Pharmacists improve diabetes outcomes: a randomized controlled trial

BackgroundThere is a growing shortage of primary care physicians. Pharmacists can fill the gap, and interdisciplinary teams are being evaluated as part of health care reform.ObjectiveThis study aimed to determine whether adding a pharmacist to an interprofessional health team will improve diabetes outcomes.MethodsIn this 2-phase pilot study, Medicaid-eligible patients with diabetes were randomized to receive standard of care (control arm) or standard of care plus the care of a pharmacist (intervention arm) for 12 months (phase 1). The primary outcome was change in glycated hemoglobin (A1C) from baseline. Secondary outcomes included identifying and correcting medication therapy problems (MTPs) for comorbid conditions, adherence to preventive care visits, health care utilization, self-rated health, and satisfaction surveys. After phase 1, patients in the control arm who did not achieve an A1C of < 8% were eligible to enroll into phase 2 where they received treatment with a pharmacist for 6 months.ResultsOf the 239 patients enrolled, 122 completed phase 1. At 12 months, intervention patients’ mean A1C was 1.85 percentage point (pp) below baseline versus 0.94 pp for control (between-group difference 0.91 pp; P = 0.0218). Most control patients (79%) who completed phase 1 and enrolled into phase 2 improved their A1C by more than 1 pp (P < 0.01). The pharmacists completed 806 patient visits and identified 2638 MTPs. Intervention patients were more adherent to preventive care visits with nutrition (P = 0.043), ophthalmology (P = 0.002), and dentistry (P = 0.007). For intervention patients, 78% rated their experience with the pharmacist as excellent whereas, for control patients, 37% rated their experience with their provider as excellent.ConclusionPharmacist comanagement of patients with diabetes can significantly improve glucose control and patient satisfaction. Creative payment models were used to include pharmacists in the interprofessional patient care team.     

Brief alcohol intervention for general hospital inpatients: a randomized controlled trial

AIM: To test the effectiveness of a brief alcohol intervention among non-dependent general hospital inpatients with alcohol problems, delivered by either a specialized liaison service or hospital physicians. METHOD: All inpatients of 29 wards from four general hospitals of one region in Germany were screened for alcohol problems (n=14,332). Of those screening positive, 595 patients were included in a randomized controlled group design using a time-frame. Patients with alcohol dependence were not considered in this study. Patients received Motivational Interviewing based counselling either by a specialized liaison service, by hospital physicians trained under routine conditions or received hospital treatment as usual without additional counselling. One year later, alcohol consumption, motivation and well-being were assessed. Sample survey analyses and generalized estimating equations were conducted. RESULTS: At baseline, the three groups differed regarding motivation, with higher motivation among the controls. At follow-up, the groups did not differ regarding alcohol consumption, alcohol-related problems and well-being. All groups decreased their alcohol consumption significantly. Regarding motivation, longitudinal analyses revealed significant interaction effects of time and intervention (p<0.05), indicating a stronger increase of readiness to change drinking and a less profound drop of readiness to seek help among those who received intervention compared to the controls. CONCLUSION: The intervention was not effective in reducing alcohol consumption or in increasing well-being 12 months after hospitalization. It had a positive effect on readiness to change drinking and on readiness to seek formal help for alcohol problems. The intervention groups compensated their lag of motivation.     

A randomized trial of two behavioral interventions to improve outcomes following inpatient detoxification for alcohol dependence

Participants (n=150), undergoing inpatient alcohol detoxification, were randomized into 3 groups: treatment as usual (TAU), motivation enhancement therapy (MET), or peer-delivered 12-step facilitation (P-TSF). The main outcome was the initiation of any type of subsequent rehabilitation service (i.e., professional treatment or self-help) within 30 and 90 days of discharge. At the 30-day follow-up interview, there was no significant difference among the groups in the rate of initiation of any type of subsequent care (82%, 74%, and 82%, respectively, p=0.617); however, the MET group had significantly more patients initiate subsequent inpatient treatment by the 90-day follow-up interview compared to the P-TSF group (31% and 61%, respectively, p=0.007) and a greater proportion of MET participants completed subsequent inpatient treatment compared to both the TAU and P-TSF groups. There were no differences in drinking-related outcomes. MET during inpatient detoxification may help patients initiate subsequent inpatient rehabilitation treatment.     

