A Community Developed, Culturally-Based Palliative Care Tele-Consult Program for African American and White Rural Southern Elders With a Life Limiting Illness
Phase: NA
Conditions: Cancer, Cardiac Disease, Pulmonary Disease, Neuro-Degenerative Disease, Renal Disease, Stroke, Sepsis, Hepatic Disease
Sponsor: University of Alabama at Birmingham

A Community Developed, Culturally Based Palliative Care Tele-
Consult Program for African American and White Rural 
Southern Elders with a Life Limiting Illness 
 
 
Study Protocol & Statistical Analysis Plan 
 
 
NCT 03767517 
 
 
Date of Last Protocol Approval 
December 2, 2022 
 
 
                         Ronit Elk, PhD, Principal Investigator  
Professor Associate Director, Center of Palliative and 
Supportive Care Associate Director, Southeast Institute for 
Innovation in Palliative and Supportive Care, Co-Director, Mixed 
Methods, CBPR and Thematic Analysis Institutional Core, 
Division of Geriatrics, Gerontology, and Palliative Care, 
Department of Medicine, Heersink School of Medicine, UAB 
Birmingham, AL 35294 
 

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APPENDIX I: STUDY PROTOCOL 
 
A Community-Developed, Culturally-Based PC Tele-Consult Program for African 
American and White Rural Southern Elders with Life Limiting Illness  
IRB Protocol #: 300002420; Grant #: 1R01NR017181-01A1; NCT #: 03767517  
Phase III Clinical Trial 
 
Study Personnel and Staff Directory 
 
The University of Alabama (UAB) 
Ronit Elk, PhD 
relk@uabmc.edu; 205.976.1702 
Marie Bakitas, DNSc, NP-C, FAAN 
mbakitas@uab.edu; 205.934.5277 
Rodney Tucker, MD 
rtucker@uabmc.edu; 205.934.9261 
Susan McCammon, MD 
Felicia Underwood, LMSW, MPA 
smccammon@uabmc.edu; 205.801.7859 
faunderwood@uabmc.edu; 205.974.7905 
Shena Gazaway, PhD, RN 
gazaways@uab.edu; 205.975.5304 
Richard Kennedy, MD, PhD 
rekenned@uab.edu; 205.975.7563 
 
Russell Medical Center (AL) 
Michele Goldhagen, MD 
mgoldhagen@russellmedcenter.com; 256.496.2638 
Sarah Beth Gettys 
sbgettys@russellmedcenter.com; 256.329.7390 
Marlee Duffie 
mduffie@russellmedcenter.com; TBD  
Vantrice Heard 
vheard@russellmedcenter.com; TBD 
 
Anderson Regional Medical Center (MS)  
Donna Herrington 
Bonnie Parker, RN, BSN 
    dherrington@andersonregional.org;601-703-3415 
BParker@andersonregional.org; 601-703-3654 
Lisa Massey, RN 
           lisa33852@andersonregional.org; 601-527-0378 
 
UMMC (MS) 
J K Mansel, MD 
jmansel@umc.edu; 601.288.4306 
 
Aiken Regional Hospital (SC) 
Sidney Rhoades, MD 
sfrhoadesmd@yahoo.com; 803.226.0739 
Sheila McCormick 
Sheila.Mccormick@uhsinc.com; TBD  
 
 
 
 

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Northwestern University (NU) 
Joshua Hauser, MD 
j-hauser@northwestern.edu; 312.503.3478 
 
University of California, Los Angeles (UCLA) 
Marjorie Kagawa-Singer, PhD, MN, RN, FAAN 
mkagawa@ucla.edu; 310.825.9481 
 
 
 

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A Community-Developed, Culturally-Based PC Tele-Consult Program for African 
American and White Rural Southern Elders with Life Limiting Illness 
 
