A Feasibility Trial of a Stakeholder-Enhanced, Lay-Navigator-Delivered Intervention to Improve the Decisional Partnership of Chronic Kidney Disease Dyads
Phase: NA
Conditions: Kidney Diseases, Cardiometabolic Risk Factors
Sponsor: University of Alabama at Birmingham

Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi) 
 
Study Protocol and Statistical Analysis Plan 
 
NCT 06067009 
 
Date of last protocol approval May 24, 2024 
 
Shena Gazaway, PhD, RN, Principal Investigator 
Assistant Professor 
School of Nursing, University of Alabama at Birmingham 
Brimingham AL 35294 
 
 

IRB Protocol #: 300011311  
 
Grant#: P50MD017338-01  (Pilot Award)   
 
NCT#: 06067009 
 
Study Personnel and Staff Directory 
 
The University of Alabama at Birmingham (UAB) 
Shena Gazaway, PhD, RN 
 
 
 
 
 
 
 
gazaways@uab.edu 
Clare Lyas, MD  
 
 
 
 
 
 
 
 
clyas@uabmc.edu 
Rachel Wells, PhD, RN  
 
 
 
 
 
 
 
raduncan@uab.edu 
Alicia Cole, BS, MHQS 
 
 
 
 
 
 
 
 
acole@569@uab.edu  
J. Nicholas Odom, PhD, RN 
 
 
 
 
 
 
 
dionneod@uab.edu 
Orlando Gutiérrez, MD  
 
 
 
 
 
 
 
ogutierrez@uabmc.edu 
 
 
 
 

I. 
Overview 
While Black individuals comprise 13% of the U.S. population, they encompass ~35% of patients with kidney 
failure receiving dialysis. Black patients face higher rates of advancing disease and have poorer control of CKD 
risk factors, like cardiovascular disease (CVD); CKD shares risk factors associated with older age, male sex, 
hypertension, diabetes, smoking, and family history of CVD. Hypertension as a significant risk factor for CVD is 
thought to exist in approximately 80-85% of individuals with CKD.  However, hypertension control is suboptimal 
and has low control rates in this population. Patients with CKD, especially those in poverty, are at higher risk of 
experiencing inadequately controlled hypertension, which can accelerate kidney injury and potentially hasten 
disease progression. Results from the Systolic Blood Pressure Intervention Trial (SPRINT) demonstrate a clear 
cardiovascular and mortality benefit for controlling hypertension in patients with CKD, thus, emphasizing the 
link between the management of CVD risk factors in the CKD population.  
Black CKD patients and their care partners often report poor clinician communication and lower quality 
information-giving, resulting in less engagement in decision-making. In the concurrent management of 
hypertension and CKD, it has been found that Black patients remain unaware of their risk for advancing kidney 
illness. Data support that risks are not discussed in depth during physician-based encounters. In addition, 
Black patients negotiating concurrent illnesses are more likely to live in poorly resourced neighborhoods that 
lack access to supportive resources. In these communities, the lifestyle modifications routinely suggested to 
control CVD, and CKD progression are not readily available.   
Our main question is, does participation in decision support training impact Black CKD patients and their care 
partners' ability to 1. contemplate the decision needed, 2. request resources/support, and 3. make an informed 
patient-centered decision?  We acknowledge that standard nephrology care includes access to CKD 
educational materials through clinic-based classes, online platforms, and the availability to seek referrals to 
allied health professionals. Yet, Black patients and care partners report being under-informed, unsure about 
their resources, and wanting more information about delaying disease progression. Black CKD patients and 
their care partners experiencing these inequalities in CKD management increase Black patients’ risk of 
receiving treatments inconsistent with their values and preferences and a higher risk of early mortality. This gap 
between resource availability and access highlights the critical need to train CKD patients to effectively partner 
with a care partner and clinicians in shared decision-making before the disease progresses. Thus, we aim to 
provide short-term Community & Public Health Benefits to health promotion by addressing answer-seeking 
behaviors, thereby reducing patient decision conflict and enhancing patient reports of effective social support. 
In addition, we seek to understand the quality of life benefits for patients and caregivers. We will explore this 
connection by examining how introducing decision-support skills upstream of advanced disease impacts 
healthy behavior engagement in the community setting, potentially affecting disease progression.   
II. 
Aims of the Study: 
Acknowledging that historic racist policies have created environments that present barriers to effective health-
related decision-making, the aim of this study are to: seek to explore the feasibility and acceptability of 
participation in a decision-support training program led by lay navigators. This program is designed to 
empower Black CKD patients and their care partner to seek the resources and support needed to be activated 
allies when making health-related decisions. 
III. 
Study Population 
UAB Nephrology Services  
UAB Nephrology is a recognized leader in kidney transplantation. Our nationally ranked kidney disease 
program is consistently listed among the best in the country by U.S. News & World Report. UAB’s Division of 
Nephrology was designated a George M. O’Brien Kidney Research Center by the National Institutes of Health 
(NIH), making us one of just eight such federally funded centers in the country dedicated to the study of acute 
kidney injury and kidney failure. UAB’s strong research programs put us at the forefront of developing new 
methods to treat, prevent and cure diabetes and its complications, and our participation in clinical trials 
increases the chances of providing our patients with cutting-edge therapies not yet available at other medical 
centers. The UAB Nephrology program features a multi-disciplinary team that provides state-of-the-art clinical 
care, research, teaching, and disease management for patients with diverse types of kidney disease. As one of 
the largest kidney transplantation centers in the nation, we provide complete renal evaluation services in a 
compact, efficient time frame. We also are a national leader in providing transplantation to patients who do not 
have a living donor or whose donor’s tissue does not match the potential recipient. Patients may be seen in 

