Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors

NCT ID: NCT03053245

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2022-10-31

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.

Conditions

Acute Respiratory Failure; Post-Intensive Care Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile Critical Care Program

Intervention Type: 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.

Attention Control

The attention control group will receive telephone based check ins related to their health from the research study team.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Attention Control

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Babar Khan, MD, MS

Assistant Professor of Medicine Research Scientist, Regenstrief Institute, Inc. Research Scientist, Indiana University Center for Aging Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Babar A Khan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University Center for Aging Research

Locations

Eskenazi Hospital

Indianapolis, Indiana, United States

Methodist Hospital

Indianapolis, Indiana, United States

University Hospital

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39526840 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38289602 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29415760 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HL131730

Identifier Type: NIH

Identifier Source: org_study_id

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