 
Table of Contents 
I. 
Overview ....................................................................................................... 3 
II. 
Aims of the Study .......................................................................................... 4 
III. 
Study Population ........................................................................................... 4 
IV. 
Study Design ................................................................................................. 5 
V. 
Study Duration and Timeline ........................................................................ 6 
VI. 
Inclusion and Exclusion Criteria ................................................................... 6 
VII. 
Randomization Plan....................................................................................... 7 
VIII. Community Advisory Groups (CAGs) .......................................................... 7 
IX. 
Patient Recruitment and Consent Process ..................................................... 8 
X. 
Description of Tele-consult Intervention ...................................................... 9 
XI. 
Statistical Analysis Plan .............................................................................. 11 
XII. 
Data Management Plan................................................................................ 11 
XIII. Confidentiality/Privacy Considerations ...................................................... 12 
XIV. Study Risks and Discomforts ...................................................................... 13 
XV. Patient/Caregiver Payment for Participation in Research .................... …...14 
 
 
 

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I. 
Overview  
The triple threat of rural geography, racial inequities, and older age hinders access to high quality 
palliative care (PC) for a significant proportion of Americans. Rural patients with life-limiting 
illness are at very high risk of not receiving appropriate care due to a lack of health professionals, 
long distances to treatment centers, and limited PC clinical expertise. Although culture strongly 
influences people’s response to diagnosis, illness and treatment preferences, culturally-based 
care models are not currently available for most seriously-ill rural patients and their family 
caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients.   
The two major public health consequences of these problems are:  
1) Access-Rural patients have sub-optimal or no access to PC. Despite significant nationwide 
growth, access to PC is grossly inadequate for the 60 million US citizens who live in rural or 
non-metropolitan areas. There is low PC use in rural and minority populations. As a result, rural 
patients experience significant suffering from uncontrolled symptoms that PC expertise could 
alleviate.  
2) Acceptability-Even when palliative and hospice services are available, African Americans 
(AA), compared to Whites (W) are more likely to receive medically-ineffective, poor quality 
care due to a culturally-insensitive health care system and mistrust of health care providers. 
Making culturally competent PC available for diverse underserved and rural Americans is a 
national priority.    
Our community-developed, culturally based tele-consult intervention, specifically targets the 
gaps of PC access and acceptability. It was developed by and for rural, Deep South AA and W 
patients and providers, and uses state-of-the-art telehealth methods, to provide PC consultation to 
hospitalized seriously-ill patients and family. Using National Consensus Project guidelines, and 
the culturally-based, community-developed PC Tele-consult intervention, a remote PC expert 
conducts a comprehensive PC patient assessment, in collaboration with local providers. 
Following interdisciplinary PC team review, the remote clinician communicates 
recommendations. Two additional structured follow up contacts at Day 3 and 6 ensure care 
coordination and smooth transitions that enable patients to receive guideline concurrent PC in 
their communities.  
Almost three decades after the Institute of Medicine’s landmark report, “Approaching Death” 
their revised report, “Dying in America,” continued to document that hospitalized patients with 
serious illness are experiencing unnecessary suffering from uncontrolled symptoms. This occurs 
disproportionally in rural and minority citizens, especially those in the Deep South. Our study 
will move the field forward by testing a promising culturally-based tele-consult intervention that 
is scalable, and was developed by and for the community it will serve. 
 
 
 

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II. 
Aims of the Study 
The aims of this study are to compare a robust, culturally-based tele-consult program to usual 
hospital care to: 
a.  Primary Aim: Determine whether a culturally-based PC tele-consult program leads to lower 
symptom burden in hospitalized AA and W older adults with a life-limiting illness. 
b.  Secondary Aim: Determine whether a culturally-based PC tele-consult program results in 
higher patient and caregiver quality of life, care satisfaction, and lower caregiver burden at 
Day 7 post-consultation, and lower resource use (hospital readmission, emergency visits) 30-
days post-discharge 
c. Exploratory Aim: Explore mediators and moderators of patient symptom and caregiver 
burden outcomes. 
 
