Clinical trial NCT03053245: Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
Official title: Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Post-Intensive Care Syndrome
Keywords: Collaborative Care Model
Intensive Care Unit
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Hospitalized in the ICU
* Diagnosed with Acute Respiratory Failure (ARF) requiring greater than or equal to 24 hours of mechanical ventilation or noninvasive positive pressure ventilation or high flow nasal canula.
* Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care
* English speaking
* Able to consent either in-person or through legally authorized representative
* Have access to a telephone

Exclusion Criteria:

* Hospitalized to a regular non-ICU ward
* Diagnosis of cancer with life expectancy less than 1 year
* Admitted with ischemic or hemorrhagic cerebrovascular accident, traumatic brain injury, or undergoing neurosurgery
* History of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, or vascular dementia
* Unable to complete study questionnaire due to severe hearing loss
* Legally blind
* Pregnant (assessed by urine pregnancy test) or nursing
* Living outside the greater Indianapolis area
* Recent history of alcohol or substance abuse
* Status post tracheostomy and not eligible for a speaking valve
* Incarcerated at the time of study enrollment
* Schizophrenia or bipolar disorder (confirmed by EMR)
* Homelessness
* Illiterate

Primary outcomes:
measure: Self Reported Quality of Life PCS: Physical Component Score at 1 Year
timeFrame: 1 year
measure: Self Reported Quality of Life MCS: Mental Component Score at 1 Year
timeFrame: 1 year
measure: Cognitive Assessment Score at 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Depression Symptoms at 1 Year
timeFrame: 1 year
measure: Anxiety Symptoms at 1 Year
timeFrame: 1 year
measure: Physical Performance at 1 Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Center for Aging Research
name: Babar A Khan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khan S, Biju A, Wang S, Gao S, Irfan O, Harrawood A, Martinez S, Brewer E, Perkins A, Unverzagt FW, Lasiter S, Zarzaur B, Rahman O, Boustani M, Khan B. Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial. Trials. 2018 Feb 7;19(1):94. doi: 10.1186/s13063-018-2449-2.