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2.  Treatment dismantling pilot study to identify the active ingredients in personalized feedback interventions for hazardous alcohol use: randomized controlled trial 
Background
There is a considerable body of evidence supporting the effectiveness of personalized feedback interventions for hazardous alcohol use—whether delivered face-to-face, by postal mail, or over the Internet (probably now the primary mode of delivery). The Check Your Drinking Screener (CYD; see www.CheckYourDrinking.net) is one such intervention.
Objectives
The current treatment dismantling study assessed which components of personalized feedback interventions were effective in motivating change in drinking. Specifically, the major objective of this project was to conduct a randomized controlled trial (RCT) comparing the impact of the normative feedback and other personalized feedback components of the CYD intervention in the general population.
Methods
Participants were recruited to take part in an RCT and received either the complete CYD final report, just the normative feedback sections of the CYD, just the personalized feedback components of the CYD, or were assigned to a no-intervention control group. Participants were followed-up at 3 months to assess changes in alcohol consumption.
Results
A total of 741 hazardous drinking participants were recruited for the trial, of which 73 percent provided follow-up data. Analyses using an intent-to-treat approach found some evidence for the impact of the personalized feedback components of the CYD in reducing alcohol consumption on the variables, number of drinks in a week and AUDIT-C (p = .028 and .047 respectively; no impact on highest number of drinks on one occasion; p = .594). However, there was no significant evidence of the impact of the normative feedback components (all p > .3).
Conclusions
Personalized feedback elements alone could provide an active intervention for hazardous drinkers, particularly in situations where normative feedback information was not available.
Trials registration
ClinicalTrials.gov NCT01608763.
Electronic supplementary material
The online version of this article (doi:10.1186/s13722-014-0022-1) contains supplementary material, which is available to authorized users.
doi:10.1186/s13722-014-0022-1
PMCID: PMC4288561  PMID: 25539597
Alcohol; Brief intervention; Internet; Randomized controlled trial; Mechanisms of change
3.  Implementation of smoking cessation guidelines in the emergency department: a qualitative study of staff perceptions 
Background
The US Public Health Service smoking cessation practice guideline specifically recommends that physicians and nurses strongly advise their patients who use tobacco to quit, but the best approach for attaining this goal in the emergency department (ED) remains unknown. The aim of this study was to characterize emergency physicians’ (EPs) and nurses’ (ENs) perceptions of cessation counseling and to identify barriers and facilitators to implementation of the 5 A’s framework (Ask-Advise-Assess-Assist-Arrange) in the ED.
Methods
We conducted semi-structured, face-to-face interviews of 11 EPs and 19 ENs following a pre-post implementation trial of smoking cessation guidelines in two study EDs. We used purposeful sampling to target EPs and ENs with different attitudes toward cessation counseling, based on their responses to a written survey (Decisional Balance Questionnaire). Conventional content analysis was used to inductively characterize the issues raised by study participants and to construct a coding structure, which was then applied to study transcripts.
Results
The main findings of this study converged upon three overarching domains: 1) reactions to the intervention; 2) perceptions of patients’ receptivity to cessation counseling; and 3) perspectives on ED cessation counseling and preventive care. ED staff expressed ambivalence toward the implementation of smoking cessation guidelines. Both ENs and EPs agreed that the delivery of smoking cessation counseling is important, but that it is not always practical in the ED on account of time constraints, the competing demands of acute care, and resistance from patients. Participants also called attention to the need for improved role clarity and teamwork when implementing the 5 A’s in the ED.
Conclusions
There are numerous challenges to the implementation of smoking cessation guidelines in the ED. ENs are generally willing to take the lead in offering brief cessation counseling, but their efforts need to be reinforced by EPs. ED systems need to address workflow, teamwork, and practice policies that facilitate prescription of smoking cessation medication, referral for cessation counseling, and follow-up in primary care. The results of this qualitative evaluation can be used to guide the design of future ED intervention studies.
Trial registration
ClinicalTrials.gov registration number NCT00756704
doi:10.1186/1940-0640-9-1
PMCID: PMC3902188  PMID: 24460974
Emergency medical services; Smoking cessation; Attitude of health personnel; Qualitative research; Content analysis
4.  Continuous quality improvement (CQI) in addiction treatment settings: design and intervention protocol of a group randomized pilot study 
Background
Few studies have designed and tested the use of continuous quality improvement approaches in community based substance use treatment settings. Little is known about the feasibility, costs, efficacy, and sustainment of such approaches in these settings.
Methods/Design
A group-randomized trial using a modified stepped wedge design is being used. In the first phase of the study, eight programs, stratified by modality (residential, outpatient) are being randomly assigned to the intervention or control condition. In the second phase, the initially assigned control programs are receiving the intervention to gain additional information about feasibility while sustainment is being studied among the programs initially assigned to the intervention.
