Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors (m-CCRP)
Primary Purpose
Acute Respiratory Failure, Post-Intensive Care Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Critical Care Program
Attention Control
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Collaborative Care Model, Intensive Care Unit
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
Sites / Locations
- Eskenazi Hospital
- Methodist Hospital
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile Critical Care Recovery Program
Attention Control
Arm Description
The group will receive the Mobile Critical Care Recovery Program (m-CCRP) intervention which includes care coordination and collaborative care model for one year post enrollment.
The attention control group will receive telephone based check ins related to their health from the research study team.
Outcomes
Primary Outcome Measures
Change in Self Reported Quality of Life
Utilizing SF-36
Change in Cognitive Assessment Score
Utilizing RBANS
Secondary Outcome Measures
Change in Physical Performance
Utilizing SPPB
Change in Depression Symptoms
PHQ-9
Change in Anxiety Symptoms
GAD-7
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03053245
Brief Title
Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
Acronym
m-CCRP
Official Title
Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Post-Intensive Care Syndrome
Keywords
Collaborative Care Model, Intensive Care Unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
503 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Critical Care Recovery Program
Arm Type
Experimental
Arm Description
The group will receive the Mobile Critical Care Recovery Program (m-CCRP) intervention which includes care coordination and collaborative care model for one year post enrollment.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
The attention control group will receive telephone based check ins related to their health from the research study team.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Critical Care Program
Intervention Description
The m-CCRP revolves around the central figure of a care coordinator who will organize and align recovery resources. The care coordinator is a registered nurse whose scope of practice includes health coaching, case managing, community organizing, and nursing care provider. The m-CCRP support team will consist of a critical care physician (Dr. Khan), a geriatrician with expertise in collaborative care (Dr. Boustani), an ICU collaborative care nurse (Dr. Lasiter), and a psychologist (Dr. Unverzagt). This team will meet weekly with the care coordinator. Drs. Khan and Boustani will be accessible to the coordinator through phone or pager at all times.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Patients in this group will receive regular wellness calls from the research team.
Primary Outcome Measure Information:
Title
Change in Self Reported Quality of Life
Description
Utilizing SF-36
Time Frame
1 year
Title
Change in Cognitive Assessment Score
Description
Utilizing RBANS
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Physical Performance
Description
Utilizing SPPB
Time Frame
1 year
Title
Change in Depression Symptoms
Description
PHQ-9
Time Frame
1 year
Title
Change in Anxiety Symptoms
Description
GAD-7
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babar A Khan, MD, MS
Organizational Affiliation
Indiana University Center for Aging Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
29415760
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.
Results Reference
derived
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Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
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