Multicomponent intervention to improve blood pressure management in chronic kidney disease: a protocol for a pragmatic clinical trial

IntroductionThe purpose of this study is to incorporate behavioural economic principles and user-centred design principles into a multicomponent intervention for the management of uncontrolled hypertension (HTN) in chronic kidney disease (CKD) in primary care.Methods and analysisThis is a multicentre, pragmatic, controlled trial cluster-randomised at the clinician level at The Brigham and Women’s Practice -Based Research Network of 15 practices. Of 220 total clinicians, 184 were eligible to be enrolled, and the remainder were excluded (residents and clinicians who see urgent care or walk-in patients); no clinicians opted out. The intervention consists of a clinical decision support system based in behavioural economic and user-centred design principles that will: (1) synthesise existing laboratory tests, medication orders and vital sign data; (2) increase recognition of CKD, (3) increase recognition of uncontrolled HTN in CKD patients and (4) deliver evidence-based CKD and HTN management recommendations. The primary endpoint is the change in mean systolic blood pressure between baseline and 6 months compared across arms. We will use the Reach Effectiveness Adoption Implementation Maintenance framework. At the conclusion of this study, we will have: (1) validated an intervention that combines laboratory tests, medication records and clinical information collected by electronic health records to recognise uncontrolled HTN in CKD patients and recommend a course of care, (2) tested the effectiveness of said intervention and (3) collected information about the implementation of the intervention that will aid in dissemination of the intervention to other practice settings.Ethics and disseminationThe Human Subjects Institutional Review Board at Brigham and Women’s Hospital provided an expedited review and approval for this study protocol, and a Data Safety Monitoring Board will ensure the ongoing safety of the trial.Trial registration numberNCT03679247.

PP230 Safety, Effectiveness, And Cost Effectiveness Of Interventions For Preventing Delirium In Hospitalized Patients

IntroductionDelirium is a prevalent syndrome in the hospital setting and the elderly are the most affected. The objective was to assess the safety, clinical effectiveness, and cost effectiveness of interventions for preventing delirium among people aged 65 years or older at hospital admission.MethodsA systematic review of available scientific literature (randomized controlled trials) on the safety, effectiveness, and cost effectiveness of the interventions was conducted. The overall effect size for each type of intervention was estimated through a meta-analysis. A cost-effectiveness study in the context of the Spanish National Healthcare System was performed.ResultsForty-nine studies were included for the effectiveness and safety assessment (25 on pharmacological interventions, 12 on perioperative interventions, 2 on non-pharmacological interventions, and 10 on multicomponent interventions). The following interventions reduced delirium incidence relative to usual care or placebo: hypnotics and sedatives (13 studies; risk ratio [RR] 0.54: 95% confidence interval [CI] 0.36–0.80); perioperative interventions aimed at limiting opioid use (two studies; RR 0.50, 95% CI: 0.29–0.86); controlling the intensity of general anesthesia (three studies; RR 0.77, 95% CI: 0.59–0.99); and multicomponent interventions (10 studies; RR 0.62, 95% CI: 0.54–0.72). In addition, multicomponent interventions reduced the duration (mean difference −1.18, 95% CI: −1.95 - −0.40) and severity of delirium (standardized mean difference −0.98, 95% CI: −1.46 - −0.49), while dexmedetomidine reduced the duration of delirium (mean difference −0.70, 95% CI: −1.03 - −0.37).The economic analysis of a multicomponent preventive intervention estimated an average cost of EUR7,282 per patient, which was EUR140 per patient more expensive than usual care. The incremental cost-effectiveness ratio was EUR21,391 per quality-adjusted life-year, which is below the acceptability threshold used in Spain. The literature review yielded two economic evaluations that estimated the cost effectiveness of a multicomponent intervention in the United Kingdom and found that the multicomponent intervention was a dominant strategy.ConclusionsThis meta-analysis suggests that multicomponent interventions and dexmedetomidine are effective in reducing the incidence of delirium in hospitalized patients and that multicomponent interventions could be a cost-effective strategy in Spain.