Pilot randomized controlled trial of a brief alcohol intervention group for adolescents

The aim of this study was to identify whether a brief motivational interviewing and cognitive - behavioural-based alcohol intervention group (AIG) programme is feasible with young people at risk of developing a problem with alcohol, and to assess the short-term effectiveness of the intervention. Participants were assigned randomly to receive a group intervention of four sessions duration (n = 17; AIG) or no treatment (n = 17, control group). Participants were volunteers recruited from a youth centre on the Central Coast of New South Wales, Australia, comprising youths aged 12 - 19 years who were interested in participating in the study. The Readiness to Change Questionnaire, items from the AUDIT, the DAP Quick Screen and a knowledge questionnaire were administered at pretreatment, post-treatment and at 1- and 2-month follow-ups. Participants in the AIG programme showed an increase in readiness to reduce their alcohol consumption. They also reduced their frequency of drinking at post-treatment and the first follow-up assessment, while the control group reported increases at the second follow-up assessment. The control group also increased their hazardous drinking and frequency of binge drinking compared to the AIG. The intervention appeared to improve the AIG participants' knowledge about alcohol and its effects. The results provide preliminary evidence for the effectiveness of the AIG programme in training young people to set limits on alcohol consumption, increase awareness of safe drinking levels and the effects of alcohol abuse. This pilot study also showed that young people who are identified as being 'at risk' of developing alcohol abuse, and who are also ambivalent about changing drinking behaviours, can be recruited and retained in a treatment programme. [Bailey KA, Baker AL, Webster RA, Lewin TJ. Pilot randomized controlled trial of a brief alcohol intervention group for adolescents. Drug Alcohol Rev 2004;23:157 - 166]     

A randomized clinical trial of a therapeutic community treatment for female inmates: outcomes at 6 and 12 months after prison release

This random assignment study compared female offenders (n = 468) with substance use disorders in a prison therapeutic community program with those in a cognitive-behavioral intervention. The study demonstrates that all women benefitted from gender-sensitive prison treatment, but the therapeutic community was more effective in reducing drug use, criminal activity, and exposure to trauma and increasing mental health functioning and time until reincarceration during the year after prison. In addition, the ability to sustain and even improve behavior change after the women leave prison highlights the importance of providing accessible community-based continuity of mental health and substance abuse services during reentry.     

The efficacy of compliance therapy in pharmacotherapy for alcohol dependence: a randomized controlled trial

OBJECTIVE: This study sought to evaluate the effectiveness of compliance therapy in increasing adherence to pharmacological treatment for alcohol dependence. METHOD: Forty subjects were randomly allocated to receive usual medical care (n = 20) or usual medical care plus compliance therapy (n = 20). All subjects were prescribed acamprosate (Campral) for 4 months. Subjects were volunteers treated at a hospital-based outpatient drug and alcohol treatment service, and were men and women who were 18-65 years old and with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of alcohol dependence. All subjects received usual medical care consisting of seven medical reviews (duration = 15 minutes) over 4 months. Compliance therapy consisted of four to six individual sessions (duration = 60 minutes) in which beliefs about medication side effects, ambivalence, the benefits of treatment, treatment maintenance and relapse prevention were addressed and explored with motivational interviewing and cognitive behavior therapy techniques. RESULTS: The outcome variables were number of days taking acamprosate, days to first drink, days to first relapse (more than five drinks) and days to first extended relapse (greater than 2 consecutive days of more than five drinks). Intention-to-treat analyses showed little difference between the two groups in the outcome drinking measures. Nevertheless, the per-protocol analyses revealed that participation in three or more sessions of compliance therapy significantly increased adherence to acamprosate and improved overall treatment outcomes. CONCLUSIONS: The present study highlights the need for psychological interventions to improve adherence to pharmacotherapy in the treatment of alcohol dependence and provides initial support for compliance therapy as an effective intervention.     

