Clinic-based vs. Home-based Support to Improve Care and Outcomes for Older Asthmatics
Phase: NA
Conditions: Asthma
Sponsor: Icahn School of Medicine at Mount Sinai

Clinic-based vs home-based support to improve care and outcomes for older 
asthmatics
PI: Alex Federman, MD, MPH
NCT02316223
Document Date: June 13, 2016

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
1 
Revised  9/2/14 
MSSM Protocol HRP-503a 
 
This study is funded by the Patient-Centered Outcomes Research Institute (PCORI). PCORI has 
established a two-staged approach to its study development, implementation, and analysis of 
findings.   
 
In Stage I, we will include development of interventions, solidifying partnerships, IRB 
approval, and training of project staff. Research activities in this Stage I will include: 
conducting focus groups and one-on-one cognitive interviews with stakeholders to 
provide feedback on the intervention materials and on the content and flow of the 
EMR-based asthma decision support tool.  
 
 
In Stage II, we will conduct a 3-arm randomized controlled trial among elderly patients 
with poorly controlled asthma from the clinics of the Mount Sinai Hospital, Mount 
Sinai’s St. Luke’s-Roosevelt, and Institute for Family Health. Patients will be randomized 
to clinic- or home-based support programs or to a usual care control arm and will be 
observed for 12-months.  
 
Brief Summary of Research (250-400 words): 
We will compare the effectiveness of home-based vs. clinic-based care coordination and self-
management support to improve asthma treatment and outcomes for older adult asthmatics 
from Latino and African-American communities. Older Latino and African-American adults with 
asthma have a disproportionately higher risk of poorer health and health outcomes resulting 
from their disease compared to whites. Several contributing factors include but are not limited 
to multiple morbidities, greater medication regimen complexity, limited health literacy and 
English proficiency, healthcare costs, and beliefs about medications and illness that affect 
medication use.  
 
Clinics have successfully leveraged the electronic medical record (EMR) to improve asthma care 
by providers. Unfortunately, this clinician-centric strategy cannot compensate for the diverse 
demographic, psychosocial, health status and health systems challenges faced by older adults. 
However, two viable patient-centric strategies have emerged with great promise: clinic-based 
care management support led by a care coach, and home-based patient/family support led by 
a community health worker. At present, no study to our knowledge has directly compared these 
approaches for improving asthma care and outcomes for any adults, including the elderly.  
 
In this study, we will compare these two patient-centric self-management support strategies, 
and couple them with clinician-centric, EMR-based clinician decision support to complete a 3600 
approach to improving asthma care and outcomes for older adults.  
 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
2 
Revised  9/2/14 
1) Objectives: 
Our specific aims and hypotheses are: 
Aim 1: To compare the effectiveness of clinic and home-based asthma care coordination 
and self-management support to improve care and asthma-related outcomes. 
Hypotheses: Compared to usual care, patients receiving either clinic- or home-based 
support will: 
1) have better asthma outcomes (control, quality of life, less need for urgent care) 
2) have better asthma self-management (medication adherence, trigger avoidance, 
appointment keeping, use of action plans) 
Aim 2: To identify subsets of individuals who will have greater benefit from home-based 
care coordination and self-management support compared to clinic-based support. 
Hypothesis: Patients with more severe asthma and those at greater risk of missed clinic 
appointments because of physical or cognitive impairment and psychosocial issues (e.g., 
substance abuse, mental illness) will be more likely to benefit from the home-based 
intervention. 
 
In Stage I, we will address these aims through future developing the intervention. We will 
conduct focus groups and one-on-one cognitive interviews with stakeholders to provide 
feedback on the intervention materials and on the content and flow of the EMR-based asthma 
decision support tool. 
 
In Stage II, we will conduct a 3-arm randomized controlled trial among elderly patients with 
poorly controlled asthma from the clinics of the Mount Sinai Hospital, Mount Sinai’s St. Luke’s-
Roosevelt and Institute for Family Health. Patients will be randomized to clinic- or home-based 
support programs or to a usual care control arm and will be observed for 12-months.  
 
2) Background 
IMPACT OF THE CONDITION ON THE HEALTH OF INDIVIDUALS  
Asthma, Disparities, and Aging. African-Americans and Latinos, low-income individuals, and 
the elderly suffer disproportionately from asthma in the US. Physical factors like frailty and 
long term changes to the lung and immune system can contribute to poorer outcomes 
among older asthmatics. Much of asthma outcomes in the elderly are traceable to the care 
they receive and their ability to effectively manage their illness between medical visits. 
Compared with younger adult asthmatics, the elderly have more chronic illnesses and more 
complex medication regimens, and higher prevalence of depression and cognitive and 
functional impairments. They are also more likely to have low health literacy, fixed incomes 
and high healthcare costs, and less likely to have reliable social supports. Alone or in 
combination, these factors challenge the self-management skills of older adults.  
 
POTENTIAL OF THE STUDY TO IMPROVE CARE AND OUTCOMES 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
3 
Revised  9/2/14 
Re-Thinking Asthma Interventions to Address Aging and Disparities. Numerous interventions 
to improve asthma outcomes across the lifespan - from young children, early adulthood, and 
onward have been extensively described. But very few have been specifically designed for older 
adults or comprehensively address the barriers to asthma control commonly found in the 
elderly. Current interventions fail to address the multiple needs of these complex patients as 
they seek to improve asthma care and outcomes. Moreover, they often provide patients with a 
broad understanding of asthma disease and its management with small benefit, rather than 
tailoring to the specific needs of the patient. Such broad-stroke, unfocused approaches may 
unduly complicate patient learning and distract attention from the key information and skills 
needed to improve asthma control, especially among older adults who are disproportionately 
affected by low literacy and cognitive limitations that further limit new learning and retention. 
Many published interventions also have patients spend time in lengthy training sessions or 
complete complex tasks thereby limiting opportunities for engagement as well as retention of 
information.   
 
We have chosen to compare 2 promising mechanisms for engaging older adults in asthma care, 
improving their care, health and quality of life. The approaches take advantage of emerging 
models of care delivery, use of the practice-based care coordinator and the community health 
worker conducting home visits.  
 
