Prevention of Alcohol-related Incidents in the U.S. Air Force: Results From a Cluster Randomized Trial

2021 ◽  
Author(s):  
Melissa A Little ◽  
Robert C Klesges ◽  
Indika Mallawaarachchi ◽  
Timothy McMurry ◽  
Kinsey Pebley ◽  
...  
Keyword(s):  
Air Force ◽  
Cluster Randomized Trial ◽  
Future Research ◽  
Alcohol Intervention ◽  
Primary Analysis ◽  
Training Costs ◽  
Significant Difference ◽  
Cluster Randomized ◽  
The U.S

ABSTRACT Background Alcohol misuse poses significant public health concerns in the U.S. Military. An Alcohol Misconduct Prevention Program (AMPP), which includes a brief alcohol intervention (BAI) session, plus random breathalyzer program, has been shown to reduce alcohol-related incidents (ARIs) among Airmen undergoing training. Purpose The current study sought to examine whether a booster BAI administered at the end of Airmen’s training reduced ARIs out to a 1-year follow-up. Methods Participants were 26,231 U.S. Air Force Technical Trainees recruited between March 2016 and July 2018. Participants were cluster randomized by cohort to two conditions: AMPP + BAI Booster or AMPP + Bystander Intervention. The primary analysis was a comparison of the interventions’ efficacies in preventing Article 15 ARIs at a 1-year follow-up, conducted using a generalized estimating equations logistic regression model controlling for covariates. Results There was no significant difference by condition in Article 15 ARIs at the 1-year follow-up (P = .912). Conclusions Findings suggest that a booster may not be necessary to produce maximum effects beyond the initial AMPP intervention. It is also possible that alcohol behaviors changed as a result of the intervention but were not captured by our outcome measures. Future research should consider alternative outcomes or participant-tracking measures to determine whether a different or more intensive BAI booster is effective. The majority of Article 15 ARIs were for underage drinking; therefore, developing an intervention focused on this problem behavior could lead to large reductions in training costs in the military.

scholarly journals Effects of the Anti-stigma Workplace Intervention “Working Mind” in a Canadian Health-Care Setting: A Cluster-Randomized Trial of Immediate Versus Delayed Implementation: Effets d’une intervention en milieu de travail anti-stigmates, l’Esprit au travail, dans un milieu canadien de soins de santé: un essai randomisé en grappes d’une mise en œuvre immédiate plutôt que reportée

2020 ◽  
pp. 070674372096173
Author(s):  
Keith S. Dobson ◽  
Veronika Markova ◽  
Alainna Wen ◽  
Laura M. Smith
Keyword(s):  
Mental Health ◽  
Cluster Randomized Trial ◽  
Past Research ◽  
Future Research ◽  
Mental Health Stigma ◽  
Control Group ◽  
Essai Randomisé ◽  
Program Effects ◽  
Cluster Randomized

Objectives: The Working Mind is a program designed to reduce stigmatizing attitudes toward mental illness, improve resilience, and promote mental health in the general workplace. Previous research has revealed positive program effects in a variety of workplace settings. This study advances previous work in implementing randomization and a control group to assess the intervention’s efficacy. Methods: The program was evaluated using a cluster-randomized design, with pretest, posttest, and a 3-month follow-up in 2 implementation groups across 4 sites. Results: The Working Mind program was effective at decreasing mental health stigma and increasing self-reported resilience and coping skills at the pre–post assessment in both delivery groups. The program’s effects were maintained to the time of 3-month follow-up. Qualitative data provided further evidence that participants benefited from the program. Conclusions: This study represents an advancement over past research and provides further support for efficacy of the Working Mind program. Directions for future research, including replication using rigorous methodological procedures and examination of program effects over longer follow-up intervals, are discussed.

scholarly journals Design and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data

2021 ◽  
pp. 174077452110285
Author(s):  
Conner L Jackson ◽  
Kathryn Colborn ◽  
Dexiang Gao ◽  
Sangeeta Rao ◽  
Hannah C Slater ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Mixed Effects ◽  
Small Sample ◽  
Mixed Effects Models ◽  
Type I ◽  
Cluster Randomized ◽  
Cluster Level ◽  
Generalized Estimating