Web-based alcohol prevention for incoming college students: A randomized controlled trial

College students are an at-risk population based on their heavy alcohol consumption and associated consequences. First-year students are at particular risk due to greater freedom and access to alcohol on campus. Web-based (electronic) interventions (e-interventions) are being rapidly adopted as a universal approach to prevent high-risk drinking, but have not been well evaluated. The objective of this study was to investigate the effectiveness of the two most widely adopted EIs, AlcoholEdu and The Alcohol eCHECKUP TO GO (e-Chug), in reducing both alcohol use and alcohol-related consequences in incoming college students. To do so, we conducted a 3-group randomized trial (N = 82) comparing AlcoholEdu and e-Chug to an assessment-only control group. Compared to the assessment-only control group, participants in the AlcoholEdu and e-Chug groups reported lower levels of alcohol use across multiple measures at 1-month follow-up. Participants who received AlcoholEdu showed significantly fewer lower alcohol-related consequences than assessment-only controls, while there was a trend for reduced consequences in participants who received e-Chug versus assessment-only. Findings indicate that e-intervention is a promising prevention approach to address the problem of college student alcohol consumption, especially for campuses that have limited resources.     

Genetic susceptibility testing in smoking-cessation treatment: One-year outcomes of a randomized trial

This study evaluated the long-term impact of genetic susceptibility biomarker feedback on smoking behavior change and symptoms of depression in 426 male and female smokers. Smokers were randomized to one of three smoking-cessation interventions: minimal contact quit-smoking counseling (QSC), QSC + exposure biomarker feedback (EBF), and QSC + EBF + biomarker feedback about genetic susceptibility to lung cancer (SBF). The logistic regression model for quit attempt revealed a significant main effect for treatment such that participants in the SBF group were more than two times more likely to make a quit attempt than participants in the QSC group. There was not a significant difference between EBF and QSC participants. The results also revealed a significant effect for baseline stage of change. Those smokers in the preparation stage at baseline were more than three times more likely to make a quit attempt over the 12 months following treatment. The models for 30-day cessation and follow-up smoking rate revealed no significant main or interacting effects for treatment. A repeated measures analysis of variance revealed a significant main effect for time, indicating that an initial increase in depression in the genetic susceptibility group was not maintained over time. Genetic susceptibility feedback has the intended effects on motivation to quit, but it may need to be delivered within a more intensive smoking-cessation treatment for the heightened motivation to translate into smoking cessation.     

Effects of topiramate on neural responses to alcohol cues in treatment-seeking individuals with alcohol use disorder: preliminary findings from a randomized,placebo-controlled trial

Topiramate, a GABA/glutamate modulator, is efficacious in reducing alcohol consumption, though the mechanisms underlying this effect are not well characterized. This study analyzed functional magnetic resonance imaging (fMRI) data from 22 heavy drinkers enrolled in a 12-week placebo-controlled, randomized clinical trial of topiramate to examine the effects of topiramate on alcohol cue-elicited brain responses, craving, and heavy drinking in individuals with DSM-5 alcohol use disorder. Patients were randomized to receive either topiramate (maximal daily dosage of 200 mg/day) or placebo and were administered an fMRI alcohol cue-reactivity task at baseline (before starting medication) and after 6 weeks of double-blind treatment. Analyses compared the topiramate (n = 12) and placebo (n = 8) groups on (1) the change in brain responses during alcohol cue exposure (vs non-alcohol cues) within five a priori regions of interest related to reward—the bilateral and medial orbitofrontal cortex (OFC) and bilateral ventral striatum (VS) and (2) change in craving and heavy drinking days (HDDs) from baseline and scan 2. Topiramate, relative to placebo, reduced alcohol cue-elicited activation of the left VS, bilateral OFC, and medial OFC, alcohol cue-elicited craving, and HDDs between baseline and 6 weeks of treatment. The reduction in alcohol cue-elicited activation in the medial OFC correlated with reductions in craving, and reduced activation in the right VS, right OFC, and medial OFC correlated with the reduction in HDD. This preliminary study provides evidence that topiramate’s attenuation of alcohol cue-elicited brain activation and craving are key elements of the drug’s neurobiological mechanism of action in reducing heavy drinking.Subject terms: Translational research, Predictive markers     

Reducing the severity of alcohol withdrawal with oral baclofen: a randomized controlled trial

Background: Alcohol withdrawal syndrome (AWS) increases the complexity of inpatient medical care. Baclofen has shown promise in previous studies to modulate the symptoms of AWS. Our objective was to determine if baclofen, when added to symptom triggered benzodiazepines, could prevent medical inpatients at risk for AWS from progressing to moderate or severe AWS.

