Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial

Sikandar Khan,Emily Brewer,Omar Irfan,Sophia Wang,Frederick W Unverzagt,Sujuan Gao,Anthony Perkins,Stephanie Martinez,Malaz Boustani,Ashok Biju,Sue Lasiter,Ben Zarzaur,Amanda Harrawood,Omar Rahman,Babar Khan

doi:10.1186/s13063-018-2449-2

Abstract

BackgroundPatients admitted to intensive care units (ICU) with acute respiratory failure (ARF) face chronic complications that can impede return to normal daily function. A mobile, collaborative critical care model may enhance the recovery of ARF survivors.MethodsThe Mobile Critical Care Recovery Program (m-CCRP) study is a two arm, randomized clinical trial. We will randomize 620 patients admitted to the ICU with acute respiratory failure requiring mechanical ventilation in a 1:1 ratio to one of two arms (310 patients per arm) – m-CCRP intervention versus attention control. Those in the intervention group will meet with a care coordinator after hospital discharge in predetermined intervals to aid in the recovery process. Baseline assessments and personalized goal setting will be used to develop an individualized care plan for each patient after discussion with an interdisciplinary team. The attention control arm will receive printed material and telephone reminders emphasizing mobility and management of chronic conditions. Duration of the intervention and follow-up is 12 months post-randomization.Our primary aim is to assess the efficacy of m-CCRP in improving the quality of life of ARF survivors at 12 months. Secondary aims of the study are to evaluate the efficacy of m-CCRP in improving function (cognitive, physical, and psychological) of ARF survivors and to determine the efficacy of m-CCRP in reducing acute healthcare utilization.DiscussionThe proposed randomized controlled trial will evaluate the efficacy of a collaborative critical care recovery program in accomplishing the Institute of Healthcare Improvement’s triple aims of better health, better care, at lower cost. We have developed a collaborative critical care model to promote ARF survivors’ recovery from the physical, psychological, and cognitive impacts of critical illness. In contrast to a single disease focus and clinic-based access, m-CCRP represents a comprehensive, accessible, mobile, ahead of the curve intervention, focused on the multiple aspects of the unique recovery needs of ARF survivors.Trial registrationNCT03053245, clinicaltrials.gov, registered February 1, 2017.

Highlights

Patients admitted to intensive care units (ICU) with acute respiratory failure (ARF) face chronic complications that can impede return to normal daily function
post-intensive care syndrome (PICS) is defined as a cluster of debilitating symptoms characterized by physical and cognitive impairment as well as symptoms of depression and anxiety, with a negative impact on their overall quality of life (QOL) [3,4,5,6,7,8,9,10,11,12,13,14,15]
Primary aim To assess the efficacy of Mobile Critical Care Recovery Program (m-CCRP) in improving the QOL of ARF survivors compared to attention control at 12 months post hospital discharge

Summary

Introduction

Patients admitted to intensive care units (ICU) with acute respiratory failure (ARF) face chronic complications that can impede return to normal daily function. With advances in medical technology and an aging population, the United States has millions of acute respiratory failure (ARF) survivors [1, 2]. PICS is prevalent, with greater than 50% of ARF survivors affected, and impairs recovery after hospital discharge and can persist for years [16, 17]. Primary care providers often do not have appropriate resources to identify or treat PICS symptoms, resulting in diminished QOL and longterm disability for patients [18, 19,20,21,22]. More than 50% of ARF survivors suffer from functional or cognitive disability, major or minor depression, and anxiety

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