cluster randomized control trial
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2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Melissa L. Harry ◽  
Ella A. Chrenka ◽  
Laura A. Freitag ◽  
Daniel M. Saman ◽  
Clayton I. Allen ◽  
...  

Abstract Background Electronic health record (EHR)-linked clinical decision support (CDS) may impact primary care clinicians’ (PCCs’) clinical care opinions. As part of a clinic cluster-randomized control trial (RCT) testing a cancer prevention and screening CDS system with patient and PCC printouts (with or without shared decision-making tools [SDMT]) for patients due for breast, cervical, colorectal, and lung cancer screening and/or human papillomavirus (HPV) vaccination compared to usual care (UC), we surveyed PCCs at study clinics pre- and post-CDS implementation. Our primary aim was to learn if PCCs' opinions changed over time within study arms. Secondary aims including examining whether PCCs' opinions in study arms differed both pre- and post-implementation, and gauging PCCs’ opinions on the CDS in the two intervention arms. Methods This study was conducted within a healthcare system serving an upper Midwestern population. We administered pre-implementation (11/2/2017–1/24/2018) and post-implementation (2/2/2020–4/9/2020) cross-sectional electronic surveys to PCCs practicing within a RCT arm: UC; CDS; or CDS + SDMT. Bivariate analyses compared responses between study arms at both time periods and longitudinally within study arms. Results Pre-implementation (53%, n = 166) and post-implementation (57%, n = 172) response rates were similar. No significant differences in PCC responses were seen between study arms on cancer prevention and screening questions pre-implementation, with few significant differences found between study arms post-implementation. However, significantly fewer intervention arm clinic PCCs reported being very comfortable with discussing breast cancer screening options with patients compared to UC post-implementation, as well as compared to the same intervention arms pre-implementation. Other significant differences were noted within arms longitudinally. For intervention arms, these differences related to CDS areas like EHR alerts, risk calculators, and ordering screening. Most intervention arm PCCs noted the CDS provided overdue screening alerts to which they were unaware. Few PCCs reported using the CDS, but most would recommend it to colleagues, expressed high CDS satisfaction rates, and thought patients liked the CDS’s information and utility. Conclusions While appreciated by PCCs with high satisfaction rates, the CDS may lower PCCs’ confidence regarding discussing patients’ breast cancer screening options and may be used irregularly. Future research will evaluate the impact of the CDS on cancer prevention and screening rates. Trial registration clinicaltrials.gov, NCT02986230, December 6, 2016.


2021 ◽  
pp. 001440292110625
Author(s):  
Kara Hume ◽  
Samuel L. Odom ◽  
Jessica R. Steinbrenner ◽  
Leann Smith DaWalt ◽  
Laura J. Hall ◽  
...  

We tested the efficacy of a comprehensive intervention program designed for high school students across the autism spectrum, the Center on Secondary Education for Students with Autism (CSESA) model, in a cluster randomized control trial involving 60 high schools in three states (California, North Carolina, Wisconsin), with implementation occurring over a 2-year period. We examined outcomes for the schools, students ( N = 547), and families. At the conclusion of the study, CSESA schools had significantly higher program quality than the services-as-usual (SAU) schools. In addition, students in the CSESA schools had significantly higher total attainment of educational goals than students in SAU schools. There were not significant differences between the two groups on standardized assessment outcomes. We discuss implications for intervention implementation and future research with this population in the public school context.


2021 ◽  
pp. 026010602110567
Author(s):  
Gizaw Sisay ◽  
Adane Tesfaye

Background: Due to the scarcity of intervention trials, especially in Ethiopia, the effect of nutrition education and counseling intervention on pregnancy outcomes is not well studied. Aim: To assess the effect of nutrition education and counseling on the outcomes of pregnancy among pregnant mothers in public health care institutions of Gedeo Zone, Southern, Ethiopia. Methods: A cluster randomized control trial study design was undertaken. Simple random sampling followed by cluster sampling was used to reach eligible study participants. A total sample of 235 (115 intervention vs.120 control group) pregnant women who followed anti-natal care service in public health facilities of Gedeo Zone was included in the study. Independent t-test was used to analyze the group difference for continuous variable and chi-square test for categorical variables. The post-intervention values between the two groups were compared using analysis of covariance by adjusting to baseline variable. Results: After nutrition education, pregnant women in the control group had less weight gain than in the intervention. The proportion of LBW neonate was 17.8% in the intervention group and 38.2% in the control group ( P < 0.001). Multivariable logistic regression analysis showed that the risk of LBW in the control group was 2.43 more likely than in the intervention group (AOR = 2.43; 95% CI: (1.2, 4.92)). Conclusion: Nutrition education delivered to pregnant women during pregnancy could reduce maternal malnutrition and low birth weight. Recommendation: The intervention is easy to implement in the health facilities of Gedeo zone and would be implemented without delay to achieve the sustainable development goals.