either the UAB General Nephrology Outpatient Offices or the Chronic Kidney Disease Clinic. At the Chronic 
Kidney Disease Clinic, patients receive more frequent monitoring and more extensive education on their kidney 
disease. UAB nephrologists see patients on our main campus at The Kirklin Clinic of UAB Hospital and in our 
neighborhood clinic locations in Hoover and Leeds.  
Cooper Green Mercy Health Services Authority  
Cooper Green Health Services Authority is an affiliate of UAB Health System and is committed to providing 
high-quality healthcare to all residents of Jefferson County, regardless of ability to pay. Cooper Green is a full-
service ambulatory care facility that includes primary and specialty care, urgent care, physical, occupational, 
speech therapy, laboratory services, radiology, and a pharmacy. In addition, Cooper Green’s Nephrology 
Specialty clinics are staffed by UAB Nephrologists. Copper Green is an essential advantage for Dr. Gazaway’s 
work. Cooper Green will serve as a second site to recruit diverse patients and their care partners for this pilot 
work and future work as needed. 
IV. 
Study Design 
We propose a pragmatic, randomized, wait-list control pilot trial with an embedded qualitative process to 
identify effective components 
and potential component 
combinations of an early 
decision-support training 
intervention to improve 
health-related decisions 
making. We will recruit 32 
dyads consisting of Black 
individuals with stage 3 or 4 
kidney disease (eGFR 15 – 
45 based on the new race-
free equation) and 
concurrent uncontrolled 
hypertension and their care 
partner for a total of 64 
participants. This pilot study 
will examine two 
interventions educating the 
dyad on 1) communication 
and 2) social support 
effectiveness topics. Two 
groups will each get one 
intervention, another group 
will get both, and a fourth 
group will serve as a control 
group and be wait-listed to receive interventions after the study period. While these psychoeducation 
components have been utilized in CKD, their potential benefits have not been explored singularly or in 
combination; none have explored the feasibility of involving a care partner, and many lack representation of 
Black individuals. We acknowledge not all individuals have care partners. Still, to ensure consistency, we will 
not enroll individuals who, after questioning and support from the study staff, cannot identify one person with 
whom they discuss their illness. However, we will provide all those individuals with the toolkit resources.  
V. 
Study Duration and Timeline 
Enrollment: March 2024 [Actual] 
Primary Completion: 2/15/2025 [Anticipated] 
Study Completion: March 30 2025 [Anticipated] 
 
 
 

 
 
 
Study Timeline *subject to change 
 
VI. Inclusion and Exclusion Criteria  
Eligibility Criteria (Patients): Inclusion: 1) Age ≥18; 2) EMR documented diagnosis of stage 3 or 4 CKD  
(2 eGFR 45-15 within 90 days); and concurrent cardiometabolic disease,  
3) Ability to speak and read English and complete baseline questionnaires;  
4) Patients must have a care partner enrolled in the study - the team will assist any patient in identifying a care 
partner, if interested.  
Exclusion: 1) Receiving hospice;  
2) Receiving dialysis;  
3) Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, 
suicidal ideation, uncorrected hearing loss, and active substance abuse.  
 
