Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 resour
• Другое 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 p

Первичные конечные точки

• Time-to-Kidney Replacement Therapy w/Central Venous Catheter [Срок оценки: Throughout study participation up to 12 months]
• Time-to-death [Срок оценки: Throughout study participation up to 12 months]

Вторичные конечные точки (12)

• Time to progression to end stage kidney disease (ESKD) [Срок оценки: Throughout study participation up to 12 months]
• Time-to-optimal Kidney Replacement Therapy (KRT) referral [Срок оценки: Throughout study participation up to 12 months]
• Number of participants who transition-to-Kidney Replacement Therapy w/Central Venous Catheter [Срок оценки: Throughout study participation up to 12 months]
• Mortality rate [Срок оценки: Throughout study participation up to 12 months]
• Nephrology appointment attendance [Срок оценки: Throughout study participation up to 12 months]
• CKD Symptom Burden [Срок оценки: Baseline, 6 months and 12 months]
• Quality of Life Scale [Срок оценки: Baseline, 6 months and 12 months]
• Patient activation Score [Срок оценки: Baseline, 6 months and 12 months]
• Decisional conflict scale [Срок оценки: Baseline, 6 months and 12 months]
• Medical Mistrust Organization Score [Срок оценки: Baseline, 6 months and 12 months]
• Discrimination in Medical Settings (DMS) Scale [Срок оценки: Baseline, 6 months and 12 months]
• CKD treatment Knowledge [Срок оценки: Baseline, 6 months and 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Emory University Hospital Midtown — Atlanta
• Emory Healthcare System — Atlanta

Идентификаторы

NCT: NCT06693661 · STUDY00007938 · 1U01DK137269 · 2025P008750

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