Dataset Information

A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments.

ABSTRACT: OBJECTIVE:This study piloted procedures and obtained data on intervention acceptability to determine the feasibility of a definitive randomised controlled trial (RCT) of the effectiveness of a computer-based brief intervention in the emergency department (ED). DESIGN:Two-arm, multi-site, pilot RCT. SETTING AND PARTICIPANTS:Adolescents aged 12-17 years presenting to three Canadian pediatric EDs from July 2010 to January 2013 for an alcohol-related complaint. INTERVENTIONS:Standard medical care plus computer-based screening and personalised assessment feedback (experimental group) or standard care plus computer-based sham (control group). ED and research staff, and adolescents were blinded to allocation. OUTCOMES:Main: change in alcohol consumption from baseline to 1- and 3?months post-intervention. Secondary: recruitment and retention rates, intervention acceptability and feasibility, perception of group allocation among ED and research staff, and change in health and social services utilisation. RESULTS:Of the 340 adolescents screened, 117 adolescents were eligible and 44 participated in the study (37.6% recruitment rate). Adolescents allocated to the intervention found it easy, quick and informative, but were divided on the credibility of the feedback provided (agreed it was credible: 44.4%, disagreed: 16.7%, unsure: 16.7%, no response: 22.2%). We found no evidence of a statistically significant relationship between which interventions adolescents were allocated to and which interventions staff thought they received. Alcohol consumption, and health and social services data were largely incomplete due to modest study retention rates of 47.7% and 40.9% at 1- and 3?months post-intervention, respectively. CONCLUSIONS:A computer-based intervention was acceptable to adolescents and delivery was feasible in the ED in terms of time to use and ease of use. However, adjustments are needed to the intervention to improve its credibility. A definitive RCT will be feasible if protocol adjustments are made to improve recruitment and retention rates; and increase the number of study sites and research staff. TRIAL REGISTRATION:clinicaltrials.gov NCT01146665.

SUBMITTER: Newton AS

PROVIDER: S-EPMC5724197 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments.

Newton Amanda S AS Dow Nadia N Dong Kathryn K Fitzpatrick Eleanor E Cameron Wild T T Johnson David W DW Ali Samina S Colman Ian I Rosychuk Rhonda J RJ

BMJ open 20170811 8

<h4>Objective</h4>This study piloted procedures and obtained data on intervention acceptability to determine the feasibility of a definitive randomised controlled trial (RCT) of the effectiveness of a computer-based brief intervention in the emergency department (ED).<h4>Design</h4>Two-arm, multi-site, pilot RCT.<h4>Setting and participants</h4>Adolescents aged 12-17 years presenting to three Canadian pediatric EDs from July 2010 to January 2013 for an alcohol-related complaint.<h4>Interventions ...[more]

PMID: 28801399

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Project description:BackgroundRisky driving and hazardous drinking are associated with significant human and economic costs. Brief interventions for more than one risky behavior have the potential to reduce health-compromising behaviors in populations with multiple risk-taking behaviors such as young adults. Emergency department (ED) visits provide a window of opportunity for interventions meant to reduce both risky driving and hazardous drinking.MethodsWe determined the efficacy of a Screening, Brief Intervention, and Referral to Treatment (SBIRT) protocol addressing risky driving and hazardous drinking. We used a randomized controlled trial design with follow-ups through 12 months. ED patients aged 18 to 44 who screened positive for both behaviors (n = 476) were randomized to brief intervention (BIG), contact control (CCG), or no-contact control (NCG) groups. The BIG (n = 150) received a 20-minute assessment and two 20-minute interventions. The CCG (n = 162) received a 20-minute assessment at baseline and no intervention. The NCG (n = 164) were asked for contact information at baseline and had no assessment or intervention. Outcomes at 3, 6, 9, and 12 months were self-reported driving behaviors and alcohol consumption.ResultsOutcomes were significantly lower in BIG compared with CCG through 6 or 9 months, but not at 12 months: Safety belt use at 3 months (adjusted odds ratio [AOR], 0.22; 95% confidence interval [CI], 0.08 to 0.65); 6 months (AOR, 0.13; 95% CI, 0.04 to 0.42); and 9 months (AOR, 0.18; 95% CI, 0.06 to 0.56); binge drinking at 3 months (adjusted rate ratio [ARR] 0.84; 95% CI, 0.74 to 0.97) and 6 months (ARR, 0.81; 95% CI, 0.67 to 0.97); and ≥5 standard drinks/d at 3 months (AOR, 0.43; 95% CI, 0.20 to 0.91) and 6 months (AOR, 0.41; 95% CI, 0.17 to 0.98). No substantial differences were observed between BIG and NCG at 12 months.ConclusionsOur findings indicate that SBIRT reduced risky driving and hazardous drinking in young adults, but its effects did not persist after 9 months. Future research should explore methods for extending the intervention effect.

