Cluster-randomized Controlled Trial (cluster-randomized + controlled_trial)

Distribution by Scientific Domains


Selected Abstracts


Internet-based prevention for alcohol and cannabis use: final results of the Climate Schools course

ADDICTION, Issue 4 2010
Nicola C. Newton
ABSTRACT Aims To establish the long-term efficacy of a universal internet-based alcohol and cannabis prevention programme in schools. Methods A cluster-randomized controlled trial was conducted to assess the effectiveness of the Climate Schools: Alcohol and Cannabis Course. The evidence-based course, aimed at reducing alcohol and cannabis use, is facilitated by the internet and consists of 12 novel and curriculum consistent lessons delivered over 6 months. Participants A total of 764 year 8 students (13 years) from 10 Australian secondary schools were allocated randomly to the internet-based prevention programme (n = 397, five schools), or to their usual health classes (n = 367, five schools). Measures Participants were assessed at baseline, immediately post, and 6 and 12 months following completion of the intervention, on measures of alcohol and cannabis knowledge, attitudes, use and related harms. Results This paper reports the final results of the intervention trial, 12 months following the completion of the Climate Schools: Alcohol and Cannabis Course. The effectiveness of the course 6 months following the intervention has been reported previously. At the 12-month follow-up, compared to the control group, students in the intervention group showed significant improvements in alcohol and cannabis knowledge, a reduction in average weekly alcohol consumption and a reduction in frequency of drinking to excess. No differences between groups were found on alcohol expectancies, cannabis attitudes or alcohol- and cannabis-related harms. The course was found to be acceptable by teachers and students as a means of delivering drug education in schools. Conclusions Internet-based prevention programs for school-age children can improve student's knowledge about alcohol and cannabis, and may also reduce alcohol use twelve months after completion. [source]


School-based alcohol education: results of a cluster-randomized controlled trial

ADDICTION, Issue 3 2009
Matthis Morgenstern
ABSTRACT Objective This study aimed to examine the effects of a school-based alcohol education intervention. Design Two-arm three-wave cluster-randomized controlled trial, with schools as the unit for randomization. Surveys were conducted prior to intervention implementation, then 4 and 12 months after baseline. Setting A total of 30 public schools in Schleswig-Holstein, Germany. Participants Baseline data were obtained from 1686 7th graders. The retention rate was 85% over 12 months. Intervention The intervention consisted of four interactive lessons conducted by teachers, booklets for students and booklets for parents. Measures Knowledge, attitudes, life-time alcohol consumption (ever use alcohol without parental knowledge, ever been drunk and ever binge drinking) and past-month alcohol use. Results Intention-to-treat analyses revealed that intervention status was associated with more general knowledge about alcohol and lower levels of life-time binge drinking. No effects were found with respect to students' self-reported attitudes, intentions to drink, life-time alcohol use and past-month alcohol use. Conclusions The results indicate that this brief school-based intervention had a small short-term preventive effect on alcohol misuse. [source]


Improved guideline adherence to pharmacotherapy of chronic systolic heart failure in general practice , results from a cluster-randomized controlled trial of implementation of a clinical practice guideline

JOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 5 2008
Frank Peters-Klimm MD
Abstract Rationale and aims, Clinical practice guidelines (CPG) reflect the evidence of effective pharmacotherapy of chronic (systolic) heart failure (CHF) which needs to be implemented. This study aimed to evaluate the effect of a new, multifaceted intervention (educational train-the-trainer course plus pharmacotherapy feedback = TTT) compared with standard education on guideline adherence (GA) in general practice. Method, Thirty-seven participating general practitioners (GPs) were randomized (18 vs. 19) and included 168 patients with ascertained symptomatic CHF [New York Heart Association (NYHA) II-IV]. Groups received CPG, the TTT intervention consisted of four interactive educational meetings and a pharmacotherapy feedback, while the control group received a usual lecture (Standard). Outcome measure was GA assessed by prescription rates and target dosing of angiotensin converting enzyme (ACE) inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers (BB) and aldosterone antagonists (AA) at baseline and 7-month follow-up. Group comparisons at follow-up were adjusted to GA, sex, age and NYHA stage at baseline. Results, Prescription rates at baseline (n = 168) were high (ACE-I/ARB 90, BB 79 and AA 29%) in both groups. At follow up (n = 146), TTT improved compared with Standard regarding AA (43% vs. 23%, P = 0.04) and the rates of reached target doses of ACE-I/ARB (28% vs. 15%, P = 0.04). TTT group achieved significantly higher mean percentages of daily target dose (52% vs. 42%, mean difference 10.3%, 95% CI 0.84,19.8, P = 0.03). Conclusion, Despite of pre-existing high GA in both groups and an active control group, the multifaceted intervention was effective in quality of care measured by GA. Further research is needed on the choice of interventions in different provider populations. [source]