Clinic-Based Care Coordination and Self-Management Support (CC/SMS). Self-management 
support programs have been used extensively in primary care for several decades with 
important benefits, including for older adults. Mount Sinai Hospital (MSH) and The Institute 
for Family Health (IFH) have developed successful models of care coordination/self-
management support based on the Chronic Care Model and others. At MSH, the Preventing 
Admissions Care Team uses care coordinators to provide patients with extensive self-
management and social services support. This program has resulted in a 50% reduction in 
hospital readmissions among frequently hospitalized Medicare patients. MSH has also 
applied this approach to reducing ED revisits by older adults, and has created a team of care 
coaches in the primary care practices who use the same strategies toward the goal of 
improving diabetes care and outcomes. At IFH, a Chronic Care Model-based diabetes care 
management program resulted in a 22% reduction in HbA1c levels, a measure of diabetes 
control, indicating substantially improved diabetes control. IFH has also broadly and 
successfully implemented the Collaborative Care Model for depression management in 
primary care, again using care coordination and self-management support as a core 
element.  
 
Community Health Worker Programs.  Programs use community health workers (CHWs) to 
promote the well-being and improve the health of individuals with diseases like asthma, 
diabetes and hypertension by engaging the patient and their social supports, addressing 
barriers to care, and promoting self-management activities. CHWs are lay persons with 
limited training in self-management support for one or more conditions. They are typically 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
4 
Revised  9/2/14 
residents of the communities in which they serve. The American Public Health Association 
explains that CHWs develop trusting relationships with patients, social networks, and other 
community members and organizations that allow them to serve as influential healthcare 
liaisons to the community to improve health outcomes and self-management. The Institute 
of Medicine supported the use of CHWs to close the gap in the quality of care received by 
populations experiencing racial and ethnic disparities. CHW programs have a proven record 
of success for several chronic diseases. CHW programs have been effective for asthma. The 
literature on CHW interventions for asthma, however, focuses almost exclusively on 
pediatric populations. A major innovation of our study is the plan to adopt the CHW model 
for older asthmatics. 
 
Comparing Home- and Clinic-Based CC/SMS. Our emphasis on comparing home versus clinic-
based strategies is highly germane to older asthmatic patients, as both have legitimate strengths 
and weaknesses. Home-based interventions allow for patient engagement in a setting where the 
CHW can more directly and objectively determine asthma self-management concerns related to 
one’s physical environment. In addition, elderly patients are often socially isolated and have 
fixed incomes, posing challenges for transport to and from the clinic. Further, with greater 
comorbidity, more frequent visits may not be as plausible. Yet there are negatives as well for 
home-based approaches; when outsourcing care coordination and self-management support 
services, there may continue to be a disconnect between these activities and clinical decision 
making and care since it is not based directly in the clinic itself. Furthermore, some patients may 
be less receptive to the intrusion of a home visit. For clinic-based care, the strengths of home-
based interventions are the weaknesses here. Assessments and interventions are not tailored to 
one’s living situation (i.e. avoiding triggers, helping patients organize and store medicine). At 
times follow-up may require phone calls rather than face-to-face meetings to reach patients. 
And collaboration between the care coach and PCP is greatly enhanced when the two work in 
the same location. 
 
3) Setting of the Human Research 
In Stage I, we will recruit stakeholders to participate in focus groups and cognitive 
interviews, and in Stage II we will recruit patients to participate in a 3-arm RCT. The research 
will take place at Mount Sinai Hospital, the Institute for Family Health, and Mount Sinai’s St. 
Luke’s-Roosevelt. At Mount Sinai Hospital, the participating site will be the Internal 
Medicine Associates (IMA) and Pulmonary clinic. Interviews with IMA stakeholders will be 
conducted in the Center for Advanced Medicine, 17 East 102nd Street, New York, NY, 
10029. At St. Luke’s Roosevelt Hospital, the participating sites will be University Medical 
Practice Associates (UMPA), 2771 Frederick Douglass Blvd., New York, NY 10039, and the St. 
Luke’s Medical Group (SLMG), 1090 Amsterdam Ave., New York, NY, 10025, and the 
Pulmonary Clinic. At the Institute for Family Health (IFH), the participating sites will be at the 
Family Health Center of Harlem, 1824 Madison Ave, New York, NY, 10035 and the Walton 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
5 
Revised  9/2/14 
Family Health Center and Center for Counseling, 1894 Walton Ave, Bronx, NY, 10453.In 
stage II, patients will also be recruited from additional IFH sites: Sidney Hillman/Philips 
Family Practice, 16 E 16 St., New York, NY 10003, Amsterdam Center, 690 Amsterdam Av., 
New York, NY 10025, Mt. Hope Family Practice, 130 W Tremont Av., Bronx, NY 10453, Urban 
Horizons Family Health Center, 50-98 E 168th St., Bronx, NY, 10452, Stevenson Family Health 
Center, 731 White Plains Road, Bronx, NY 10473. 
The following table describes the Stage I activities: 
 
Stage I -- Research Activity 
Subjects 
30 Cognitive Interviews 
- One subject per interview 
- Focus: intervention protocols and 
materials 
 
- Patients, caregivers, and clinicians (30 subjects total) 
- 10 subjects recruited from and invited to Mount 
Sinai 
- 10 subjects recruited from and invited to IFH  
- 10 subjects recruited from and invited to SLR 
9-12 Focus groups 
- 8 individuals per focus group 
- Focus: intervention protocols and 
materials 
 
- Patients, caregivers, and clinicians (60 subjects total) 
- 20 subjects recruited from and invited to Mount 
Sinai 
- 20 subjects recruited from and invited to IFH 
- 20 subjects recruited from and invited to SLR 
9-12 Focus groups  
- 8 individuals per focus group 
- Focus: EMR-decision support tool 
 
- Clinicians only (60 subjects total) 
- 20 subjects recruited from and invited to Mount 
Sinai  
- 20 subjects recruited from and invited to IFH 
- 20 subjects recruited from and invited to SLR 
 
The follow table describes Stage II activities: 
 
Stage II -- Research Activity 
Subjects 
In-person Interview (at baseline) 
- Patients 
- 175 subjects recruited from and invited to Mount 
Sinai 
- 175 subjects recruited from and invited to IFH  
- 100 subjects recruited from and invited to SLR 
Phone Follow up (at 3-months and 6-
months) 
In-person Interview (at 12-months) 
 
4) Resources Available to Conduct the Human Research 
Based on our estimation of 900 eligible patients from Mount Sinai. Approximately 9% (100/900) 
of eligible patients will need to be recruited in order to meet recruitment goals in Stage I. 
Approximately 20% (175/900) of eligible patients will need to be recruited to meet recruitment 
goals in Stage II.  
 
