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A Randomized Feasibility Trial of a New Lifestyle Referral Assessment Versus Usual Assessment in an Acute Cardiology Setting.

ABSTRACT: A healthy diet, taking exercise, and not smoking or consuming alcohol in excess are important to reduce the risk of cardiovascular disease either alone or in combination with statin medication. Health education, including providing information to patients on healthy living and guidance on how to achieve it, is a key nursing function.This study aims first to assess the feasibility of conducting a full-scale trial of lifestyle referral assessment as shown by recruitment rate, data collection, and follow-up and second to assess proof of concept and explore possible mechanisms of change.This was a single-center, randomized, 2-arm, parallel-group, unblinded feasibility trial conducted in an acute teaching hospital trust. Participants were followed up at 3 and 6 months after randomization.Eight hundred eighty-seven patients were screened for eligibility, of whom 132 (15%) were randomized into the trial. Of the patients allocated to the individualized assessment, 27% accepted referral or self-referred by 3 months in comparison to 5% allocated to the usual assessment.We demonstrated that a full-scale trial is feasible and that an individualized approach increased the number of patients accepting referral to a formal program and initiating lifestyle change. However, we should consider the aim of the assessment and ways in which the process of change can be optimized in order to produce long-term benefit for patients.current controlled trials ISRCTN41781196.

SUBMITTER: Hill K

PROVIDER: S-EPMC4743063 | biostudies-literature | 2016 Nov/Dec

REPOSITORIES: biostudies-literature

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A Randomized Feasibility Trial of a New Lifestyle Referral Assessment Versus Usual Assessment in an Acute Cardiology Setting.

Hill Kate K Walwyn Rebecca R Camidge Diana D Murray Jenni J Meads David D Reynolds Greg G Farrin Amanda A House Allan A

The Journal of cardiovascular nursing 20161101 6

<h4>Background</h4>A healthy diet, taking exercise, and not smoking or consuming alcohol in excess are important to reduce the risk of cardiovascular disease either alone or in combination with statin medication. Health education, including providing information to patients on healthy living and guidance on how to achieve it, is a key nursing function.<h4>Objectives</h4>This study aims first to assess the feasibility of conducting a full-scale trial of lifestyle referral assessment as shown by r ...[more]

PMID: 26422640

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Project description:IntroductionIn patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome, and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness are lacking.AimTo determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness.DesignA feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up).InterventionPatients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the 6 months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline and 1, 3, and 6 months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consultations will be based on middle-range theory of self-care.OutcomeFeasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors, and health outcomes will be evaluated in the intervention and the control group at baseline and 1, 3, 6, and 12 months.DiscussionThe present study will contribute with knowledge on how to implement a feasible social support intervention targeting patients treated for cardiac disease who experience loneliness and, furthermore, investigate the preliminary effect on health behavior and health outcome in the early rehabilitation period.Trial registrationThe trial is registered on clinicaltrials.gov (NCT05503810) 18.08.2022.

Project description:BACKGROUND:Alarming rates of unhealthy alcohol, non-prescription drug, and tobacco use highlight the preventable health risks of substance abuse and the urgent need to activate clinicians to recognize and treat risky use. Screening, brief intervention, and referral to treatment (SBIRT) is an efficacious and effective processes to identify, reduce and prevent risky use of substances. This paper describes a study protocol testing implementation of a toolkit to enhance use of SBIRT in acute care settings to recognize and address patient risky alcohol, drug, and tobacco use. METHODS:This study uses a phased cluster randomized mixed method design to test nurse-led implementation of an SBIRT toolkit on one medical-surgical unit at 14 acute care hospitals (critical access, community and academic health centers). Medical surgical units will be randomly assigned to implement the SBIRT toolkit (engagement and communication, assessment, planning, training, and evaluation tools) or a wait-list usual care control group that begins implementation 6 months later. Primary endpoints are documentation of SBIRT delivery in randomly selected electronic medical records at baseline, 6 months and 12 months after group 1 implementation (61 records per unit per time period, N?=?2562). Two surveys will be administered to unit nurses: smoking cessation activities will be assessed at baseline and SBIRT use will be assessed on randomly-selected days after implementation. In addition, site coordinators will complete a baseline capacity assessment, an implementation fidelity survey post-implementation, and a structured interview at the end of the study. Multilevel mixed-effects effects logistic and linear models will be used to analyze use of SBIRT and cost outcomes. DISCUSSION:This study will guide subsequent SBIRT implementation, dissemination, and spread across rural, community and urban healthcare systems throughout the state and beyond. The long-term objective is to activate clinicians to recognize, intervene and refer people with risky substance use to improve health and decrease substance use disorders. Trial registration ClinicalTrials.gov NCT03560076.

