Collaborating Leaders to Address Racism With Interventions for Equity: Kidney Disease
- Conditions
- Kidney Diseases
- Registration Number
- NCT06693661
- Lead Sponsor
- Emory University
- Brief Summary
Through the use of community-engaged processes and an anti-racism approach, 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 effects of structural racism 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.
- Detailed Description
This study has two Aims. In Aim 1, the research team will develop and implement multi-level, multi-component interventions that target patient-and provider-level outcomes across primary care and acute care access points, nephrology, and dialysis care, using the Chronic Care Model (CCM) and Public Health Critical Race Praxis (PHCRP) as organizing frameworks.
Aim 1: Implement multi-level, multi-component interventions across primary care, acute care access points, nephrology, and dialysis care using the Chronic Care Model (CCM) and PHCRP as organizing frameworks. The research team will deliver patient-centered kidney health coaching, with full-time kidney health coaches (KHC). They must have lived experience with chronic kidney disease (CKD) and will be selected for certain personality characteristics. The KHCs will undergo training to deliver patient support that aligns with 4 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.
Aim 2: Conduct a 2-group, single-blinded randomized design-controlled trial to determine the effectiveness of the intervention on primary and secondary outcomes measured via patient self-report and the electronic medical record.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 600
- Identifies as African American or Black;
- Age 18 and over;
- 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 University Hospital-Midtown 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time of disease progression to intervention Throughout study participation up to 12 months The time of disease progression to intervention will be calculated from a composite measure that captures the participant's transition to KRT, central venous catheter (CVC) use, and death (whichever comes first). Data will be collected monthly from the electronic medical record (EMR). At the end of the follow-up period, the research team will calculate the time to event for all participants.
- Secondary Outcome Measures
Name Time Method Time to progression to end stage kidney disease (ESKD) Throughout study participation up to 12 months 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.
CKD Symptom Burden Scale Baseline, 6 months and 12 months 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.
Number of referrals for optimal KRT start Throughout study participation up to 12 months Referrals for optimal KRT will be a composite measure that captures whether the patient was referred for vascular surgery, kidney transplant evaluation, or home dialysis. Data will be collected monthly from the EMR. At the end of the follow-up period time to event will be calculated for all participants.
Shared Decision-Making Score Baseline, 6 months and 12 months 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.
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.Number of participants who transition to KRT and CVC use or death Throughout study participation up to 12 months The number of participants will be collected from monthly EMR data focusing on KRT, CVC use, and death. A dichotomous measure will indicate whether participants transitioned to KRT and CVC use or died. At the end of the follow-up period, researchers will calculate the number of participants who transitioned to KRT with a CVC or died by the study's conclusion to generate this variable.
Proportion of appointments attended Throughout study participation up to 12 months The proportion of appointments attended during the participants' study follow-up period. 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.
Quality of Life Scale Baseline, 6 months and 12 months 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.
Patient activation Score Baseline, 6 months and 12 months 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.
Decisional conflict scale Baseline, 6 months and 12 months 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." This information will be collected at baseline, 6, and 12 months. The response options are on a 5-point scale. Scores can range from 16 to 70. Higher Scores indicate higher decisional conflicts.
Medical mistrust organization score. Baseline, 6 months and 12 months 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.
CKD treatment Knowledge Baseline, 6 months and 12 months To measure CKD treatment knowledge, participants 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.
Kidney replacement therapy (KRT) Knowledge Score Baseline, 6 months and 12 months KRT knowledge will be measured using the Rotterdam Renal Replacement Knowledge test. Participants will complete the 21-item test over the phone, assessing their knowledge 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.
Trial Locations
- Locations (1)
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States