III. 
Study Population 
The hospitals chosen for this study represent typical rural hospitals in size and population 
representativeness of many of the underserved facilities in the Deep South.  
a. Russell Medical Center, Alexander City, AL: Russell Medical Center is a not-for-profit, 
acute care facility serving the needs of east Central Alabama. It is a general medical and 
surgical hospital in Alexander City, AL, with 80 beds. Survey data for the latest year 
available shows that 24,827 patients visited the hospital's emergency room. There are 67 
physicians affiliated with the hospital, and the hospital had a total of 3,245 admissions. Its 
physicians performed 835 inpatient and 3,264 outpatient surgeries. Russell Medical Center 
also expounds upon community health education services through health screenings, support 
groups, childbirth classes, self-help programs, and athletic trainers to multiple sports teams in 
its service area. 
b. Highland Community Hospital, Picayune, MS: Highland Community Hospital is a 60-bed 
not-for-profit hospital and affiliated clinics provide access to a broad range of quality 
services, supporting the community and enhancing the level of care for the residents of 
Picayune MS and the surrounding areas. There are 100 physicians affiliated with the 
Highland Community Hospital. Its community outreach includes classes and events in 
different themes including community education, continuing education, screenings, support 
groups etc. 
c. Aiken Regional Hospital, Aiken, SC: Aiken Regional Medical Centers, located in Aiken, 
South Carolina, is a 245-bed acute care facility offering a comprehensive range of specialties 
and services. The medical staff includes over 900 skilled healthcare/support professionals, a 
medical staff of more than 120 multi- specialty physicians, and a team of 230 volunteers. The 
center provides nearly 50 specialty services through its acute care facility, behavioral 
healthcare hospital and the cancer care institutes of Carolina. Its services reached in Aiken 
and its surrounding communities. There are different types of the community outreach in 
Aiken Regional Medical center, including classes, seminars, support groups, or information 
about new services. 
 

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IV. 
Study Design  
This study consists of 2 phases: 
Phase I Convening & Soliciting CAG 
Participation in study design. This 
phase will consist of assembling CAG 
members to review study procedures and 
some CAG members will be trained to 
approach potential study participants. 
Potential CAG members (8, with equal 
numbers of AA and W) will be identified 
by the hospital staff and community 
leaders of each of the three sites, and 
invited to participate in the CAG. 
Potential CAG members will include 
respected members of the community, 
those who have recently lost a loved one 
and understand end of life care, and 
community leaders. Potential members 
will be discussed by the recruiters with 
the study PIs to ensure there is socio-
demographic balance, and equal 
representation of African American and 
White members, to ensure all will feel comfortable participating and contributing, and to ensure 
that they are not all from the same family/church/social group. Following this step, a formal 
written invitation will be extended to those selected, followed by a phone call by the Study 
Manager. 
Phase II Conducting the RCT.  In Phase II, we will conduct a randomized controlled trial 
(RCT) at the 3 sites to test the effectiveness of this innovative program. We will recruit 352 
hospitalized AA and W adults over age 65 whose treating physician would not be surprised if 
they died within the next year and the patients’ family/friend caregiver. Half of the patient 
participants (N=176) will be randomized to receive usual care appropriate to their illness. 
Patients randomized to usual care in each of the three participating hospitals will receive 
inpatient care appropriate to their illness. This includes assessment and treatment by the 
admitting physician, along with any subspecialists that are consulted. The formulation and 
sharing of prognostic information and the engagement of patients and families in establishing 
goals of care will be according to the standards of the admitting physician and subspecialists. 
Treating clinicians may include hospitalists, nurse practitioners, social workers, pastoral care, 
and occasionally, the patient’s primary care practitioners who have hospital privileges. 
The other half of the patient participants (N=176) will receive the culturally-based palliative care 
consult. Patients in the intervention group will receive usual care as described above, and, in 
addition, will participate in a standardized, comprehensive palliative care Tele-consult 

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assessment as well as a follow up by the palliative care physician on Day 3 and 6 following the 
initial consult.   
Recruitment Estimates by Hospital  
 
 
V. 
Study Duration and Timeline 
 
Enrollment: September 2019 [Anticipated]  
Primary Completion: January 2023 [Anticipated]  
Study Completion: September 2023 [Anticipated] 
 