Eligibility Criteria (Care partners): Inclusion:  
1) Age ≥18; 2) Self-endorsing or identified by the patient as "a relative, friend, or partner that has a close 
relationship with you and who assists you with your medical decisions and who may or may not live in the 
same residence as you and who is not paid for their help";  
2) Ability to speak and read English and complete baseline questionnaires;  
3) Care partners must have an enrolled patient.  
Exclusion:  
1) Self-reported unmedicated mental illness, mild-severe dementia, active suicidal ideation, uncorrected 
hearing loss, or active substance abuse ascertained by study introduction questioning. 
VII. Randomization Plan 
Scheme. The randomization scheme will be executed via REDCap. Participants will be randomly assigned to 
one of 4 groups using a computer-generated permuted block algorithm (sizes 4 and 8) overseen by the study 
manager. Blinding. A research coordinator will oversee randomization procedures in REDCap and notify the 
lay navigator of the dyad's assigned condition.  

VIII. Community Advisory Board (CAB) 
Comprises 5 people, identifying as CKD patients, care partners, or clinicians. These individuals have a history 
of working with the P.I. The members of this group do not represent one entity but represent CKD patients and 
care partners throughout Alabama and the nation. This group will meet once/per month via Zoom, with local 
members invited to meet in person. Members have agreed to be paid $45 per meeting. Members will assist 
with intervention refinement, study protocol development, recruitment ideas, and dissemination planning. 
IX. Patient recruitment and Consent Process 
Recruitment: Dyads will be screened and recruited from the UAB outpatient nephrology clinics, UAB CKD 
clinic, and primary and nephrology care at Cooper Green. We will employ procedures utilized previously to 
recruit diverse patients and their care partners. In brief, upon receiving a HIPAA waiver, the P.I. and research 
coordinator will screen the EMR to identify eligible patients with planned office visits in the next 1-2 weeks. 
After receiving clinician permission, patients will be mailed an opt-out letter and informed consent form. Those 
who have not opted out will be called within 10 -14 days of the mailing date or an in-person approach will be 
conducted before their next clinic appointment. Those interested in participating will have the study explained 
in further detail and asked to identify a primary care partner. Care partners will be contacted by phone to 
explain the study and invite those interested. If a care partner is present at the appointment, they will be 
presented with study details and informed consent documentation. Recruited individuals will provide informed 
consent verbally over the phone. Those approached in person will sign the informed consent document in 
person.  
X. Description of the Intervention 
ImPart Content. Dyads will be randomized to receive one or more ImPart-Multi courses delivered in a semi-
structured, 30-45-minute session format with a lay navigator. Course 1. Communication Training: 1 
telehealth session reviewing and discussing shared decision-making and how to communicate questions or 
concerns, listening, questioning, and sending messages. Course 2: Social Support Effectiveness Training - 
3 Telehealth Sessions focused respectively on reviewing and discussing principles of effective decision-making 
and principles of effective decision-making. All participants will receive a guidebook containing intervention 
material. The rationale for all components is to instill social and decision support skills through reflection and 
regular contact with a lay navigator, and is based on interviews, literature, and advisory group feedback. The 
accessibility interviews will provide feedback about the dyadic approach and combination to determine how 
best to impact change.  
Table 3. Study Measures  
Baseline 
12 weeks 
Measure 
Pt 
CP 
Pt 
CP 
Feasibility: Intervention completion rate (# participants completing assigned 
components) & assessment completion rate (# participants completing each study 
assessment [Baseline, 12 weeks]) will be tabulated, ≥75% completion rates for 
assigned components & study assessments will be considered evidence of feasibility.  
X 
X 
Acceptability: Determined by thematic analysis, of digitally recorded, semi-
structured qualitative interviews adapted from prior study teams' work.  Open-ended 
questions will query participants about their experiences with their assigned 
intervention components, the navigator, study procedures, how program impacted 
their engagement in shared decision-making and healthy behaviors, and changes 
they would like to see made to the intervention and study procedures. 
X 
X 
Decision-making process: Decision Conflict Scale (DCS)|16-item measure; 
perceptions of uncertainty in choosing options, factors contributing to uncertainty 
(e.g., feeling uninformed, unclear values) and feeling that decisions were informed 
and values-based.  
X 
 