Based on our estimation of 500 eligible patients from SLR. Approximately 10% (50/500) of 
eligible patients will need to be recruited in order to meet recruitment goals in Stage I. 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
6 
Revised  9/2/14 
Approximately 20% (100/500) of eligible patients will need to be recruited to meet recruitment 
goals in Stage II. 
 
 
Key Personnel from Mount Sinai involved in the study: 
Name 
Department 
Role 
Alex Federman, MD, MPH 
Medicine - General Internal Medicine 
Principal Investigator 
Juan Wisnivesky, MD, DrPH 
Medicine - General Internal Medicine 
Co-Investigator 
Joseph Kannry, MD 
Medicine - General Internal Medicine 
Co-Investigator 
Joel Erblich 
Oncological Sciences 
Co-Investigator 
Jonathan Arend, MD 
Medicine - General Internal Medicine 
Significant Contributor 
Victoria Wagner 
New York State Department of Health* 
Co-Investigator 
Diane Hauser, MPA 
The Institute for Family Health* 
Co-Investigator 
Manmeet Kaur 
City Health Works* 
Significant Contributor 
Tim Johnson 
Greater New York Hospital Association 
Significant Contributor 
Virna Little, PysD, LMSW 
The Institute for Family Health* 
Co-Investigator 
Ray Lopez 
Little Sisters of the Assumption* 
Co-Investigator 
Joseph Lurio, MD 
The Institute for Family Health* 
Co-Investigator 
Jennifer Mane 
New York State Department of Health 
Significant Contributor 
Carla Nelson 
Greater New York Hospital Association 
Significant Contributor 
Rosemary Obiapi 
Union Settlement 
Consultant 
Michael Wolf, PhD 
Northwestern University*‡ 
Co-Investigator 
Edwin Young, MD 
St. Luke’s Roosevelt* 
Co-Investigator 
*Partner organization (subcontracted) 
Research compliance of study activities with IFH or SLR subjects will be monitored by the IFH or 
SLR IRBs, respectively. 
‡Research compliance of study activities involving qualitative data analysis will be monitored by 
the Northwestern IRB. 
 
Non-Key Personnel involved in the study participating in research activities with Mount Sinai 
and SLR subjects will be managed by the PI. Requisite certifications and records for these 
individuals will be included in the Regulatory Binder and Financial Conflicts of Interest will be 
reported on Sinai Central.  
 
5) Study Design 
a) 
Recruitment Methods 
IDENTIFICATION OF HUMAN SUBJECTS (Patients, Caregivers and Clinicians):   
Potentially eligible patients (Stage I and II) will be identified through queries of the clinical 
billing records systems (Cerner) at Mount Sinai and through EPIC and queries of eClinicialWorks 
at SLR (generated by Dr. Edwin Young). This application includes a Waiver of Authorization to 
access patient medical records at Mount Sinai and at SLR.  
 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
7 
Revised  9/2/14 
 
In Stage I, the queries will identify patients ≥60 years with an asthma diagnosis, and will list their 
names, medical record numbers, date of birth, date and time of upcoming clinic appointment 
(within 4 weeks), address, phone number, and name of primary care provider.  At Mount Sinai, 
these queries will identify patients ages ≥50 years. 
 
In Stage II, three queries will identify patients ≥55 years with an asthma diagnosis.  
 
 
POPULATION MANAGEMENT REPORT: Query #1 will be a monthly report. At MOUNT SINAI, 
this report will be the primary method for recruiting asthma patients who access regular 
primary care and pulmonary services. We expect this query to identify patients with both 
controlled and uncontrolled asthma. The report will list patients’ names, medical record 
numbers, social security numbers, date of birth, date and time of upcoming clinic 
appointment (within 4 weeks), address, phone number, and name of primary care provider. 
At ST. LUKE’S, this query will also be generated.  
 
ACUTE CARE REPORT: Query #2 will be a daily report. At MOUNT SINAI, this report will be 
used to identify patients who were recently in the ED or hospital for an acute asthma attack. 
We expect this report to identify patients with uncontrolled or severe asthma. The report 
will list patients’ names, medical record numbers, social security numbers, date of birth, 
address, phone number, oral steroid use, latest ED/hospital visit (in past 12 months) and 
name of primary care provider. At ST. LUKE’S, this query will not be generated. 
 
POINT OF CARE REFERRAL REPORT: Query #3 will be a daily report. At MOUNT SINAI, this 
query will not be generated. At ST. LUKE’S, this report will be used as described in Stage I 
activities (see below) to assist PCPs with approaching patients.  
 
At MOUNT SINAI: 
We will obtain permission from physicians to recruit their patients. A request form will be 
distributed to physicians who see patients in IMA and pulmonary clinics. If we do not hear back 
by two weeks by email, mail, or fax, we will assume that we have permission to offer eligible 
patients the opportunity to participate in this study. Each physician will choose their preferred 
method of recruitment for their patients. Physicians will choose to:  
a) Allow RAs to offer participation to all asthma patients under their care who are ≥50 years; 
b) Require RAs to ask their permission by email or telephone on a patient-by-patient basis, or;  
c) Prohibit study personnel from directly approaching patients under their care. 
 
Eligible patients will also be identified from a previous study (NIH Grant#: R01HL096612; GCO#: 
08-1084; HSM#11-00706). Patients previously enrolled in the aforementioned study indicated 
that they would like to be contacted to participate in future studies. A master list of these 
patients (name, medical record number, date of birth, address, phone number, and name of 
provider) will be generated for recruitment in this new study. 
 
At ST. LUKE’S ROOSEVELT: 
There will be two methods in which recruitment will occur in the Internal Medicine and 
Pulmonary clinics. 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
8 
Revised  9/2/14 
 
In the first method:  
1) A list will be generated from an eCW query to identify patients with asthma who are 55years 
and older.  
2) The RA will pre-screen the list for potentially eligible patients on eCW.  
3) The RA will then email the providers of potentially eligible patients asking permission to 
approach them.  
4) The RA will then approach the patient during their scheduled visit and introduce the study 
and administer the eligibility screener to those interested in participation. 
 
