12-month follow-up | Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 12-month after baseline. | 12-month after baseline | 
| Compare the primary outcome using intention-to-treat (ITT), per-protocol (PP) and as-treated (AP) analysis with Compliance Average Causal Effect (CACE) analysis | To estimate large, moderate and null (same as the control) treatment effects and check whether ITT, AP and PP analysis estimates are biased compared with CACE estimates (alcohol consumption per week at 6-month follow-up) | 6-month after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of alcohol consumption per week (gram/week) at 6-month follow-up | Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 6-month after baseline. | 6-month after baseline | 
| AUDIT scores at 6-month follow-up | Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use) and compare the AUDIT between intervention and control group at 6-month after baseline. | 6-month after baseline | 
| AUDIT scores at 12-month follow-up | Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use) and compare the AUDIT between intervention and control group at 12-month after baseline. | 12-month after baseline | 
| Number of standard drinks (10g of alcohol) per week at 6-month follow-up | Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 6-month | 6-month after baseline | 
| Number of standard drinks (10g of alcohol) per week at 12-month follow-up | Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 12-month | 12-month after baseline | 
| Episode of binge drinking in the past 30-day at 6-month follow up | Defined by 5 standard drink [male] or 4 standard drink [female] in one occasion for binge drinking and compare the episode of binge drinking between intervention group and control at baseline and 6-month follow-up questionnaires | at 6-month after baseline | 
| Episode of binge drinking in the past 30-day at 12-month follow up | Defined by 5 standard drink [male] or 4 standard drink [female] in one occasion for binge drinking and compare the episode of binge drinking between intervention group and control at baseline and 12-month follow-up questionnaires | at 12-month after baseline | 
| Episode of heavy drinking in the past 30-day at 6-month follow up | Defined by 15 standard drink [male] or 8 standard drink[female] in a week for heavy drinking and compare the episode of heavy drinking between intervention group and control at baseline and 6-month follow-up questionnaires | at 6 -month after baseline | 
| Episode of heavy drinking in the past 30-day at 12-month follow up | Defined by 15 standard drink [male] or 8 standard drink [female] in a week for heavy drinking and compare the episode of heavy drinking between intervention group and control at baseline and 12-month follow-up questionnaires | at 12-month after baseline | 
| Planned drinking measured in the coming 30-day at 6-month follow up | Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 6-month follow-up questionnaires | at 6-month after baseline | 
| Planned drinking measured in the coming 30-day at 12-month follow up | Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 12-month follow-up questionnaires | at 12-month after baseline | 
| Alcohol Problems Scale at 6-month follow-up | The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires | at 6-month after baseline | 
| Alcohol Problems Scale at 12-month follow-up | The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires | at 12- month after baseline | 
| Subgroup analysis of baseline intention to quit/reduce drinking | Subgroup analysis to check whether the intervention is more effective with participants with intention to quit/reduce drinking on outcomes | at 12- month after baseline | 
| Content analysis of IM Apps conversation using alcohol BCT taxonomy | The conversations between the participants and the nurse will be analyzed and categorized into different sub-type of BCT taxonomy | at 12- month after baseline | 
| Patient Health Questionnaire 4-item (PHQ-4) at 6-month | Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires | at 6-month after baseline | 
| Patient Health Questionnaire 4-item (PHQ-4) at 12-month | Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires | at 12-month after baseline | 
| Perceived Stress Scale 4-item (PSS-4) at 6-month | Subjects' responses are measured on a five-point scale (0 = never, 1 = almost never, 2 =sometimes, 3 = fairly often, 4 = very often). Scoring: PSS-4 scores are obtained by summing across all four items. Scoring items 2 and 3 require reverse coding. This involves assigning the opposite score. For example, a score of 0=4, 1=3, 2=2, 3=1, and 4=0. The higher the score, the more perceived stress. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires | at 6-month after baseline | 
| Perceived Stress Scale 4-item (PSS-4) at 12-month | Subjects' responses are measured on a five-point scale (0 = never, 1 = almost never, 2 =sometimes, 3 = fairly often, 4 = very often). Scoring: PSS-4 scores are obtained by summing across all four items. Scoring items 2 and 3 require reverse coding. This involves assigning the opposite score. For example, a score of 0=4, 1=3, 2=2, 3=1, and 4=0. The higher the score, the more perceived stress. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires | at 12-month after baseline | 
| Perceived usefulness of IM app intervention at 12-month | Score ranges from 0 to 10 with higher score indicates a higher level of usefulness of our intervention. | at 12-month after baseline | 
| Intention to continue using IM app intervention at 12-month | Ask for intention to use (yes/no) IM app intervention to reduce/quit drinking at 12-month | at 12-month after baseline | 
| Self-efficacy to reduce/quit drinking at 6-month | Perceived difficulty, confidence and importance of quitting/reducing to drink will be asked. Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires | at 6-month after baseline | 
| Self-efficacy to reduce/quit drinking at 12-month | Perceived difficulty, confidence and importance of quitting/reducing to drink will be asked. Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires | at 12-month after baseline | 
| Re-attendance of AED at 6-month | Ask for attendance of AED (yes/no) in the past 3-month at 6-month | at 6-month after baseline | 
| Re-attendance of AED at 12-month | Ask for attendance of AED (yes/no) in the past 3-month at 12-month | at 12-month after baseline | 
| Health status of participants at 6-month | Measured by EQ-5D-5L. Comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION), each dimension has five response levels:no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The participant is asked to indicate his/her health state by checking the box next to the most appropriate response level. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. Extreme problem is coded as 5, severe problem is coded as 4, moderate is coded as 3, slight problem is coded as 2 and no problem is coded as 1. | at 6-month after baseline | 
| Health status of participants at 12-month | Measured by EQ-5D-5L. Comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION), each dimension has five response levels:no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The participant is asked to indicate his/her health state by checking the box next to the most appropriate response level. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. Extreme problem is coded as 5, severe problem is coded as 4, moderate is coded as 3, slight problem is coded as 2 and no problem is coded as 1. | at 12-month after baseline | 
| Current health of participants at 6-month | Measured by EQ VAS. Participant is asked to rate his/her health on a vertical visual analogue scale. The scale is numbered from 0-100.100 means the best health, 0 is the worst. Participant will put a cross on the scale to indicate his/her current health. | at 6-month after baseline | 
| Current health of participants at 12-month | Measured by EQ VAS. Participant is asked to rate his/her health on a vertical visual analogue scale. The scale is numbered from 0-100.100 means the best health, 0 is the worst. Participant will put a cross on the scale to indicate his/her current health. | at 12-month after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chat-based IM, AED, Alcohol brief intervention, AUDIT