Study Timeline *Subject to Change* 
 
 
VI. 
Inclusion and Exclusion Criteria 
 
Patient Inclusion Criteria: 
(1) AA or W; 
(2) > 65 years old; has a condition which fits into one of 3 illness paradigms (including: cancer, 
cardiac disease, pulmonary disease, neuro-degenerative disease, renal disease, stroke, sepsis, 
hepatic disease) 
(3) Clinician answers “no” to question: “Would you be surprised if this person died in the next 
12 months?” 
(4) Patient has a caregiver who has been involved in their care. 
(5) Able to complete baseline interviews. 
 
Patient Exclusion Criteria: 
ACTIVITY
Sept.
Oct.
Nov.
Dec.
Jan.
Apr.
Jul.
Oct.
Jan.
Apr.
Jul.
Oct.
Jan.
Apr. 
Jul.
Oct.
Jan.
Apr.
Jul.
Oct.
Jan.
Apr.
Jul.
Oct.
IRB approval
Build relationships with hospital staff, 
orient to study & eligibility criteria
PC MD training in culturally-based tele-
consult
Establish CAG, provide orientation & 
training
CAG quarterly meetings
Patient enrollment
Data collection
Data analysis
Progress reports/final reports
Presentations and publications
2021
2022
2023
2018
2019
2020

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(1) Unable to complete baseline interviews; 
(2) Currently receiving hospice care; 
(3) No family member/caregiver. 
 
Caregiver Inclusion Criteria: 
(1) Age ≥21 years 
(2) English-speaking 
(3) Community-dwelling 
(4) Not a “sitter” 
 
VII. 
Randomization Plan  
The randomization scheme will be executed via REDCap, a clinical trials management software 
program. Participants will be randomly assigned to group (1:1) using a computer-generated 
program overseen by Dr. Kennedy. The randomization scheme will be stratified by site (SC, AL, 
MS) race (W, AA), and illness trajectory. As the Central Coordinating Site, UAB will manage 
the randomization process. The UAB study manager will be alerted to the assignment by 
REDCap and will trigger the local unblinded study coordinator to communicate assignment to 
the participant and initiate study protocol. All other members of the research team will remain 
blind to group assignment and participants will be instructed not to discuss their assignment with 
the local study coordinator collecting the outcome assessments. 
 
VIII. Community Advisory Groups (CAGs) 
The community advisory groups (CAGs) will be an integral part of the study.  A CAG will be 
formed at each of the three study sites. Each CAG will be made up of eight members, with equal 
numbers of African American (AA) community members (four), and White (W) community 
members (four). Potential CAG members will be identified by hospital staff and community 
leaders and will include respected members of the community, or those who have recently lost a 
loved one and understand end of life care.  
The role of the a CAG members on the study is three-fold:   
a. Advisory: CAG members will be invited to meet with the study team members and PC 
physicians every three months throughout the study, hear about progress, and challenges, and 
provide advice when problems arise.  The last meeting of this study will be a full report-back and 
summary to the CAG.  
b. Cultural recognition: CAG members will meet with and be trained by the CAG members 
from Beaufort, South Carolina, who developed the pilot study. We anticipate that the 
appreciation for and recognition of the southern rural African American or White culture by this 
study, and a recognition that the community has been instrumental in creating a program that 
could benefit their community, will result in an appreciation for the potential value of this study.  
 

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c. Introducing patients to the study: The CAG member will be the first to meet potential study 
participants (regardless of which group they get randomized to) to introduce them to the study, 
and will introduce the CSC. CAG members will be the first to meet potential study participants 
(regardless of which group they get randomized to) to introduce them to the study. The role of 
the CAG member in meeting with patients is primarily to make the patient and caregiver feel at 
ease, and to help build trust. In the pilot study, we found that if an African American CAG 
member met with an African American patient and caregiver, it helped to address feelings of 
mistrust in the research study.  Particularly helpful was that the pilot CAG members assured 
patients and caregivers of their belief in the study, and their confidence and trust in the palliative 
care (PC) physician. CAG members will receive gas cards to cover their travel expenses to and 
from the hospital. 
Before study recruitment begins at the hospital site, the coordinating study coordinator will 
create a CAG member schedule and telephone tree, to determine which CAG members will be 
‘on call’ each day, and the best way to reach them.  This will facilitate the quick action needed to 
meet with potential study participants after they have been identified and permission has been 
granted.   
 