Discussion
By using this design in a pilot study, we help inform the field about the feasibility, costs, efficacy and sustainment of the intervention. Determining information at the pilot stage about costs and sustainment provides value for designing future studies and implementation strategies with the goal to reduce the time between intervention development and translation to real world practice settings.
doi:10.1186/1940-0640-9-4
PMCID: PMC3906762  PMID: 24467770
Continuous quality improvement; Group randomized controlled pilot trial; Stepped wedge design; Costs; Sustainment; Feasibility
5.  Outcomes among buprenorphine-naloxone primary care patients after Hurricane Sandy 
Background
The extent of damage in New York City following Hurricane Sandy in October 2012 was unprecedented. Bellevue Hospital Center (BHC), a tertiary public hospital, was evacuated and temporarily closed as a result of hurricane-related damages. BHC’s large primary care office-based buprenorphine clinic was relocated to an affiliate public hospital for three weeks. The extent of environmental damage and ensuing service disruption effects on rates of illicit drug, tobacco, and alcohol misuse, buprenorphine medication supply disruptions, or direct resource losses among office-based buprenorphine patients is to date unknown.
Methods
A quantitative and qualitative semi-structured survey was administered to patients in BHC’s primary care buprenorphine program starting one month after the hurricane. Survey domains included: housing and employment disruptions; social and economic support; treatment outcomes (buprenorphine adherence and ability to get care), and tobacco, alcohol, and drug use. Open-ended questions probed general patient experiences related to the storm, coping strategies, and associated disruptions.
Results
There were 132 patients enrolled in the clinic at the time of the storm; of those, 91 patients were recruited to the survey, and 89 completed (98% of those invited). Illicit opioid misuse was rare, with 7 respondents reporting increased heroin or illicit prescription opioid use following Sandy. Roughly half of respondents reported disruption of their buprenorphine-naloxone medication supply post-event, and self-lowering of daily doses to prolong supply was common. Additional buprenorphine was obtained through unscheduled telephone or written refills from relocated Bellevue providers, informally from friends and family, and, more rarely, from drug dealers.
Conclusions
The findings highlight the relative adaptability of public sector office-based buprenorphine treatment during and after a significant natural disaster. Only minimal increases in self-reported substance use were reported despite many disruptions to regular buprenorphine supplies and previous daily doses. Informal supplies of substitute buprenorphine from family and friends was common. Remote telephone refill support and a temporary back-up location that provided written prescription refills and medication dispensing for uninsured patients enabled some patients to maintain an adequate medication supply. Such adaptive strategies to ensure medication maintenance continuity pre/post natural disasters likely minimize poor treatment outcomes.
doi:10.1186/1940-0640-9-3
PMCID: PMC3940298  PMID: 24467734
6.  HealthCall for the smartphone: technology enhancement of brief intervention in HIV alcohol dependent patients 
Background
Heavy drinking jeopardizes the health of patients in HIV primary care. In alcohol dependent patients in HIV primary care, a technological enhancement of brief intervention, HealthCall administered via interactive voice response (HealthCall-IVR) was effective at reducing heavy drinking. The smartphone offered a technology platform to improve HealthCall.
Methods
Working with input from patients, technology experts, and HIV clinic personnel, we further developed HealthCall, harnessing smartphone technological capacities (HealthCall-S). In a pilot study, we compared rates of HealthCall-S daily use and drinking outcomes in 41 alcohol dependent HIV-infected patients with the 43 alcohol dependent HIV-infected patients who used HealthCall-IVR in our previous efficacy study. Procedures, clinic, personnel, and measures were largely the same in the two studies, and the two groups of patients were demographically similar (~90% minority).
Results
Pilot patients used HealthCall-S a median of 85.0% of the 60 days of treatment, significantly greater than the corresponding rate (63.8%) among comparison patients using HealthCall-IVR (p < .001). Mean end-of-treatment drinks per drinking day was similar in the two groups. Patients were highly satisfied with HealthCall-S (i.e., 92% reported that they liked using HealthCall-S).
Conclusions
Among alcohol dependent patients in HIV primary care, HealthCall delivered via smartphone is feasible, obtains better patient engagement than HealthCall-IVR, and is associated with decreased drinking. In HIV primary care settings, HealthCall-S may offer a way to improve drinking outcomes after brief intervention by extending patient engagement with little additional demands on staff time.
doi:10.1186/1940-0640-9-5
PMCID: PMC3943503  PMID: 24533631
HIV; Alcohol; Brief intervention; Technology intervention; Smartphone; Primary care
7.  Inconsistencies between alcohol screening results based on AUDIT-C scores and reported drinking on the AUDIT-C questions: prevalence in two US national samples 
Background
The AUDIT-C is an extensively validated screen for unhealthy alcohol use (i.e. drinking above recommended limits or alcohol use disorder), which consists of three questions about alcohol consumption. AUDIT-C scores ≥4 points for men and ≥3 for women are considered positive screens based on US validation studies that compared the AUDIT-C to “gold standard” measures of unhealthy alcohol use from independent, detailed interviews. However, results of screening—positive or negative based on AUDIT-C scores—can be inconsistent with reported drinking on the AUDIT-C questions. For example, individuals can screen positive based on the AUDIT-C score while reporting drinking below US recommended limits on the same AUDIT-C. Alternatively, they can screen negative based on the AUDIT-C score while reporting drinking above US recommended limits. Such inconsistencies could complicate interpretation of screening results, but it is unclear how often they occur in practice.
Methods
This study used AUDIT-C data from respondents who reported past-year drinking on one of two national US surveys: a general population survey (N = 26,610) and a Veterans Health Administration (VA) outpatient survey (N = 467,416). Gender-stratified analyses estimated the prevalence of AUDIT-C screen results—positive or negative screens based on the AUDIT-C score—that were inconsistent with reported drinking (above or below US recommended limits) on the same AUDIT-C.
