Multisite Randomized Clinical Trial Research Articles

Hispanic Subgroups, Acculturation, and Substance Abuse Treatment Outcomes

This study explored Hispanic subgroup differences in substance use treatment outcomes, and the relationship of acculturation characteristics to these outcomes. Data were from a multisite randomized clinical trial of motivational enhancement therapy versus treatment as usual in a sample of Spanish-speaking substance abusers. Participants were Cuban American (n=34), Mexican American (n=209), Puerto Rican (n=78), and other Hispanic American (n=54). Results suggested that Cuban Americans and individuals with more connection to Hispanic culture had lower treatment retention. Hispanics born in the U.S and those who spoke English at home had a lower percentage of days abstinent during weeks 5–16, although Puerto Ricans born in the U.S. and Cuban Americans living more years in the U.S. had a higher percentage of days abstinent in weeks 1–4 and 5–16, respectively. Results may inform future hypothesis-driven studies in larger Hispanic treatment seeking samples of the relationship between acculturation and treatment outcome.

Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial.

Heart failure (HF) has a major effect on patients' health status, including their symptom burden, functional status, and health-related quality of life. To determine the effectiveness of a collaborative care patient-centered disease management (PCDM) intervention to improve the health status of patients with HF. The Patient-Centered Disease Management (PCDM) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF. A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of less than 60 (heavy symptom burden and impaired functional status and quality of life) were enrolled between May 2009 and June 2011. The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator, cardiologist, psychiatrist, and primary care physician; home telemonitoring and patient self-management support; and screening and treatment for comorbid depression. The primary outcome was change in the KCCQ overall summary score at 1 year (a 5-point change is clinically significant). Mortality, hospitalization, and depressive symptoms (Patient Health Questionnaire 9) were secondary outcomes. There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention (n=187) vs usual care (n=197); baseline mean KCCQ overall summary scores were 37.9 vs 36.9 (P=.48). There was significant improvement in the KCCQ overall summary scores in both groups after 1 year (mean change, 13.5 points in each group), with no significant difference between groups (P=.97). The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month, 6-month, and 12-month data (P=.74). Among secondary outcomes, there were significantly fewer deaths at 1 year in the intervention arm (8 of 187 [4.3%]) than in the usual care arm (19 of 197 [9.6%]) (P = .04). Among those who screened positive for depression, there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm (2.1 points lower, P=.01). There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm (29.4% vs 29.9%, P=.87). This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care. clinicaltrials.gov Identifier: NCT00461513.

A multi-site randomized clinical trial to reduce suicidal ideation in suicidal adult outpatients with Major Depressive Disorder: Development of a methodology to enhance safety.

Suicide is a major public health concern, yet there are very few randomized clinical trials that have been conducted to reduce suicidal ideation in patients at risk of suicide. We describe the rationale and refinements of such a trial that is designed to assess the effect of a hypnotic medication on suicidal ideation in adult outpatients currently experiencing suicidal ideation. "Reducing Suicidal Ideation Through Insomnia Treatment" is a multi-site randomized clinical trial that includes three recruiting sites and one data management site. This 4-year study is in its second year of recruitment. The purpose of the study is to compare hypnotic medication versus placebo as an add-on treatment to a selective serotonin reuptake inhibitor as a means of reducing suicidal ideation in depressed adult outpatients with insomnia and suicidal ideation. The safety features of the study follow the 2001 National Institutes of Health guidelines for studies that include patients at risk of suicide. In total, 584 potential participants have undergone telephone screening; 67% of these failed the phone screen, most often due to an absence of expressed suicidal ideation (26% of the telephone screen fails). A total of 115 people appeared for a face-to-face baseline assessment, and 40 of these had completed a taper off of their ineffective psychotropic medications before the baseline assessments. In all, 64% of those who completed baseline assessments failed to proceed to randomization, most commonly because of no clinically significant suicidal ideation (51% of those excluded at baseline). One participant was offered and accepted voluntary psychiatric hospitalization in lieu of study participation. Thus far, 40 participants have been randomized into the study and 88.7% of scheduled visits have been attended, with 93.8% adherence to the selective serotonin reuptake inhibitor and 91.6% adherence to the randomized hypnotic versus placebo. None of the randomized participants have required hospitalization or had a suicide attempt. By carefully considering the inclusion and exclusion criteria and other safety features, the safe conduct of randomized clinical trials in suicidal adult patients is possible, including the inclusion of participants who have undergone a prescribed tapering off of psychotropic medications prior to baseline assessment.

