Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03053245 |
| Other study ID # |
R01HL131730 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2017 |
| Est. completion date |
October 31, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The m-CCRP randomized controlled trial will evaluate the efficacy of a collaborative critical
care recovery program from acute respiratory failure (ARF) survivors in accomplishing the
Institute of Healthcare Improvement's triple aims of better health, better care, at lower
cost.
Primary Aim:
To assess the efficacy of m-CCRP in improving the QOL of ARF survivors compared to attention
control at twelve months post hospital discharge.
Secondary Aims:
1. To evaluate the efficacy of m-CCRP in improving cognitive, physical, and psychological
function of ARF survivors at twelve months post hospital discharge when compared to
attention control.
2. To evaluate the efficacy of m-CCRP in reducing health-care utilization, defined as time
from enrollment to emergency department visits and/or hospital re-admission, by ARF
survivors as compared to attention control at twelve months post hospital discharge.
Description:
Five million Americans require admission to intensive care units (ICU) annually due to life
threatening illnesses, and this number is expected to rise.4 Two million of these ICU
admissions are secondary to Acute Respiratory Failure (ARF) with more than half requiring
mechanical ventilation. Greater than 50% of the patients with ARF who survive their ICU stay
suffer from long-term morbidity in the form of functional disability, cognitive disability,
major or minor depression, and anxiety. These complications negatively impact the quality of
life (QOL) of ARF survivors, interfere with their physical and emotional recovery, and lead
to long-term disability with less than half of ARF survivors returning to the work force.
Ongoing care for ARF survivors has been estimated to cost $3.5 million per ARF survivor at 1
year. This constellation of ICU sequelae with attendant morbidity has been designated as the
post-intensive care syndrome (PICS). There are community resources and rehabilitation
services available to ARF survivors, but the current fragmented nature of our healthcare
system is unable to integrate and coordinate care in order to provide the most meaningful
recovery.
The Institute of Medicine recommends the development of care coordination programs to deliver
patient-centered and interdisciplinary-based medical care. Indiana University Center for
Aging Research (IUCAR) has over 20 years of experience in delivering interdisciplinary,
collaborative care through pragmatic interventions utilizing care coordinators. Care
coordinator delivery models have improved care of patients with dementia, depression,
functional decline and PICS. Our PICS clinic, the Critical Care Recovery Center (CCRC) was
developed in 2011 to enhance cognitive, physical, and psychological recovery of ICU
survivors.
Since then, CCRC has provided care to over 200 survivors with a high burden of PICS (88% had
cognitive impairment; 60% had depression). CCRC showed feasibility and initial efficacy in
managing PICS. However given its traditional outpatient clinic structure, CCRC has limited
physical access to ARF survivors, leading to delayed evaluation and an added travel burden on
ARF survivors. Building from the experience of the CCRC and our other successful care
coordinator based programs; we now propose a mobile model of post-ICU collaborative care with
greater access to enhance the recovery of ARF survivors.
The overarching aim of the proposed program is to improve the QOL of patients who survived an
episode of ARF by maximizing their cognitive, physical, and psychological recovery utilizing
a mobile care coordinator. The care coordinator will bring the intervention to the patient
irrespective of the patient's physical location and will be supported by an interdisciplinary
team of a critical care physician, a health services scientist, an ICU nurse, and a
psychologist, with input from other consultants as needed. In addition, dynamic feedback
through process measurement tools and care coordination support software will inform the
recovery process. We propose to evaluate the efficacy of our collaborative care intervention
termed the "Mobile Critical Care Recovery Program (m-CCRP)" through a randomized clinical
trial among survivors of ARF.