Results
Among men who reported drinking, 13.8% and 21.1% of US general population and VA samples, respectively, had screening results based on AUDIT-C scores (positive or negative) that were inconsistent with reported drinking on the AUDIT-C questions (above or below US recommended limits). Among women who reported drinking, 18.3% and 20.7% of US general population and VA samples, respectively, had screening results that were inconsistent with reported drinking.
Limitations
This study did not include an independent interview gold standard for unhealthy alcohol use and therefore cannot address how often observed inconsistencies represent false positive or negative screens.
Conclusions
Up to 21% of people who drink alcohol had alcohol screening results based on the AUDIT-C score that were inconsistent with reported drinking on the same AUDIT-C. This needs to be addressed when training clinicians to use the AUDIT-C.
doi:10.1186/1940-0640-9-2
PMCID: PMC3946205  PMID: 24468406
AUDIT-C; Brief intervention; Unhealthy alcohol use; Alcohol screening; Heavy episodic drinking
8.  Randomized clinical trial of the effects of screening and brief intervention for illicit drug use: the life shift/shift gears study 
Background
Although screening, brief intervention, and referral to treatment (SBIRT) has shown promise for alcohol use, relatively little is known about its effectiveness for adult illicit drug use. This randomized controlled trial assessed the effectiveness of the SBIRT approach for outcomes related to drug use among patients visiting trauma and emergency departments (EDs) at two large, urban hospitals.
Methods
A total of 700 ED patients who admitted using illegal drugs in the past 30 days were recruited, consented, provided baseline measures of substance use and related problems measured with the Addiction Severity Index-Lite (ASI-Lite), and then randomized to the Life Shift SBIRT intervention or to an attention-placebo control group focusing on driving and traffic safety (Shift Gears). Both groups received a level of motivational intervention matched to their condition and risk level by trained paraprofessional health educators. Separate measurement technicians conducted face-to-face follow-ups at 6 months post-intervention and collected hair samples to confirm reports of abstinence from drug use. The primary outcome measure of the study was past 30-day drug abstinence at 6 months post-intervention, as self-reported on the ASI-Lite.
Results
Of 700 participants, 292 (42%) completed follow-up. There were no significant differences in self-reported abstinence (12.5% vs. 12.0% , p = 0.88) for Life Shift and Shift Gears groups, respectively. When results of hair analyses were applied, the abstinence rate was 7 percent for Life Shift and 2 percent for Shift Gears (p = .074). In an analysis in which results were imputed (n = 694), there was no significant difference in the ASI-Lite drug use composite scores (Life Shift +0.005 vs. Shift Gears +0.017, p = 0.12).
Conclusions
In this randomized controlled trial, there was no evidence of effectiveness of SBIRT on the primary drug use outcome.
Trial registration
ClinicalTrials.gov NCT01683227.
doi:10.1186/1940-0640-9-8
PMCID: PMC4046000  PMID: 24886786
Screening and brief intervention; Drug use; Emergency department patients
9.  Participation in a novel treatment component during residential substance use treatment is associated with improved outcome: a pilot study 
Background
A person-centered substance use treatment component, the Natural Recovery Program, was developed. The Natural Recovery Program is comprised of small group therapy combined with pursuit of hobbies.
Methods
This was a pilot study of the program and was not randomized. A retrospective record review of 643 veterans in an inpatient mental health recovery and rehabilitation program was analyzed to determine if participants of Natural Recovery had a different rate of treatment completion than those who elected to participate in the core program alone. Univariate and multivariate analyses were conducted on: participation in the Natural Recovery Program; co-morbid psychiatric disorders; and legal, medical, and psychiatric issues.
Results
Participation in Natural Recovery was significantly associated with successful treatment completion when analyzed by univariate analysis (p = 0.01). Other significant variables associated with successful completion included: no co-morbid psychiatric diagnosis, fewer prior suicide attempts, and no homelessness prior to admission. Binary logistic regression demonstrated that participation in Natural Recovery was associated with improved treatment completion, even when other variables were considered (p = 0.01). Treatment retention was longer for patients who participated in Natural Recovery, even if they did not complete treatment.
Conclusions
The Natural Recovery Program was associated with improved outcomes, as measured by treatment retention in the first 60 days and by treatment completion. Participants of Natural Recovery with co-morbid psychiatric disorders completed treatment at a higher rate than those with co-morbid psychiatric disorders who participated in the core program. Patients reported high satisfaction with the program. This program may be a valuable adjunct to residential treatment.
doi:10.1186/1940-0640-9-7
PMCID: PMC4047771  PMID: 24886745
Person-centered care; Treatment completion; Dual diagnosis; Co-morbid; Recovery model; Residential treatment; Psychosocial treatment
10.  Opioid use in Albuquerque, New Mexico: a needs assessment of recent changes and treatment availability 
Background
New Mexico has consistently high rates of drug-induced deaths, and opioid-related treatment admissions have been increasing over the last two decades. Youth in New Mexico are at particular risk: they report higher rates of nonmedical prescription opioid use than those over age 25, are more likely than their national counterparts to have tried heroin, and represent an increasing proportion of heroin overdoses.
Methods
Commissioned by the City of Albuquerque, semistructured interviews were conducted from April to June of 2011 with 24 substance use treatment agencies and eight key stakeholders in Albuquerque to identify recent changes in the treatment-seeking population and gaps in treatment availability. Themes were derived using template analysis and data were analyzed using NVivo 9 software.