Effects of a One-Year Physical Activity Program on Serum C-Terminal Agrin Fragment (CAF) Concentrations among Mobility-Limited Older Adults.

C-terminal Agrin Fragment (CAF) has been proposed as a potential circulating biomarker for predicting changes in physical function among older adults. To determine the effect of a one-year PA intervention on changes in CAF concentrations and to evaluate baseline and longitudinal associations between CAF concentrations and indices of physical function. Ancillary study to the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P), a multi-site randomized clinical trial designed to evaluate the effects of chronic exercise on the physical function of older adults at risk for mobility disability. Four academic research centers within the U.S. Three hundred thirty three older adults aged 70 to 89 with mild to moderate impairments in physical function. A 12-month intervention of either structured physical activity (PA) or health education promoting successful aging (SA). Serum CAF concentrations and objectives measures of physical function - i.e. gait speed and performance on the Short Physical Performance Battery (SPPB). The group*time interaction was not significant for serum CAF concentrations (p=0.265), indicating that the PA intervention did not significantly reduce serum CAF levels compared to SA. Baseline gait speed was significantly correlated with baseline CAF level (r = -0.151, p= 0.006), however the association between CAF and SPPB was not significant. Additionally, neither baseline nor the change in CAF concentrations strongly predicted the change in either performance measure following the PA intervention. In summary, the present study shows that a one-year structured PA program did not reduce serum CAF levels among mobility-limited older adults. However, further study is needed to definitively determine the utility of CAF as a biomarker of physical function.

Comorbidities and Race/Ethnicity Among Adults with Stimulant Use Disorders in Residential Treatment

Comorbid physical and mental health problems are associated with poorer substance abuse treatment outcomes; however, little is known about these conditions among stimulant abusers at treatment entry. This study compared racial and ethnic groups on baseline measures of drug use patterns, comorbid physical and mental health disorders, quality of life, and daily functioning among cocaine and stimulant abusing/dependent patients. Baseline data from a multi-site randomized clinical trial of vigorous exercise as a treatment strategy for a diverse population of stimulant abusers (N = 290) were analyzed. Significant differences between groups were found on drug use characteristics, stimulant use disorders, and comorbid mental and physical health conditions. Findings highlight the importance of integrating health and mental health services into substance abuse treatment and could help identify potential areas for intervention to improve treatment outcomes for racial and ethnic minority groups.

Effects of Religious vs. Conventional Cognitive-Behavioral Therapy on Inflammatory Markers and Stress Hormones in Major Depression and Chronic Medical Illness: A Randomized Clinical Trial

Background: Depressive disorder is often accompanied by physiological changes that may adversely affect the course of medical illness, including an increase in pro-inflammatory cytokines. Methods: We examine the effects of religious cognitive behavioral therapy (RCBT) vs. conventional CBT (CCBT) on pro-/anti-inflammatory indicators and stress hormones in 132 individuals with major depressive disorder (MDD) and chronic medical illness who were recruited into a multi-site randomized clinical trial. Biomarkers (C-reactive protein and pro-inflammatory cytokines TNF-α, IL-1β, IFN-γ, IL-6, IL-12-p70), anti-inflammatory cytokines (IL1ra, IL-4, IL-10), and stress hormones (urinary cortisol, epinephrine, norepinephrine) were assessed at baseline, 12 weeks, and 24 weeks. Differential effects of baseline religiosity on treatment response were also examined, along with effects of religiosity on changes in biomarkers over time independent of treatment group. Biomarker levels were log transformed where possible to normalize distributions. Mixed models were used to examine trajectories of change. Results: CRP increased and IL-4, IL-10, and epinephrine decreased over time, mostly in the opposite direction expected (except epinephrine). No significant difference between RCBT and CCBT was found on average trajectory of change in any biomarkers. Religiosity interacted with treatment group in effects on IL-6, such that CCBT was more effective than RCBT in lowering lL-6 in those with low religiosity whereas RCBT appeared to be more effective than CCBT in those with high religiosity. Higher baseline religiosity also tended to predict an increase in pro-inflammatory cytokines INF-γ and IL-12 (p70) and urinary cortisol over time. Conclusions: RCBT and CCBT had similar effects on stress biomarkers. CCBT was more effective in reducing IL-6 levels in those with low religiosity, whereas RCBT tended to be more effective in those with high religiosity. Unexpectedly, higher baseline religiosity was associated with an increase in several stress biomarkers.