Methodological approach of Sport and Health for Overweight children (SHOW) intervention study

Prevention and treatment of overweight among children have been a global challenge. A better understanding of different interventions to improve overweight children’s health is needed. This paper describes the methodological approach of Sport and Health for Overweight children (SHOW) study, which investigated the effects of a multicomponent intervention on health markers of overweight children. The SHOW study is a non-randomized clinical trial performed during 16 weeks enrolling 72 overweight children aged eight to 12 years in an intervention (IG = 35) and control group (CG = 37). It is a multicomponent intervention program including generalized sport initiation, health education, and weekly communication between parents and researchers. Besides characterizing the participants’, several health outcomes were analyzed in the SHOW study. Primary outcomes were accelerometer based physical activity and anthropometric indicators of overweight and obesity. Secondary outcomes were made up of cardiometabolic, fitness, behavioral, and psychological health indicators. We hypothesize that the SHOW study improves health outcomes and can be replicated in other settings as well as implemented by public policies.

The impact of food addiction behaviours on the treatment of overweight students

The present study evaluated the association of food addiction (FA), the change of the BMI/AgeZ-score, and the consumption of ultra-processed foods in overweight students undergoing a 16-month, multicomponent intervention in the school environment. FA was investigated using the Yale Food Addiction Scale for Children and the dietary assessment was estimated using the Semi-quantitative Food Frequency Questionnaire in overweight 9- to 11-year-old students (BMI/ageZscore≥1) of both sexes at their baseline and after the intervention (n=120). Among the schoolchildren, 33.4% had FA in at least one of the two assessments. The analysis of mixed-effects models to assess the effect of the intervention and the change of the BMI/AgeZ-score between evaluations showed that the occurrence of FA influenced the maintenance of weight (time#FA, β=0.30, 95%CI=0.05 to 0.54), p=0.016. Weight loss was observed only in individuals who did not present FA (BMI/Age Z-score= −0.3). When evaluating the effect of the intervention and the dietary variables, we verified a reduction in the consumption of sugary milk-based drinks (−17 kcal, p=0.04) only in non-FA students at the end of the study. FA has been identified as an underlying factor with therapeutic relevance, and an enhanced understanding of FA can open new paths for the prevention and management of obesity.

Behavioral Activation as an ‘active ingredient’ of interventions addressing depression and anxiety among young people: a systematic review and evidence synthesis

Background Psychological interventions such as behavioral activation (BA) that focus on overt behaviors rather than complex cognitive skills may be developmentally well-suited to address youth mental health problems. The current systematic review synthesized evidence on the characteristics, effectiveness and acceptability of behavioral activation (BA) to examine its role as a potential ‘active ingredient’ for alleviating depression and anxiety among young people aged 14 to 24 years. Methods Evidence across the following sources were synthesized: (i) randomized control trials (RCT) evaluating interventions where BA has been used as a standalone intervention or as part of a multicomponent intervention, (ii) qualitative studies examining the acceptability of BA as an intervention or as a coping strategy among young people with lived experiences. Consultations with a youth advisory group (YAG) from India were used to draw inferences from existing evidence and identify future research priorities. Results As part of the review, 23 RCTs were identified; three studies examined BA as a standalone intervention, and the remaining studies examined multicomponent intervention where BA was a constituent element. The intervention protocols varied in composition, with the number of intervention elements ranging between 5 to 18. There was promising but limited evidence in standalone interventions for thse effectiveness of BA for depression. The impact of BA in multicomponent interventions was difficult to evaluate in the absence of focal assessment of activation outcomes. Evidence from 37 additional qualitative studies of youth lived experience literature, corroborated by the YAG inputs, indicated that young people preferred using behavioral strategies similar to BA to cope with depression in their own life. Themes indicated that the activities that are important to an individual and their socio-contextual factors need to be considered in the planning and implementing BA intervention. Evidence for the use of BA in anxiety was limited across data sources. Conclusions Overall, there was preliminary empirical evidence for the effectiveness and acceptability of BA for youth depression. Further research is needed to examine the components and mechanisms that contribute to its effectiveness as an active intervention ingredient for depression and anxiety.