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Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. METHODS:IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. DISCUSSION:This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03095417 . Registered on 23 March 2017. Last updated on 15 May 2017.

SUBMITTER: Wang S

PROVIDER: S-EPMC5869765 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

Wang Sophia S Hammes Jessica J Khan Sikandar S Gao Sujuan S Harrawood Amanda A Martinez Stephanie S Moser Lyndsi L Perkins Anthony A Unverzagt Frederick W FW Clark Daniel O DO Boustani Malaz M Khan Babar B

Trials 20180327 1

<h4>Background</h4>Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a ...[more]

PMID: 29580264

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Project description:BACKGROUND:Over the last decade, health care delivery has shifted to partnering with patients and their families to improve health and quality of care, and to lower costs. Partnering with family members (FMs) of critically ill patients who lack capacity is particularly important for improving experiences and outcomes for both patients and FMs. How best to apply such partnering strategies, however, is yet unknown. The IMPACT trial will evaluate two interventions that enable partnerships with families of critically ill patients, each in a distinct content area, but similar in that they empower and support FMs. METHODS:This multi-center, open-label, randomized, phase II clinical trial aims to randomize 150 older, long-stay ICU patients and their families into one of three groups (50 in each group): (1) The OPTimal nutrition by Informing and Capacitating FMs of best practices (OPTICs) group, a multi-faceted intervention to engage and empower FMs to advocate for, and audit, best nutritional practices for their critically ill FMs, (2) A web-based decision-support intervention called the ICU Workbook (The Canadian Researchers at the End of Life Network (CARENET) ICU Workbook; https://www.myicuguide.ca/ . Accessed 3 Feb 2017.) to support families in shared decision-making process regarding goals of medical treatments, and (3) Usual care. The main outcomes for this trial include nutritional adequacy in hospital and hand-grip strength prior to hospital discharge; satisfaction with decision-making; decision conflict; and degree of shared decision-making. DISCUSSION:With the goal of improving the functional recovery of nutritionally high-risk older patients and the quality of care at the end of life for these patients and their FMs in the ICU, we have proposed two novel family capacitation strategies. We hope that the nutrition and decision-support interventions implemented and evaluated in our study will contribute to the evidentiary basis for best family partnered care pathways focused on optimizing the quality of ICU care for patients with life-threatening illness and their families. TRIAL REGISTRATION:Clinical trials.gov, ID: NCT02920086 . Registered on 30 September 2016. Protocol version dated 11 October 2016.

Project description:BackgroundThe majority of surgical interventions are performed in day care and patients are discharged after the first critical postoperative period. At home, patients have limited options to contact healthcare providers in the hospital in case of severe pain and nausea. A smartphone application for patients to self-record pain and nausea when at home after day care surgery might improve patient's recovery. Currently patient experiences with smartphone applications are promising; however, we do not know whether remote monitoring with such an application also improves the patient's recovery. This study aims to evaluate the experienced quality of recovery after day care surgery between patients provided with the smartphone application for remote monitoring and patients receiving standard care without remote monitoring.MethodsThis non-blinded randomized controlled trial with mixed methods design will include 310 adult patients scheduled for day care surgery. The intervention group receives the smartphone application with text message function for remote monitoring that enables patients to record pain and nausea. An anaesthesia professional trained in empathetic communication, who will contact the patient in case of severe pain or nausea, performs daily monitoring. The control group receives standard care, with post-discharge verbal and paper instructions. The main study endpoint is the difference in perceived quality of recovery, measured with the QoR-15 questionnaire on the 7th day after day care surgery. Secondary endpoints are the overall score on the Quality of Recovery-15 at day 1, 4 and 7-post discharge, the perceived quality of hospital aftercare and experienced psychological effects of remote monitoring during postoperative recovery from day care surgery.DiscussionThis study will investigate if facilitating patients and healthcare professionals with a tool for accessible and empathetic communication might lead to an improved quality of the postoperative recovery period.Trial registrationThe 'Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial' is approved and registered on 23 February 2022 by Research Ethics Committees United with registration number R21.076/NL78144.100.21. The protocol NL78144.100.21, 'Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial', is registered at the ClinicalTrials.gov public website (registration date 16 February 2022; NCT05244772).

