Identifying and responding to trial implementation challenges during multisite clinical trials.

INTRODUCTION: The National Drug Abuse Treatment Clinical Trials Network (CTN) was initiated by the National Institute on Drug Abuse (NIDA) in 2000 with the aim of improving substance use treatment and reducing the time between the discovery of effective treatments and their implementation into clinical practice. While initial trials were conducted almost exclusively in specialty addiction treatment settings, the CTN began evolving strategically in 2010 to conduct research in general medical settings, including healthcare systems, primary care settings, emergency departments, and pharmacies, to broaden impact. The advantages of a research network like the CTN is not only the collective content expertise that investigators contribute to the network, but the collective experience gained by conducting studies in the network and then applying those lessons to future studies. OBJECTIVE: To summarize trial implementation challenges encountered, and the process by which solutions were identified and implemented, within one of the last early-phase CTN Stage II behavioral intervention studies conducted in a specialty addiction treatment setting. METHOD AND RESULTS: We describe the implementation of the CTN-0037 STimulant Reduction Intervention using Dosed Exercise (STRIDE) trial. Issues encountered during study implementation are categorized into four major areas, described in terms useful to future study teams: 1) study team infrastructure challenges, 2) participant- and site- level challenges, 3) intervention-related challenges, and 4) longitudinal study design challenges. Potential consequences of identified problems and the solutions developed to manage these problems are discussed within the context of these four areas. We propose how to extend these implementation lessons and apply them in other healthcare settings to expand the CTN. CONCLUSIONS: Effective study management allows for flexible, collaborative solutions to expected and unexpected obstacles to study success. Implementation strategies derived from the first 15 to 20 years of CTN studies are a result of working with providers and participants, and the ongoing collaboration among CTN investigators and network staff. Timely identification and response to problems during study implementation are critical to the success of a trial, regardless of its design. We believe a collaborative approach to identifying and responding to study implementation challenges will increase the likelihood of successful adoption of relevant, efficacious interventions. As the CTN continues to expand, the wealth of successful trial implementation strategies developed during the first 20 years of the CTN need to be applied and adapted to studies in broader network settings, and considered in conjunction with more formalized implementation science processes that are currently available.

Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder: Results From the CTN-0037 STimulant Reduction Intervention Using Dosed Exercise (STRIDE) Study.

OBJECTIVE: To evaluate exercise as a treatment for stimulant use disorders. METHODS: The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study was a randomized clinical trial conducted in 9 residential addiction treatment programs across the United States from July 2010 to February 2013. Of 497 adults referred to the study, 302 met all eligibility criteria, including DSM-IV criteria for stimulant abuse and/or dependence, and were randomized to either a dosed exercise intervention (Exercise) or a health education intervention (Health Education) control, both augmenting treatment as usual and conducted thrice weekly for 12 weeks. The primary outcome of percent stimulant abstinent days during study weeks 4 to 12 was estimated using a novel algorithm adjustment incorporating self-reported Timeline Followback (TLFB) stimulant use and urine drug screen (UDS) data. RESULTS: Mean percent of abstinent days based on TLFB was 90.8% (SD = 16.4%) for Exercise and 91.6% (SD = 14.7%) for Health Education participants. Percent of abstinent days using the eliminate contradiction (ELCON) algorithm was 75.6% (SD = 27.4%) for Exercise and 77.3% (SD = 25.1%) for Health Education. The primary intent-to-treat analysis, using a mixed model controlling for site and the ELCON algorithm, produced no treatment effect (P = .60). In post hoc analyses controlling for treatment adherence and baseline stimulant use, Exercise participants had a 4.8% higher abstinence rate (78.7%) compared to Health Education participants (73.9%) (P = .03, number needed to treat = 7.2). CONCLUSIONS: The primary analysis indicated no significant difference between exercise and health education. Adjustment for intervention adherence showed modestly but significantly higher percent of abstinent days in the exercise group, suggesting that exercise may improve outcomes for stimulant users who have better adherence to an exercise dose. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01141608.

A cross-sectional assessment of the long term effects of brief strategic family therapy for adolescent substance use.

BACKGROUND: Young adult drug use and law-breaking behaviors often have roots in adolescence. These behaviors are predicted by early drug use, parental substance use disorders, and disrupted and conflict-ridden family environments. AIM: To examine long-term outcomes of Brief Strategic Family Therapy (BSFT) compared to treatment as usual (TAU) in the rates of drug use, number of arrests and externalizing behaviors in young adults who were randomized into treatment conditions as adolescents. DESIGN: 261 of 480 adolescents who had been randomized to BSFT or TAU in the BSFT effectiveness study were assessed at a single time, 3-7 years post randomization. METHODS: Assessments of drug use, externalizing behaviors, arrests and incarcerations were conducted using Timeline Follow Back, Adult Self Report, and self-report, respectively. Drug use, arrests and incarcerations were examined using negative binomial models and externalizing behaviors were examined using linear regression. RESULTS: When compared with TAU, BSFT youth reported lower incidence of lifetime (IRR = 0.68, 95%CI [0.57, 0.81]) and past year (IRR = 0.54, 95%CI [0.40, 0.71]) arrests; lower rates of lifetime (IRR = 0.63, 95%CI [0.49, 0.81]) and past year (IRR = 0.70, 95%CI [0.53, 0.92]) incarcerations; and lower scores on externalizing behaviors at follow-up (B = -0.42, SE = .15, p = .005). There were no differences in drug use. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: BSFT may have long term effects in reducing the number of arrests, incarcerations and externalizing problems. These effects could be explained by the improvements in family functioning that occurred during the effectiveness study. This study contributes to the literature by reporting on the long term outcomes of family therapy for adolescent drug abuse.

Patient perspectives on the doctor of the future.

BACKGROUND AND OBJECTIVES: Health care reform has been the subject of considerable debate, particularly among those in politics, insurance, and business. Patients, however, have largely been ignored in this discussion. As the role of the health care consumer receives increased attention, it is important to consider patient values and preferences for a future system of care. This study describes what patients want and value in a future doctor METHODS: This study was conducted in 1999-2000, using focus group methodology involving 78 members of communities in seven regions of Colorado. Participants were selected to ensure a distribution of rural/urban, racial/ethnic groups and different regions of the state. All participants had visited a health care provider in the previous 10 years. Data were analyzed with a team-based editing approach. RESULTS: Participants identified several primary domains and subthemes that describe what they want in a doctor of the future. The primary themes related to future doctors' medical and contextual knowledge of the patient, their personal characteristics and philosophical approach to health and health care, and desired qualities of the doctor-patient relationship. CONCLUSIONS: Patients wanted their future doctors to improve their experience of care and to be patient-centered, family-oriented, and community-oriented doctors. Patient perspectives of the doctor of the future should be considered in decisions about health care policy.