Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
Phase: NA
Conditions: Acute Respiratory Failure, Post-Intensive Care Syndrome
Sponsor: Indiana University

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NHLBI Health Information Center
P.O. Box 30105
Bethesda, MD 20824-0105
Mobile Critical Care Recovery Program
(m-CCRP)
Protocol
Babar Khan, MD, MS
Research Scientist, IU Center for Aging Research
Assistant Professor of Medicine, IU School of Medicine
Division of Pulmonary/Critical Care

 
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Table of Contents: 
 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants 
or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 
Follow-up and Record Retention 
11.0 
References 
 
 

 
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1. Background 
 
Acute Respiratory Failure (ARF) and Post-intensive Care Syndrome (PICS):  
As the population ages and as advances in health care technology continue;49 the US now has 
millions of ARF survivors.50 The ARF survivors by virtue of their illness severity, physiologic 
derangements, procedural and pharmacologic interventions, mechanical ventilation, and 
delirium among others are exposed to extreme stressors. These stressors predispose survivors 
to physical, cognitive and psychological morbidity with a negative impact on the overall quality 
of life (QOL).11-19,51-54 Recently these impairments are characterized under a unifying diagnosis 
of “post-intensive care syndrome (PICS)”.28 PICS is defined as a cluster of debilitating symptoms 
characterized by physical impairment, cognitive impairment, and symptoms of depression and 
anxiety. It is experienced by greater than 50% of ARF survivors, impairs recovery after hospital 
discharge and could persist for years.12,28,36  
 
After discharge from the ICU, PICS patients are referred back to their primary care providers 
who are ill prepared and inadequately resourced to care for them. The ensuing inadequate care 
affects PICS patients’ health related QOL, leads to long-term disability, and impedes return to 
previous roles (e.g. < 50% of survivors return to work).55-60 At present, there are few care 
models to guide healthcare providers to deliver excellent longitudinal care to ARF survivors. A 
model to provide specialized and coordinated recovery care for ARF survivors with physical, 
psychological and cognitive impairments beginning at the time of discharge could fill the current 
gap and increase the likelihood of full functional recovery. 
 
Current state of literature on recovery services for ARF survivors:  
There are guidelines for post-ICU care,23,61 but there is little supporting evidence to recommend 
their implementation on a wide spread scale. A limited number of randomized trials have been 
conducted among ICU survivors with conflicting results. One randomized controlled trial 
evaluating the effects of a self-directed manual of exercises, psychological advice, and smoking 
cessation demonstrated improved physical function-related QOL, higher smoking cessation 
rates, and a trend towards decreased depression.62 A small trial (n: 21) testing a 
multicomponent program of in-home cognitive and physical rehabilitation showed 
improvements in cognitive and physical outcomes at 3 months.63 However, another 
randomized trial of home-based rehabilitation for 8 weeks demonstrated no improvement in 
physical function-related QOL.64 Similarly, the PRaCTICal trial of a nurse-led outpatient follow-
up program for 3 months after an ICU stay showed no improvements in QOL, anxiety, or 
depression.65 The recently published RECOVER randomized trial testing a mobility, exercise and 
nutrition intervention lasting from ICU discharge to hospital discharge failed to show 
improvement in mobility and QOL at 3 months. The QOL scores remained static from 3 to 12 
months.66 The studies at present do not delineate a clear path to manage the multiple 
comorbidities of PICS. A number of these studies were performed outside the US, had small 
sample sizes, and failed to address the multi-component nature of PICS. Studies with adequate 
sample sizes tested interventions for short durations thereby limiting the exposure to the 
intervention.64-66 Similar gaps were identified in proceedings from the Society of Critical Care 
Medicine stakeholders’ conference.28 We plan to overcome these limitations by designing an 

 
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interdisciplinary team-based intervention led by a care coordinator for a duration of 12 months. 
This approach is based on our prior successful experiences in using collaborative care model to 
manage the complex biopsychosocial needs of vulnerable older adults suffering from 
psychological, cognitive, and functional impairments.35,67,68  
 
