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Project QUIT (Quit Using Drugs Intervention Trial): a randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use.

ABSTRACT: To assess the effect of a multi-component primary care delivered brief intervention for reducing risky psychoactive drug use (RDU) among patients identified by screening.Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated.Primary care waiting rooms of five federally qualified health centers in Los Angeles County (LAC), USA.A total of 334 adult primary care patients (171 intervention; 163 control) with RDU scores (4-26) on the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) self-administered on tablet computers. 261 (78%) completed follow-up. Mean age was 41.7?years; 62.9% were male; 37.7% were Caucasian.Intervention patients received brief (typically 3-4 minutes) clinician advice to quit/reduce their drug use reinforced by a video doctor message, health education booklet and up to two 20-30-minute follow-up telephone drug use coaching sessions. Controls received usual care and cancer screening information. Primary outcome was patient self-reported use of highest scoring drug (HSD) at follow-up.Intervention and control patients reported equivalent baseline HSD use at 3-month follow-up. After adjustment for covariates, in the complete sample linear regression model, intervention patients used their HSD on 3.5 fewer days in the previous month relative to controls (P<0.001), and in the completed sample model, intervention patients used their HSD 2.2 fewer days than controls (P?

SUBMITTER: Gelberg L

PROVIDER: S-EPMC4948983 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Project QUIT (Quit Using Drugs Intervention Trial): a randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use.

Gelberg Lillian L Andersen Ronald M RM Afifi Abdelmonem A AA Leake Barbara D BD Arangua Lisa L Vahidi Mani M Singleton Kyle K Yacenda-Murphy Julia J Shoptaw Steve S Fleming Michael F MF Baumeister Sebastian E SE

Addiction (Abingdon, England) 20151101 11

<h4>Aims</h4>To assess the effect of a multi-component primary care delivered brief intervention for reducing risky psychoactive drug use (RDU) among patients identified by screening.<h4>Design</h4>Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated.<h4>Setting</h4>Primary care waiting rooms of five federally qualified health centers in Los ...[more]

PMID: 26471159

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Project description:BackgroundRisky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK.?This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care.MethodsThe trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n?=?31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants' views on instruments and procedures will be sought to confirm their acceptability.DiscussionThe study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.Trial registrationCurrent Controlled Trials ISRCTN43218782.

Project description:BACKGROUND:QUIT is the only primary care-based brief intervention that has previously shown efficacy for reducing risky drug use in the United States (Gelberg et al., 2015). This pilot study replicated the QUIT protocol in one of the five original QUIT clinics primarily serving Latinos. DESIGN:Single-blind, two-arm, randomized controlled trial of patients enrolled from March-October 2013 with 3-month follow-up. SETTING:Primary care waiting room of a federally qualified health center (FQHC) in East Los Angeles. PARTICIPANTS:Adult patients with risky drug use (4-26 on the computerized WHO ASSIST): 65 patients (32 intervention, 33 control); 51 (78%) completed follow-up; mean age 30.8 years; 59% male; 94% Latino. INTERVENTIONS AND MEASURES:Intervention patients received: 1) brief (typically 3-4?minutes) clinician advice to quit/reduce their risky drug use, 2) video doctor message reinforcing the clinician's advice, 3) health education booklet, and 4) up to two 20-30?minute follow-up telephone drug use reduction coaching sessions. Control patients received usual care and cancer screening information. Primary outcome was reduction in number of days of drug use in past 30days of the highest scoring drug (HSD) on the baseline ASSIST, from baseline to 3-month follow-up. RESULTS:Controls reported unchanged HSD use between baseline and 3-month follow-up whereas Intervention patients reported reducing their use by 40% (p<0.001). In an intent-to-treat linear regression analysis, intervention patients reduced past month HSD use by 4.5 more days than controls (p<0.042, 95% CI: 0.2, 8.7). Similar significant results were found using a complete sample regression analysis: 5.2 days (p<0.03, 95% CI: 0.5, 9.9). Additionally, on logistic regression analysis of test results from 47 urine samples at follow-up, intervention patients were less likely than controls to test HSD positive (p<0.05; OR: 0.10, 95% CI: 0.01, 0.99). CONCLUSIONS:Findings support the efficacy of the QUIT brief intervention for reducing risky drug use.