Project description:Study objectiveBrief interventions have been shown to reduce alcohol use and improve outcomes in hazardous and harmful drinkers, but evidence to support their use in emergency department (ED) patients is limited. The use of research assessments in studies of brief interventions may contribute to uncertainty about their effectiveness. Therefore we seek to determine (1) if an emergency practitioner-performed Brief Negotiation Interview or a Brief Negotiation Interview with a booster reduces alcohol consumption compared with standard care; and (2) the impact of research assessments on drinking outcomes using a standard care-no-assessment group.MethodsWe randomized 889 adult ED patients with hazardous and harmful drinking. A total of 740 received an emergency practitioner-performed Brief Negotiation Interview (n=297), a Brief Negotiation Interview with a 1-month follow-up telephone booster (Brief Negotiation Interview with booster) (n=295), or standard care (n=148). We also included a standard care with no assessments (n=149) group to examine the effect of assessments on drinking outcomes. Primary outcomes analyzed with mixed-models procedures included past 7-day alcohol consumption and 28-day binge episodes at 6 and 12 months, collected by interactive voice response. Secondary outcomes included negative health behaviors and consequences collected by telephone surveys.ResultsThe reduction in mean number of drinks in the past 7 days from baseline to 6 and 12 months was significantly greater in the Brief Negotiation Interview with booster (from 20.4 [95% confidence interval {CI} 18.8 to 22.0] to 11.6 [95% CI 9.7 to 13.5] to 13.0 [95% CI 10.5 to 15.5]) and Brief Negotiation Interview (from 19.8 [95% CI 18.3 to 21.4] to 12.7 [95% CI 10.8 to 14.6] to 14.3 [95% CI 11.9 to 16.8]) than in standard care (from 20.9 [95% CI 18.7 to 23.2] to 14.2 [95% CI 11.2 to 17.1] to 17.6 [95% CI 14.1 to 21.2]). The reduction in 28-day binge episodes was also greater in the Brief Negotiation Interview with booster (from 7.5 [95% CI 6.8 to 8.2] to 4.4 [95% CI 3.6 to 5.2] to 4.7 [95% CI 3.9 to 5.6]) and Brief Negotiation Interview (from 7.2 [95% CI 6.5 to 7.9] to 4.8 [95% CI 4.0 to 5.6] to 5.1 [95% CI 4.2 to 5.9]) than in standard care (from 7.2 [95% CI 6.2 to 8.2] to 5.7 [95% CI 4.5 to 6.9] to 5.8 [95% CI 4.6 to 7.0]). The Brief Negotiation Interview with booster offered no significant benefit over the Brief Negotiation Interview alone. There were no differences in drinking outcomes between the standard care and standard care-no assessment groups. The reductions in rates of driving after drinking more than 3 drinks from baseline to 12 months were greater in the Brief Negotiation Interview (38% to 29%) and Brief Negotiation Interview with booster (39% to 31%) groups than in the standard care group (43% to 42%).ConclusionEmergency practitioner-performed brief interventions can reduce alcohol consumption and episodes of driving after drinking in hazardous and harmful drinkers. These results support the use of brief interventions in ED settings.