Results
Respondents reported a noticeable increase in youth seeking treatment for opioid use and a general increase in nonmedical prescription opioid use. Most noted difficulties with finding buprenorphine providers and a lack of youth services. Additionally, stigma, limited interagency communication and referral, barriers to prescribing buprenorphine, and a lack of funding were noted as preventing opioid users from quickly accessing effective treatment.
Conclusions
Recommendations for addressing these issues include developing youth-specific treatment programs, raising awareness about opioid use among youth, increasing the availability of buprenorphine through provider incentives and education, developing a resource guide for individuals seeking treatment in Albuquerque, and prioritizing interagency communication and referrals.
doi:10.1186/1940-0640-9-10
PMCID: PMC4070335  PMID: 24942534
Opioids; Heroin; Buprenorphine; Treatment; Youth; Needs assessment; New Mexico
11.  Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics 
Background
Tobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers, but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients. Methadone clinic-based, directly observed therapy (DOT) programs for HIV and tuberculosis improve adherence and clinical outcomes, but have not been evaluated for smoking cessation. We describe a randomized controlled trial to evaluate whether a methadone clinic-based, directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment.
Methods/Design
We plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual (self-administered varenicline) for 12 weeks. Our outcome measures are: 1) pill count adherence and 2) carbon monoxide-verified tobacco abstinence. We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models.
Discussion
This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based, directly observed varenicline for improving adherence and smoking cessation outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment.
Trial Registration
clinicaltrials.gov NCT01378858
doi:10.1186/1940-0640-9-9
PMCID: PMC4084498  PMID: 24928218
Adherence; Smoking cessation; Varenicline; Directly observed therapy; DOT; Methadone; Opioid-related disorders
12.  Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study 
Background
Brief interventions via the internet have been shown to reduce university students’ alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students.
Methods
Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly’s app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks.
Results
Among 28574 students offered participation, 4823 agreed to join; 415 were excluded due to incomplete data, and 1932 fulfilled eligibility criteria for randomization. Attrition was 22.7–39.3 percent, higher among heavier drinkers and highest in Group 2. Self-reported app use was higher in Group 1 (74%) compared to Group 2 (41%). Per-protocol analyses revealed only one significant time-by-group interaction, where Group 1 participants increased the frequency of their drinking occasions compared to controls (p = 0.001). Secondary analyses by gender showed a significant difference among men in Group 1 for frequency of drinking occasions per week (p = 0.001), but not among women. Among all participants, 29 percent showed high-risk drinking, over the recommended weekly drinking levels of 9 (women) and 14 (men) standard glasses.
Conclusions
Smartphone apps can make brief interventions available to large numbers of university students. The apps studied using eBAC calculation did not, however, seem to affect alcohol consumption among university students and one app may have led to a negative effect among men. Future research should: 1) explore ways to increase user retention, 2) include apps facilitating technical manipulation for evaluation of added components, 3) explore the effects of adapting app content to possible gender differences, and 4) offer additional interventions to high-risk users.
Trial registration
clinicaltrials.gov: NCT01958398.
doi:10.1186/1940-0640-9-11
PMCID: PMC4091647  PMID: 24985342
Randomized controlled trial; Problem drinking; Alcohol abuse; College; University; Smartphone; Mobile phone; eHealth; mHealth; Brief intervention
13.  An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers 
Background
One of the pressing concerns in health care today is the slow rate at which promising interventions, supported by research evidence, move into clinical practice. One potential way to speed this process is to conduct hybrid studies that simultaneously combine the collection of effectiveness and implementation relevant data. This paper presents implementation relevant data collected during a randomized effectiveness trial of an abstinence incentive intervention conducted in substance use disorders treatment clinics at two Veterans Health Administration (VHA) medical centers.
Methods
Participants included patients entering substance use disorders treatment with diagnoses of alcohol dependence and/or stimulant dependence that enrolled in the randomized trial, were assigned to the intervention arm, and completed a post intervention survey (n = 147). All staff and leadership from the participating clinics were eligible to participate. A descriptive process evaluation was used, focused on participant perceptions and contextual/feasibility issues. Data collection was guided by the RE-AIM and PARIHS implementation frameworks. Data collection methods included chart review, intervention cost tracking, patient and staff surveys, and qualitative interviews with staff and administrators.
Results
Results indicated that patients, staff and administrators held generally positive attitudes toward the incentive intervention. However, staff and administrators identified substantial barriers to routine implementation. Despite the documented low cost and modest staff time required for implementation of the intervention, securing funding for the incentives and freeing up any staff time for intervention administration were identified as primary barriers.
Conclusions
Recommendations to facilitate implementation are presented. Recommendations include: 1) solicit explicit support from the highest levels of the organization through, for example, performance measures or clinical practice guideline recommendations; 2) adopt the intervention incrementally starting within a specific treatment track or clinic to reduce staff and funding burden until local evidence of effectiveness and feasibility is available to support spread; and 3) educate staff about the process, goals, and value/effectiveness of the intervention and engage them in implementation planning from the start to enhance investment in the intervention.
doi:10.1186/1940-0640-9-12
PMCID: PMC4106217  PMID: 25008457
Substance use disorders treatment; Abstinence incentive intervention; Implementation; Process evaluation; Hybrid design
14.  Dissemination of a computer-based psychological treatment in a drug and alcohol clinical service: an observational study 
Background
There is emerging evidence for the potential of computer-based psychological treatments (CBPT) as an add-on to usual clinical practice in the management of health problems.