Strategies to influence attitudes towards pharmacotherapies for alcohol and opioid use disorders

Clinical Trials Network 0019 (CTN 0019) (Tross et al., 2008). The CTN 0019 protocol was a multi-site randomized clinical trial that assessed the intervention of Safer Sex Skills Building (SSSB) in women substance abusers on reducing HIV sexual risk. The current study consists of 124 AA women from the CTN 0019 dataset. Participation eligibility required women to be at least 18 years of age, proficient in English, enrolled in substance abuse treatment, and to acknowledge unprotected heterosexual intercourse within the past 6 months. Results: In the current sample, 70.2% (N=87) endorsed lifetime physical abuse from a male sexual partner. Of the women experiencing physical abuse, 33.3% (N=29) reported physical abuse from their current main partner. Independent sample t-tests showed that women who self-reported physical abuse had lower levels of SRP than those who did not (t(118) =3.18; p< .01). The moderation model of SRP decreasing the relationship between victimization and risky sexual behavior approached significance (p= .064). Conclusions: The current study is among the first to examine moderating factors of SRP in substance-abusing African American women. The findings from this study provide evidence that substance abuse interventions may benefit from activities promoting the development of sexual relationship power and self-efficacy in substance-abusing African American women who have experienced victimization. Financial support: No financial support was provided for the current study.

Abstract 16320: The Practical Use of the Latest Standards of Electrocardiography (PULSE) Trial: Nursing-Focused Intervention Improves Nurses’ Knowledge and Quality of ECG Monitoring

Objectives: To evaluate the effect of implementing AHA practice standards for ECG monitoring on nurses’ knowledge (NK), quality of care (QoC), and patient outcomes (PO). We hypothesized that our intervention would increase NK, which would enhance QoC, which would lead to improved PO. Methods: The PULSE Trial was a 6-year multi-site randomized clinical trial with crossover that took place in 65 cardiac units in 17 hospitals. We randomized hospitals to the Experimental (Exp) or Control group after obtaining baseline data at T1. We collected data at 2 additional time points: T2 after the intervention in the Exp group and T3 after the intervention in the Control group. The 2-part intervention consisted of an interactive online ECG monitoring education program and strategies to implement and sustain change in practice, led by nurse champions on each unit. We measured NK by a validated 20-item online test. We assessed QoC over 5 consecutive days by observing monitors and electrode placement, reviewing current medical records, and comparing arrhythmias stored in the monitor with nurses’ documentation. For PO, we used administrative and lab data to identify a subset of medical records for review to determine mortality and in-hospital MI. To account for covariates and intra-hospital and unit correlations, we used linear mixed models for NK, generalized linear mixed models for QoC, and generalized estimating equations for PO. The intervention was significantly associated with better NK and improved markers of QoC. NK was not sustained at T3 in the Exp group, but was significantly better than at T1 (p&lt;.0001). For several QoC variables, at T2 the Exp group was better than at T1 (p&lt;.05), and better than the Control group (p&lt;.05); at T3, the Control group improved (p&lt;.05) and improvement was sustained in the Exp group. The intervention was not associated with change in PO. Conclusions: Online education and strategies to change practice can result in improved NK and QoC related to ECG monitoring.

The ROARI project – Road Accident Acute Rehabilitation Initiative: a randomised clinical trial of two targeted early interventions for road-related trauma

Objectives: To determine the effectiveness of an Early Rehabilitation Intervention (ERI ) versus a Brief Education Intervention (BEI) following road trauma. Primary objective: return to work or usual activities at 12 weeks (for minor/moderate injury) and 24 weeks for major injury. Secondary objectives: Reduction in pain, anxiety, depression, disability and incidence of Post Traumatic Stress Disorder and improved quality of life. Design: A multi-site single-blinded stratified randomized clinical trial (RCT). Methods: 184 patients (92 in each arm) were recruited over 18 months and followed for 12 weeks (minor/moderate injury) and 24 weeks (major injury). Screening questionnaires at 2-4 weeks and follow-up interviews by phone for all outcome measures were undertaken. For those in the ERI group with a positive screen for high risk of persistent symptoms, an early assessment and intervention by a Rehabilitation Physician was offered. Those in the BEI group were sent written information and advised to see their GP. Results: 89.4% of injuries were mild in this cohort. At 12 weeks 73.8% and 69.1% of patients in the ERI and the BEI groups respectively had returned to work or usual activities. There were no significant differences between the two intervention groups with respect to the primary or any secondary outcome measures. Conclusion: This is the first RCT of an ERI following road trauma in Australia. A targeted ERI is as effective as a BEI in assisting those with mild/moderate trauma to return to work or usual activities.