Project description:BACKGROUND: Brief interventions (BIs) have been shown to be effective in modifying hazardous drinking behaviours in a range of settings. However, they are underutilised in hospitals due to resource constraints. We explored the perspectives of admitted trauma patients about the appeal, acceptability and content of a Brief Intervention (BI) delivered via text messages. METHODS: Thirty mobile phone users (≥16 years old) admitted to Auckland City Hospital as a result of injury were recruited (December 2010 - January 2011). Participants were interviewed face-to-face during their hospital stay using a semi-structured interview guide that explored topics including perceptions of the proposed intervention to reduce hazardous drinking and related harm, and perceived acceptability of an m-health program. Where issues relating to content of messages were raised by participants these were also captured. In addition, a brief survey captured information on demographic information, mobile phone usage and type of phone, along with the frequency of alcohol use. RESULTS: 22 of the 30 participants were male, and almost half were aged 20 to 39 years. The majority of participants identified as New Zealand Europeans, six as Māori (New Zealand's indigenous population) and of the remainder two each identified as Pacific and of Asian ethnicity. Most (28/30) participants used a mobile phone daily. 18 participants were deemed to be drinking in a non-hazardous manner, seven were hazardous drinkers, and three were non-drinkers. Most participants (21/30) indicated that text messages could be effective in reducing hazardous drinking and related harms, with more than half (17/30) signalling they would sign-up. Factors identified that would increase receptiveness included: awareness that the intervention was evidence-based; participants readiness-to-change; informative messages that include the consequences of drinking and practical advice; non-judgemental messages; and ease-of-use. Areas of potential concern included: confidentiality and frequency of messages. The cultural relevance of the messages for Māori was highlighted as important. CONCLUSIONS: This study indicates that trauma patients recognize potential benefits of mobile-health interventions designed to reduce hazardous drinking. The feedback provided will inform the development of an intervention to be evaluated in a randomised controlled trial.

Project description:BackgroundThe harmful use of alcohol is a causal factor in more than 200 disease and injury conditions and leads to over 3 million deaths every year worldwide. Relatively few problem alcohol users access treatment due to stigma and lack of services. Alcohol-specific digital health interventions (DHI) may help them, but trial data comparing DHI with face-to-face treatment are lacking.MethodsWe conducted a feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2015 for 12 months. Participants were adults, drinking at hazardous and harmful levels, recruited from hospital emergency departments (ED) in London or recruited online. Participants were randomised to HeLP-Alcohol, a six module DHI with weekly reminder prompts (phone, email or text message), or to face-to-face treatment as usual (TAU). Participants were invited to take part in qualitative interviews after the trial.ResultsThe trial website was accessed 1074 times: 420 people completed online eligibility questionnaires; 350 did not meet eligibility criteria, 51 declined to participate, and 19 were recruited and randomised. Follow-up data were collected from three participants (retention 3/19), and four agreed to be interviewed for the process evaluation. The main themes of the interviews were:Participants were not at equipoise. They wanted to try the website and were disappointed to be randomised to face-to-face, so they were less engaged and dropped out.Other reasons for drop out included not accepting that they had a drink problem; problem drinking interfering with their ability to take part in a trial or forgetting appointments; having a busy life and being randomised to TAU made it difficult to attend appointments.ConclusionsThis feasibility RCT aimed to test recruitment, randomisation, retention, and data collection methods, but recruited only 19 participants. This illustrates the importance of undertaking feasibility studies prior to fully powered RCTs. From the qualitative interviews we found that potential recruits were not at equipoise for recruitment. An alternative methodology, for example a preference RCT recruiting from multiple locations, needs to be explored in future trials.Trial registrationInternational Standard Randomized Controlled Trial Number: ISRCTN31789096.

Project description:BackgroundEngagement with digital behavior change interventions (DBCIs) is considered a prerequisite for intervention efficacy. However, in many trials on DBCIs, participants use the intervention either only little or not at all.ObjectiveTo analyze engagement with a web-based intervention to reduce harmful drinking, we explored (1) whether engagement with a web-based alcohol intervention is related to drinking outcomes, (2) which user characteristics are associated with measures of engagement, and (3) whether reported outcomes are associated with data captured by voluntary intervention questionnaires.MethodsWe analyzed data of the intervention arm of a randomized controlled trial on a DBCI to reduce risky alcohol consumption. Data were collected at baseline (T0), after 90 days (T1), and at the end of the 180-day usage period (T2). Engagement with the intervention was measured via system usage data as well as self-reported usage. Drinking behavior was measured as average daily alcohol consumption as well as the number of binge drinking days. User characteristics included demographics, baseline drinking behavior, readiness to change, alcohol-related outcome expectancies, and alcohol abstinence self-efficacy. Following a bivariate approach, we performed two-tailed Welch's t tests and Wilcoxon signed rank/Mann-Whitney U tests or calculated correlation coefficients.ResultsThe data of 306 users were analyzed. Time spent engaging with the intervention as measured by system usage did not match self-reported usage. Higher self-reported usage was associated with higher reductions in average daily alcohol consumption (T1: ρ=0.39, P<.001; T2: ρ=0.29, P=.015) and in binge drinking days (T1: ρ=0.62, P<.001; T2: ρ=0.3, P=.006). Higher usage was reported from users who were single (T1: P<.001; T2: P<.001), users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1: P=.001; T2: P=.004). Relationships between self-reported usage and clinical or psychological baseline characteristics were complex. For system usage, the findings were mixed. Reductions in drinking captured by intervention questionnaires were associated with reported outcomes.ConclusionsThough self-reported usage could be consistently linked to better outcomes and multiple user characteristics, our findings add to the overall inconclusive evidence that can be found throughout the literature. Our findings indicate potential benefits of self-reports as measures of engagement and intervention questionnaires as a basis for tailoring of intervention content. Future studies should adopt a theory-driven approach to engagement research utilizing psychometrically sound self-report questionnaires and include short ecological momentary assessments within the DBCIs.Trial registrationGerman Clinical Trials Register DRKS00006104; https://tinyurl.com/y22oc5jo.