Objective
The study set out to observe if, when, and how clinicians working in a publically funded alcohol/other drug (AOD) clinical service might utilize SHADE (Self-Help for Alcohol and other drug use and DEpression), a CBPT program for comorbid depression and alcohol or cannabis use, in their clinical practice.
Methods
Thirteen clinicians working within an AOD service on the Central Coast of New South Wales, Australia, were recruited. At baseline, all 13 clinicians were assessed for their computer anxiety and openness to innovation. Clinicians referred current clients to the study, with consenting and eligible clients (N = 35) completing a baseline and 15-week follow-up clinical assessment. The assessment comprised a range of mental health and AOD measures administered by an independent research assistant. Over the course of the study, clinicians submitted session checklists detailing information about session content, including the context and extent to which SHADE was used for each client.
Results
Descriptive statistics showed that clinicians employed the SHADE program in a variety of ways. When SHADE modules were used, they were generally introduced in the early phase of treatment, on average, around session 4 (M = 3.77, SD = 5.26, range 1–36). However, only 12 of the 35 clients whose session checklists were available were exposed to the SHADE modules; this, despite 28/35 clients indicating that they would be willing to use CBPT during their current treatment program.
Conclusions
Treatment seekers in the AOD service of the current trial were generally open to receiving CBPT like SHADE; however, clinicians tended to use SHADE with only 34 percent of clients. This indicates the importance of providing ongoing support and encouragement to clinicians, in addition to an initial training session, to encourage the adoption of innovative technologies into clinical practice, and perhaps to engage clients in a discussion about CBPT more routinely.
Trial registration
Australian Clinical Trial Registration Number ACTRN12611000382976.
doi:10.1186/1940-0640-9-15
PMCID: PMC4131058  PMID: 25106668
Computer/internet-based psychological treatment; Computer anxiety; Openness to innovation; Alcohol/other drug clinical service
15.  The efficacy-effectiveness distinction in trials of alcohol brief intervention 
Three recent sets of null findings from trials of alcohol brief intervention (BI) have been disappointing to those who wish to see a reduction in alcohol-related harm through the widespread dissemination of BI. Saitz (7) has suggested that these null findings result from a failure to translate the effects of BI seen in efficacy trials, which are thought to contribute mainly to the beneficial effects of BI shown in meta-analyses, to effectiveness trials conducted in real-world clinical practice. The present article aims to: (i) clarify the meaning of the terms “efficacy” and “effectiveness” and other related concepts; (ii) review the method and findings on efficacy-effectiveness measurement in the 2007 Cochrane Review by Kaner and colleagues; and (iii) make suggestions for further research in this area. Conclusions are: 1) to avoid further confusion, terms such as “efficacy trial”, “effectiveness trial”, “clinical representativeness”, etc. should be clearly defined and carefully used; 2) applications of BI to novel settings should begin with foundational research and developmental studies, followed by efficacy trials, and political pressures for quick results from premature effectiveness trials should be resisted; 3) clear criteria are available in the literature to guide progress from efficacy research, through effectiveness research, to dissemination in practice; 4) to properly interpret null findings from effectiveness studies, it is necessary to ensure that interventions are delivered as intended; 5) in future meta-analyses of alcohol BI trials, more attention should be paid to the development and application of a psychometrically robust scale to measure efficacy-effectiveness or clinical representativeness; 6) the null findings under consideration cannot be firmly attributed to a failure to translate effects from efficacy trials to real-world practice, because it is possible that the majority of trials included in meta-analyses on which the evidence for the beneficial effects of alcohol BI was based tended to be effectiveness rather than efficacy trials; and 7) a hypothesis to explain the null findings in question is that they are due to lack of fidelity in the implementation of BI in large, organizationally complex, cluster randomized trials.
doi:10.1186/1940-0640-9-13
PMCID: PMC4134461  PMID: 25127717
Alcohol-related harm; Brief interventions; Efficacy trials; Effectiveness trials; Meta-analyses
16.  Costs of care for persons with opioid dependence in commercial integrated health systems 
Background
When used in general medical practices, buprenorphine is an effective treatment for opioid dependence, yet little is known about how use of buprenorphine affects the utilization and cost of health care in commercial health systems.
Methods
The objective of this retrospective cohort study was to examine how buprenorphine affects patterns of medical care, addiction medicine services, and costs from the health system perspective. Individuals with two or more opioid-dependence diagnoses per year, in two large health systems (System A: n = 1836; System B: n = 4204) over the time span 2007–2008 were included. Propensity scores were used to help adjust for group differences.
Results
Patients receiving buprenorphine plus addiction counseling had significantly lower total health care costs than patients with little or no addiction treatment (mean health care costs with buprenorphine treatment = $13,578; vs. mean health care costs with no addiction treatment = $31,055; p < .0001), while those receiving buprenorphine plus addiction counseling and those with addiction counseling only did not differ significantly in total health care costs (mean costs with counseling only: $17,017; p = .5897). In comparison to patients receiving buprenorphine plus counseling, those with little or no addiction treatment had significantly greater use of primary care (p < .001), other medical visits (p = .001), and emergency services (p = .020). Patients with counseling only (compared to patients with buprenorphine plus counseling) used less inpatient detoxification (p < .001), and had significantly more PC visits (p = .001), other medical visits (p = .005), and mental health visits (p = .002).
