The PREvention Program for Alzheimer’s RElated Delirium (PREPARED) cluster randomized trial: a study protocol

Background Delirium is a significant cause of morbidity and mortality among older people admitted to both acute and long-term care facilities (LTCFs). Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30–73%) by acting on modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTCFs. Methods The objective is to assess the effectiveness of the multicomponent PREPARED Trial intervention in reducing the following primary outcomes: incidence, severity, duration, and frequency of delirium episodes in cognitively impaired residents. This 4-year, parallel-design, cluster randomized study will involve nursing staff and residents in 45–50 LTCFs in Montreal, Canada. Participating public and private LTCFs (clusters) that provide 24-h nursing care will be assigned to either the PREPARED Trial intervention or the control (usual care) arm of the study using a covariate constrained randomization procedure. Approximately 400–600 LTC residents aged 65 and older with dementia and/or cognitive impairment will be enrolled in the study and followed for 18 weeks. Residents must be at risk of delirium, delirium-free at baseline and have resided at the facility for at least 2 weeks. Residents who are unable to communicate verbally, have a history of specific psychiatric conditions, or are receiving end-of-life care will be excluded. The PREPARED Trial intervention consists of four main components: a decision tree, an instruction manual, a training package, and a toolkit. Primary study outcomes will be assessed weekly. Functional autonomy and cognitive levels will be assessed at the beginning and end of follow-up, while information pertaining to modifiable delirium risk factors, medical consultations, and facility transfers will be collected retrospectively for the duration of the follow-up period. Primary outcomes will be reported at the level of intervention assignment. All researchers analyzing the data will be blinded to group allocation. Discussion This large-scale intervention study will contribute significantly to the development of evidence-based clinical guidelines for delirium prevention in this frail elderly population, as it will be the first to evaluate the efficacy of a multicomponent delirium prevention program translated into LTC clinical practice on a large scale. Trial registration NCT03718156, ClinicalTrials.gov.

Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol

Background The consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as intended, that is, with fidelity. As part of a planned pilot trial, participants will be randomized to ingest resistant starches or a placebo. They will also be asked to collect stool samples and keep symptom and dose diaries to inform trial outcomes. We aim to identify potential factors impacting fidelity to the receipt and enactment of trial intervention and data collection activities from the perspective of patients and caregivers in the trial. Identifying fidelity barriers and enablers at the pilot trial phase of a clinical intervention may help to determine optimization processes when expanding to multiple sites in future trials. Methods We will conduct 15-30 semi-structured interviews with pilot trial participants (aged 8-17) and their caregivers. Trial participants will be approached for interviews approximately 6 months after the start of their trial participation. Personal projects analysis, a tool for understanding how individuals manage competing demands in their daily lives, will guide an in-depth exploration of how trial participants engage in activities related to intervention and data collection fidelity (ingesting resistant starches or placebo, collecting stool samples, keeping a symptom and dose diary) amidst the complexities of daily living. Discussion The present study will seek to explore and demonstrate how theory-informed fidelity assessments can be conducted alongside pilot trials to inform future multisite trials. Study results will clarify what factors may affect fidelity to trial intervention and data collection activities. Results may suggest what to modify to optimize the design and conduct, and ensure the integrity, of future multisite trials. Conducting process evaluations alongside clinical trials has the potential to improve our understanding of trial participant experiences. Results will provide a better understanding of how trial participants manage to engage in necessary trial activities along with other priorities.

Cost of childhood acute otitis media in primary care in the Netherlands: economic analysis alongside a cluster randomised controlled trial

Background Acute otitis media (AOM) is among the most common paediatric conditions managed in primary care. Most recent estimates of the cost of AOM date from a decade ago and lack a full societal perspective. We therefore explored the societal cost of childhood AOM in the Netherlands within the setting of a trial comparing the effectiveness of an intervention aimed at educating general practitioners (GPs) about pain management in AOM compared to usual care. Methods Economic analysis alongside a cluster randomised controlled trial conducted between February 2015 and May 2018 in 37 practices (94 GPs). In total, 224 children with AOM were included of which 223 (99%) completed the trial (intervention: n = 94; control: n = 129). The cost of AOM due to health care costs, patient and family costs, and productivity losses by parent caregivers were retrieved from study diaries and primary care electronic health records, during 28-day follow-up. We calculated mean cost (€ and $) per AOM episode per patient with standard deviations (SD, in €) regardless of study group assignment because there was no clinical effect of the trial intervention. In sensitivity analysis, we calculated cost in the intervention and usual care group, after exclusion of extreme outliers. Results Mean total AOM cost per patient were €565.93 or $638.78 (SD €1071.01); nearly 90% of these costs were due to productivity losses experienced by parents. After exclusion of outliers, AOM cost was €526.70 or $594.50 (SD €987.96) and similar in the intervention and usual care groups: €516.10 or $582.53 (SD €949.69) and €534.55 or $603.36 (SD €920.55) respectively. Conclusions At €566 or $639 per episode, societal cost of AOM is higher than previously known and mainly driven by productivity losses by children’s parents. Considering its high incidence, AOM poses a significant economic burden that extends beyond direct medical costs. Trial registration Netherlands Trial Register no. NTR4920: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4920.