Project description:IntroductionAcute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection.Methods and analysisThe LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes.Ethics and disseminationThe LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The results from the trial will be presented at national and international colorectal conferences and will be submitted for publication to peer-reviewed journals.Trial registration numberISRCTN15681041; Pre-results.

Project description:Background and objectivesSurvivors of AKI are at higher risk of CKD and death, but few patients see a nephrologist after hospital discharge. Our objectives during this 2-year vanguard phase trial were to determine the feasibility of randomizing survivors of AKI to early follow-up with a nephrologist or usual care, and to collect data on care processes and outcomes.Design, setting, participants, & measurementsWe performed a randomized controlled trial in patients hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2-3 AKI at four hospitals in Toronto, Canada. We randomized patients to early nephrologist follow-up (standardized basket of care that emphasized BP control, cardiovascular risk reduction, and medication safety) or usual care from July 2015 to June 2017. Feasibility outcomes included the proportion of eligible patients enrolled, seen by a nephrologist, and followed to 1 year. The primary clinical outcome was a major adverse kidney event at 1 year, defined as death, maintenance dialysis, or incident/progressive CKD.ResultsWe screened 3687 participants from July 2015 to June 2017, of whom 269 were eligible. We randomized 71 (26%) patients (34 to nephrology follow-up and 37 to usual care). The primary reason stated for declining enrollment included hospitalization-related fatigue (n=65), reluctance to add more doctors to the health care team (n=59), and long travel times (n=40). Nephrologist visits occurred in 24 of 34 (71%) intervention participants, compared with three of 37 (8%) participants randomized to usual care. The primary clinical outcome occurred in 15 of 34 (44%) patients in the nephrologist follow-up arm, and 16 of 37 (43%) patients in the usual care arm (relative risk, 1.02; 95% confidence interval, 0.60 to 1.73).ConclusionsMajor adverse kidney events are common in AKI survivors, but we found the in-person model of follow-up posed a variety of barriers that was not acceptable to many patients.Clinical trial registry name and registration numberNephrologist Follow-up versus Usual Care after an Acute Kidney Injury Hospitalization (FUSION), NCT02483039 CJASN 16: 1005-1014, 2021. doi: https://doi.org/10.2215/CJN.17331120.

Project description:Background:Enhancing the capacity to experience positive affect could help improve recovery across a range of areas of mental health. Experimental psychopathology research indicates that a computerized cognitive training paradigm involving generation of positive mental imagery can increase state positive affect, and more recent clinical studies have suggested that this training could be used as an adjunct treatment module to target symptoms related to positive affect deficits, specifically anhedonia. The current study investigates the feasibility of adding a positive mental imagery computerized training module to treatment for patients in inpatient mental health settings, with a focus on increasing positive affect and reducing anhedonia. The positive mental imagery training (PMIT) is added to treatment as usual (TAU) in the inpatient setting, and compared to TAU alone, or TAU plus an alternative cognitive training module not hypothesized to increase positive affect, cognitive control training (CCT). Methods:The study is a feasibility randomized controlled trial with three parallel arms. Up to 90 patients admitted to inpatient mental health treatment clinics in Germany will be randomized to PMIT?+?TAU, CCT?+?TAU, or TAU on a 1:1:1 ratio. PMIT or CCT consist of an introductory session followed by up to 8 full training sessions over 2 weeks. All three arms (including TAU) include regular completion of mood measures over the 2-week period. Outcome measures are completed pre and post this 2-week training/monitoring period, and at 2-week follow-up. Data will be presented in the form of both raw means and standardized effect sizes, with 95% confidence intervals, for both intention-to-treat and per-protocol samples. Discussion:The study will inform feasibility of conducting a fully powered randomized controlled trial investigating the addition of the positive mental imagery training as a treatment adjunct to inpatient treatments for mental health, including potential refinement of study procedures, inclusion/exclusion criteria, and preliminary indications of the likely range of effect sizes. Trial registration:clinicaltrials.gov, NCT02958228 (date registered: 4 November 2016).

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A Randomized Feasibility Trial of a New Lifestyle Referral Assessment Versus Usual Assessment in an Acute Cardiology Setting.

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A Randomized Feasibility Trial of a New Lifestyle Referral Assessment Versus Usual Assessment in an Acute Cardiology Setting.

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