Conclusions
Buprenorphine is a viable alternative to other treatment approaches for opioid dependence in commercial integrated health systems, with total costs of health care similar to abstinence-based counseling. Patients with buprenorphine plus counseling had reduced use of general medical services compared to the alternatives.
doi:10.1186/1940-0640-9-16
PMCID: PMC4142137  PMID: 25123823
Substance abuse; Cost analysis; Health care utilization; Commercial health insurance; Parity
17.  The best evidence for alcohol screening and brief intervention in primary care supports efficacy, at best, not effectiveness: You say tomāto, I say tomăto? That’s not all it’s about 
The review related to this manuscript is available at http://www.ascpjournal.org/content/9/1/13.
doi:10.1186/1940-0640-9-14
PMCID: PMC4146443  PMID: 25168288
18.  Identifying Aboriginal-specific AUDIT-C and AUDIT-3 cutoff scores for at-risk, high-risk, and likely dependent drinkers using measures of agreement with the 10-item Alcohol Use Disorders Identification Test 
Background
The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item alcohol screener that has been recommended for use in Aboriginal primary health care settings. The time it takes respondents to complete AUDIT, however, has proven to be a barrier to its routine delivery. Two shorter versions, AUDIT-C and AUDIT-3, have been used as screening instruments in primary health care. This paper aims to identify the AUDIT-C and AUDIT-3 cutoff scores that most closely identify individuals classified as being at-risk drinkers, high-risk drinkers, or likely alcohol dependent by the 10-item AUDIT.
Methods
Two cross-sectional surveys were conducted from June 2009 to May 2010 and from July 2010 to June 2011. Aboriginal Australian participants (N = 156) were recruited through an Aboriginal Community Controlled Health Service, and a community-based drug and alcohol treatment agency in rural New South Wales (NSW), and through community-based Aboriginal groups in Sydney NSW. Sensitivity, specificity, and positive and negative predictive values of each score on the AUDIT-C and AUDIT-3 were calculated, relative to cutoff scores on the 10-item AUDIT for at-risk, high-risk, and likely dependent drinkers. Receiver operating characteristic (ROC) curve analyses were conducted to measure the detection characteristics of AUDIT-C and AUDIT-3 for the three categories of risk.
Results
The areas under the receiver operating characteristic (AUROC) curves were high for drinkers classified as being at-risk, high-risk, and likely dependent.
Conclusions
Recommended cutoff scores for Aboriginal Australians are as follows: at-risk drinkers AUDIT-C ≥ 5, AUDIT-3 ≥ 1; high-risk drinkers AUDIT-C ≥ 6, AUDIT-3 ≥ 2; and likely dependent drinkers AUDIT-C ≥ 9, AUDIT-3 ≥ 3. Adequate sensitivity and specificity were achieved for recommended cutoff scores. AUROC curves were above 0.90.
doi:10.1186/1940-0640-9-17
PMCID: PMC4158391  PMID: 25179547
AUDIT; AUDIT-C; AUDIT-3; Alcohol; Measures; Aboriginal
19.  Study design to develop and pilot-test a web intervention for partners of military service members with alcohol misuse 
Background
Alcohol misuse among military service members from the recent conflicts in Iraq and Afghanistan is over two times higher compared to misuse in the civilian population. Unfortunately, in addition to experiencing personal consequences from alcohol misuse, partners and family members of alcohol-misusing service members also suffer in negative ways from their loved one’s drinking. These family members represent important catalysts for helping their loved ones identify problem drinking and overcoming the barriers to seeking care. This paper describes the protocol to a pilot study evaluating a 4-session, web-based intervention (WBI) for concerned partners (CPs) of service members with alcohol misuse.
Methods/design
The WBI will be adapted from the Community Reinforcement and Family Training (CRAFT) intervention. In the first phase, we will develop and beta-test the WBI with 15–20 CPs. In the second phase, we will randomize CPs to WBI (n = 50) or to delayed-WBI (n = 50) and evaluate the impact of the WBI on CPs’ perceptions of service member help-seeking and drinking, as well as the CP’s well-being and relationship satisfaction 3 months after the intervention. In the third phase, we will recruit 15–20 service members whose partners have completed the study. We will interview the service members to learn how the CP-focused WBI affected them and to assess whether they would be receptive to a follow-on WBI module to help them.
Discussion
This project has the potential to benefit a large population of military service members who may be disproportionately affected by recent conflicts and whose drinking misuse would otherwise go undetected and untreated. It also develops a new prevention model that does not rely on service members or partners attending a hospital or clinical facility to access care.