In the second method: 
1) A list will be generated from an eCW query to identify patients with asthma who are 55 
years and older.  
2) The RA will pre-screen the list for potentially eligible participants on eCW.  
3) The RA will then email the providers of potentially eligible participants and request 
permission to send a letter on their behalf describing the study. We will only send a 
recruitment letter to those patients the provider recommends for the study.  
4) The RA will then send the recruitment letter #1 where patients are provided with a phone 
number to opt in and hotline number to opt out. 
5) If the study team did not hear from the patients after 10 days, recruitment letter #2 will be 
sent.  This letter states that a member of the study team will call them in 10 days if we do 
not receive an opt out call from them. 
6) Patients who do not opt-out after 10 days will be contacted by the RA to introduce the 
study. 
7) Patients who speak with the RA on the telephone will be screened for eligibility. 
 
Potentially eligible caregivers (Stage I only) will be identified from our eligible patient lists. At 
Mount Sinai, we will ask patients if they have a caregiver and if we may contact them to 
participate in Stage I of the study.  At St. Luke’s Roosevelt, we will provide patients with a letter 
to give their caregiver. The letter to their caregiver will have an opt-in hotline.  
 
Potentially eligible clinicians (Stage I only) will be identified from clinical practices participating 
in this study. 
 
RECRUITMENT OF HUMAN SUBJECTS (Patients, Caregivers and Clinicians):  
In Stage I, we will recruit stakeholders to participate in focus groups and cognitive interviews. In 
Stage II, we will recruit patients to participate in a 3-arm RCT. In both stages, we will approach 
participants as described below: 
- 
Patients (Stage I and II)– RAs at Mount Sinai will recruit patients from Mount Sinai 
(physician-approved) and SLR (release form provided) by sending them a recruitment 
letter. The recruitment letter will have an opt-out hotline number to call. Ten (10) days 
after the recruitment letter, an RA will approach the patient over the telephone. RAs 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
9 
Revised  9/2/14 
will use a recruitment script. If PCP approaches a patient about the study in a clinic 
appointment and the patient is interested in meeting with the RA in-person, the patient 
will be offered the opportunity to complete the eligibility screener that same day and 
bypass the recruitment letter and ten day waiting period. 
- 
Caregivers (Stage I only)– RAs will ask eligible patients if they have a caregiver, and if we 
may approach their caregiver for participation in one of these focus groups or cognitive 
interviews as well. Caregivers will be approached over the telephone. RAs will use a 
recruitment script. At SLR, we will provide a letter for the patient to provide to the 
caregiver. The letter will include an opt-in hotline.  
- 
Clinicians (Stage I only)– The PIs will make announcements at faculty meetings, staff 
meetings, and send out Division-wide recruitment emails. Clinicians will be invited to 
contact RAs if interested in participating.  
 
In Stage I, RAs will schedule interested subjects for either a focus group session or cognitive 
interview. On the day of a focus group session or cognitive interview, the RA will meet with the 
subjects to administer the informed consent procedure. In Stage II, RAs will administer the 
eligibility screen and schedule the baseline research visit at the patient’s preferred location (in 
the clinic or in the patient’s home). The RA will call to confirm the baseline research visit 1-2 
days in advance.  
 
Note:  No identifiable information beyond what is listed in the Waiver of Authorization will be 
automatically collected from the potential subjects prior to them being consented. If the 
potential subject decides not to sign informed consent, they will be asked to verbally give 
permission for de-identified information to be recorded in order to keep track of whether 
subjects who decide not to participate are different from those who decide to participate. They 
will be clearly told that this is optional and that if they refuse, it will have no bearing on their 
medical care. They will be told that the de-identified information we would like to record is the 
following: gender, age (not date of birth), race, and ethnicity. In the unlikely event that anyone 
is older than 89 years, they will be categorized as ’90 or older’ rather than specifying the age.  
 
While this application and protocol seeks approval for conducting the study at Mount 
Sinai and SLR sites, IFH recruitment procedures are as follows:  
Epic queries will identify potentially eligible patients; Epic reports will list their 
name, medical record number, date of birth, date and time of upcoming clinic 
appointment (within 4 weeks), address, phone number, and name of primary 
care provider. We will obtain permission from physicians to recruit their patients 
(see Letter request at Attachment A.) A request form will be distributed to 
physicians who see patients at the study sites. Each physician will choose their 
preferred method of recruitment for their patients. Physicians will choose to: 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
10 
Revised  9/2/14 
a) Allow RAs to offer participation to all asthma patients under their care 
who are over age 55; 
b) Require RAs to ask their permission by email or telephone on a 
patient-by-patient basis, or; 
c) Prohibit study personnel from directly approaching patients under 
their care. 
Following approval by the PCP, patients will receive a letter about the research study 
and an upcoming call from the RA. The letter will have a toll-free telephone number 
patients can call to opt-out of the study. The RA will phone patients who have not opted 
out after 10 days. The RA will describe the study, recruit, screen for asthma control and 
eligibility, and schedule a baseline research interview.  
 
b) Inclusion and Exclusion Criteria 
PATIENTS:  Inclusion Criteria: we will include English and Spanish speaking adults 
ages 55 years (50 years at Mount Sinai for Stage I only) who have a physician 
diagnosis of asthma. Exclusion Criteria: COPD or other chronic lung condition, ≥15 
pack-years 
CAREGIVERS:  Inclusion Criteria: we will include English and Spanish speaking adults 
ages 21 years who provide formal (6 continuous months) or informal care to an 
older adult (age  60 years) with a physician diagnosis of asthma. Exclusion Criteria: 
n/a 
CLINICIANS:  Inclusion Criteria: we will include English speaking clinicians from 
participating clinics (adults ages 21 years). Exclusion Criteria: n/a 
 
c) Number of Subjects 
In Stage I, a total of 150 subjects (patients, caregivers, providers) will be recruited to 
participate in focus group sessions and/or cognitive interviews. We will recruit 100 subjects 
from the IMA clinic and 50 subjects from the UMPA and SLMG practices at SLR. In Stage II, a 
total of 405 patients will be recruited for this study. We will recruit 175 patients from the 
Mount Sinai Hospital’s IMA and Pulmonary clinics, 175 from all aforementioned sites at the 
Institute for Family Health, and 100 patients from the Mount Sinai’s St.Luke’s Roosevelt 
UMPA, SLMG, and 59th Street practices.  
 