The effect of implementing the Outcome Questionnaire-45.2 feedback system in Norway: A multisite randomized clinical trial in a naturalistic setting

It has been claimed that the monitoring of ongoing psychotherapy is of crucial importance for improving the quality of mental health care. This study investigated the effect of using the Norwegian version of the patient feedback system OQ®-Analyst using the Outcome Questionnaire-45.2. Patients from six psychiatric clinics in Southern Norway (N = 259) were randomized to feedback (FB) or no feedback (NFB). The main effect of feedback was statistical significant (p = .027), corroborating the hypothesis that feedback would improve the quality of services, although the size of the effect was small to moderate (d = 0.32). The benefits of feedback have to be considered against the costs of implementation.

Use of a Frequency-Modulated System for Veterans with Blast Exposure, Perceived Hearing Problems, and Normal Hearing Sensitivity

Traumatic brain injury can impact the central auditory system leading to poor auditory recall and increased difficulties hearing in poor acoustic environments. In recent years, audiologists have increasingly encountered blast-exposed veterans who report speech understanding problems that are disproportionate to their essentially normal hearing sensitivity, and thus are thought to have an auditory processing disorder. In light of studies showing frequency-modulated (FM) systems to be effective rehabilitation for auditory processing difficulties, we examined the use of an FM system intervention for blast-exposed veterans with functional hearing problems in the presence of normal hearing sensitivity. The outcomes for three veterans who were provided with an FM system as part of a multisite randomized clinical trial are described. Data indicate that FM systems are beneficial for some patients reporting hearing problems in the presence of normal hearing sensitivity but factors other than audiometric profile and reported complaints influence outcome. These include understanding of speech in noise, patient communication demands, auditory lifestyle, and the presence of posttraumatic stress disorder or other mental health factors. Furthermore, education (and reeducation if necessary) of the patient and their spouse or family is critical to successful outcome.

Eating disorder symptoms and quality of life: where should clinicians place their focus in severe and enduring anorexia nervosa?

The aim of this study was to examine the relationship between quality of life (QoL), weight, and eating disorder symptoms across treatment in individuals with severe and enduring anorexia nervosa (SE-AN). Participants were 63 adult females with SE-AN presenting to an outpatient, multisite randomized clinical trial. QoL was assessed using three well-validated QoL questionnaire measures, the EDQOL, SF-12, and WSAS. Participants' weight and severity of symptoms was assessed by Eating Disorder Examination (EDE) and weekly BMI change. Predictors of QoL were evaluated in the context of concurrent, prospective,1 and lagged mixed-effects models. Changes in both BMI and EDE were found to significantly affect current and future QoL ratings. Findings suggest that improvements in QoL may be dependent on symptom change and weight gain. Treatments seeking solely to improve QoL may be unlikely to produce lasting change and clinicians should maintain a focus on weight and behavioral symptoms as much as on improvements in QoL.

Characteristics of a Treatment-Seeking Population in Outpatient Addiction Treatment Centers in Mexico

Background: Baseline patients’ characteristics are critical for treatment planning, as these can be moderators of treatment effects. In Mexico, information on treatment seekers with substance use disorders is scarce and limited to demographic characteristics. Objective: This paper presents and analyses demographic characteristics, substance use related problems, clinical features, and addiction severity in a sample of treatment seekers from the first multi-site randomized clinical trial implemented in the Mexican Clinical Trials Network on Addiction and Mental Health. Methods: A total of 120 participants were assessed prior randomization. Chi square or F-tests were used to compare sites across variables. Spearman correlation was used to associate negative consequences of substance use and motivation to change. Results: The majority of participants were men, and the most prevalent substances reported were alcohol, marijuana, and cocaine. Participants were predominantly on the contemplation or action stage of change, and this was correlated with the perception of the negative consequences associated with substance use. Participants reported a high prevalence of substance use related problems. Conclusions: Substance use related problems, clinical features, and addiction severity reported by treatment seekers are important characteristics to take into account when planning treatment as they facilitate tailoring treatment to meet patients’ needs.