Methods: Double Blind, placebo controlled, randomized trial. Trial registered at ClinicalTrials.gov registration ID NCT02052440. Medical inpatients at a University-affiliated, urban public safety net hospital who were at risk for, or with mild, AWS received Baclofen 10?mg or placebo by mouth every 8?h plus usual care. The primary outcome was the percentage of patients progressing to moderate or severe AWS. Secondary outcomes included the difference in the mean AWS assessment scores at 24, 48, and 72?h and peak and total dosages of benzodiazepines.

Results: 101 of 166 targeted patients were enrolled. The primary outcome occurred in 13 of 50 (26%) patients receiving baclofen and 16 of 51 (31%) receiving placebo (p?=?0.55). Mean cumulative diazepam administered was 66?mg (±51 SD) in the baclofen group and 85?mg (±63) in the placebo group (p?=?0.13). Mean highest dose diazepam was 11?mg (±3) in the baclofen group and 12?mg (±7) in the placebo group (p =?0.14).

Conclusion: The addition of baclofen to usual care did not result in a significant difference in progression to moderate or severe AWS but we interpret this result with caution given that we did not meet the enrollment goal.

Trial registration: ClinicalTrials.gov identifier: NCT02052440.     

Randomized trial of a reentry modified therapeutic community for offenders with co-occurring disorders: crime outcomes

This article describes a randomized study to determine the effectiveness of a reentry modified therapeutic community (RMTC) for offenders with co-occurring substance use and mental disorders (co-occurring disorders or COD). Men with COD, approved for community corrections placement postrelease, were recruited from nine Colorado prisons and stratified according to the type of treatment received while incarcerated (i.e., a prison modified therapeutic community [MTC] program or standard care). When released, each offender was randomly assigned either to the experimental RMTC (E-RMTC) condition (n = 71) or to the control parole supervision and case management (PSCM) condition (n = 56). An intent-to-treat analysis 12 months postprison release showed that the E-RMTC participants were significantly less likely to be reincarcerated (19% vs. 38%), with the greatest reduction in recidivism found for participants who received MTC treatment in both settings. These findings support the RMTC as a stand-alone intervention and provide initial evidence for integrated MTC programs in prison and in aftercare for offenders with COD.     

A preliminary,randomized trial of aerobic exercise for alcohol dependence

Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relatively untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n = 25) or a brief advice to exercise intervention (BA-E; n = 23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Furthermore adherence to AE strengthened the beneficial effect of intervention on alcohol use outcomes. While high levels of moderate-intensity exercise appeared to facilitate alcohol recovery regardless of intervention arm, attending the group-based AE intervention seemed to further enhance the positive effects of exercise on alcohol use. Study findings indicate that a moderate intensity, group aerobic exercise intervention is an efficacious adjunct to alcohol treatment. Improving adherence to the intervention may enhance its beneficial effects on alcohol use.     

Developmentally inspired drug prevention: middle school outcomes in a school-based randomized prevention trial

Prior investigations have linked behavioral competencies in primary school to a reduced risk of later drug involvement. In this randomized prevention trial, we sought to quantify the potential early impact of two developmentally inspired universal preventive interventions on the risk of early-onset alcohol, inhalant, tobacco, and illegal drug use through early adolescence. Participants were recruited as they entered first grade within nine schools of an urban public school system. Approximately, 80% of the sample was followed from first to eighth grades. Two theory-based preventive interventions, (1) a family-school partnership (FSP) intervention and (2) a classroom-centered (CC) intervention, were developed to improve early risk behaviors in primary school. Generalized estimating equations (GEE) multivariate response profile regressions were used to estimate the relative profiles of drug involvement for intervention youths versus controls, i.e. youth in the standard educational setting. Relative to control youths, intervention youths were less likely to use tobacco, with modestly stronger evidence of protection associated with the CC intervention (RR=0.5; P=0.008) as compared to protection associated with the FSP intervention (RR=0.6; P=0.042). Intervention status was not associated with risk of starting alcohol, inhalants, or marijuana use, but assignment to the CC intervention was associated with reduced risk of starting to use other illegal drugs by early adolescence, i.e. heroin, crack, and cocaine powder (RR=0.32, P=0.042). This study adds new evidence on intervention-associated reduced risk of starting illegal drug use. In the context of 'gateway' models, the null evidence on marijuana is intriguing and merits attention in future investigations.     