Background: Cluster-randomized trials allow for the evaluation of a community-level or group-/cluster-level intervention. For studies that require a cluster-randomized trial design to evaluate cluster-level interventions aimed at controlling vector-borne diseases, it may be difficult to assess a large number of clusters while performing the additional work needed to monitor participants, vectors, and environmental factors associated with the disease. One such example of a cluster-randomized trial with few clusters was the “efficacy and risk of harms of repeated ivermectin mass drug administrations for control of malaria” trial. Although previous work has provided recommendations for analyzing trials like repeated ivermectin mass drug administrations for control of malaria, additional evaluation of the multiple approaches for analysis is needed for study designs with count outcomes. Methods: Using a simulation study, we applied three analysis frameworks to three cluster-randomized trial designs (single-year, 2-year parallel, and 2-year crossover) in the context of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria. Mixed-effects models, generalized estimating equations, and cluster-level analyses were evaluated. Additional 2-year parallel designs with different numbers of clusters and different cluster correlations were also explored. Results: Mixed-effects models with a small sample correction and unweighted cluster-level summaries yielded both high power and control of the Type I error rate. Generalized estimating equation approaches that utilized small sample corrections controlled the Type I error rate but did not confer greater power when compared to a mixed model approach with small sample correction. The crossover design generally yielded higher power relative to the parallel equivalent. Differences in power between analysis methods became less pronounced as the number of clusters increased. The strength of within-cluster correlation impacted the relative differences in power. Conclusion: Regardless of study design, cluster-level analyses as well as individual-level analyses like mixed-effects models or generalized estimating equations with small sample size corrections can both provide reliable results in small cluster settings. For 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria, we recommend a mixed-effects model with a pseudo-likelihood approximation method and Kenward–Roger correction. Similarly designed studies with small sample sizes and count outcomes should consider adjustments for small sample sizes when using a mixed-effects model or generalized estimating equation for analysis. Although the 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria is already underway as a parallel trial, applying the simulation parameters to a crossover design yielded improved power, suggesting that crossover designs may be valuable in settings where the number of available clusters is limited. Finally, the sensitivity of the analysis approach to the strength of within-cluster correlation should be carefully considered when selecting the primary analysis for a cluster-randomized trial.

Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽  
2017 ◽  
Vol 70 (suppl_1) ◽  
Author(s):  
Karen L Margolis ◽  
Stephen E Asche ◽  
Anna R Bergdall ◽  
Steven P Dehmer ◽  
Beverly B Green ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Trial ◽  
Clinical Care ◽  
Cluster Randomized Trial ◽  
Home Blood Pressure ◽  
Uncontrolled Hypertension ◽  
Routine Clinical Care ◽  
Differential Reduction ◽  
Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

scholarly journals Parent-Focused Sexual Abuse Prevention: Results From a Cluster Randomized Trial

2020 ◽  
pp. 107755952096387
Author(s):  
Kate Guastaferro ◽  
John M. Felt ◽  
Sarah A. Font ◽  
Christian M. Connell ◽  
Sheridan Miyamoto ◽  
...  
Keyword(s):  
Sexual Abuse ◽  
Parent Training ◽  
Randomized Trial ◽  
Parenting Behaviors ◽  
Cluster Randomized Trial ◽  
Protective Behaviors ◽  
Significant Group ◽  
Cluster Randomized ◽  
General Parenting

This study tested whether a child sexual abuse (CSA) prevention program, Smart Parents–Safe and Healthy Kids (SPSHK), could be implemented as an additional module in evidence-based parent training and whether the added module might detract from the efficacy of the original program. In a cluster randomized trial, six community-based organizations were randomized to deliver Parents as Teachers (PAT) with SPSHK (PAT+SPSHK) or PAT as usual (PAT-AU). CSA-related awareness and protective behaviors, as well as general parenting behaviors taught by PAT were assessed at baseline, post-PAT, post-SPSHK, and 1-month follow-up. Multilevel analyses revealed significant group by time interactions for both awareness and behaviors ( ps < .0001), indicating the PAT+SPSHK group had significantly greater awareness of CSA and used protective behaviors more often (which were maintained at follow-up) compared to the PAT-AU group. No differences were observed in general parenting behaviors taught by PAT suggesting adding SPHSK did not interfere with PAT efficacy as originally designed. Results indicate adding SPHSK to existing parent training can significantly enhance parents’ awareness of and readiness to engage in protective behavioral strategies. Implementing SPHSK as a selective prevention strategy with at-risk parents receiving parent training through child welfare infrastructures is discussed.

Cluster-randomized trial of early palliative care for patients with metastatic cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9003-9003 ◽  
Author(s):  
Camilla Zimmermann ◽  
Nadia Swami ◽  
Gary Rodin ◽  
Ian Tannock ◽  
Monika K. Krzyzanowska ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Trial ◽  
Symptom Severity ◽  
Metastatic Cancer ◽  
Symptom Control ◽  
Cluster Randomized Trial ◽  
Satisfaction With Care ◽  
Early Palliative Care ◽  
Cluster Randomized