IX. 
Patient Recruitment and Consent Process 
Each site will have two part-time study coordinators: a) Coordinating Study Coordinator (CSC) 
and b) Blinded Study Coordinator (BSC).  
Consent Process: 
a. Approaching the patient and family: The CSC will screen admissions each weekday and 
will only approach potential study participants after confirming eligibility (e.g. “surprise 
question”) and getting approval from the treating clinician.  
 
b. CAG and CSC meet with patient and family: Following approval, the CSC will contact the 
CAG member “on-call” for the day to speak with the patient. The CAG member and CSC will 
approach the patient. The CAG member will introduce themselves and the CSC, and describe the 
study to the patient. The CAG will emphasize their role in developing the study and how this 
study was designed to help the community. If the patient indicates that he/she would like to 
participate, the CSC will provide an overview of the study, including a description of palliative 
care, the tele-consult equipment and process, (if randomized to that group), and randomization 
using a simple visual diagram. (These materials were developed by the R21 CAG and will be 
reviewed and adapted by each hospital-specific CAG). The CSC will then read the consent form 
to all patients (assuming no or limited literacy) unless the patient prefers to read it themselves. 
The family member is invited to participate and will sign a separate consent agreeing to complete 
questionnaires regardless of group assignment. The CSC will assist the patient (and separately 
the family member) to complete the baseline questionnaires using an electronic tablet that 
connects directly to the REDCap database. Baseline data are collected prior to randomization, so 
study coordinator blinding is not necessary. 

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The CSC will screen, obtain consent and organize the tele-consult. The CSCs will remain in 
daily contact with hospital staff and participate in tem meetings to remind clinicians about 
eligibility criteria. Team meeting attendance will allow the CSC to clarify the study goals and 
protocol and to strategize solutions if challenges arise. The BSC will collect all data following 
patient randomization.  
X. 
Description of Tele-consult Intervention 
Tele-consult Intervention. The tele-consult intervention consists of 3 interactions between the 
remote palliative care physician/interdisciplinary team (IDT) and the local patient/caregiver and 
hospitalist/treatment team. 
Community-developed, Culturally-Based Inpatient Teleconsult- Intervention 
Contact # 
When 
With Whom 
Method 
Purpose 
#1 Palliative 
Care Tele-
consult 
As soon after 
randomization as 
possible 
Patient (family) 
referring hospitalist 
& remote palliative 
clinician 
Local Study 
coordinator  
Remote IDT 
Members 
Secure tele-
consult  
Remote IDT 
review 
eHR document 
1. 
Conduct community-
developed, culturally 
based palliative 
assessment. 
2. 
IDT review 
3. 
Develop 
recommendations & 
palliative care plan 
#2  
Follow up  
Day 3 
Within 3 days post 
consult 
Remote & local 
clinicians 
eHR document  
Telephone 
1. 
Provide 
recommendations & 
care plan 
2. 
Respond to patient, 
family & remote team 
questions 
3. 
Identify community 
care team & initiate 
referrals as needed 
(including primary 
clinician/hospice 
provider if 
appropriate). 
#3  
Follow up 
Day 6  
Within 6 days post 
consult 
Remote Clinician  
Patient/family & 
local community 
care team members 
Telephone 
1. 
Reassess patient and 
care plan 
2. 
Assess adequacy of 
discharge plan or home 
experience 
3. 
Refer to community 
resources 
 
Contact #1: the Coordinated Study Coordinator [CSC] will work closely with the patient/family, 
local team, and remote palliative care physician to determine a time suitable (within 48 hours on 
weekdays) to perform the Tele-consult. The CSC and the hospitalist/a member of the treatment 
team will be in the room with the patient and family. The CSC will set up the HIPAA protected 
telehealth laptop next to the patient’s bed, introduce the patient to the remote palliative 
physician, and the tele-consult will proceed.  All Tele-Consults are digitally-recorded within the 
secure portal. Most consults take 45-60 minutes. To ensure a comfortable conversation with 

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minimal interruptions we have instituted several steps including checking with floor nurse, 
putting up signs on the door, and tasking the CSC with running interference in case of 
interruptions. 
 