Making a Case for a Collaborative Critical Care Model to enhance Recovery of ARF Survivors:  
The Institute of Medicine has prioritized the development and implementation of new care 
coordination programs to improve patient-centered and interdisciplinary health care delivery.32 
Although there are community resources, rehabilitation centers, and in-home services available 
to ARF survivors, these services are accessed at the discretion of multiple clinical disciplines.29,31 
The fragmented nature of our current health care system does not integrate the multitude of 
services to promote rapid recovery of ARF survivors.29,31 The disjointed process of recovery 
support programs and healthcare system complexity places unnecessary burdens on vulnerable 
ARF survivors.69 The ARF survivors suffer from complex and multiple health related problems 
that require care coordination. Access to a care coordinator empowered with the tools and 
support to integrate and connect essential resources has the potential to enhance the recovery 
of ARF survivors. 
In response to the Institute of Medicine call, and utilizing IUCAR’s expertise in collaborative, 
care-coordinator based care, we have developed the Mobile Critical Care Recovery Program (m-
CCRP) to provide comprehensive, collaborative and specialized care for ARF survivors with 
physical, psychological and cognitive impairment. The proposed randomized controlled trial will 
evaluate the efficacy of such a collaborative critical care recovery program in accomplishing the 
Institute of Healthcare Improvement’s triple aims of better health, better care, at lower cost.70  
 
2. Rationale and Specific Aims 
 
Five million Americans require admission to intensive care units (ICU) annually due to life-
threatening illnesses,1-3 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.5,6 Greater than 50% of the patients with ARF who survive their ICU stay 
suffer from long-term morbidity in the form of functional disability,7-11 cognitive disability,10-14 
major or minor depression,13-17 and anxiety.14,17-19 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.7,20-26 
Ongoing care for ARF survivors has been estimated to cost $3.5 million per ARF survivor at 1 
year.27 This constellation of  ICU sequelae with attendant morbidity has been designated as the 
post-intensive care syndrome (PICS).28 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.29-
31  
 
The Institute of Medicine recommends the development of care coordination programs to 
deliver patient-centered and interdisciplinary-based medical care.32 Indiana University Center 
for Aging Research (IUCAR) has over 20 years of experience in delivering interdisciplinary, 

 
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collaborative care through pragmatic interventions utilizing care coordinators.33-36 Care 
coordinator delivery models have improved care of patients with dementia, depression, 
functional decline and PICS.33-36 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).36 CCRC showed feasibility and initial efficacy in 
managing PICS.36 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.37-
39 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 by pursuing the following specific aims: 
 
Primary Specific Aim: 
 To evaluate the efficacy of m-CCRP in improving the health related quality of life of ARF 
survivors compared to attention control at twelve months post hospital discharge. 
 
Hypothesis: ARF survivors randomized to twelve months of m-CCRP will have higher scores on 
Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Medical 
Outcomes Study 36-item short form (SF-36),40-42 compared to those randomized to attention 
control at twelve months post discharge.  
 
Secondary Specific Aim 1:  
To evaluate the efficacy of m-CCRP in improving the cognitive, physical, and psychological 
function of ARF survivors compared to attention control at twelve months post hospital 
discharge. 
 
Hypotheses: ARF survivors randomized into twelve months of m-CCRP will have higher 
composite cognitive scores as assessed by the Repeatable Battery for the Assessment of 
Neuropsychological Status (RBANS);43 higher physical performance as measured by the Short 
Physical Performance Battery (SPPB);44 and lower depression and anxiety symptoms as 
measured by the Patient Health Questionnaire–9 (PHQ-9),45,46 and the Generalized Anxiety 
Disorder (GAD-7) scale47,48 than those randomized to attention control at twelve months post 
hospital discharge. 
 

 
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Secondary Specific Aim 2:  
To evaluate the efficacy of m-CCRP in reducing health-care utilization by ARF survivors as 
compared to attention control at twelve months post hospital discharge. 
 