d) Study Timelines 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
11 
Revised  9/2/14 
The duration of Stage I is 8 months. The duration of Stage II is 2 years and 4 months. 
Patients will be followed from the time of consent from baseline through the 12-month 
follow up. 
 
e) Study Endpoints 
Stage I activities are estimated to close on 11/30/2014. Stage II activities are estimated to 
close on 12/30/2017. We will follow patients for one year (12 months) or until death. We 
will continue to track patients throughout hospitalizations or after withdraw from the either 
study arm.  
 
f) Procedures Involved in the Human Research 
STAGE I.  Focus Groups and Cognitive Interviews. (Months 0-8) 
We will conduct focus groups and cognitive interviews with patients, caregivers, and 
clinicians. We expect to conduct 30 cognitive interviews with stakeholders on the 
intervention protocols and materials, 9-12 focus groups on this same topic and 8-10 
interviews with clinicians focusing on the EMR-decision support tool. Team members will 
compare notes after conducting two interviews at each site and will revise the protocols, 
materials, and EMR-screen shots before proceeding to the next round of interviews. 
Interviews will continue until no further substantive changes are required. We will 
reimburse subjects $25 in cash. The table below describes the topics to be discussed in the 
interviews. At the end of each focus groups or cognitive interview, we will ask participants 
to complete an Information Sheet. The Information Sheet for patients/caregivers asks about 
gender, age, race, ethnicity, educational attainment, income, English ability, and age the 
patient was first told they had asthma. The Information Sheet for providers asks about their 
gender, role in the clinic, clinical training, work domain, what electronic medical records 
they have used in the past. The sheet also asks them to rate their knowledge and skills in 
managing asthma in adults, how helpful Epic is in helping them to manage their patients 
with asthma, and provide any suggestions for what features could be added to Epic to help 
them to better manage their patients with asthma.  
 
Research Activity 
Topics 
30 Cognitive Interviews 
- One subject per interview 
- Focus: intervention protocols and 
materials 
- Patients, caregivers, and clinicians 
 
- Intervention materials 
- Clinical protocols 
- EMR-content and programming 
- Research data collection 
- Assembly of materials  
- Creation of manuals 
 
9-12 Focus groups 
- 8 individuals per focus group 
- Asthma symptoms and how they affect your life 
- Roles and responsibilities of the care coach 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
12 
Revised  9/2/14 
- Focus: intervention protocols and 
materials 
- Patients, caregivers, and clinicians 
 
- Clinical intervention protocol – i.e., calls vs. visits, length 
of calls and visits, optimum number of reminders 
- Best practices for notifying patients about disease belief 
misconceptions 
- Review of optimum patient education materials 
 
9-12 Focus groups  
- 8 individuals per focus group 
- Focus: EMR-decision support tool 
- Clinicians only 
 
- Information required for a patient assessment 
- Decision support tool 
- Other support tools to model 
- Overall program 
 
 
 
STAGE II. Randomized Controlled Trial. (Months 9-36) 
ACC AND CHW ASTHMA PROGRAM DETAILS. The ACC and CHW programs for asthma CC/SMS 
will have the same objectives and provide the same general services. The primary difference will 
be the location, home or office, in which the bulk of services are provided, and the attendant 
advantages and disadvantages these locations present. Note: the ACC and CHW programs will 
be developed from existing, successfully operating programs at IFH and MSH, and in the East 
Harlem and South Bronx communities.  
 
 
Training. During this Stage I there will be a brief orientation to the study for all clinical 
and non-clinical staff in the participating clinics. The project manager will train the four 
RAs in all study protocols. The RAs will have appropriate Human Subjects Training 
Program certification. Our team of experts (Asthma Social Workers, Care Managers, 
General Internists, and Pulmonologists) will train the ACCs and CHWs. All protocols and 
materials will be carefully reviewed. A pulmonologist and asthma social worker 
(overseen by Dr. Wisnivesky) will conduct the asthma trainings, which will cover basic 
disease processes and the role of allergens and other triggers, symptom and severity 
assessments (ACT and peak flow), medications and other management strategies, 
medication adherence and other self-management behaviors (action plans, trigger 
avoidance, appointment keeping, etc.). Mr. Lopez will lead training on home 
assessment, with a discussion on performing the assessment by patient self-reports 
(germane to the work of the ACC). Dr. Little will lead the training on chronic illness 
management (e.g., methods to support adherence, motivational interviewing) and 
principals of care coordination, and Dr. Baum will supplement this with information and 
methods relevant to the CHW and home-based support. We will include some existing 
CHWs and CCs for this study, thus limiting additional training to asthma-specific 
management, basic management of other chronic conditions, and the program 
protocols. Trainings will include role playing and interviews with actual patients. 
Complete training will be approximately 60 hours. During Stage II, ACC/CHWs will be 
supervised at regular intervals of program implementation to ensure fidelity to program 
protocols and to reinforce learning.  

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
13 
Revised  9/2/14 
 
RESEARCH COMPONENT DETAILS. We will conduct a 3-arm, patient-randomized pragmatic 
clinical trial following older adults with uncontrolled asthma for up to 12 months. We will 
register the trial at ClinicalTrials.gov.  
 
Recruitment. (Procedures are described in detail above in #5a.) Patients will be 
identified from several EMR reports. Following approval by the PCP, patients will receive 
a letter about the research study and the upcoming call from the RA. The letter will have 
a toll-free telephone number to enable patients to call and opt-out. The RA will phone 
patients to describe the study, recruit, screen for asthma control and eligibility, and 
schedule for a baseline research interview. All research interviews will take place at the 
preferred location of the patient (in the clinic or in patients’ home). 
 
