Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors

NCT03053245 | Completed Results DMC

• 1 other identifier: R01HL131730
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 3

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. 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. 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.

Conditions

Acute Respiratory Failure; Post-Intensive Care Syndrome

Keywords

Collaborative Care Model; Intensive Care Unit

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Depression Symptoms at 1 Year

  1 year

• Anxiety Symptoms at 1 Year

  1 year

• Physical Performance at 1 Year

  1 year

Study Arms (2)

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.

Behavioral: Mobile Critical Care Program

Attention Control

ACTIVE COMPARATOR

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

Behavioral: Attention Control

Interventions

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.

Mobile Critical Care Recovery Program

Attention Control BEHAVIORAL

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

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

• 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.

  PMID: 39526840 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.

  PMID: 38289602 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.

  PMID: 29415760 DERIVED

MeSH Terms

Conditions

postintensive care syndrome

Results Point of Contact

• Title: Babar Khan, MD, MS
• Organization: Indiana University

bakhan@iu.edu

(317) 274-9132

Study Officials

• Babar A Khan, MD, MS

  Indiana University Center for Aging Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine Research Scientist, Regenstrief Institute, Inc. Research Scientist, Indiana University Center for Aging Research

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 15, 2017
• Study Start: March 1, 2017
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)