Hypothesis: ARF survivors randomized to m-CCRP will have lower health care utilization as 
measured by emergency department visits and re-hospitalizations, compared to those 
randomized to attention control. 
 
3. Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
x At least 18 years of age 
x Hospitalized in the ICU 
x 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. 
x Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute 
care 
x English speaking 
x Able to consent either in-person or through legally authorized representative 
x Have access to a telephone 
 
Exclusion Criteria 
x Hospitalized to a regular non-ICU ward 
x Diagnosis of cancer with life expectancy less than 1 year 
x Admitted with ischemic or hemorrhagic cerebrovascular accident, traumatic brain injury, or 
undergoing neurosurgery 
x History of dementing illnesses and other neurodegenerative disease such as Alzheimer’s 
disease, Parkinson’s disease, or vascular dementia (confirmed by EMR),or current prescription of 
anti-dementia medication, or ruled out by Functional Activities Questionnaire (FAQ) score defining 
dementia 
x Unable to complete study questionnaire due to severe hearing loss 
x Legally blind 
x Pregnant (assessed by urine pregnancy test) or nursing 
x Living outside the greater Indianapolis area 
x Recent history of alcohol abuse > 5 drinks per day or substance abuse consistently over the 
last 3 months 
x Status post tracheostomy and not eligible for a speaking valve 
x Incarcerated at the time of study enrollment 
x Schizophrenia or bipolar disorder (confirmed by EMR) 
x Homelessness 
x Illiterate 
 
 

 
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4. Enrollment/Randomization 
 
Recruitment Targets: 
ARF survivors will be recruited from three local tertiary care hospitals: 1) Indiana University 
Health Methodist, 2) University Hospital, and 3) Eskenazi Health. Recruitment from three 
hospitals with different demographics will increase the generalizability of our program in 
addition to achieving the target recruitment of enrolling 620 ARF survivors in our study. 
 
Recruitment Procedures: 
Research staff will check the electronic medical records of ICU patients daily for eligibility. 
Eligible individuals (those who meet inclusion criteria and do not meet any exclusion criteria) will be 
screened twice per day for delirium until ICU discharge using the CAM-ICU-7. Eligible patients’ primary 
clinical teams will be approached to confirm the eligibility. Within 48 hours of anticipated 
discharge, patients and/or their legally authorized representatives will be approached for study 
participation and enrollment. 
 
Enrollment: 
Research assistants will obtain informed consent and authorization for release of the patient’s 
medical records, and complete the Initial Evaluation around the time of discharge. This Initial 
Evaluation includes quality of life (SF-36), cognitive (RBANS, MOCA), physical function (SPPB), 
depression (PHQ-9),  anxiety (GAD-7), and sleep (ISI-7) assessments. To estimate the treatment 
effect in key domains, a “step-down” battery, consisting of a subset of outcome measures, will be 
administered when a participant is not able to tolerate the full outcome assessments. This “step-down” 
battery may also be administered via phone if subject is unable to complete an in-person assessment. 
Randomization: 
Following the Initial Evaluation, ARF survivors will then be randomized in a 1:1 manner via a 
computer-generated randomization scheme into m-CCRP intervention or attention control 
group stratified by hospital  
 
Dual Enrollment (OPTIONAL): Patients who are eligible for and enroll in Examining 
Neuropsychiatric Disorders in Survivors of COVID-19 Related Critical Illness (EN-COV; IRB 
#11444) may be dually enrolled in this project. EN-COV is a minimal risk study. These studies 
contain the same study procedures at hospital discharge and 6-month time points; therefore, 
data will be shared across these studies for any patient who dually enrolls to ensure study 
visits/assessments are not duplicated. The EN-COV study will be considered the “main study” in 
these instances, and will have all original source documents on file for dually enrolled subjects.  
 