Project description:AimsDue to the stressful nature of policing, police employees are at risk of mental health problems and problematic alcohol use. We aim to determine the prevalence of hazardous and harmful alcohol use in the UK Police Service, and to explore the associations with job strain and mental health problems.MethodsCross-sectional data from the Airwave Health Monitoring Study (N = 40 986) included measures of alcohol consumption (total units in past week), mental health (depression, anxiety and post-traumatic stress disorder [PTSD]) and job strain. The associations between mental health and job strain with alcohol consumption (i.e. abstinence, low-risk [<14 units per week, reference group], hazardous [>14 to 35 units for women, >14 to 50 units for men], harmful [>35 units for women, >50 units for men]), were analysed using multinomial logistic regressions, adjusting for potential confounders (i.e. age, gender, ethnicity, marital status, children under 18, income and smoking status).ResultsA total of 32.6% of police employees reported hazardous drinking, with 3.0% drinking at harmful levels. Compared to those without a mental health problem, police employees with depression, anxiety or PTSD were twice as likely to be harmful drinkers and were also 1.3 times more likely to report abstinence. Those reporting low strain (reference group) were more likely to drink hazardously compared to those reporting high strain, which was statistically moderated by mental health. When the sample was stratified by mental health status, the association between low strain (compared to all other categories) and hazardous drinking, was significant only in those without a mental health problem.ConclusionsThese findings indicate that police employees may be an occupational group at risk of alcohol harm, with one-third drinking hazardously. The J-shaped relationship between mental health and alcohol use highlights a need for an integration of mental health and alcohol services, tailored for the UK Police Service.

Project description:BackgroundGiven the scarcity of alcohol prevention and use disorder treatments in many low- and middle-income countries (LMICs), the World Health Organization has launched an eHealth portal that includes the web-based self-help program "Alcohol e-Health."ObjectiveWe aimed to test the effectiveness of the Alcohol e-Health program in a randomized controlled trial.MethodsThis was a two-arm, individually randomized, and controlled trial across four LMICs comparing the self-help program and a psychoeducation and internet access as usual waiting list. Participants were broadly recruited from community samples in Belarus, Brazil, India, and Mexico from January 2016 through January 2019. The primary outcome measure was change in the Alcohol Use Disorders Identification Test (AUDIT) score with a time frame of 6 months between baseline and follow-up. Secondary outcomes included self-reported numbers of standard drinks over the previous week and cessation of harmful or hazardous drinking (AUDIT score <8).ResultsFor this study, we recruited 1400 predominantly male (n=982, 70.1%) at least harmful or hazardous alcohol drinkers. The mean age was 37.6 years (SD 10.5). The participants were recruited from Brazil (n=587), Mexico (n=509), India (n=212), and Belarus (n=92). Overall, complete case analysis identified higher AUDIT changes in the intervention group (B=-4.18, 95% CI -5.42 to -2.93, P<.001, d=0.56) that were mirrored by changes in weekly standard drinks (B=-9.34, 95% CI -15.90 to -2.77, P=.005, d=0.28) and cessation rates for harmful or hazardous drinking (χ21=14.56, N=561, P<.001). The supplementary intention-to-treat analyses largely confirmed these initial results.ConclusionsThe expansion of the Alcohol e-Health program to other LMICs with underdeveloped alcohol prevention and treatment systems for alcohol use disorders should be considered after successful replication of the present results.Trial registrationISRCTN ISRCTN14037475; https://www.isrctn.com/ISRCTN14037475.International registered report identifier (irrid)RR2-10.1111/add.14034.

Dataset Information

A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments.

Publications

A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments.

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