Effects of rapid response systems on clinical outcomes: Systematic review and meta-analysis

JOURNAL OF HOSPITAL MEDICINE, Issue 6 2007
Sumant R. Ranji MD
Abstract BACKGROUND A rapid response system (RRS) consists of providers who immediately assess and treat unstable hospitalized patients. Examples include medical emergency teams and rapid response teams. Early reports of major improvements in patient outcomes led to widespread utilization of RRSs, despite the negative results of a subsequent cluster-randomized trial. PURPOSE To evaluate the effects of RRSs on clinical outcomes through a systematic literature review. DATA SOURCES MEDLINE, BIOSIS, and CINAHL searches through August 2006, review of conference proceedings and article bibliographies. STUDY SELECTION Randomized and nonrandomized controlled trials, interrupted time series, and before-after studies reporting effects of an RRS on inpatient mortality, cardiopulmonary arrests, or unscheduled ICU admissions. DATA EXTRACTION Two authors independently determined study eligibility, abstracted data, and classified study quality. DATA SYNTHESIS Thirteen studies met inclusion criteria: 1 cluster-randomized controlled trial (RCT), 1 interrupted time series, and 11 before-after studies. The RCT showed no effects on any clinical outcome. Before-after studies showed reductions in inpatient mortality (RR = 0.82, 95% CI: 0.74-0.91) and cardiac arrest (RR = 0.73, 95% CI: 0.65-0.83). However, these studies were of poor methodological quality, and control hospitals in the RCT reported reductions in mortality and cardiac arrest rates comparable to those in the before-after studies. CONCLUSIONS Published studies of RRSs have not found consistent improvement in clinical outcomes and have been of poor methodological quality. The positive results of before-after trials likely reflects secular trends and biased outcome ascertainment, as the improved outcomes they reported were of similar magnitude to those of the control group in the RCT. The effectiveness of the RRS concept remains unproven. Journal of Hospital Medicine 2007;2:422,432. © 2007 Society of Hospital Medicine. [source]


Safety of Paramedics with Extended Skills

ACADEMIC EMERGENCY MEDICINE, Issue 7 2008
Suzanne Mason MBBS
Abstract Background:, The role of paramedics with extended skills is evolving, enabling them to assess and treat patients in the community. A United Kingdom service led by extended-role paramedic practitioners (PPs) is aimed at managing minor acute illness and injury among older people in the home when appropriate, avoiding unnecessary transfer to the emergency department (ED). Objectives:, The objectives were to evaluate the safety of clinical decisions made by PPs operating within the new service. Methods:, As part of a cluster-randomized controlled trial, patients aged >60 years contacting the emergency medical services (EMS) with a minor injury or illness were included in the study. The safety of the new PP intervention was compared with standard practice of EMS transfer and ED treatment. Outcomes included unplanned ED attendance within 7 days of the index episode. Clinical records were rated independently by two senior ED clinicians to identify related episodes, avoidable subsequent episodes, and suboptimal care. Results:, Of the 2,025 patients included in this analysis, 219 (10.9%) went on to have an unplanned ED attendance within 7 days. Of these, 162 (74.0%) re-presented with a condition related to their index episode. The independent raters agreed on suboptimal care 83.4% of the time. There were 16 agreed upon episodes related to suboptimal care (0.80%). No significant differences were found between intervention and control groups in relation to re-presentation at hospital within 7 days for a related condition or rates of assessed suboptimal care. Conclusions:, This study suggests that appropriately trained paramedics with extended skills treating older people with minor acute conditions in the community are as safe as standard EMS transfer and treatment within the ED. [source]