An interventional study of Mobile Critical Care Program and Attention Control in Acute Respiratory Failure and Post-Intensive Care Syndrome, sponsored by Indiana University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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:
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.
49 studies on the registry are indexed under postintensive care syndrome; 26 are open to participants now.
This study's enrollment of 503 is above the median of 91 across 25 interventional studies indexed under postintensive care syndrome.
Browse postintensive care syndrome studies →Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Mobile Critical Care Program
The attention control group will receive telephone based check ins related to their health from the research study team.
Behavioral: Attention Control
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.
Patients in this group will receive regular wellness calls from the research team.
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
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
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
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
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
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
| Milestone | Mobile Critical Care Recovery Program | Attention Control |
|---|---|---|
| Started | 233 | 233 |
| Completed | 153 | 147 |
| Not completed | 80 | 86 |
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.
| score on a scale | Mobile Critical Care Recovery Program | Attention Control |
|---|---|---|
| Self Reported Quality of Life PCS: Physical Component Score at 1 Year | 36.22 ± 12.55 | 35.29 ± 12.20 |
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.
| score on a scale | Mobile Critical Care Recovery Program | Attention Control |
|---|---|---|
| Self Reported Quality of Life MCS: Mental Component Score at 1 Year | 49.81 ± 11.75 | 51.12 ± 10.23 |
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.
| Z-score | Mobile Critical Care Recovery Program | Attention Control |
|---|---|---|
| Cognitive Assessment Score at 1 Year | 0.27 ± 0.70 | 0.26 ± 0.68 |
PHQ-9 (Patient Health Questionnaire-9) Scores range from 0 to 27 on the PHQ-9 with higher scores indicating greater severity of depression.
| score on a scale | Mobile Critical Care Recovery Program | Attention Control |
|---|---|---|
| Depression Symptoms at 1 Year | 5.94 ± 6.13 | 5.66 ± 5.37 |
GAD-7 (Generalized Anxiety Disorder-7) Scores range from 0 to 21 on the GAD-7 with higher scores greater anxiety.
| score on a scale | Mobile Critical Care Recovery Program | Attention Control |
|---|---|---|
| Anxiety Symptoms at 1 Year | 5.04 ± 6.08 | 4.82 ± 5.25 |
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
| score on a scale | Mobile Critical Care Recovery Program | Attention Control |
|---|---|---|
| Physical Performance at 1 Year | 8.8 ± 3.0 | 8.7 ± 2.8 |
Collected over Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Critical Care Recovery Program | 24/233 (10.3%) | 0/233 (0%) | 0/233 (0%) |
| Attention Control | 38/233 (16.3%) | 0/233 (0%) | 0/233 (0%) |
| Age, Continuous(years) | Mobile Critical Care Recovery Program | Attention Control | Total |
|---|---|---|---|
| Mean | 55.2 ± 14.3 | 56.9 ± 14.4 | 56.1 ± 14.4 |
| Sex: Female, Male(Participants) | Mobile Critical Care Recovery Program | Attention Control | Total |
|---|---|---|---|
| Female | 125 | 125 | 250 |
| Male | 108 | 108 | 216 |
| Ethnicity (NIH/OMB)(Participants) | Mobile Critical Care Recovery Program | Attention Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 5 | 5 |
| Not Hispanic or Latino | 233 | 228 | 461 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Mobile Critical Care Recovery Program | Attention Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 94 | 78 | 172 |
| White | 134 | 146 | 280 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 2 | 5 | 7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.
Ran from Mar 2017 to primary completion in Oct 2022, 67 months.
Results were first posted in Jun 2024, 1 year 7 months after primary completion.
Of 21 interventional studies with no phase under postintensive care syndrome, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 38. This study's 67 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.