Trial Outcomes & Findings for Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors (NCT NCT03053245)
NCT ID: NCT03053245
Last Updated: 2024-06-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
503 participants
Primary outcome timeframe
1 year
Results posted on
2024-06-24
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
233
|
|
Overall Study
COMPLETED
|
153
|
147
|
|
Overall Study
NOT COMPLETED
|
80
|
86
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
Baseline characteristics by cohort
| Measure |
Mobile Critical Care Recovery Program
n=233 Participants
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.
|
Attention Control
n=233 Participants
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.
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
233 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
461 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
94 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Only participants who were able to complete the scale are included in the analysis.
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.
Outcome measures
| Measure |
Mobile Critical Care Recovery Program
n=153 Participants
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.
|
Attention Control
n=146 Participants
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.
|
|---|---|---|
|
Self Reported Quality of Life PCS: Physical Component Score at 1 Year
|
36.22 score on a scale
Standard Deviation 12.55
|
35.29 score on a scale
Standard Deviation 12.20
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Only participants who were able to complete the scale are included in the analysis.
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.
Outcome measures
| Measure |
Mobile Critical Care Recovery Program
n=153 Participants
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.
|
Attention Control
n=146 Participants
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.
|
|---|---|---|
|
Self Reported Quality of Life MCS: Mental Component Score at 1 Year
|
49.81 score on a scale
Standard Deviation 11.75
|
51.12 score on a scale
Standard Deviation 10.23
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Only participants who were able to complete the scale are included in the analysis.
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.
Outcome measures
| Measure |
Mobile Critical Care Recovery Program
n=129 Participants
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.
|
Attention Control
n=133 Participants
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.
|
|---|---|---|
|
Cognitive Assessment Score at 1 Year
|
0.27 Z-score
Standard Deviation 0.70
|
0.26 Z-score
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Only participants who were able to complete the scale are included in the analysis.
PHQ-9 (Patient Health Questionnaire-9) Scores range from 0 to 27 on the PHQ-9 with higher scores indicating greater severity of depression.
Outcome measures
| Measure |
Mobile Critical Care Recovery Program
n=153 Participants
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.
|
Attention Control
n=147 Participants
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.
|
|---|---|---|
|
Depression Symptoms at 1 Year
|
5.94 score on a scale
Standard Deviation 6.13
|
5.66 score on a scale
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Only participants who were able to complete the scale are included in the analysis.
GAD-7 (Generalized Anxiety Disorder-7) Scores range from 0 to 21 on the GAD-7 with higher scores greater anxiety.
Outcome measures
| Measure |
Mobile Critical Care Recovery Program
n=153 Participants
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.
|
Attention Control
n=147 Participants
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.
|
|---|---|---|
|
Anxiety Symptoms at 1 Year
|
5.04 score on a scale
Standard Deviation 6.08
|
4.82 score on a scale
Standard Deviation 5.25
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Only participants who were able to complete the scale are included in the analysis. Post COVID-19 no SPPB Tests were performed.
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
Outcome measures
| Measure |
Mobile Critical Care Recovery Program
n=34 Participants
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.
|
Attention Control
n=32 Participants
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.
|
|---|---|---|
|
Physical Performance at 1 Year
|
8.8 score on a scale
Standard Deviation 3.0
|
8.7 score on a scale
Standard Deviation 2.8
|
Adverse Events
Mobile Critical Care Recovery Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 24 deaths
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 38 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place