Abstract 210: Determining In-Hospital Myocardial Infarction Rate from Administrative Data in a Large Tertiary-Care Hospital

Background &amp; Objective: The PULSE Trial is a 5-year multisite randomized clinical trial to evaluate implementation of American Heart Association Practice Standards for Electrocardiographic Monitoring on nurses' knowledge, quality of care, and patient outcomes. The primary intervention was an online ECG monitoring education program for nurses. A key indicator in assessing patient outcomes is the incidence of myocardial infarction (MI) while on a monitored unit. Determination of MI while in hospital can be challenging, requiring time-consuming medical record review. We propose a method of reducing the number of medical records necessary for review to determine occurrence of an in-hospital MI by using an algorithm that incorporates administrative and laboratory data. Methods: Administrative data from a large tertiary-care hospital in the US were obtained for a 6-month period. Fields included patient identifier, admission identifier, demographic data, unit transfers, length of stay, procedural codes, and diagnostic codes. Troponin and CK-MB levels were matched with administrative data. Step 1: We deleted all patient encounters where there were no troponin or CK-MB values above the upper reference limit (URL). We then deleted all encounters where all values occurred &lt;24 hours after admission and the patient did not have coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). Finally, we deleted all patient encounters for which all values &gt;24 hours after admission were either decreasing or below the URL and the patient did not have CABG or PCI. This allowed us to exclude all those who did not have a MI, or had one prior to being admitted to a unit. Step 2: If patients had an elevated biomarker &lt;24 hours after admission, we examined if there was an increase of &gt;20% in value following the index event or CABG or PCI procedure. If yes, they were considered to have an MI. If patients had an elevated biomarker &gt;24 hours after admission, we determined if the values were 3x and 5x the URL for PCI and CABG, respectively. If yes, they were considered to have an MI; those who did not required further record review. Results: We had 7,691 admissions. In step 1 we were able to rule out MI in 6,849 admissions. In step 2 we determined 596 had elevated biomarkers within 24 hours of admission. We determined 193 had an MI. The remaining 403 required further review. We determined that 245 had elevated biomarkers &gt;24 hours after admission. Of those, 21 had an elective PCI or CABG, 4 of whom had 3x or 5x the URL of biomarkers and were consider to have a MI. The 224 who did not have an elective PCI or CABG required further review. Conclusions: This algorithm reduced the number of medical record reviews from 7,691 to 627 and allowed for determination of an outcome that is not easily assessed, thereby precluding the need for lengthy medical record reviews. The algorithm can be adjusted to reflect changing criteria for MI.

Preliminary findings on the association between clients’ perceived helpfulness of substance abuse treatment and outcomes: Does race matter?

BackgroundFew studies examine the helpfulness and effectiveness of substance abuse treatment from the clients’ perspective. MethodsThe current secondary analysis examined the perceived helpfulness of substance abuse treatment components and its relationship to treatment outcomes among 387 Black and White adults participating in a multisite randomized clinical trial (RCT) of Motivational Enhancement Therapy. Throughout the 16-week RCT, participants self-reported substance use. Upon completion of treatment, participants completed a self-report measure assessing the perceived helpfulness of treatment components. ResultsBlack participants rated 9 out of 12 treatment components (e.g., “learning skills that will help me cope with my problems”) as being more helpful than their White counterparts, even after controlling for age, gender, employment status, primary drug type, and treatment assignment. However, perceived helpfulness ratings were not associated with substance use outcomes among Black or White participants. ConclusionsClients’ perceived helpfulness of treatment components is an important factor to consider in improving the delivery of substance abuse treatment, especially for Black adults.

Financial Management of a Large Multisite Randomized Clinical Trial

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity.

Caring letters for suicide prevention: Implementation of a multi-site randomized clinical trial in the U.S. military and veteran affairs healthcare systems

Caring letters is a suicide prevention intervention that entails the sending of brief messages that espouse caring concern to patients following discharge from treatment. First tested more than four decades ago, this intervention is one of the only interventions shown in a randomized controlled trial to reduce suicide mortality rates. Due to elevated suicide risk among patients following psychiatric hospitalization and the steady increase in suicide rates among the U.S. military personnel, it is imperative to test interventions that may help prevent suicide among high-risk military personnel and veterans. This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems. The primary outcome is suicide mortality rates to be determined 24months post-discharge from index hospital stay. Healthcare re-utilization rates will also be evaluated and comprehensive data will be collected regarding suicide risk factors. Recommendations for navigating the military and VA research regulatory processes and implementing a multi-site clinical trial at military and VA hospitals are discussed.