X 
 
Decision-making process: Social Support Effectiveness- Questionnaire|25 item 
measure; perceptions of help received in last 3 months with higher scores indicating 
more effective support.  
X 
X 
X 
 
D. Patient Wellbeing: Kidney Disease Quality of Life Scale (KDQOL 36)|36 items 
measure three components: physical health score, mental health score, and kidney 
disease health score. 
X 
 
X 
 
E. Care partner Wellbeing: PROMIS Global Health 10|10 items measure global 
health-related quality of life (HRQOL) in 2 domains: physical and mental health; 
scoring allows for cost-effectiveness estimates. 
X 
X 

Dyadic Interaction: Dyadic Coping Inventory|37-item instrument designed to 
measure perceived communication and dyadic coping in close relationships when 
one or both partners are stressed. 
 
 
X 
X 
Patient Demographics: Age, gender, race/ethnicity, income, education, 
employment, marital status, religious affiliation, health insurance, residence, Charlson 
Comorbidity Scores  
X 
 
 
 
Caregiver Demographics: Age, gender, race/ethnicity, income, education, 
employment, marital status, religious affiliation, health insurance, residence;  
relationship to care recipient, # days/week providing care, # hours/week providing 
care 
 
X 
 
 
 
XI. Statistical Analysis Plan 
Patient characteristics and baseline measures will be summarized using descriptive statistics. The effect of the 
interventions on each outcome at 12 weeks will be modeled using linear regression, adjusting for the baseline 
value. The intervention groups will initially be modeled as a 4-level categorical variable with the wait-listed 
controls as the reference group to provide specific efficacy estimates for each group.   
XII. Data Management Plan 
Study team members will securely manage all PHI per HIPAA and IRB regulations, and maintain data 
confidentiality and anonymity. All study documents contained only patient-assigned participant IDs and no 
identifiers. The study PI will transmit all study data from the REDCap databases to team statistician for data 
analysis. 
A. Spreadsheets 
1. Screening Spreadsheet: This spreadsheet tracks potential participants based on medical record screen. The 
spreadsheet includes the following: 
1. Site 
2. Screen Date 
3. Patient Name 
4. MRN 
5. Clinician's last name 
6. DOB 
7. Age 
8. Rache 
9. Ethnicity 
10. Gender 
11. Kidney disease stage 
12. other metabolic disease 
13. Mental illness 
14. Substance use 
15. Suicidal ideation 
16. Dementia 
17. Hearing loss 
18. English Speaking 
19. Hospice status 
20. Dialysis status 
The spreadsheet is password-protected, stored behind an institutional firewall, and shared only with members 
of the study team who need it. 

2. Implementation of the Education Sessions Documentation: Coaches documented on a spreadsheet that 
served as a place to document session completion, session tracking, and to review pertinent patient details 
prior to the sessions.  
B. Questionnaires 
The questionnaires are stored in the REDCap database, which is a password-protected, institutional software 
developed to collect and store study data. Only study team members who need it have access to the REDCap 
database, and the system is only accessed from institutional computers.  
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. 
- 
The Forge Ahead Center, National Institute of Minority Health and Health Disparities 
- 
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. No data will be sent electronically, study team members will access the 
information needed from the password-protected file located on the UAB server.  
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 future decision-making may cause emotional distress 
for patients or caregivers. Patients may get tired when answering questions during the acceptability 
interview. If they are tired, they can stop the interview at no penalty to them. 
b. Loss confidentiality: There is a chance that people not associated with he study will see 
patient/caregiver answers to questionnaires or interview questions. Patient/caregiver names and other 
identifying information will be removed from all study documents. Data will be kept in a secure, 
password-protected database at UAB.  
XV. Patient/caregiver payment for participation in Research 
The patient and the caregiver are paid $20/baseline and $20/12-week completion, and $20 for the acceptability 
interview. If the patient or caregiver does not complete all data collections they will be paid for the data 
collections they completed prior to deciding to stop taking part in the study.  
 
 
 

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