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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

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

Published in: Trials | Issue 1/2018

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Abstract

Background

Patients 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.

Methods

The 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.

Discussion

The 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 registration

NCT03053245, clinicaltrials.gov, registered February 1, 2017.
Appendix
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Metadata
Title
Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial
Authors
Sikandar Khan
Ashok Biju
Sophia Wang
Sujuan Gao
Omar Irfan
Amanda Harrawood
Stephanie Martinez
Emily Brewer
Anthony Perkins
Frederick W. Unverzagt
Sue Lasiter
Ben Zarzaur
Omar Rahman
Malaz Boustani
Babar Khan
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2449-2

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