Trial registration
NCT02073825.
doi:10.1186/1940-0640-9-18
PMCID: PMC4159379  PMID: 25179672
Military spouse; Alcohol misuse; Unhealthy alcohol use; Web intervention; Computer-assisted intervention; CRAFT; Spouse or significant other
20.  Pharmacogenetic approaches in the treatment of alcohol use disorders: addressing clinical utility and implementation thresholds 
Despite advances in characterizing genetic influences on addiction liability and treatment response, clinical applications of these efforts have been slow to evolve. Although challenges to clinical translation remain, stakeholders already face decisions about evidentiary thresholds for the uptake of pharmacogenetic tests in practice. There is optimism about potential pharmacogenetic applications for the treatment of alcohol use disorders, with particular interest in the OPRM1 A118G polymorphism as a moderator of naltrexone response. Findings from human and animal studies suggest preliminary evidence for the clinical validity of this association; on this basis, arguments for clinical implementation can be made in accordance with existing frameworks for the uptake of genomic applications. However, generating evidence-based guidelines requires evaluating the clinical utility of pharmacogenetic tests. This goal will remain challenging, largely due to minimal data to inform clinical utility estimates. The pace of genomic discovery highlights the need for clinical utility and implementation research to inform future translation efforts. Near-term implementation of promising pharmacogenetic tests can help expedite this goal, generating an evidence base to enable efficient translation as additional gene-drug associations are discovered.
doi:10.1186/1940-0640-9-20
PMCID: PMC4165632  PMID: 25217046
Evidence-based medicine; Personalized medicine; Pharmacogenomics; Alcohol; Mu opioid receptor; Asn40Asp; rs1799971
21.  Review of the assessment and management of neonatal abstinence syndrome 
Neonatal abstinence syndrome (NAS) secondary to in-utero opioid exposure is an increasing problem. Variability in assessment and treatment of NAS has been attributed to the lack of high-quality evidence to guide management of exposed neonates. This systematic review examines available evidence for NAS assessment tools, nonpharmacologic interventions, and pharmacologic management of opioid-exposed infants. There is limited data on the inter-observer reliability of NAS assessment tools due to lack of a standardized approach. In addition, most scales were developed prior to the prevalent use of prescribed prenatal concomitant medications, which can complicate NAS assessment. Nonpharmacologic interventions, particularly breastfeeding, may decrease NAS severity. Opioid medications such as morphine or methadone are recommended as first-line therapy, with phenobarbital or clonidine as second-line adjunctive therapy. Further research is needed to determine best practices for assessment, nonpharmacologic intervention, and pharmacologic management of infants with NAS in order to improve outcomes.
doi:10.1186/1940-0640-9-19
PMCID: PMC4166410  PMID: 25199822
Neonatal abstinence syndrome assessment; Neonatal abstinence syndrome management; Neonatal abstinence syndrome treatment
22.  A chance to stop and breathe: participants’ experiences in the North American Opiate Medication Initiative clinical trial 
Background
The North American Opiate Medication Initiative (NAOMI) clinical trial compared the effectiveness of injectable diacetylmorphine (DAM) or hydromorphone (HDM) to oral methadone maintenance treatment (MMT). This study aimed to determine participants’ perceptions of treatment delivered in NAOMI.
Methods
A qualitative sub-study was conducted with 29 participants (12 female): 18 (62.1%) received injectable DAM or HDM and 11 (37.9%) received MMT. A phenomenological theoretical framework was used. Semi-structured interviews were audio-recorded and transcribed verbatim. A thematic analysis was used over successive phases and was driven by the semantic meanings of the data.
Results
Participants receiving injectable medications suggested that the supervised delivery model was stringent but provided valuable stability to their lives. Females discussed the adjustment required for the clinical setting, while males focused on the challenging clinic schedule and its impact on employment abilities. Participants receiving MMT described disappointment with being randomized to this treatment; however, positive aspects, including the quick titration time and availability of auxiliary services, were also discussed.
Conclusion
Treatment with injectable DAM (or HDM) is preferred by participants and considered effective in reducing the burden of opioid dependency. Engaging patients in research regarding their perceptions of treatment provides a comprehensive assessment of treatment needs and barriers.
Clinical trial registration
NCT00175357
doi:10.1186/1940-0640-9-21
PMCID: PMC4181618  PMID: 25262567
Opioid dependency; Diacetylmorphine; Injectable; Oral methadone; Opioid maintenance treatment; Qualitative methods
23.  Clinically relevant characteristics associated with early treatment drug use versus abstinence 
Background
This study describes early treatment drug use status and associated clinical characteristics in a diverse sample of patients entering outpatient substance abuse psychosocial counseling treatment. The goal is to more fully characterize those entering treatment with and without active use of their primary drug in order to better understand associated treatment needs and resilience factors.
Methods
We examined baseline data from a NIDA Clinical Trials Network (CTN) study (Web-delivery of Treatment for Substance Use) with an all-comers sample of patients (N = 494) entering 10 outpatient treatment centers. Patients were categorized according to self-identified primary drug of abuse (alcohol, cocaine/stimulants, opioids, marijuana) and by baseline drug use status (positive/negative) based on urine testing or self-reports of recent use (alcohol). Characteristics were examined by primary drug and early use status.
Results
Classified as drug-negative were 84%, 76%, 62%, and 33% of primary opioid, stimulant, alcohol, and marijuana users; respectively. Drug-positive versus -negative patients did not differ on demographics or rates of substance abuse/dependence diagnoses. However, those negative for active use had better physical and mental health profiles, were less likely to be using a secondary drug, and were more likely to be attending 12-step self-help meetings.
Conclusions
Early treatment drug abstinence is common among substance users entering outpatient psychosocial counseling programs, regardless of primary abused drug. Abstinence (by negative UA) is associated with better health and mental health profiles, less secondary drug use, and more days of 12-step attendance. These data highlight differential treatment needs and resiliencies associated with early treatment drug use status.