 
 
 
5. Study Procedures 
 
Main Components of the Mobile Critical Care Recovery Program:  
m-CCRP Care Coordinator: 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. She has received additional education in the following areas: a) 

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recognizing the symptoms of PICS; monitoring the biopsychosocial needs and outcomes of ICU 
survivors; c) monitoring negative effects of medications; d) monitoring caregiver burden; e) 
delivering cognitive, physical, and psychological recovery protocols; f) enhancing the self-
management capacity of patients and their informal 
caregivers; g) communicating and coordinating care with 
primary and specialty healthcare providers; h) 
coordinating community resources; and assisting 
patients and caregivers in developing symptom 
management skills. 
The care coordinator will be responsible for conducting
the home and facility visits; collaborating with the m-
CCRP interdisciplinary team (see below); maintaining 
communication with the patient’s primary care provider 
and specialists; conducting root-cause analysis for any 
preventable hospitalization or emergency department 
visit; implementing the individualized care plans; and 
monitoring the effectiveness of these care plans (Box 1). 
The care coordinator will be responsible for a new patient panel of 70 patients at any given 
time-point and will be supervised by the m-CCRP team.
m-CCRP interdisciplinary team:
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. 
m-CCRP Tools:
m-CCRP Care Protocols: Care protocols have been developed by our interdisciplinary team and 
successfully utilized in the CCRC and m-CCRP pilot. These protocols address cognition, physical 
function, personal care, mobility, sleep disturbances, depression, anxiety, agitation or 
aggression, delusions or hallucinations, the caregiver's stress and physical health, driving safety, 
nutrition, and medication adherence (Box 1). 
m-CCRP mobile access to patients: m-CCRP care coordinator will interact with patients in a 
variety of settings including primary care clinics; the patient’s home; specialty clinics; hospitals; 
or rehabilitation centers. In contrast to our ICU survivor clinic, m-CCRP will physically go to 
patient rather than patient coming to m-CCRP.
m-CCRP Process Measures: The Care Coordination Support Software (EMR-ABC): We will utilize 
a modified version of the software that was developed for the ABC-Med Home39,72 to meet the 
needs of the ARF survivors. This web-based care-coordination software includes the following 
functions: a) flexible and secure access to the platform from multiple locations and by various 
users; b) manual and web-based solutions to capture patient-centered cognitive, physical, and 
psychological symptoms; c) decision support to deliver personalized pharmacological and non-
pharmacological care recovery protocols; d) tracking process of care coordination delivered by 

 
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the care coordination team; e) monitoring patients’ and informal caregivers’ responses to care 
recovery protocols; f) monitoring population-based outcomes to guide the overall program 
performance; g) integration capacity with other informatics tools such as the local electronic 
medical record and regional health information exchange; and h) an easy interface to move 
data from the software to analyzable datasets.  
The Healthy Aging Brain Care (HABC) Monitor: The HABC Monitor37,38 will be utilized to monitor 
the cognitive, physical, and psychological symptoms of patients and caregiver stress. The HABC 
monitor has 32 items tapping the previous four constructs (see appendix for instrument). While 
the total HABC Monitor score is helpful to measure change over time, each question also 
indicates a specific care area where help or coping strategies might be indicated. The HABC 
Monitor also includes questions on dangerous behaviors such as falls, home safety and 
automobile driving. When these cognitive, physical, or psychological symptoms will be 
identified, the m-CCRP team will work with the primary care clinician and other providers to 
begin initial pharmacological and non-pharmacological management. Hence the HABC-M will 
serve as a longitudinal monitoring tool that will guide the personalization of the m-CCRP care 
protocols to the needs of the patient at any point in time during recovery. The HABC-M will also 
provide dynamic feedback to allow for adaptation and customization of the intervention in real 
time by the care coordinator. 
 
