N/A
N=466
Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
Acute Respiratory Failure · Post-Intensive Care Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03053245 ↗Enrolled (actual)
466
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Self Reported Quality of Life PCS: Physical Component Score at 1 Year — 36.22; 35.29 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mobile Critical Care Program (Behavioral); Attention Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self Reported Quality of Life PCS: Physical Component Score at 1 Year |
36.22; 35.29 | — |
| PRIMARY Self Reported Quality of Life MCS: Mental Component Score at 1 Year |
49.81; 51.12 | — |
| PRIMARY Cognitive Assessment Score at 1 Year |
0.27; 0.26 | — |
| SECONDARY Depression Symptoms at 1 Year |
5.94; 5.66 | — |
| SECONDARY Anxiety Symptoms at 1 Year |
5.04; 4.82 | — |
| SECONDARY Physical Performance at 1 Year |
8.8; 8.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03053245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.