Trial registration
NCT01104805.
doi:10.1186/1940-0640-9-6
PMCID: PMC4234981  PMID: 24708748
Substance abuse; Substance abuse treatment; Co-occurring disorders; Co-morbidity; Screening
24.  Feasibility of a computer-assisted alcohol SBIRT program in an urban emergency department: patient and research staff perspectives 
Objectives
The study objective was to assess the feasibility of a computerized alcohol-screening interview (CASI) program to identify at-risk alcohol users among adult emergency department (ED) patients. The study aimed to evaluate the feasibility of implementing a computerized screening, brief intervention, and referral to treatment (SBIRT) program within a busy urban ED setting, to report on accurate deployment of alcohol screening results, and to assess comprehension and satisfaction with CASI from both patient and research staff perspectives.
Methods
Research assistants (RAs) screened a convenience sample of medically stable ED patients. The RAs brought CASI to patients’ bedsides, and patients entered their own alcohol consumption data. The CASI intervention consisted of an alcohol use screening identification test, a personalized normative feedback profile, NIAAA low-risk drinking educational materials, and treatment referrals (when indicated).
Results
Five hundred seventeen patients were enrolled. The median age of participants was 37 years (range, 21-85 years); 37% were men, 62% were Hispanic, 7% were Caucasian, 30% were African American, and 2% were multiracial. Eighty percent reported regular use of computers at home. Eighty percent of patients approached consented to participate, and 99% of those who started CASI were able to complete it. Two percent of interviews were interrupted for medical tests and procedures, however, no patients required breaks from using CASI for not feeling well. The CASI program accurately provided alcohol risk education to patients 100% of the time. Thirty-two percent of patients in the sample screened positive for at-risk drinking. Sixty percent of patients reported that CASI increased their knowledge of safe drinking limits, 39% reported some likeliness to change their alcohol use, and 28% reported some intention to consult a health care professional about their alcohol use as a result of their screening results. Ninety-three percent reported CASI was easy to use, 93% felt comfortable receiving alcohol education via computer, and 89% liked using CASI. Ninety percent of patients correctly identified their alcohol risk level after participating in CASI. With regard to research staff experience, RAs needed to provide standby assistance to patients during <1% of CASI administrations and needed to troubleshoot computer issues in 4% of interviews. The RAs distributed the correct alcohol risk normative profiles to patients 97% of the time and provided patients with treatment referrals when indicated 81% of the time. The RAs rated patients as “not bothered at all” by using CASI 94% of the time.
Conclusions
This study demonstrates that an ED-based computerized alcohol screening program is both acceptable to patients and effective in educating patients about their alcohol risk level. Additionally, this study demonstrates that few logistical problems related to using computers for these interventions were experienced by research staff: in most cases, staff accurately deployed alcohol risk education to patients, and in all cases, the computer provided accurate education to patients. Computer-assisted SBIRT may represent a significant time-saving measure, allowing EDs to reach larger numbers of patients for alcohol intervention without causing undue clinical burden or interruptions to clinical care. Future studies with follow-up are needed to replicate these results and assess drinking reductions post-intervention.
doi:10.1186/1940-0640-8-2
PMCID: PMC3554507  PMID: 23324597
Computerized alcohol screening; Brief intervention; Emergency department; SBIRT
25.  Alcohol use disorder-related sick leave and mortality: a cohort study 
Background
Alcohol use disorders (AUDs) are associated with the highest all-cause mortality rates of all mental disorders. The majority of patients with AUDs never receive inpatient treatment for their AUD, and there is lack of data about their mortality risks despite their constituting the majority of those affected. Absenteeism from work (sick leave) due to an AUD likely signals worsening. In this study, we assessed whether AUD-related sick leave was associated with mortality in a cohort of workers in Germany.
Methods
128,001 workers with health insurance were followed for a mean of 6.4 years. We examined the associations between 1) AUD-related sick leave managed on an outpatient basis and 2) AUD-related psychiatric inpatient treatment, and mortality using survival analysis, and Cox proportional hazard regression models (separately by sex) adjusted for age, education, and job code classification. We also stratified analyses by sick leave related to three groups of alcohol-related conditions (all determined by International Classification of Diseases 9th ed. (ICD-9) codes): alcohol abuse and dependence; alcohol-induced mental disorder; and alcohol-induced medical conditions.
Results
Outpatient-managed AUD-related sick leave was significantly associated with higher mortality (hazard ratio (HR) 2.90 (95% Confidence interval (CI) 2.24-3.75) for men, HR 5.83 (CI 2.90-11.75) for women). The magnitude of the association was similar for receipt of AUD-related psychiatric inpatient treatment (HR 3.2 (CI 2.76-3.78) for men, HR 6.5 (CI 4.41-9.47) for women). Compared to those without the conditions, higher mortality was observed consistently for outpatients and inpatients across the three groups of alcohol-related conditions. Those with alcohol-related medical conditions who had AUD-related psychiatric inpatient treatment appeared to have the highest mortality.
Conclusions
Alcohol use disorder-related sick leave as documented in health insurance records is associated with higher mortality. Such sick leave does not necessarily lead to any specific AUD treatment. Therefore, AUD-related sick leave might be used as a trigger for insurers to intervene by offering AUD treatment to patients to try to reduce their risk of death.
doi:10.1186/1940-0640-8-3
PMCID: PMC3565982  PMID: 23363536
Workers; Alcohol; Mortality; Gender; Addiction; Outpatients; Inpatients

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