Within 24 hours of conducting the Tele-consult, the remote palliative physician will seek an 
interdisciplinary team review, develop the plan, and make recommendations, which may include 
immediate patient care (e.g., symptom relief) and continuing care, related to the hospital stay and 
following discharge. Recommendations may also include referrals to other supportive resources 
such as a hospital social worker or pastor. The written consult will be documented using a 
standardized note template that corresponds to the 8 NCP palliative care domains and will be 
provided via a secure HIPAA-compliant portal that will be part of the patients’ inpatient medical 
record. As needed, verbal contact will also occur between the palliative care physician and the 
hospitalist staff.   
 
Contact #2 Day 3 (approximately 24-48 hours after first contact). The CSC will arrange a follow 
up videoconference between the remote palliative care physician and patient if in hospital or via 
phone if the patient has been discharged. The purpose of this second contact is to determine how 
patient is progressing, if the plan was implemented, if hospital staff/patient has encountered any 
challenges or questions, and to determine who will be assuming the patient’s care in the 
community. Documentation of the contact will be provided as described above.    
 
Contact #3 Day 6 (post consult) (via videoconference if patient is in hospital, via phone if 
discharged.) To determine if patient is experiencing new or ongoing challenges, to confirm 
availability of community or hospice care as appropriate. 
 
Tele-consult Intervention + Usual 
Care. In the usual care group and the 
intervention group, a study 
coordinator at each site will 
administer questionnaires to the 
patient and their designated 
family/friend caregiver, in person or 
telephone (if patients are discharged 
during the study period) at baseline 
(T1), Day 7 (T2) and Day 30 after 
hospital discharge (T3). (Study 
coordinators administering T2/T3 
assessments will be blinded to study 
group- aka Blinded Study 
Coordinators [BSC]).  
 
 

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XI. 
Statistical Analysis Plan 
Demographic variables (e.g., age, sex, race, disease) will be summarized and compared across 
treatment groups using t-tests and nonparametric Wilcoxon signed rank tests for continuous 
measures (age), binomial tests (sex, race), and chi-square statistics for categorical variables (e.g., 
marital status, education).  All demographics and stratification variables found to differ across 
treatment groups will be included in regression models (referred to as the vector 𝑍𝑍𝑖𝑖 in the 
regression models to follow); however, race will be included in the final models separately from 
the vector 𝑍𝑍𝑖𝑖 vector. Tabulations of binary and categorical variables will be presented for all 
measures and broken down by treatment group. Age will be summarized by mean and standard 
deviation for all participants, and broken down by treatment group. 
 
XII. 
Data Management Plan 
Study coordinators will securely manage all data and PHI in accordance with HIPAA and IRB 
regulations, and maintain data confidentiality and anonymity.  The only physical study document 
that will contain identifiable information will be the informed consent document, which the study 
coordinator will store in a secure, locked location until it can be securely transferred to a locked 
cabinet at the University of Alabama at Birmingham (UAB).  All other study documents will 
only contain the patient’s UID, but no identifiers. 
The CSC and BSC will transmit all study documents to Dr. Kennedy, the study statistician, for 
data analysis. This includes questionnaires, fidelity checklists, data collection sheets, 
spreadsheets, and any other data collection instruments and tools.  
a. Spreadsheets 
Each CSC and BSC will maintain a number of spreadsheets and documents to track all aspects of 
data collection at their respective sites.   
Referral spreadsheet 
One spreadsheet should track potential patient referrals. No identifiable information should be 
included in the spreadsheet.  The spreadsheet should include the following: 
• Referral number (e.g., ‘referral 001’) 
• Date of referral 
• Name and title of person making referral (e.g., ‘Nora, nurse’) 
• Patient age, ethnicity, sex 
• Patient diagnosis 
• Name of treating clinician 
• Whether or not treating clinician’s permission was granted 
• If no, why not? 
• Date of treating clinician’s permission/denial 
• Whether or not patient enrolled’ 
• If no, why not? 
• Date of patient’s enrollment/non-enrollment 
• If yes, patient UID 

