Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease (CLARIFy-KD)

Improving Access to Nephrology Treatment and Care Among Patients at Greatest Risk for Kidney Failure

Through the use of community-engaged processes, this project seeks to develop and implement clinical decision support (CDS) and a kidney health coaching (KHC) intervention. The CDS seeks to streamline workflows to effectively screen, identify, and link to care for those patients with advanced chronic kidney disease (CKD).

The overall project goals are to 1.) Design and conduct community-engaged clinical trials to test new interventions that dismantle the systemic factors that contribute to kidney health disparities. 2.) Foster research collaborations between investigators, people living with kidney disease, community-based organizations, and other key stakeholders.

Researchers aim to assess whether the KHC intervention is effective at delaying the transition to kidney replacement therapy (KRT) and central venous catheter use or death.

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases
• Intervention / Treatment: Other: Kidney Health Coaching; Other: Usual Care

Detailed Description

The team aims to implement multi-level, multi-component interventions across primary care and acute care access points and nephrology care, using an experimental 2-group randomized controlled trial, to assess the effectiveness of a kidney health coaching intervention on delaying a) the transition to kidney replacement therapy and central venous catheter use and b) death.

The research team will deliver patient-centered kidney health coaching through full-time kidney health coaches (KHCs), who have lived experience with chronic kidney disease (CKD) and have been selected for certain personality characteristics. The KHCs have undergone training to deliver patient support that aligns with the constructs of the Chronic Care Model: Clinical information systems, Patient self-management, and treatment decision-making support, Delivery system redesign, and Community resources.

Participants enrolled in the intervention will receive 6 months of kidney health coaching. Those eligible for participation will be invited to participate and undergo the informed consent process via telephone. Next, study staff will administer the baseline assessment via telephone interview for those who consent.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly R Jacob Arriola, PhD, MPH; Phone Number: 404-727-2600; Email: kjacoba@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Identifies as African American or Black
• Two estimated glomerular filtration rates (eGFRs) < 29 separated by at least 90 days but within the past 2 years, or a Kidney Failure Risk Equation (KFRE) score of 10% or greater likelihood of kidney failure within the next 2 years
• Had an encounter at Emory Healthcare through an ambulatory visit or inpatient stay (i.e., ER or hospital visit within the previous 2 months
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

