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

Abstract

BackgroundDelirium 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.MethodsIMPROVE 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT03095417. Registered on 23 March 2017. Last updated on 15 May 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2569-8) contains supplementary material, which is available to authorized users.

Potential for Cognitive Communication Impairment in COVID-19 Survivors: A Call to Action for Speech-Language Pathologists

“…Importantly, this fluctuation is particularly characteristic of delirium and not seen in dementia or other forms of cognitive impairment (Hopkins & Jackson, 2006). Delirium occurs in up to 70% of critically ill older adults in ICUs (Wang et al, 2018), and its presence and duration is the strongest risk factor for the persistence of cognitive impairment following recovery. Its presentation is often accompanied by myopathy or polyneuropathy due to long-term debilitation in an ICU, along with psychological comorbidities (anxiety, depression, and posttraumatic stress disorder [PTSD]; Mart & Ware, 2020).…”

“…Several randomized controlled trials are currently underway focusing on combinations of physical and cognitive training (cf. Fuke et al, 2018;Kondo et al, 2017;Wang et al, 2018), though most of these are being conducted by investigators in critical care medicine and not specific to the rehabilitation approaches that may be most advantageous over time. The data on interprofessional intervention approaches for delirium highlight the importance of early physical mobility to potentially improve at least the short-term physical concerns in PICS (Fuke et al, 2018;Kondo et al, 2017;Maheswaran et al, 2020).…”

Delirium and long term cognition in critically ill patients

“…The primary outcome will be cognitive performance at three months after discharge from hospital. Secondly, the Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) study (clinicaltrials.gov NCT03095417), is a four arm RCT comprising cognitive training and physical exercise, cognitive control and physical exercise, cognitive training and physical exercise control, and cognitive and physical exercise control 162. Cognitive training facilitated by online modules in patients’ homes and physical exercise will also be administered using internet enabled videoconferencing in small groups.…”

Instruments to measure outcomes of post-intensive care syndrome in outpatient care settings – Results of an expert consensus and feasibility field test

“…40,41,54,72 Previous or current ICU survivorship research has applied several of the PHQ scales. 8,13,[73][74][75][76] While the ultra-short depression and anxiety screening tool PHQ-4 is part of the proposed PICS screening, we suggest the 7-item Generalized Anxiety Disorder Scale (GAD-7) and the 8-item depression scale (PHQ-8) for the extended assessment. The measurement quality of the PHQ-8 is equivalent to that of the PHQ-9, which has an additional item for thoughts of death and self-harm.…”

“…Unfortunately, to our knowledge, there are no studies elucidating measurement quality of these tools in ICU survivors. 9,15,75,89,90 Users should also consider the licensing fees of the RBANS.…”