Study Flow:  
Initial Evaluation: After enrolling subjects, the research assistants will perform blinded baseline 
quality of life (SF-36), cognitive (RBANS, MOCA) (Trails A and B), physical function (SPPB) 2 
minute step test, post-traumatic stress syndrome questionnaire (PTSS-10), delirium experience 
questionnaire, depression (PHQ-9),  anxiety (GAD-7), and sleep (ISI-7) assessments around the 
time of hospital discharge. After the randomization step, the care coordinator will contact the 
patients randomized into the intervention arm to start the m-CCRP intervention. Care 
coordinator will review hospital discharge and rehabilitation plan, identify the primary care 
physician, obtain the approval of the primary care to co-manage post ICU care of the eligible 
patients, and schedule a face-to-face visit with the patients at their place of discharge (home, 
sub-acute rehabilitation facility/skilled nursing facility or long-term acute care). This in-hospital 
step is important for relationship building and answering any concerns or queries. 
The 12-month m-CCRP Intervention:  
The First Visit: The care coordinator will conduct a face-to-face encounter at the patient’s 
residence within a week post  randomization. At the selected location, the coordinator will 
assess the patient’s cognitive, physical, and psychological status using the Mini Mental State 
Examination (MMSE)86and/or the Montreal Cognitive Assessment (MoCA) Timed up and Go 
test,87 Activities of daily living (Katz scale),88 Instrumental activities of daily living (Lawton 
Scale),89 Hospital Anxiety and Depression scale (HADS),90 and the Healthy Aging Brain Care 
Monitors (HABC-M).37,38 Caregiver stress will be noted with the HABC-M.3 
The m-CCRP intervention instruments are different from the outcome assessments to ensure 
outcomes concealment from investigators. The coordinator will perform a community needs 
assessment for both the patient and the caregiver and will reconcile all prescribed and over the 
counter medications. The coordinator will make note of all scheduled and recommended 
appointments made at discharge with specialists and therapists. Initial and follow-up visits will 
be documented in the care coordination support software, the EMR-ABC.39 (See above) Patients 

 
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and caregivers will be inquired of their personal recovery goals to be incorporated in the care 
plan (see below) 
8 
 
Creation of an Individualized Care Plan: Using the assessments and the information provided by 
the patient and the informal caregiver on the first visit, the coordinator will collaborate with the 
remainder of the m-CCRP team consisting of Drs. Khan, Boustani, Lasiter, and Unverzagt along 
with the primary care to finalize the individualized care plan. Patients that may benefit from 
specialty care will be recommended for specialty evaluation and co-management. If necessary, 
the patient will be referred for a more extensive cognitive and psychological evaluation at the 
local mental health practices. This decision would be jointly reached by the care coordinator, 
the m-CCRP team members, the patient, their caregiver, and the patient’s primary care 
provider. Finally, a second face-to-face visit within 2 weeks of the first visit will be arranged.  
 
The Second Visit: During the second visit, the coordinator will review the individualized 
recovery care plan with both the patient and the informal caregiver. This process will include a) 
understanding the diagnoses; b) process of monitoring the patient’s recovery; c) 
implementation of the appropriate care recovery protocols; d) distribution and explanation of 
the corresponding educational recovery handouts (patient and informal caregiver); and e) 
connection to in-home services and community resources.  
 
The 12-month Interaction Period: Follow-up includes a 12-month interaction period between 
the care coordinator, the patients and the informal caregivers via face-to-face home or clinic 
visit, phone contact, email, fax or mail. The minimum amount of contact during this time will be 
every two weeks for first 6 months and then once per month for last 6 months. During these 
interactions, the coordinator will answer any 
questions generated from previous visits; 
collect patient and caregiver’s feedback; 
review and reconcile medications and discuss 
adherence; review specialists and therapists 

 
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appointments and adherence to care plans; have the patient and the caregiver complete the 
HABC Monitor to trigger or modify the use of specific care recovery protocols; and facilitate the 
caregiver’s access to appropriate community resources (Figure 3). Throughout the duration of 
the follow-up phase, the m-CCRP coordinator will continue to work with the patients, their 
caregivers, m-CCRP team, and the patient’s primary care and specialists to monitor, implement, 
and revise as necessary the individualized recovery care plan based on the prior set recovery 
goals. The m-CCRP team and care coordinator will meet once per week to discuss new patients 
and monitoring patients’ progress. If a patient develops an acute illness that requires 
hospitalization, the team activates the acute care transition phase where the coordinator 
contacts the hospital team and provides them with relevant information about the patient’s 
cognitive, physical, and psychological symptoms as well as the patient’s most updated 
medication list. Following a hospital discharge, the coordinator will conduct a home visit within 
72 hours to reconcile medications and coordinate post discharge care plan. At the end of 12 
months, every patient will be transitioned to receive full care by his or her primary care 
provider. Figure 3 demonstrates the central role of the care coordinator with feedback from 
patient and caregiver, the m-CCRP team and the m-CCRP tools of HABC-M and EMR-ABC 
(directions of arrows show information and care plan flow).  
 