• Currently on dialysis
• currently receiving hospice care or other types of conservative management for terminal illness
• Currently on waitlist, or referred for/or completed a transplant evaluation visit within the past 2 years
• Kidney or another solid organ transplant
• Active cancer treatment
• Non-English speaking
• Participating in another treatment or intervention study at the time of enrollment
• Currently pregnant or planning to become pregnant at the time of recruitment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control: Usual Care; Participants will receive the usual care based on where patients are identified (Emergency Room- ER, Primary Care, Hospital Discharge, Primary Care, or Nephrology)	Other: Usual Care; ER Discharge (d/c): Participants may receive consultations and support from Care Management in the ER, such as transportation or medication assistance. Follow-up by a social worker varies post-discharge. Hospital d/c: All hospitalized patients are assessed by the care management team to identify psychosocial needs and begin discharge planning, which may include follow-up appointments and resources. High-risk patients receive additional follow-up from a care transitions coordinator for 30 days post-discharge. Primary Care: Patients in primary care clinics have access to various support services. Those recently hospitalized or identified as high-risk receive care coordination from social workers. Internal referrals are managed by referral coordinators, while external referrals come from clinic staff. Discharge information is provided after visits. Nephrology: There are no coordinated support services for chronic kidney disease (CKD) patients receiving nephrology care.; Other Names: Control
Other: Intervention: Kidney Health Coaching; Participants will receive patient-centered health coaching delivered by three full-time kidney health coaches for six months.	Other: Kidney Health Coaching; The intervention entails support from a KHC that includes: An initial rapport-building call; Ongoing telephone support at least twice a month for six months; Meeting the patient at all in-person clinic appointments; Documenting interactions in the EMR using a customized platform Telephone support begins with a social determinants of health (SDoH) screening tool to identify barriers and facilitators to CKD self-management and appointment adherence. This tool provides access to local resources based on the patient's ZIP code. Subsequent calls will follow up on resource usage, review CKD educational materials and treatment options, complete the Decision Aid for Renal Therapy tool, and facilitate communication through the patient portal. Each call will start with specific goals (e.g., review National Kidney Foundation CKD materials) and conclude with goals for the next session.; Other Names: KHC Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-Kidney Replacement Therapy w/Central Venous Catheter	Composite measure of time to transition to Kidney Replacement Therapy (KRT) using a central venous catheter (CVC) over the course of the study period	Throughout study participation up to 12 months
Time-to-death	Composite measure of time to death over the course of the study period. A record of death in the electronic medical record (EMR), and the date of death will be recorded. If the data is not available in EMR, national death statistics will be checked, and the patient's family will be asked.	Throughout study participation up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Scale	Participants will complete a 10-item phone survey that assesses their perceived quality of life. Responses are recorded on a 5-point scale, with total scores ranging from 10 to 50; higher scores indicate better self-reported health-related quality of life.	Baseline, 6 months and 12 months
Patient activation Score	Patient activation will be measured using the Patient Activation Measure (PAM), completed by phone. PAM is a validated self-reported questionnaire designed to assess an individual's knowledge, skills, and confidence in managing their well-being. It captures participants' agreement with 22 statements regarding their self-efficacy in maintaining health, measured on a scale from "Strongly Disagree" to "Strongly Agree." The response options are on a 4-point scale. Scores range from 0 to 100, with higher scores indicating greater activation.	Baseline, 6 months and 12 months
Time to progression to end stage kidney disease (ESKD)	Composite measure of time to ESKD diagnosis over the course of the study period. Progression to ESKD will be analyzed using monthly data collected from the EMR, capturing each participant's progression characterized by a significant loss of kidney function (defined as a glomerular filtration rate (GFR) of less than 15 mL/min) requiring KRT. Time to event will be calculated for all participants at the end of the follow-up period.	Throughout study participation up to 12 months
Time-to-optimal Kidney Replacement Therapy (KRT) referral	Composite measure of time to referral for optimal KRT start over the course of the study. This includes referral for vascular surgery, preemptive kidney transplant evaluation, and/or home dialysis initiation. Data will be collected monthly from the EMR.	Throughout study participation up to 12 months
Number of participants who transition-to-Kidney Replacement Therapy w/Central Venous Catheter	Number of participants who transitioned to Kidney Replacement Therapy (KRT) with the use of a central venous catheter (CVC) during the course of the study.	Throughout study participation up to 12 months
Mortality rate	Mortality during study participation.	Throughout study participation up to 12 months
CKD Symptom Burden	Self-reported occurrence of physical and emotional symptoms commonly experienced in individuals with CKD. Participants will complete a 29-item CKD Symptom Burden questionnaire that captures the frequency at which patients experience symptoms. Response options are on a 4-point scale (0 'never' to 4 'every day'). The summed total score ranges from 0 to 29. The greater the frequency of symptoms, the poorer the health-related and self-perceived quality of life.	Baseline, 6 months and 12 months
Medical Mistrust Organization Score	Medical mistrust organization will be measured using the Medical Mistrust Index adapted to address general mistrust of healthcare providers. Participants will answer the questions over the phone. Questions will capture their level of agreement with seven statements regarding healthcare organizations. Responses are measured on a 4-point scale, ranging from "Strongly Disagree" to "Strongly Agree". Scores can range from 7 to 28.	Baseline, 6 months and 12 months
CKD treatment Knowledge	To measure participants' CKD treatment knowledge, they will complete a 9-item yes/no questionnaire over the phone. The research team will count the number of correct responses, resulting in a score ranging from 0 to 9.	Baseline, 6 months and 12 months
Rotterdam Renal Replacement Knowledge test	KRT knowledge will be measured using the Rotterdam Renal Replacement Knowledge test. Participants will complete the 21-item test over the phone, assessing their understanding of renal replacement therapy. The research team will count the correct responses, allowing scores to range from 0 to 21. Higher scores suggest a better understanding of KRT, indicating preparedness to make informed decisions about treatment options.	Baseline, 6 months and 12 months