9003 Background: Patients with metastatic cancer have compromised quality of life (QOL), which tends to worsen towards the end of life. We conducted a cluster-randomized trial of early versus routine palliative care in patients with metastatic cancer, to assess impact on QOL, symptom control and satisfaction with care. Methods: Twenty-four medical oncology clinics were randomized, stratified by tumour site (4 lung clinics, 8 gastrointestinal, 4 genito-urinary, 6 breast, 2 gynecological), to intervention and follow-up (at least monthly) by a palliative care team, or to routine cancer care. Eligible patients had ECOG performance status 0-2 and a clinical prognosis of 6 months to 2 years. Patients completed measures of QOL (FACIT-Sp, including physical, social, emotional, functional and spiritual well-being; range 0-156, with higher scores indicating better QOL), symptom severity (Edmonton Symptom Assessment System; range 0-90, with higher scores indicating worse symptom severity), and satisfaction with care (FAMCARE-P16; score range 16-80) at baseline and monthly for 4 months. The primary outcome was the change in FACIT-Sp at 3 months. The planned sample size was 225 patients per arm, assuming 80% power and a 2-sided significance level of 0.05. Results: From December 2006 to September 2010, 461 patients completed baseline measures (228 intervention, 233 control); 442 patients completed at least one follow-up assessment (mean patients/cluster 18.8±11.6 control, 18.1±12.6 intervention). At 3 months, patients in the intervention group had marginally improved QOL (mean change in intervention vs. control, 1.6±14.5 vs. -2.0±13.6, p=0.07) but not symptom severity (0.1±16.9 vs. 2.1±13.9, p=0.34). At 4 months the change in QOL was more marked (2.5±15.5 vs. -4.0±14.2, p=0.008) and symptom severity was marginally better (-1.3±16.0 vs. 3.2±13.9, p=0.05). Improvement in satisfaction with care was evident at one month (p=0.001) and remained significant at both 3 months (2.3±9.1 vs.-1.8±8.2, p=0.001) and 4 months (3.7±8.6 vs. -2.4±8.3, p<0.001). Conclusions: In patients with metastatic cancer, early palliative care intervention immediately improved satisfaction with care, while QOL and symptom control improved later.

Effects of group-based educational songwriting on craving in patients on a detoxification unit: A cluster-randomized effectiveness study

2017 ◽  
Vol 47 (2) ◽  
pp. 241-254 ◽  
Author(s):  
Michael J. Silverman
Keyword(s):  
Music Therapy ◽  
Future Research ◽  
Effectiveness Study ◽  
Single Session ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Cluster Randomized ◽  
And Control ◽  
Therapy Intervention

Psychosocial methods for reducing craving are essential for people with substance use disorders. Although songwriting is a commonly-used music therapy intervention for people with addictions, there is no randomized controlled music therapy study systematically investigating how songwriting impacts craving in patients on a detoxification unit. The purpose of this cluster-randomized effectiveness study was to measure the effects of a single group-based educational songwriting intervention on craving with patients on a detoxification unit. To provide treatment to all participants in an inclusive single-session design, participants ( N = 129) were cluster-randomized to one of three conditions: educational songwriting targeting relapse prevention and recovery, recreational music therapy targeting social and affective gains, or wait-list control. There was a significant difference ( p = .033) in the craving subscale of expectancy between the educational songwriting and control conditions. Although no other difference reached significance, participants in the songwriting condition tended to have lower subscale and total craving mean scores than participants in the control and recreational music therapy conditions. Group-based educational songwriting interventions may temporarily relieve craving by distracting patients in an engaging, motivating, and creative intervention. Implications for clinical practice, suggestions for future research, and limitations are provided.

scholarly journals Longitudinal Trends in Vaccine Hesitancy in a Cohort of Mothers Surveyed in Washington State, 2013-2015

2017 ◽  
Vol 132 (4) ◽  
pp. 451-454 ◽  
Author(s):  
Nora B. Henrikson ◽  
Melissa L. Anderson ◽  
Douglas J. Opel ◽  
John Dunn ◽  
Edgar K. Marcuse ◽  
...  
Keyword(s):  
Item Analysis ◽  
Cluster Randomized Trial ◽  
Washington State ◽  
Vaccine Hesitancy ◽  
Point Reduction ◽  
Increased Risk ◽  
Cluster Randomized ◽  
Level Cluster ◽  
First Time

Parents who refuse or delay vaccines because of vaccine hesitancy place children at increased risk for vaccine-preventable disease. How parental vaccine hesitancy changes as their children age is not known. In 2015, we conducted a follow-up survey of 237 mothers enrolled in a 2-arm clinic-level cluster randomized trial (n = 488) in Washington State that was completed in 2013. We surveyed mothers at their baby’s birth, age 6 months, and age 24 months using a validated measure of vaccine hesitancy. Both mean hesitancy scores (mean 4.1-point reduction; 95% CI, 2.5-5.6; P = .01) and the proportion of mothers who were vaccine hesitant (9.7% at baseline vs 5.9% at 24 months; P = .01) decreased significantly from child’s birth to age 24 months. Changes from baseline were similar for first-time mothers and experienced mothers. Individual item analysis suggested that the decrease may have been driven by increases in maternal confidence about the safety and efficacy of vaccines. Our results suggest that hesitancy is a dynamic measure that may peak around childbirth and may remit as experience with vaccines accumulates.

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