Outcomes Assessment at 3, 6, and 12  months:   
Research assistants will perform blinded in-person outcomes assessments similar to the 
baseline assessment using the same instruments (SF-36, RBANS MOCA, Trails A and B, SPPB, 2 
minute step test, PTSS-10, employment questions, PHQ-9, GAD-7, and ISI-7) at 3, 6, and 12 . 
Figure 4 summarizes the study flow. We will employ multiple techniques to ensure 
concealment of outcomes assessment.91,92 Our research assistants will be trained not to inquire 
about study assignments. They will be conducting structured assessments that do not provide 
room for qualitative interviewing that should prevent unblinding. They will not be involved in 
study assignments and treatment administrations. Subjects will be instructed not to discuss 
their therapy with the research assistants. Loss of information could occur if subjects are unable to 
complete outcome assessments. To estimate the treatment effect in key domains, a “step-down” 
battery, consisting of a subset of outcome measures, will be administered when a participant is not able 
to tolerate the full outcome assessments. This “step-down” battery may also be administered via phone 
if subject is unable to complete an in-person assessment for the 3, 6 or 12 month outcomes. 
 
Attention Control:  
The study research coordinator will identify the primary care providers of patients in the 
attention control group and ensures appointment at the time of hospital discharge. The 
patients will receive a guide for ICU survivors containing phone numbers for relevant 
community resources, education on caregiver coping skills, and legal and financial advice. In 
addition, the attention control group will receive scripted phone calls by an independent care 
coordinator assistant not involved in any outcomes assessments. The calls frequency will be 
similar to the visit frequency of intervention arm (within one week post randomization) within 
two weeks post first phone call, afterwards twice per month for first six months, and once per 
month for the next six months). The phone calls will follow a script designed to ask the patients 
regarding their physical, cognitive, emotional and general wellbeing (see ICU survivors guide). 
Patients will be directed to the phone guide provided at the time of discharge. For those 

 
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without access to the guide, the relevant phone numbers will be provided on the call and a new 
guide mailed within 24 hours of the phone call. We have decided upon a phone based attention 
control after team discussions, literature review and by our prior clinical experience.93-95 An in-
home attention control was avoided due to the risk of diluting a care-coordinator home based 
intervention. 
 
6. Reporting of Adverse Events or Unanticipated Problems  
 
If a participant indicates suicide ideation on the PHQ-9, the patient’s care team will be notified.  
Suicide ideation will also be reported to Dr. Khan and Dr. Sophia Wang (clinical psychiatrist 
working at IU Center for Aging Research) for additional follow up. Unanticipated problems will 
be reported according to Indiana University policy. 
 
7. Study Withdrawal/Discontinuation 
 
Participants who wish to withdraw from the study will notify the study team verbally during 
study interactions or via letter as outlined in the HIPAA authorization document. 
 
8. Statistical Considerations 
 
We will compare randomization results to pre-planned randomization schedule to ensure 
randomization integrity. To verify the comparability of the randomized groups, patients’ 
baseline characteristics between the intervention and the usual care group will be compared 
using t-tests or Wilcoxon rank-sum tests for continuous variables and Chi-squared tests for 
categorical variables. All analyses will be conducted using SAS 9.4 software. 
 
