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Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors

Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03053245
Acronym
m-CCRP
Enrollment
503
Registered
2017-02-15
Start date
2017-03-01
Completion date
2022-10-31
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Post-Intensive Care Syndrome

Keywords

Collaborative Care Model, Intensive Care Unit

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.

Interventions

BEHAVIORALMobile Critical Care Program

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.

BEHAVIORALAttention Control

Patients in this group will receive regular wellness calls from the research team.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self Reported Quality of Life PCS: Physical Component Score at 1 Year1 yearUtilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.
Self Reported Quality of Life MCS: Mental Component Score at 1 Year1 yearUtilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.
Cognitive Assessment Score at 1 Year1 yearUtilizing RBANS: Repeatable Battery for the Assessment of Neuropsychological Status. The overall RBANS z-score is the mean of the 7-item (RBANS subscale) z-scores that could be collected in person and by phone. The 7 subscales are: List Learning, Story Memory, Semantic fluency, Digit Span, List Recall, List Recognition, Story Recall. A Z-Score of 0 is the population mean. Values above 0 represent better outcomes.

Secondary

MeasureTime frameDescription
Depression Symptoms at 1 Year1 yearPHQ-9 (Patient Health Questionnaire-9) Scores range from 0 to 27 on the PHQ-9 with higher scores indicating greater severity of depression.
Anxiety Symptoms at 1 Year1 yearGAD-7 (Generalized Anxiety Disorder-7) Scores range from 0 to 21 on the GAD-7 with higher scores greater anxiety.
Physical Performance at 1 Year1 yearUtilizing SPPB The Short Physical Performance Battery (SPPB) will measure physical training effects on balance and strength. Ranges from 0-12: higher score is better outcome

Countries

United States

Participant flow

Pre-assignment details

Per protocol subjects were considered to be enrolled in the study at the time of completion of the informed consent process. 503 subjects were enrolled. 466 subjects were randomized to one of the two study groups.

Participants by arm

ArmCount
Mobile Critical Care Recovery Program
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. Mobile Critical Care Program: 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.
233
Attention Control
The attention control group will receive telephone based check ins related to their health from the research study team. Attention Control: Patients in this group will receive regular wellness calls from the research team.
233
Total466

Baseline characteristics

CharacteristicAttention ControlTotalMobile Critical Care Recovery Program
Age, Continuous56.9 years
STANDARD_DEVIATION 14.4
56.1 years
STANDARD_DEVIATION 14.4
55.2 years
STANDARD_DEVIATION 14.3
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants5 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
228 Participants461 Participants233 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
3 Participants4 Participants1 Participants
Race (NIH/OMB)
Black or African American
78 Participants172 Participants94 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants7 Participants2 Participants
Race (NIH/OMB)
White
146 Participants280 Participants134 Participants
Sex: Female, Male
Female
125 Participants250 Participants125 Participants
Sex: Female, Male
Male
108 Participants216 Participants108 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
24 / 23338 / 233
other
Total, other adverse events
0 / 2330 / 233
serious
Total, serious adverse events
0 / 2330 / 233

Outcome results

Primary

Cognitive Assessment Score at 1 Year

Utilizing RBANS: Repeatable Battery for the Assessment of Neuropsychological Status. The overall RBANS z-score is the mean of the 7-item (RBANS subscale) z-scores that could be collected in person and by phone. The 7 subscales are: List Learning, Story Memory, Semantic fluency, Digit Span, List Recall, List Recognition, Story Recall. A Z-Score of 0 is the population mean. Values above 0 represent better outcomes.

Time frame: 1 year

Population: Only participants who were able to complete the scale are included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Mobile Critical Care Recovery ProgramCognitive Assessment Score at 1 Year0.27 Z-scoreStandard Deviation 0.7
Attention ControlCognitive Assessment Score at 1 Year0.26 Z-scoreStandard Deviation 0.68
Primary

Self Reported Quality of Life MCS: Mental Component Score at 1 Year

Utilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.

Time frame: 1 year

Population: Only participants who were able to complete the scale are included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Mobile Critical Care Recovery ProgramSelf Reported Quality of Life MCS: Mental Component Score at 1 Year49.81 score on a scaleStandard Deviation 11.75
Attention ControlSelf Reported Quality of Life MCS: Mental Component Score at 1 Year51.12 score on a scaleStandard Deviation 10.23
Primary

Self Reported Quality of Life PCS: Physical Component Score at 1 Year

Utilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.

Time frame: 1 year

Population: Only participants who were able to complete the scale are included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Mobile Critical Care Recovery ProgramSelf Reported Quality of Life PCS: Physical Component Score at 1 Year36.22 score on a scaleStandard Deviation 12.55
Attention ControlSelf Reported Quality of Life PCS: Physical Component Score at 1 Year35.29 score on a scaleStandard Deviation 12.2
Secondary

Anxiety Symptoms at 1 Year

GAD-7 (Generalized Anxiety Disorder-7) Scores range from 0 to 21 on the GAD-7 with higher scores greater anxiety.

Time frame: 1 year

Population: Only participants who were able to complete the scale are included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Mobile Critical Care Recovery ProgramAnxiety Symptoms at 1 Year5.04 score on a scaleStandard Deviation 6.08
Attention ControlAnxiety Symptoms at 1 Year4.82 score on a scaleStandard Deviation 5.25
Secondary

Depression Symptoms at 1 Year

PHQ-9 (Patient Health Questionnaire-9) Scores range from 0 to 27 on the PHQ-9 with higher scores indicating greater severity of depression.

Time frame: 1 year

Population: Only participants who were able to complete the scale are included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Mobile Critical Care Recovery ProgramDepression Symptoms at 1 Year5.94 score on a scaleStandard Deviation 6.13
Attention ControlDepression Symptoms at 1 Year5.66 score on a scaleStandard Deviation 5.37
Secondary

Physical Performance at 1 Year

Utilizing SPPB The Short Physical Performance Battery (SPPB) will measure physical training effects on balance and strength. Ranges from 0-12: higher score is better outcome

Time frame: 1 year

Population: Only participants who were able to complete the scale are included in the analysis. Post COVID-19 no SPPB Tests were performed.

ArmMeasureValue (MEAN)Dispersion
Mobile Critical Care Recovery ProgramPhysical Performance at 1 Year8.8 score on a scaleStandard Deviation 3
Attention ControlPhysical Performance at 1 Year8.7 score on a scaleStandard Deviation 2.8

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026