2021 ◽  
Author(s):  
Gizaw Sisay ◽  
Adane Tesfaye

Abstract BackgroundA good approach to improve maternal diet during pregnancy is nutrition education and counseling. However, due to the scarcity of intervention trials, especially in Ethiopia, the effect of nutrition education and counseling intervention on pregnancy outcomes is not well studied.ObjectiveTo assess the effect of nutrition education and counseling on maternal weight and the outcomes of pregnancy among pregnant women in public health care institutions of Gedeo Zone, Southern, Ethiopia.MethodsA cluster randomized control trial study design was undertaken. Simple random sampling followed by cluster sampling was used to reach eligible study participants. A total sample of 235 (115 intervention vs.120 control group) pregnant women who followed antenatal care service in public health facilities of Gedeo Zone were included in the study. Independent t-test was used to analyze the group difference for continuous variable and chi-square test for categorical variables. The post intervention values between two groups were compared using ANCOVA by adjusting to the baseline variables.ResultAfter nutrition education and counseling, pregnant women in the control group had less weight gain than in the intervention (65.03kg vs. 56.69kg, p = 0.001). The proportion of LBW neonate was 17.8% in the intervention group and 38.2% in the control group (p < 0.001). Multivariable logistic regression analysis showed that the risk of LBW in the control group was 2.43 more likely than in the intervention group (AOR = 2.43; 95% CI: (1.2, 4.92).ConclusionNutrition education and counseling delivered to pregnant women on the time of pregnancy could reduce maternal malnutrition and low birth weight. We can recommend that; the intervention is easy to implement in health facilities of Gedeo zone and would be implemented without delay to achieve sustainable development goals.The trial was retrospectively registered in Pan African Clinical Trial Registry (www.pactr.org) database with unique identification number for the registry is PACTR202101757871954.


Author(s):  
Noboru Minakawa ◽  
James O. Kongere ◽  
George O. Sonye ◽  
Peter A. Lutiali ◽  
Beatrice Awuor ◽  
...  

Malaria vectors have acquired an enzyme that metabolizes pyrethroids. To tackle this problem, we evaluated long-lasting insecticidal nets incorporating piperonyl butoxide (PBO-LLINs) with a community-based cluster randomized control trial in western Kenya. The primary endpoints were anopheline density and Plasmodium falciparum polymerase chain reaction (PCR)-positive prevalence (PCRpfPR) of children aged 7 months to 10 years. Four clusters were randomly selected for each of the treatment and control arms (eight clusters in total) from 12 clusters, and PBO-LLINs and standard LLINs were distributed in February 2011 to 982 and 1,028 houses for treatment and control arms, respectively. Entomological surveys targeted 20 houses in each cluster, and epidemiological surveys targeted 150 children. Cluster-level permutation tests evaluated the effectiveness using the fitted values from individual level regression models adjusted for baseline. Bootstrapping estimated 95% confidence intervals (CIs). The medians of anophelines per house were 1.4 (interquartile range [IQR]: 2.3) and 3.4 (IQR: 3.7) in the intervention and control arms after 3 months, and 0.4 (IQR: 0.2) and 1.6 (IQR: 0.5) after 10 months, respectively. The differences were –2.5 (95% CI: –6.4 to –0.6) and –1.3 (95% CI: –2.0 to –0.7), respectively. The datasets of 861 and 775 children were analyzed in two epidemiological surveys. The median PCRpfPRs were 25% (IQR: 11%) in the intervention arm and 52% (IQR: 11%) in the control arm after 5 months and 33% (IQR: 11%) and 45% (IQR: 5%) after 12 months. The PCRpfPR ratios were 0.67 (95% CI: 0.38, 0.91) and 0.74 (95% CI: 0.53, 0.90), respectively. We confirmed the superiority of PBO-LLINs.


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