 
Randomization. After the RA has completed the baseline research interview, the PM 
will access a dedicated website that implements the algorithm to obtain the assignment. 
The PM will notify the ACCs or CHWs that a new patient is assigned to their respective 
intervention arm. Randomization to the study arms will be made with a 1:1:1 scheme 
using a dynamic algorithm to minimize imbalance between treatments with respect to 
important covariates including site and level of asthma control (not well controlled vs. 
very poorly controlled as per NAEPP guidelines). A minimization technique will be 
employed (i.e., allocation is assigned to the arm that minimizes an imbalance score 
calculated based on site and asthma control). Please note: at the end of the 12-month 
study period, patients assigned to the usual care arm will be given the option to meet 
with a clinic-based care coach.  
 
 
Measures. Baseline and 12-month interviews in person, 3-month and 6-month 
interviews by phone. 
 
 
 
Outcome 
Measure 
Comments 
Asthma control 
ACT 
Baseline, 3M, 6M, 12M 
Pulmonary function 
FEV1; FEV1/FVC (hand-
held device) 
Baseline, 12M 
Asthma related QoL 
Mini-AQLQ 
Self-report measure -  Juniper (1999); Baseline, 
3M, 6M, 12M 
Resource Utilization 
Urgent clinic visits, 
emergency department 
visits, and hospitalizations 
1) Self-report (Baseline, 3M, 6M, 12M) 
2) New York State SPARCS registry (12 mos 
preceding enrollment, 12 mos post-
enrollment) 
Asthma Management behavior: 
Medication Adherence 
Medication Adherence 
Report Scale (MARS) 
10 item self-report measure – Cohen (2009); 
Baseline, 3M, 6M, 12M 
Also working on obtaining 
pharmacy claims 
 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
14 
Revised  9/2/14 
Asthma Management behavior: 
Inhaler Technique 
MDI and DPI inhaler 
technique 
RA observation on placebo device using 
validated checklist -  Manzella (1989); Baseline, 
12M. 
Asthma Management behavior: 
Self-Monitoring 
Asthma action plan use; 
Peak Flow Meters 
Self-report: Action Plan (y/n), Peak Flow (y/n) 
Peak Flow Frequency of Use; Baseline, 3M, 12M 
Trigger Avoidance 
Individual Items 
Self-report: allergy cover use, household pets, 
exposure to cigarette smoke in the home, 
washing bed sheets in hot water,  cleaning dust 
in home; Baseline, 12M 
Environmental Exposure 
Urban Environment and 
Childhood Asthma 
assessment 
Baseline and 12 months 
Appointment Keeping 
Appointment keeping 
Chart review of kept and missed clinic 
appointments; 1 year before baseline – 12M 
Patient Perspectives of Services 
CAHPS/HCAHPS 
Modified Subscales: Perceived trust, Your Care 
from Nurses.  Overall rating of intervention 
(Scale 1-10) Baseline, 3M, 12M 
Programs expectations/Exit Survey 
See attached 
questionnaire 
Exit survey at 12M.  
 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
15 
Revised  9/2/14 
 
Other Measures 
Items 
Comments 
Sociodemographics 
 Age  
 Sex  
 Race/ethnicity 
 Education  
 Income  
 Insurance type 
Interviewer administered at baseline 
Social support 
 Marital status 
 Number of household 
occupants 
 Lubben social support 
scale 
Interviewer administered at baseline, 12 
months 
Health literacy 
 Newest Vital Sign (NVS) 
Baseline  
Asthma history 
 Age of onset 
 Intubations 
 Current asthma 
medication use 
Interviewer administered at baseline 
Smoking history 
 NHANES items 
Interviewer administered at baseline, 12 
months 
Cognitive function 
 Montreal Cognitive 
Assessment (MoCA) 
Interviewer administered at baseline 
General health 
 SF-1 general health 
measure 
Baseline, 3, 6, 12 months 
Co-Morbidities 
 
From EMR abstraction at baseline 
Medications currently used 
 
From EMR abstraction at baseline 
Depression 
  NIH PROMIS Measures 
for Depression 
Interviewer administered at baseline, 6, 12 
months 
Anxiety  
 NIH PROMIS Measures 
for Depression 
Interviewer administered at baseline, 6, 12 
months 
Physical functioning 
 Activities of daily living 
 Instrumental activities 
of daily living  
Lawton and Brody 
 
 
Statewide Planning and Research Cooperative System (SPARCS) Data. The researchers 
will also access data on patients’ healthcare use (including: hospitalizations or 
emergency department visits at hospitals other than Mount Sinai) from the New York 
State Department of Health’s SPARCS data. Please note that all the SPARCS data 
collected is for research purposes only, and not clinical care. 
 
 
Assessment of Acceptance and Implementation of Intervention. In the final stages of 
the program, we will perform qualitative and quantitative assessments of provider 
acceptance, use, and implementation of the EMR-based decision support and tools, 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
16 
Revised  9/2/14 
provider experience communicating with ACCs and CHWs and vice versa, and patient 
experiences.  
 
         Qualitative assessments will involve one-to-one, semi-structured, exploratory 
interviews. Interviews will be 45 minutes and conducted on an ongoing basis until we 
have reached saturation for identified themes. We anticipate requiring up to 10 
interviews each at site and will divide them evenly among clinicians and patients. 
Participants will be compensated for the time they spend participating in qualitative 
interviews. Dr. Wolf is an expert in qualitative research and will lead this effort following 
well-established methods. 
         Quantitative data will also be collected from stakeholders via written 
questionnaires. Among patients, at month 12 we will assess: general helpfulness of the 
program for improving their health (rated on a scale of 1 to 10), and trust in the ACC or 
CHW, measured with adapted items from the CAHPS. Among all clinicians in the 
participating sites, at study month 30 we will assess general helpfulness of the program 
for improving their patients’ health, trust in the ACC or CHW, quality of the 
communication with the ACC/CHW, helpfulness of EMR-based support tool and barriers 
to using it. We will further assess clinicians’ use of the decision support tool through 
electronic inquiries of the EMR. These will include the proportion of encounters in which 
the PCPs used the decision support tools, what elements they used or actively 
disregarded, and when they were used. Assessments of ACC activities will include 
reviews of their documentation on a random selection of 20 cases for each ACC and 
CHW beginning in study month 25. These will include the number and frequency of 
contacts per patient, the duration of visits and calls, the number of calls required to 
make contact with a patient for each planned encounter, the number of missed and 
kept scheduled in-person meetings, the number and subject of topics addressed during 
in-person encounters, and the frequency of documented exchanges between the 
ACC/CHW and PCP. The RAs will use a standardized chart abstraction form. 
 