Project description:Risky 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.We 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.Outcomes 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.Our 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:Background and aims Given the widespread use of cannabis, and the concomitant risks associated with the drug, there is a need to increase the availability of interventions designed to reduce risky cannabis use. One promising intervention in the addictions employs personalized normative feedback to motivate change. Methods A two-arm randomized controlled trial (RCT) was conducted in which participants who used cannabis in a risky fashion were randomly assigned to one of two groups – those who received an online personalized feedback report in addition to educational materials about risky cannabis use and those who just received the online educational materials. Follow-up assessment occurred at three- and six-months post-randomization. Outcome variables included: number of days cannabis was used in the past 30, risky cannabis use (ASSIST score of four or more), and participant estimates of the proportion of cannabis users among those of the same age and gender. Results A total of 744 participants with risky cannabis use were recruited for the trial using online advertisements. There were no significant differences between intervention and educational materials only groups at three- and six-month follow-ups for the outcome variables, number of days used cannabis in the last 30 (p = 0.927) and proportion of participants engaging in risky cannabis use (p = 0.557). At three and six month follow-ups, participants who received the feedback intervention were more likely than those in the educational materials group to estimate that a larger proportion of people their age and gender did not use cannabis in the last year (p = 0.028). Discussion and conclusion While there was some evidence that the personalized feedback intervention modified normative perceptions about cannabis use, there did not appear to be support for the prediction that the intervention reduced cannabis consumption. Highlights • Personalized feedback intervention for risky cannabis use impacted normative misperceptions compared to educational control• Cannabis use did not appear to change as a result of providing individuals with a personalized feedback intervention

Project description:BACKGROUND:Sexually transmitted infections (STIs) are an increasingly critical and costly health problem for American childbearing women. Pregnant women who misuse substances are more likely to engage in risky sexual behavior that leads to STIs. Substance use and risky sex during pregnancy are both associated with numerous negative consequences for the woman and the developing fetus. STUDY DESIGN:A two-group, randomized controlled trial. PARTICIPANTS:Recruitment of 50 pregnant women (30% Latina; 24.4 years old [SD?=?5.31]) with an average of 13 weeks gestation (SD?=?4.5 weeks) was conducted at a prenatal clinic in a large inner-city hospital. Recruitment took place between 2015 and 2016, and data analysis took place in 2016. INTERVENTION:A computer-delivered, single-session brief motivational intervention plus booster session addressing both substance use and STI risk. OBJECTIVE:To assess participants' perceptions of the intervention and to examine the preliminary efficacy in reduction of substance use and risky sex at 4-month follow-up assessment. RESULTS:There were consistently very high ratings of acceptability of the intervention, ranging between 6.3 and 6.8 on a 1-7 scale. At the 4-month follow-up, participants in the intervention arm reported a significantly larger reduction (54%) in any marijuana or alcohol use compared with participants in the control group (16%) (p?=?0.015) based on two-group clustered logistic regression using a generalized estimating equations approach. There was a higher reduction in condomless vaginal sex at follow-up in the health checkup for expectant moms (HCEM) arm than control (27% vs. 5%), although this was not significant (p?=?0.127). CONCLUSIONS:The results of this pilot study are encouraging with respect to the acceptability and preliminary efficacy of an intervention in reducing alcohol/marijuana use and condomless sex during pregnancy, supporting the next step of testing the intervention in a larger sample.

