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Background: Many community-based self-management programs have been developed for older adults with type-2 diabetes mellitus (T2DM), bolstered by evidence from randomized controlled trials (RCTs) that T2DM can be prevented and managed through lifestyle modifications. However, the evidence for their effectiveness is contradictory and weakened by reliance on single-group designs and/or small samples. Additionally, older adults with multiple chronic conditions (MCC) are often excluded because of recruiting and retention challenges. This paper presents a protocol for a two-armed, multisite, pragmatic, mixed-methods RCT examining the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP), a new 6-month interprofessional, nurse-led program to promote self-management in older adults (aged 65 years or older) with T2DM and MCC and support their caregivers (including family and friends).Methods/design: The study will enroll 160 participants in two Canadian provinces, Ontario and Alberta. Participants will be randomly assigned to the control (usual care) or program study arm. The program will be delivered by registered nurses (RNs) and registered dietitians (RDs) from participating diabetes education centers (Ontario) or primary care networks (Alberta) and program coordinators from partnering community-based organizations. The 6-month program includes three in-home visits, monthly group sessions, monthly team meetings for providers, and nurse-led care coordination. The primary outcome is the change in physical functioning as measured by the Physical Component Summary (PCS-12) score from the short form-12v2 health survey (SF-12). Secondary client outcomes include changes in mental functioning, depressive symptoms, anxiety, and self-efficacy. Caregiver outcomes include health-related quality of life and depressive symptoms. The study includes a comparison of health care service costs for the intervention and control groups, and a subgroup analysis to determine which clients benefit the most from the program. Descriptive and qualitative data will be collected to examine implementation of the program and effects on interprofessional/team collaboration.Discussion: This study will provide evidence of the effectiveness of a community-based self-management program for a complex target population. By studying both implementation and effectiveness, we hope to improve the uptake of the program within the existing community-based structures, and reduce the research-to-practice gap.Trial Registration: ClinicalTrials.gov, Identifier: NCT02158741 . Registered on 3 June 2014. [ABSTRACT FROM AUTHOR]

Background: Sedatives are administered to 85% of intensive care unit (ICU) patients. The most commonly used sedatives are intravenous benzodiazepines and propofol. These agents are associated with over-sedation in 40 to 60% of patients, which can lead to prolonged intubation, delirium and drug-induced hypotension. Evidence is increasing that volatile anesthetic agents are associated with faster extubation times, improved cardiovascular stability with no end-organ toxicity in comparison to our standard intravenous agents for short-term critical care sedation. Use of volatile agents within the ICU is a novel technique using a specialized delivery and scavenging system, which requires staff training and cultural acceptance. This pilot randomized controlled trial aims to assess the safety and feasibility of delivering volatile agents for long-term patient sedation in the ICU with limited or no experience of this technique.Methods/design: This is a prospective multicenter pragmatic pilot RCT that is blinded to the data analyst. This study aims to recruit 60 adult ICU patients requiring mechanical ventilation and sedation for more than 48 h. Patients will be randomized 2:1 to receive inhaled isoflurane (40 patients) or intravenous midazolam and/or propofol (20 patients) sedation. Sedation is titrated to a targeted Sedation Analgesia Score (SAS) using an explicit sedation-analgesia algorithm until extubation or tracheostomy. Primary safety and feasibility outcomes will assess atmospheric volatile concentration levels and adherence to our sedation-analgesia protocol. Secondary outcomes include time to extubation, duration of ventilation, quality of sedation, delirium, vasoactive drug support, length of stay, serum fluoride levels and mortality.Discussion: This pilot project will serve as the basis for a larger RCT that will be powered for important clinical outcomes.Trial Registration: ClinicalTrials.gov, NCT01983800 (registration date 2 July 2013). [ABSTRACT FROM AUTHOR]

Background: Vitamin D is a pleiotropic hormone important for the recovery of organ systems after critical illness. Recent observational studies have suggested that three out of every four children are vitamin D deficient following cardiac surgery, with inadequate preoperative intake and surgical losses playing important contributory roles. Observed associations between postoperative levels, cardiovascular dysfunction and clinical course suggest that perioperative optimization of vitamin D status could improve outcome. With this two-arm, parallel, double blind, randomized controlled trial (RCT), we aim to compare immediate postoperative vitamin D status in children requiring cardiopulmonary bypass for congenital heart disease who receive preoperative daily high dose vitamin D supplementation (high-dose arm) with those who receive usual intake (low-dose arm).Methods/design: Eligibility requirements include age (>36 weeks, <18 years) and a congenital heart defect requiring cardiopulmonary bypass surgical correction. Enrollment of 62 participants will take place at a single Canadian tertiary care center over a period of 2 years. Children randomized to the high-dose group will receive age-based dosing that was informed by the Institute of Medicine (IOM) daily tolerable upper intake level (<1 year old = 1,600 IU/day, >1 year old = 2,400 IU/day). Children in the low-dose arm will receive usual care based on IOM recommendations (<1 year old = 400 IU, >1 year old = 600 IU). The primary outcome measure is immediate postoperative vitamin D status, using blood 25(OH)D.Discussion: Maintaining adequate postoperative vitamin D levels following surgery could represent an effective therapy to speed recovery following CHD surgery. The proposed research project will determine whether preoperative supplementation with a dosing regimen based on the IOM recommended daily upper tolerable intake will prevent postoperative vitamin-D deficiency in the majority of children. The results will then be used to inform the design of a large international RCT exploring whether preoperative optimization of vitamin D status might improve short and long-term outcomes in this vulnerable population.Trial Registration: Clinicaltrials.gov Identifier--NCT01838447 Date of registration: 11 April 2013. [ABSTRACT FROM AUTHOR]

Background: No head-to-head randomized controlled trials have demonstrated the superiority of one colorectal screening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomized controlled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), to inform the planning of a larger evaluative trial.Methods: Eligible patients (aged 50 to 70) were recruited from five primary care practices in Hamilton, ON, Canada, between March 23, 2010 and August 11, 2010, and randomized 1:1:1 in a parallel design using an automated, centralized telephone service to either FOBT, OC, or VC. To reflect conventional practice, patients received no additional reminders to complete their allocated screening test beyond those received in usual practice. The primary outcome was completion of the assigned screening procedure. Results of the index test and any follow-up investigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded to group assignment. The trial was stopped early due to lack of ongoing funding.Results: A total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. The allocated screening procedure was completed by 43 (64%) subjects allocated to FOBT (95% confidence interval [CI], 52-75%), 53 (80%) subjects allocated to OC (95% CI, 69-88%), and 50 (77%) subjects allocated to VC (95% CI, 65-85%); because the trial stopped early, we had insufficient statistical power to detect clinically relevant differences in completion rates. During 6 months follow-up, colorectal adenomas were detected in 0 (0%) subjects allocated to FOBT, 12 (18%) subjects allocated to OC, and 2 (3%) subjects allocated to VC. One subject in the OC arm had histological evidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer.Conclusions: In this pilot randomized controlled trial of colorectal cancer screening in a primary care setting, 64-80% of subjects completed their allocated screening test. These findings may be of value to investigators planning clinical trials to evaluate the effectiveness of colorectal cancer screening.Trial Registration: ClinicalTrials.gov NCT00865527. https://clinicaltrials.gov/ct2/show/NCT00865527. [ABSTRACT FROM AUTHOR]