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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Critical Care Recovery Program | Experimental | 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. |
|
| Attention Control | Active Comparator | The attention control group will receive telephone based check ins related to their health from the research study team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Critical Care Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Anxiety Symptoms at 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Babar A Khan, MD, MS | Indiana University Center for Aging Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Methodist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41938652 | Derived | Ferguson H, Sanjuan A, Perkins AJ, Elias M, Wang S, Mekala SN, Devine B, Koehler Z, Chi R, Gao S, Khan B, Khan S. Relationship Between ICU Delirium and Change in Quality of Life, Mood, and Cognition Over 12 Months in Survivors of Acute Respiratory Failure. CHEST Crit Care. 2026 Mar;4(1):100242. doi: 10.1016/j.chstcc.2026.100242. Epub 2026 Feb 26. | |
| 39526840 | Derived | Savsani PK, Khan SH, Perkins AJ, Wang S, Jawaid S, Moiz S, Monahan PO, Kroenke K, Gao S, Khan BA. Performance of the Healthy Aging Brain Care Monitor Self Report in Monitoring Post-Intensive Care Syndrome Among Acute Respiratory Failure Survivors. Crit Care Med. 2025 Feb 1;53(2):e341-e352. doi: 10.1097/CCM.0000000000006522. Epub 2024 Nov 11. |
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There is no plan to make individual participant data (IPD) available to other researchers.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only participants who were able to complete the scale are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Babar Khan, MD, MS | Indiana University | (317) 274-9132 | bakhan@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2021 | Mar 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2021 | Mar 14, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C000657744 | postintensive care syndrome |
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|
| Attention Control | Behavioral | Patients in this group will receive regular wellness calls from the research team. |
|
GAD-7 (Generalized Anxiety Disorder-7) Scores range from 0 to 21 on the GAD-7 with higher scores greater anxiety.
| 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 | 1 year |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University Hospital | Indianapolis | Indiana | 46202 | United States |
| 38289602 | Derived | Khan BA, Perkins AJ, Khan SH, Unverzagt FW, Lasiter S, Gao S, Wang S, Zarzaur BL, Rahman O, Eltarras A, Qureshi H, Boustani MA. Mobile Critical Care Recovery Program for Survivors of Acute Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353158. doi: 10.1001/jamanetworkopen.2023.53158. |
| 29415760 | Derived | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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. |
|
|
| 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. | Only participants who were able to complete the scale are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| 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. | Only participants who were able to complete the scale are included in the analysis. | Posted | Mean | Standard Deviation | Z-score | 1 year |
|
|
|
| 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. | Only participants who were able to complete the scale are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| 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. | Only participants who were able to complete the scale are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
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|
|
| 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 | Only participants who were able to complete the scale are included in the analysis. Post COVID-19 no SPPB Tests were performed. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
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|
| 24 |
| 233 |
| 0 |
| 233 |
| 0 |
| 233 |
| EG001 | 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. | 38 | 233 | 0 | 233 | 0 | 233 |
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