 
Retention Materials. We will send winter holiday postcard to study participants. The 
card will thank them for their participation, letting each enrolled/consented person 
know that we appreciate their time and effort.  
 
g) Specimen Banking 
Not applicable. 
 
h) Data Management and Confidentiality 
In Stages I and II, each subject will tracked using an Access database. Identifiers and 
other related information for coordinating research activities (recruitment outcome, 
research interview call log and interview visit schedule, etc.) will be password 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
17 
Revised  9/2/14 
protected and kept on the secure Mount Sinai network drive. Only the PI, project 
manager, and RAs will have access this database. 
 
Subject 
Identifiers in database 
Patient 
name, MRN, address, phone number, DOB, (social security number, 
insurer, and beneficiary ID in Stage II only for NYS data on resource 
utilization) 
Caregiver 
name, address, phone number, DOB  
Clinician 
name, address, phone number, email address, job title, DOB 
 
Security Measures:  Several methods will be employed to reduce the risk of breach 
of confidentiality. A study identification number will be assigned to each subject in 
the study. The research data collected and stored will have the study identification 
number and no other identifying information on it. Research data (hard copies) will 
be stored in a locked file cabinet where the project manager’s office is located in the 
Center for Advanced Medicine (CAM) Building at 17 East 102nd Street, New York, NY, 
10029. The consent forms and the de-identified study data will be kept in a separate 
locked file cabinet at the same location. Using this method, if someone were to gain 
illegal access to the locked filing cabinet with study data, they would have no way to 
link this data to any identifying information.  
 
Audiotape data access will be limited to only the PI, project manager, RAs and DSMB 
representatives. The RAs will set up and collect the audio-recordings at each taped 
session. The recording will be brought from the session directly to the project 
manager’s office at Mount Sinai. It will be stored in a locked cabinet in the project 
manager’s office. Data will be downloaded weekly from the recording device will be 
kept on the project manager’s computer using an encryption software (TrueCrypt) 
to further ensure the safety of the audiofiles. De-identified transcripts will be sent to 
one of our partner organizations (Northwestern University, Chicago, IL) for coding 
and analysis. 
 
i) Provisions to Monitor the Data to Ensure the Safety of subjects 
The Data Safety and Monitoring Plan (DSMP) for Stage I activities is described below.  The 
Data Safety and Monitoring Board (DSMB) for the study will be formed before the RCT 
begins in Stage II.  
 
 
Data Safety and Monitoring Plan 
A) Monitoring Entity: Dr. Federman will be responsible for the data safety and monitoring 
for the entire study; he will also oversee the safety and monitoring of data collected at 
ISMMS. Dr. Lurio will be responsible for the safety and monitoring of data collected at IFH. 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
18 
Revised  9/2/14 
Data collected at ISMMS and IFH will be sent for transcription. Transcribed focus groups will 
be sent to and summarized by Northwestern University. Dr. Wolf will oversee the data 
safety and monitoring of the data at Northwestern University.  
 
B)  Procedures for Monitoring Study Safety: 1) Safety reviews: The principal investigator will 
review the safety and progress of this study on a monthly basis. 2) Annual review: The 
principal investigator will review this protocol on a continuing basis for subject safety and 
include results of the review in the annual progress reports submitted to the safety officer 
and the Institutional Review Board. 3) Annual report: The annual report will include a list of 
adverse events. The annual report will address: a) whether adverse event rates are 
consistent with pre-study assumptions; b) reason for dropouts from the study; c) whether 
all participants met entry criteria; d) whether continuation of the study is justified on the 
basis that additional data are needed to accomplish the stated aims of the study; and e) 
conditions whereby the study might be terminated prematurely. 3) Institutional Review 
Board review: The Institutional Review Board will review each protocol annually for safety. 
 
Dr. Federman will be responsible for monitoring and reporting safety data from all study 
sites (ISMMS, IFH, and Northwestern University). Dr. Lurio will supervise the collection and 
reporting of safety data for all participants enrolled at IFH. Adverse events will be reported 
to the ISMMS and IFH IRBs. Additionally, safety data from IFH will be sent to ISMMS 
monthly. These data will be summarized individually and then combined with Mount Sinai 
data for reporting to the IRB and PCORI as necessary. Safety data from both study sites will 
be discussed monthly during study meetings with investigators from all study sites. We have 
used similar procedures in our prior studies conducted at ISMMS, IFH and Northwestern 
University. 
 
In addition, we will use encryption software (Truecrypt, TrueCrypt Foundation) to protect all 
electronic audio data collected at ISMMS. Audio files from ISMMS and IFH will be sent for 
transcription and the transcripts will be sent to Northwestern University. Northwestern will 
serve as the Data Coordinating Center.  
 
j) Withdrawal of Subjects 
Patients are withdrawn from the study when they are found to be ineligible or 
become ineligible after enrollment. When patients are withdrawn, they are still 
followed up with research interviews, and also with the intervention (if the 
subject had been randomized to an intervention arm), but their data is later on 
excluded from analysis.  
6) Risks to Subjects 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
19 
Revised  9/2/14 
Participation in the study poses minimal risk of psychological, social and economic 
harm.  Informing subjects in advance that they may decline to answer any question 
asked during the interview will mitigate any risks associated with expressing their 
opinions (e.g., feeling uncomfortable).  They will also be assured they can terminate 
their participation in the study at any time without penalty.   
 
Greater than minimal risk is expected for subjects in the RCT. Participants enrolled into the 
intervention arms of this study are expected to benefit, having better asthma control. While 
participants in the usual care arm of this study may not benefit directly from their 
participation, we anticipate results from this study to benefit future patients by expanding 
research on comprehensive models of chronic care, including the multidisciplinary 
management of chronic diseases and the medical home concept.  
 
There always exists, the potential for loss of private information; however, there are 
procedures in place to minimize this risk. Procedures include: regular quality control 
data checks, encryption of data, and adherence to the ISMMS policy on data safety 
and transfer. 
7) Provisions for Research Related Injury 
This research involves minimal to no risk for subjects. The investigators on this project will make 
themselves available to meet with any participants expressing medical or psychological distress 
while being interviewed.  
 