Project description:BACKGROUND:Premature infants are at risk for abnormal sensory development due to brain immaturity at birth and atypical early sensory experiences in the Neonatal Intensive Care Unit. This altered sensory development can have downstream effects on other more complex developmental processes. There are currently no interventions that address rehabilitation of sensory function in the neonatal period. METHODS:This study is a randomized controlled trial of preterm infants enrolled at 32-36 weeks postmenstrual age to either standard care or standard care plus multisensory intervention in order to study the effect of multisensory intervention as compared to standard care alone. The study population will consist of 100 preterm infants in each group (total n = 200). Both groups will receive standard care, consisting of non-contingent recorded parent's voice and skin-to-skin by parent. The multisensory group will also receive contemporaneous holding and light pressure containment for tactile stimulation, playing of the mother's voice contingent on the infant's pacifier sucking for auditory stimulation, exposure to a parent-scented cloth for olfactory stimulation, and exposure to carefully regulated therapist breathing that is mindful and responsive to the child's condition for vestibular stimulation. The primary outcome is a brain-based measure of multisensory processing, measured using time locked-EEG. Secondary outcomes include sensory adaptation, tactile processing, speech sound differentiation, motor and language function, measured at one and two years corrected gestational age. DISCUSSION:This is the first randomized controlled trial of a multisensory intervention using brain-based measurements in order to explain the causal effects of the multisensory intervention on neural processing changes to mediate neurodevelopmental outcomes in former preterm infants. In addition to contributing a critical link in our understanding of these processes, the protocolized multisensory intervention in this study is therapist administered, parent supported and leverages simple technology. Thus, this multisensory intervention has the potential to be widely implemented in various NICU settings, with the opportunity to potentially improve neurodevelopment of premature infants. TRIAL REGISTRATION:NIH Clinical Trials ( clinicaltrials.gov ): NCT03232931 . Registered July 2017.

Project description:BackgroundPatients receiving in-center hemodialysis experience disproportionate morbidity and incur high healthcare-related costs. Much of this cost stems from potentially avoidable hospitalizations. Peer mentorship has been used effectively to improve outcomes for patients with complex chronic diseases. We propose testing the efficacy of peer mentorship on hospitalization rates among patients receiving hemodialysis.MethodsThis is a multicenter parallel group randomized controlled pragmatic trial of patients treated at hemodialysis facilities in Bronx, NY and Nashville, TN. The study has two phases. Phase 1 will enroll and train 16 hemodialysis patients (10 in Bronx, NY and 6 in Nashville TN) to be mentors using a program focused on enhancing self-efficacy, dialysis self-management and autonomy-supportive communication skills. Phase 2 will enroll 200 high risk adults receiving hemodialysis (140 in Bronx, NY and 60 in Nashville, TN), half of whom will be randomized to intervention and half to usual care. Intervention participants are assigned to weekly telephone calls with trained mentors (see Phase 1) for a 3-month period. The primary outcome of Phase 1 will be engagement of mentors with training and change in knowledge scores and autonomy skills from pre- to post-training. The primary outcome of Phase 2 will be the composite count of ED visits and hospitalizations at the end of study follow-up in patient participants assigned to intervention as compared to those assigned to usual care. Secondary outcomes for Phase 2 include the change over the trial period in validated survey scores measuring perception of social support and self-efficacy, and dialysis adherence metrics, among intervention participants as compared to usual care participants.DiscussionThe PEER-HD study will test the feasibility and efficacy of a pragmatic peer-mentorship program designed for patients receiving hemodialysis on ED visit and hospitalization rates. If effective, peer-mentorship holds promise as a scalable patient-centered intervention to decrease hospital resource utilization, and by extension morbidity and cost, for patients receiving maintenance in-center hemodialysis.Trial registrationClinicaltrials.gov identifier: NCT03595748 ; 7/23/2018.Trial sponsorNational Institutes of Diabetes, Digestive and Kidney Disease (NIDDK) 5R18DK118471.FundingFunding for this study was provided by the National Institutes of Diabetes, Digestive and Kidney Disease: R18DK118471.Study statusThis is an ongoing study and not complete. We are still collecting data for observational follow-up on participants.Related articlesNo related articles for this study have been submitted to any journal. The study sponsor and funders had no role in the design, analysis or interpretation of this data. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Project description:A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the 'conscious target': patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs.A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses.This 'educational research' project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake.Clinicaltrials.gov #NCT01360346.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

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Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

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Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

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