Reducing risky relationships: a multisite randomized trial of a prison-based intervention for reducing HIV sexual risk behaviors among women with a history of drug use

Women involved in the criminal justice system, particularly those with a history of drug use, are at elevated risk of HIV infection, yet few HIV prevention interventions have been tailored for delivery to incarcerated women. Drawing on the Relational Model, the Reducing Risky Relationships for HIV (RRR-HIV) intervention was developed and evaluated in a multisite randomized clinical trial. Women with weekly drug use prior to incarceration (n = 444) who were incarcerated within correctional institutions in four states were randomized to (1) the RRR-HIV intervention consisting of an HIV educational video, five group sessions, and one postrelease booster session or (2) a control condition consisting of the HIV educational video. The RRR-HIV intervention combined didactic and interactive content regarding seven “thinking myths” about intimate relationships that may result in decisions to engage in risky sexual behaviors. Data were collected while women were still incarcerated and approximately 90 days following release from prison by trained interviewers. A negative binomial regression (NBR) model of unprotected sexual behaviors at the 90-day follow-up indicated that RRR-HIV participants reported fewer unprotected sexual behaviors than women in the control condition once the analysis was adjusted for study site. Future studies should examine the sustainability of the RRR-HIV intervention's effect on risk reduction. Implementation research is needed to determine whether delivery of this intervention by correctional staff or peers, rather than research staff, yields similar reductions in unprotected sexual behaviors.

Research staff training in a multisite randomized clinical trial: Methods and recommendations from the stimulant reduction intervention using dosed exercise (STRIDE) trial

Background: Descriptions of and recommendations for meeting the challenges of training research staff for multisite studies are limited despite the recognized importance of training on trial outcomes. The STRIDE (Stimulant Reduction Intervention using Dosed Exercise) study is a multisite randomized clinical trial that was conducted at nine addiction treatment programs across the United States within the National Drug Abuse Treatment Clinical Trials Network (CTN) and evaluated the addition of exercise to addiction treatment as usual (TAU), compared to health education added to TAU, for individuals with stimulant abuse or dependence. Research staff administered a variety of measures that required a range of interviewing, technical, and clinical skills. Purpose: In order to address the absence of information on how research staff are trained for multisite clinical studies, the current manuscript describes the conceptual process of training and certifying research assistants (RAs) for STRIDE. Methods: Training was conducted using a three-stage process to allow staff sufficient time for distributive learning, practice, and calibration leading up to implementation of this complex study. Results: Training was successfully implemented with staff across nine sites. Staff demonstrated evidence of study and procedural knowledge via quizzes and skill demonstration on six measures requiring certification. Overall, while the majority of staff had little to no experience in the six measures, all RAs demonstrated ability to correctly and reliably administer the measures throughout the study. Conclusions: Practical recommendations are provided for training research staff and are particularly applicable to the challenges encountered with large, multisite trials.

Abstract 18317: An Interactive Online Education Program Improves Knowledge of ECG Monitoring: Findings From the PULSE Trial

Introduction: Evidence suggests that ECG monitoring practices are inconsistent and inadequate, which may be due to knowledge deficits of nurses. We evaluated whether an interactive online education program improves knowledge related to ECG monitoring. Methods: The PULSE Trial is a 5-year multi-site randomized clinical trial with crossover to evaluate the effect of implementing the AHA practice standards for ECG monitoring on nurses’ knowledge, quality of care, and patient outcomes. We report data related to nurses’ knowledge from all 3 phases. The sample included nurses on cardiac units in 14 hospitals. After nurses completed a validated 20-item knowledge test, hospitals were randomized to the experimental or control group. Experimental group nurses completed the education program that covered essentials of ECG monitoring and arrhythmia, ischemia, and QT interval monitoring. They then re-took the knowledge test. In phase 3, 12-18 months later, experimental group nurses re-took the test to evaluate knowledge retention and control group nurses took the education program and test. We used mixed modeling to address repeated measures and hospital intra-correlation. Results: The sample contained 2,560 unique nurses (90% female, 75% white, mean age 38±11 years). Mean test scores improved (p&lt;.0001) in both groups (71.2) immediately after the intervention, but declined to 61.1 12-18 months later in the experimental group. This was lower (p&lt;.0001) than right after the intervention, but higher (p&lt;.0001) than before. Of the 4 subsections of the test, essentials of ECG monitoring had the highest mean post-test scores (77) and ischemia monitoring had the lowest (56). The pattern of change for all subsections was similar to the entire test. Conclusions: Although test scores improved after the education, gains diminished over time, but were better than at baseline. Whether the improved knowledge translates into better quality of care and patient outcomes will be determined.