In order to reduce the risk of subjects: 
1. Psychological distress may be provoked by issues discussed during the intervention sessions.  
In order to reduce the risk of subjects becoming psychologically distressed, subjects will be 
asked at the time of consent to inform a member of the research staff if at any point during 
the study they feel that participating in the research is causing them undue distress. 
Subjects will also be clearly instructed at each study visit that they are free to discontinue 
their participation in the research project at any time and that this will have no 
consequences at all for their continued medical care. Additionally, if study personnel find 
that the subject requires referral for mental health services (e.g., suicidal ideation) during 
the course of the intervention, the study personnel will contact the subject’s PCP directly to 
arrange for referral to mental health services. The IMA clinic has mental health professionals 
in place to address any distress that is brought on during the interview questions. The costs 
associated with these services will be included as a part of usual care in IMA.  
2. Violation of participant confidentiality is always a potential risk in research where 
identifiable data is collected. 
We have measures and protocols in place to deter the loss of identifiable data. See #5h. 
 
8) Potential Benefits to Subjects 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
20 
Revised  9/2/14 
While subjects may not benefit directly from their participation, we anticipate 
results from this study to benefit future older asthmatic patients by improving 
standard care and physician-patient communication about asthma. Clinician 
subjects may help improve their work environment by assisting with the design and 
enhancement of the EMR decision support tools to be available to clinic staff in 
Stage II of the study. 
 
9) Provisions to Protect the Privacy Interests of Subjects 
Subjects will be informed that their data is confidential. Subjects may stop participation at 
any time or skip any question if he/she feels uncomfortable. 
 
Throughout the study, steps will be taken to ensure the privacy of participants. The research 
personnel will not provide details of study to subjects in public waiting areas but will instead 
disclose details in one of the private exam rooms of the clinic. The research personnel will 
communicate with subjects through the contact numbers they provide and will not reveal 
PHI in voicemail messages. 
 
To ensure that subjects feel at ease throughout the interviews and intervention sessions, 
the research personnel will remind the subjects that if at any point he/she becomes 
frustrated or does not wish to answer a particular question or participate in an activity or 
discussion, he/she does not have to do so. In addition, the research personnel will give 
opportunities for breaks throughout the interviews and sessions.  
 
10) 
Economic Impact on Subjects 
Not applicable. 
 
11) 
Payment to Subjects 
Subjects enrolled in Stage I study activities (focus groups, cognitive interviews) will be 
reimbursed for their time and effort at each interview with $25 in cash ($25 total). 
Participating SLR staff will not receive monetary compensation; they will be provided with 
refreshments at the session. Subjects enrolled in Stage II study activities (research 
interviews at baseline, 3-months, 6-months, and 12-months) will be compensated for their 
time and effort at each interview.  
 
Subject 
Research Interview 
Payment 
Form of Payment 
Patient 
baseline 
 $ 25  
cash at close of interview 
3-month 
 $ 10 
money order mailed within 2 weeks 
6-month 
 $ 15 
money order mailed within 2 weeks 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
21 
Revised  9/2/14 
12-month 
 $ 25  
cash at close of interview 
 
12) 
Consent Process 
Waiver of HIPAA Authorization:  Waivers of HIPAA Authorization from both Mount Sinai and 
SLR are requested to identify subjects (patients) prior to enrollment into the study. 
 
Waiver of Written Documentation of the Consent Process (Mount Sinai Focus Groups only):  
A waiver of written documentation of the consent process is requested for the focus group 
participants. The written script of the information to be provided orally and all written 
information to be provided include all required and appropriate additional elements of 
consent disclosure. The research presents than minimal risk of harm to subjects. The 
research involves no procedures for which written consent is normally required outside of 
the research context.  
 
The only record linking the subject and the research would be the signed document. The 
group will be consented together and each participant will be afforded the opportunity to 
step aside from the group to ask questions.  
 
Setting:  Consent will be obtained in a private room at one of the participating Mount Sinai 
practices or in the patient’s home. 
 
Process:  We will follow the Informed Consent Process Standard Operating Procedure (SOP) 
as described in the PPHS document HRP-090. Informed consent will be viewed as a process, 
i.e. at several times during review of the IRB approved consent document, the subject will 
be asked to explain in his/her own words what his/her understanding of the consent. This 
will enable the research personnel to enter into a dialogue with the subject and ensure that 
the subject understands that he/she is free to withdraw at any time without penalty. 
Information will be provided to the subjects in terms that they can fully understand. There 
will be no exertion of any overt or covert coercion. The consent document is written in 
language that the potential subject can understand. Subjects will be asked to explain the 
purpose of the study and the expectations of their participation in their own words. They 
will be encouraged to ask questions prior to giving consent. Prior to signature of the 
informed consent document we ask the research patient to complete a set of questions 
designed to assess the patient’s essential understanding of the information contained in the 
informed consent document and given during the informed consent process. 
13) 
Process to Document Consent in Writing 
We will use the PPHS consent template. 
 
14) 
Vulnerable Populations 

 
Protocol Title: 
Clinic-based vs. home-based support to improve care and 
outcomes for older asthmatics 
Principal Investigator 
Name/Contact Info:  
Alex Federman, MD, MPH 
Email: alex.federman@mountsinai.org 
Primary Contact 
Name/Contact Info 
Irina Mindlis, MPH 
 
Date Revised: 
June 13, 2016 
Study Number: 
IF1737114, GCO#13-1401, HSM#14-00108 
 
22 
Revised  9/2/14 
Include 
Exclude 
Vulnerable Population Type 
 
 
Adults unable to consent 
 
 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
 
 
Wards of the State (e.g. foster children) 
 
 
Pregnant women 
 
 
Prisoners 
 
15) 
Multi-Site Human Research (Coordinating Center) 
Northwestern will serve as the Data Coordinating Center for Stage I activities. Audio files 
from ISMMS, SLR and IFH will be sent for transcription and the transcripts will be sent to 
Northwestern University.  
16) 
Community-Based Participatory Research 
Not applicable. 
17) 
Sharing of Results with Subjects 
Not applicable. 
18) 
IRB Review History 
 
19) 
Control of Drugs, Biologics, or Devices 
Not applicable. 
 
20) Control of Drugs, Biologics, or Devices 
Note: The IDS has its own forms that must be completed and a review process 
that must be followed before the IDS representative will sign off on Appendix B 
for submission to the PPHS.