Self-reported quality of life outcomes:  
Patient’s health–related quality of life will be assessed using the Medical Outcome Study Short 
Form (SF-36). This scale has eight components (physical functioning, role-physical, bodily pain, 
general health, vitality, social functioning, role-emotional, and mental health) that are 
aggregated into a Physical Component Summary (PCS) and a Mental Component Summary 
(MCS).40-42 Changes that differ between groups by 2 or more points on a scale of 0 to 100 have 
shown to be clinically meaningful.42 
 
Cognitive Assessment:  
We will use the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).43 
The RBANS was developed for the dual purposes of identifying and characterizing abnormal 
cognitive decline and a neuropsychological screening battery for adults aged 12-90 years. The 
entire battery takes 30 minutes to administer, and yields scaled scores for five cognitive 
domains (Immediate Memory, Visuospatial Construction, Language, Attention, and Delayed 
Memory). The RBANS has been tested and validated in neurologic, psychiatric, and healthy 
samples. RBANS has two versions and we will counterbalance for forms across the occasion of 
measurement to control for minor differences attributable to version.  

 
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Physical Performance:  
Physical recovery will be assessed via the Short Physical Performance Battery (SPPB), a 
validated objective assessment.44 The SPPB yields a performance score of 0-12 (0-4 poor, 5-7 
intermediate, 8-12 good). A difference of 1 point indicates significant change in function.   
 
Depression and Anxiety symptoms:  
We will use the Patient Health Questionnaire–9 (PHQ-9)45,46 and Generalized Anxiety Disorder 
Scale (GAD-7)47,48 to determine the impact of the intervention on ARF survivors’ mood and 
anxiety. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27 and the GAD-
7 is a seven-item anxiety scale with a total score from 0 to 21. Both of these scales are derived 
from the Patient Health Questionnaire, have good internal consistency, and test–retest 
reliability as well as convergent, construct, criterion, procedural and factorial validity for the 
diagnosis of major depression and general anxiety disorder.45-48 
 
Acute Health Care Utilization: 
 In addition to patient reported emergency department and hospital admission data, we will 
use the local data-warehouse to capture all of the data needed to determine utilization. 
Furthermore, we will also use the data from the Indiana Network for Patient Care (INPC) to 
complement any data use outside of our health system. INPC is the primary health information 
exchange in the state of Indiana and it provides data for acute care services from all of the 
health care systems within the state of Indiana. We will determine the number of emergency 
department visits and the number of re-hospitalizations during follow-up as well as the 
diagnoses associated with each utilization episode. 
 
Other Data Measures:  
Table 7 below shows other data that will be collected. 
 
Data Collection:  
Trained staff using Research Electronic Data Capture (REDCap) will collect all data.  
 
Table 7:  Other Data Measures 
Variables 
Method of Collection 
Patient demographics(age, gender, race , 
education, Body Mass Index) 
Electronic Medical Records 
Comorbidity-level & Chronic co-morbidities 
Charlson comorbidity index score 96 
Prior history of depression & anxiety 
Electronic Medical records 
Medications 
Electronic Medical records/Patient/caregiver 
Severity of illness 
APACHE-II97 through medical records at ICU admission 
Cognitive status prior to admission 
LAR interview using the IQCODE 98 
Functional status prior to admission 
ADL, IADL (Katz, Lawton scales)88,89 
Reason for ICU admission and hospitalization 
Electronic Medical records 
Duration of mechanical ventilation, 
noninvasive positive pressure ventilation or 
high flow nasal canal. delirium, length of 
ICU and hospital stay 
Electronic Medical records, CAM-ICU 7 
IQCODE: Informant Questionnaire on Cognitive Decline in Elderly; APACHE: Acute Physiology and Chronic Health Evaluation; 
ADL: Activities of daily living; IADL: Instrumental activities of daily living. LAR: Legally Authorized representative 

 
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9. Privacy/Confidentiality Issues 
 
Loss of confidentiality is a risk in this type of data collection. Our data management and quality 
assurance techniques have proven effective in past trials in maintaining confidentiality and all 
study personnel have completed training in Human Subjects Research and HIPAA standards. 
 
 
10. Follow-up and Record Retention 
 
This is a five year study and study documents will be destroyed seven years after the end date 
of the study. 
 
11. References: 
 
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