Efficacy and tolerability of baclofen in a U.S. community population with alcohol use disorder: a dose-response,randomized, controlled trial

Identification of new medications for alcohol use disorder (AUD) is important for improving treatment options. Baclofen, a GABA_B agonist, has been identified as a potential pharmacotherapy for AUD. In a 16-week double-blind, randomized, placebo-controlled trial, we investigated 30 and 90 mg/day of baclofen compared to placebo and examined effects of dose, sex, and level of pretreatment drinking. One hundred and twenty participants with DSM-IV alcohol dependence (age 46.1 (sd = 10.1) years, 51.7% male) were randomized after exclusion for unstable medical/psychiatric illness and/or dependence on drugs other than nicotine. Seventy-three participants completed the trial. A main effect of baclofen was found [%HDD (F(2,112) = 4.16, p = 0.018, d = 0.51 95%CI (0.06–0.95), 13.6 fewer HDD) and %ABST (F(2,112) = 3.68, p = 0.028, d = 0.49 95%CI (0.04–0.93), 12.9 more abstinent days)] and was driven by the 90 mg/day dose. A sex × dose interaction effect was present for both %HDD (F(2,110) = 5.48, p = 0.005) and %ABST (F(2,110) = 3.19, p = 0.045). Men showed a marginally positive effect for 90 mg/day compared to PBO (%HDD t(110) = 1.88, p = 0.063, d = 0.36 95%CI (−0.09–0.80), 15.8 fewer HDD days; %ABST t(110) = 1.68 (p = 0.096, d = 0.32 95%CI (−0.12–0.76), 15.7 more ABST)) with no effect for 30 mg/day. Women showed a positive effect for 30 mg/day (%HDD, t(110) = 3.19, p = 0.002, d = 0.61 95%CI (0.16–1.05), 26.3 fewer HDD days; %ABST t(110) = 2.73, p = 0.007, d = 0.52 95%CI (0.07–0.96), 25.4 more ABST days) with marginal effects for 90 mg/day on %ABST (p = 0.06) with drop-outs/dose reduction from sedative side-effects of 59% in women at 90 mg/day compared to 5% for men. These findings support the hypothesis that baclofen has efficacy in AUD and suggest that dose and sex be further explored as potential moderators of baclofen response and tolerability.Subject terms: Drug development, Psychiatric disorders     

Urn models for response-adaptive randomized designs: a simulation study based on a non-adaptive randomized trial

Recently, response-adaptive designs have been proposed in randomized clinical trials to achieve ethical and/or cost advantages by using sequential accrual information collected during the trial to dynamically update the probabilities of treatment assignments. In this context, urn models—where the probability to assign patients to treatments is interpreted as the proportion of balls of different colors available in a virtual urn—have been used as response-adaptive randomization rules.

We propose the use of Randomly Reinforced Urn (RRU) models in a simulation study based on a published randomized clinical trial on the efficacy of home enteral nutrition in cancer patients after major gastrointestinal surgery. We compare results with the RRU design with those previously published with the non-adaptive approach. We also provide a code written with the R software to implement the RRU design in practice.

In detail, we simulate 10,000 trials based on the RRU model in three set-ups of different total sample sizes. We report information on the number of patients allocated to the inferior treatment and on the empirical power of the t-test for the treatment coefficient in the ANOVA model. We carry out a sensitivity analysis to assess the effect of different urn compositions.

For each sample size, in approximately 75% of the simulation runs, the number of patients allocated to the inferior treatment by the RRU design is lower, as compared to the non-adaptive design. The empirical power of the t-test for the treatment effect is similar in the two designs.