Nephrology appointment attendance	Continuous measure of nephrology appointment adherence measured as the ratio of # appointments attended to # appointments scheduled during the course of the study. At the end of the follow-up period for all participants, the researchers will calculate the proportion of appointments attended as a measure of appointment adherence. This will be captured from the Emory Healthcare appointment-keeping system.	Throughout study participation up to 12 months
Decisional conflict scale	Decisional conflict will be measured using the Decisional Conflict Scale (DCS). The DCS measures personal perceptions of uncertainty in choosing options. The survey will be conducted over the phone to capture the level of agreement a participant has with 16 statements regarding their ability to make an informed decision, measured on a scale from "Strongly Disagree" to "Strongly Agree." The response options are on a 5-point scale. Scores can range from 16 to 70. Higher Scores indicate higher decisional conflicts.	Baseline, 6 months and 12 months
Discrimination in Medical Settings (DMS) Scale	DMS Scale is a validated, 7-item, 5-point Likert survey (1=never, 5=almost always) adapted from the Everyday Discrimination Scale to measure patients' self-reported experiences of, or perceptions of, mistreatment by healthcare providers due to factors like race, sex, or age. It assesses, for instance, if a patient is treated with less courtesy, respect, or receives poorer service, ranging from 7 to 35. There is no single "official" cutoff score that defines the presence of discrimination for everyone, as the DMS Scale is designed to measure the frequency of experiences on a continuous spectrum, with higher scores indicating more frequent experiences of discrimination.	Baseline, 6 months and 12 months
Shared Decision-Making Score	Shared decision-making will be measured using the Shared Decision-Making Q-9. Participants will respond by phone to 16 statements regarding their ability to make informed decisions, using a 5-point scale from "Strongly Disagree" to "Strongly Agree." Scores will range from 16 to 80. Interpretation of Scores: Low Score (16-40): Indicates poor shared decision-making, suggesting the patient may feel uninformed or not involved in their care. Moderate Score (41-60): Reflects a moderate level of shared decision-making, indicating some collaboration occurs but that improvements are needed. High Score (61-80): Suggests strong shared decision-making, where patients feel well-informed and actively involved in their healthcare decisions.	Baseline, 6 months and 12 months
Brief Health Literacy Screening Tool (BRIEF)	The BRIEF tool is a four-question screening test where clinicians can ask patients four questions to determine their health literacy level (the degree to which one can read, understand, exchange, and use health information and resources). Each item is worth 1 to 5 points depending on the response (1=Always, 5=Never). The values for the four responses are added for a total score, which ranges from a minimum of 4 to a maximum of 20. Interpretation of Scores: Limited (4 -12): Not able to read most low-literacy health materials; will need repeated oral instructions; materials should have illustrations or videotapes. Will need low literacy materials; may not be able to read a prescription label.) Marginal (13 - 16): Will be able to read and comprehend most patient education materials. Adequate (17 - 20): Will be able to read and comprehend most patient education materials.	Baseline, 6 months and 12 months
Participants with Health-Related Social Needs	Health-Related Social Needs (HRSN) Identified via the Accountable Health Communities Health-Related Social Needs (AHC HRSN) Screening Tool. HRSNs will be identified using the AHC HRSN Screening Tool, which includes five core domains (housing instability, food insecurity, transportation problems, utility help needs, interpersonal safety). Outcomes reflect the number of participants with one or more HRSNs.	Baseline, 6 months and 12 months
Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9) is a self-administered 9-item tool used to screen, diagnose, and monitor the severity of depression in adults. It assesses symptoms over the past two weeks based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria, with scores ranging from 0 to 27. A score of >=10 typically indicates moderate depression, requiring further clinical evaluation. Interpretation of Scores: 0-4: Minimal or no depression (monitor) 5-9: Mild depression (use clinical judgment) 10-14: Moderate depression (active treatment) 15-19: Moderately severe depression 20-27: Severe depression	Baseline, 6 months and 12 months
General Anxiety Disorder (GAD-7)	The Generalized Anxiety Disorder scale-7 (GAD-7) is a seven-item diagnostic tool validated in both the primary care setting and the general population, with reporting scores from 0 to 3 on all questions. It investigates how often the patient has been bothered by seven different symptoms of anxiety during the last two weeks, with response options such as " not at all," " several days '," more than half the days," and " nearly daily " scored as 0, 1, 2, and 3, respectively. The scores of 5, 10, and 15 are taken as cut-off points for mild, moderate, and severe anxiety, respectively. Interpretation of Scores: 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety	Baseline, 6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that experienced healthcare discrimination	Participants will complete an 8-item telephone survey that captures the frequency at which they experience various examples of discrimination in the healthcare setting. These are measured on a scale of Never to Always. This is followed by a question asking why they think these instances may have occurred. Response options are on a 5-point scale. Scores can range from 9 to 40 with higher scores reflecting a higher perceived discrimination.	Baseline, 6 months and 12 months
Social Risk Score	Participants will complete 10 item survey that captures information on living situation, food insecurity, transportation problems, utilities, and safety. Scores can range from 0 to 10. Higher scores reflect a higher risk.	Baseline, 6 months and 12 months
Mental Health Score	Mental health scores will be measured through a 16-item questionnaire answered over the phone, assessing participants' knowledge of depression and anxiety. Additionally, a 4-item data collection form will capture participants' understanding of medical materials and information, using a 4-point response scale. Scores will range from 16 to 64.	Baseline, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); James T. Laney School of Graduate Studies
• Investigators: Principal Investigator: Kimberly R Jacob Arriola, PhD, MPH, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: African American; Health Disparities; Chronic Care Model (CCM); Kidney Health Coach (KHC)
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases
• Other Study ID Numbers: STUDY00007938; 1U01DK137269 (U.S. NIH Grant/Contract); 2025P008750 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigator will share individual de-identified data that supports statistical analysis
• IPD Sharing Time Frame: Immediately following the completion of the study.
• IPD Sharing Access Criteria: Through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Data Repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No