Project description:BACKGROUND:Improving the quality and safety of perioperative care is a global priority. The Enhanced Peri-Operative Care for High-risk patients (EPOCH) trial was a stepped-wedge cluster randomised trial of a quality improvement (QI) programme to improve 90-day survival for patients undergoing emergency abdominal surgery in 93 hospitals in the UK National Health Service. METHODS:The aim of this process evaluation is to describe how the EPOCH intervention was planned, delivered and received, at both cluster and local hospital levels. The QI programme comprised of two interventions: a care pathway and a QI intervention to aid pathway implementation, focussed on stakeholder engagement, QI teamwork, data analysis and feedback and applying the model for improvement. Face-to-face training and online resources were provided to support senior clinicians in each hospital (QI leads) to lead improvement. For this evaluation, we collated programme activity data, administered an exit questionnaire to QI leads and collected ethnographic data in six hospitals. Qualitative data were analysed with thematic or comparative analysis; quantitative data were analysed using descriptive statistics. RESULTS:The EPOCH trial did not demonstrate any improvement in survival or length of hospital stay. Whilst the QI programme was delivered as planned at the cluster level, self-assessed intervention fidelity at the hospital level was variable. Seventy-seven of 93 hospitals responded to the exit questionnaire (60 from a single QI lead response on behalf of the team); 33 respondents described following the QI intervention closely (35%) and there were only 11 of 37 care pathway processes that >?50% of respondents reported attempting to improve. Analysis of qualitative data suggests QI leads were often attempting to deliver the intervention in challenging contexts: the social aspects of change such as engaging colleagues were identified as important but often difficult and clinicians frequently attempted to lead change with limited time or organisational resources. CONCLUSIONS:Significant organisational challenges faced by QI leads shaped their choice of pathway components to focus on and implementation approaches taken. Adaptation causing loss of intervention fidelity was therefore due to rational choices made by those implementing change within constrained contexts. Future large-scale QI programmes will need to focus on dedicating local time and resources to improvement as well as on training to develop QI capabilities. EPOCH TRIAL REGISTRATION:ISRCTN80682973 https://doi.org/10.1186/ISRCTN80682973 Registered 27 February 2014 and Lancet protocol 13PRT/7655.

Project description:BACKGROUND:Computer technologies hold promise for implementing alcohol screening, brief intervention, and referral to treatment (SBIRT). Questions concerning the most effective and appropriate SBIRT model remain. OBJECTIVE:The aim of this study was to evaluate the impact of a computerized SBIRT system called the Health Evaluation and Referral Assistant (HERA) on risky alcohol use treatment initiation. METHODS:Alcohol users (N=319) presenting to an emergency department (ED) were considered for enrollment. Those enrolled (n=212) were randomly assigned to the HERA, to complete a patient-administered assessment using a tablet computer, or a minimal-treatment control, and were followed for 3 months. Analyses compared alcohol treatment provider contact, treatment initiation, treatment completion, and alcohol use across condition using univariate comparisons, generalized estimating equations (GEEs), and post hoc chi-square analyses. RESULTS:HERA participants (n=212; control=115; intervention=97) did not differ between conditions on initial contact with an alcohol treatment provider, treatment initiation, treatment completion, or change in risky alcohol use behavior. Subanalyses indicated that HERA participants, who accepted a faxed referral, were more likely to initiate contact with a treatment provider and initiate treatment for risky alcohol use, but were not more likely to continue engaging in treatment, or to complete treatment and change risky alcohol use behavior over the 3-month period following the ED visit. CONCLUSIONS:The HERA promoted initial contact with an alcohol treatment provider and initiation of treatment for those who accepted the faxed referral, but it did not lead to reduced risky alcohol use behavior. Factors which may have limited the HERA's impact include lack of support for the intervention by clinical staff, the low intensity of the brief and stand-alone design of the intervention, and barriers related to patient follow-through, (eg, a lack of transportation or childcare, fees for services, or schedule conflicts). TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): NCT01153373; https://clinicaltrials.gov/ct2/show/NCT01153373 (Archived by WebCite at http://www.webcitation.org/6pHQEpuIF).

Dataset Information

Project QUIT (Quit Using Drugs Intervention Trial): a randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use.

Publications

Project QUIT (Quit Using Drugs Intervention Trial): a randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use.

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