Improving Outcomes for English Learners Through Technology: A Randomized Controlled Trial

English learners (ELs) in K–12 schools must acquire English while simultaneously mastering content knowledge. Educational technology may support students’ learning through the affordance of individualized language practice. The current randomized controlled trial intervention study examined the effects of Rosetta Stone Foundations software on English learning among middle school ELs. The study took place in Grades 6 to 8 of an urban U.S. school district ( N = 221). Predictors of interest included time of testing (pretest vs. posttest) and software usage, and covariates included grade level, sex, and attendance. Additionally, socioeconomic status and home language were accounted for due to sample homogeneity. Multilevel models indicated that treatment group students showed larger gains than control group students on oral/aural outcomes. These results indicate that the software intervention enables individualized practice that can produce proficiency-related gains over and above the typical classroom curriculum.

Exploring the behavioural determinants of adherence to prescription for acute febrile illnesses, and development of a training and communication clinical trial intervention: a description of research methods

ObjectiveTo explore behavioural factors relating to prescription adherence and the communication of prescription adherence messages for patients with acute febrile illness, and to develop a Training & Communication (T&C) intervention to be delivered as part of a clinical trial. The clinical trial intervention package consists of improved diagnostic tools, clinical practices and the T&C package, for children, adolescents and adults presenting with fever symptoms at outpatient facilities in five LMICs.DesignContent analysis of primary, qualitative data collection, informed by the Capability, Opportunity, Motivation (COM-B) theory of behaviour, the Theoretical Domains Framework (TDF) and Behaviour Change Wheel (BCW) approach.SettingHealth facilities and local communities in five LMICs in Africa and Asia.ParticipantsHealth facility prescribers and local community adults.InterventionFebrile illness is a common presentation among adults and children in primary care settings, but diagnosing the cause of fever is challenging, especially in low-resource settings. Prescribers’ and patients’ behaviours underpin treatment practices, and antibiotics are the customary fallback choice for lack of better alternatives. However, in most cases antibiotics would not be required, do not cure the ongoing infection, and may have short-term (toxicity, costs) and long-term (drug resistance) untoward effects.Trialling new approaches including point-of-care tests and diagnostic algorithms alone would provide limited information on real-life applicability if behaviours are not accounted for.Accordingly, we designed an innovative, multiphase, mixed methods study, combining qualitative and behaviour approaches, with a quantitative two-arm, clinic based, randomised controlled trial. Qualitative and behavioural methods are used to: support the development of the Training & Communication component of the clinical trial, collect patient information on adherence, and support recommendations for future behaviour change interventions.This paper describes the qualitative research methods used to generate the clinical trial training and communication interventions, in support of adherence to prescriptions.Article SummaryStrengths and limitations of this studyThis is the first study we know of to explore the behavioural factors affecting prescription adherence and the communication of adherence messages in the LMIC study locations.The use of behavioural frameworks to shape the design of data gathering topic guides has the potential to illuminate the drivers for antibiotic prescription adherence, and generate the knowledge needed to support the design of effective communication interventions.The local nature of behavioural drivers means it is unlikely that the research findings will be generalisable and directly usable in other locations, however the process by which behavioural drivers are identified, and the process to convert to a training and communication package intervention, are applicable beyond the study sites.The scope of the clinical trial intervention, of which the T&C package is one component, precludes a wider behaviour change intervention which may be beneficial to improving adherence. This will be explored in a set of intervention recommendations.Because the T&C intervention is one component of the package of interventions for the clinical trial, we cannot rule out the influence of other intervention components (for example the use of an increased number of diagnostic tests) on prescription adherence. Similarly, due to the intervention ‘package’ approach, we cannot conclude how much the T&C package contributed to patient recovery at Day7, the primary outcome.

Study design: what’s in a name?

The name of the study should properly reflect the actual conduct and analysis of the study. This short paper provides guidance on how to properly name the study design. The first distinction is between a trial (intervention given to patients to study its effect) and an observational study. For observational studies, it should further be decided whether it is cross-sectional or whether follow-up time is taken into account (cohort or case–control study). The distinction prospective-retrospective has two disadvantages: prospective is often seen as marker of higher quality, which is not necessarily true; there is no unifying definition that makes a proper distinction between retrospective and prospective possible.