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UID spreadsheet/linkage log. The linkage log will be the only spreadsheet that contains 
PHI/identifiable patient information.  It will contain the patient’s UID, patient’s name, 
caregiver’s name, and phone numbers.  This spreadsheet should be password encrypted, and 
shared only with members of the study team.   
Implementation of PC recommendations spreadsheet. The PC recommendations and 
implementation spreadsheet will track each patient consult using the patient UID.  It will contain 
a list of each of the PC recommendations, and whether or not each of the recommendations was 
implemented by the treating clinician(s). 
b. Fidelity checklist 
The CSC will fill out the fidelity checklist for each PC consult, to track the PC physician’s 
adherence to the cultural guidelines.  The fidelity checklist will contain the patient UID, the date, 
and the duration of the PC consult. 
 
c. Data collection sheet 
The CSC will fill out a data collection sheet for each patient (both Group A and Group B), using 
patient’s UID.  The data collection sheet will record: 
• Demographics 
• Diagnosis 
• Readmissions 
• Study group 
• PC recommendations 
• Family implementation of PC recommendations (determined via family interview) 
 
d. Questionnaires 
The DSC will send completed questionnaires (either hard copies of electronic copies) to Dr. 
Kennedy for analysis.  Each questionnaire will only have the patient UID, and no identifiable 
information. 
 
XIII. Confidentiality/Privacy Considerations  
Information obtained about the patient/caregiver will be kept confidential to the extent allowed 
by law. However, research information that identifies the patient/caregiver may be shared with 
people or organizations for quality assurance or data analysis, or with those responsible for 
ensuring compliance with laws and regulations related to research. They include: 
• The UAB Institutional Review Board (IRB). An IRB is a group that reviews the study 
to protect the rights and welfare of research participants. 
• National Institute of Nursing Research/NIH/DHHS  
• The Office for Human Research Protections (OHRP) 
The information from the research may be published for scientific purposes; however, the 
patient/caregiver’s identity will not be given out. All study documents and data sent 
electronically via HIPAA compliant system will be stored in a secure, locked file cabinet at the 
University of Alabama at Birmingham (UAB).   

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XIV. Study Risks and Discomforts 
This study has very low risk to participants. Risks that they potentially incur include: 
a. Emotional distress: Talking about their illness and symptoms may cause emotional distress 
for patients or caregivers. Patient may get tired while answering the questions with the study 
coordinator. If a patient gets too tired, we can come back later in the day. Sometimes people 
feel embarrassed or uncomfortable when being asked questions so patients/caregivers can 
refuse to answer any question. 
b. Loss of confidentially: There is a chance that people not associated with the study will see 
patient/caregiver answers to questionnaires. Patient/caregiver name and other identifying 
information will be removed from study documents. Data will be kept in locked files in the 
study research offices at UAB. All data will be housed in a secure, password protected 
database at UAB. 
c. Burden and benefits: There is a risk related to being placed into a group by chance (i.e., 
randomization). Patients in the standard care group may not have the same benefits as 
patients in the intervention group. 
 
XV. 
Patient/Caregiver Payment for Participation in Research 
The patient and the caregiver will be paid $10 for completion of baseline questionnaires, $10 for 
completion of Day 7 questionnaires, and $20 for completion of the Day 30 questionnaire. The 
total payment you may receive is $40. If the patient/caregiver does not finish the entire study, 
they will be paid at the time they decide to stop taking part in the study.