Improving Access to Nephrology Treatment and Care Among Patients at Greatest Risk for Kidney Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Time-to-Kidney Replacement Therapy w/Central Venous Catheter
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention: Kidney Health Coaching
Participants will receive patient-centered health coaching delivered by three full-time kidney health coaches for six months.
干预措施: Kidney Health Coaching (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)
干预措施: Usual Care (Other)
结局指标
主要结局
Time-to-Kidney Replacement Therapy w/Central Venous Catheter
时间窗: Throughout study participation up to 12 months
Composite measure of time to transition to Kidney Replacement Therapy (KRT) using a central venous catheter (CVC) over the course of the study period
Time-to-death
时间窗: Throughout study participation up to 12 months
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.
次要结局
- Patient activation Score(Baseline, 6 months and 12 months)
- Time to progression to end stage kidney disease (ESKD)(Throughout study participation up to 12 months)
- Quality of Life Scale(Baseline, 6 months and 12 months)
- Decisional conflict scale(Baseline, 6 months and 12 months)
- CKD treatment Knowledge(Baseline, 6 months and 12 months)
- Shared Decision-Making Score(Baseline, 6 months and 12 months)
- Time-to-optimal Kidney Replacement Therapy (KRT) referral(Throughout study participation up to 12 months)
- Time to progression to end stage kidney disease (ESKD)(Throughout study participation up to 12 months)
- Number of participants who transition-to-Kidney Replacement Therapy w/Central Venous Catheter(Throughout study participation up to 12 months)
- Mortality rate(Throughout study participation up to 12 months)
- CKD Symptom Burden(Baseline, 6 months and 12 months)
- Quality of Life Scale(Baseline, 6 months and 12 months)
- Patient activation Score(Baseline, 6 months and 12 months)
- Decisional conflict scale(Baseline, 6 months and 12 months)
- Medical Mistrust Organization Score(Baseline, 6 months and 12 months)
- CKD treatment Knowledge(Baseline, 6 months and 12 months)
- Rotterdam Renal Replacement Knowledge test(Baseline, 6 months and 12 months)
- Shared Decision-Making Score(Baseline, 6 months and 12 months)
- Nephrology appointment attendance(Throughout study participation up to 12 months)
- Discrimination in Medical Settings (DMS) Scale(Baseline, 6 months and 12 months)
- Brief Health Literacy Screening Tool (BRIEF)(Baseline, 6 months and 12 months)
- Participants with Health-Related Social Needs(Baseline, 6 months and 12 months)
- Patient Health Questionnaire (PHQ-9)(Baseline, 6 months and 12 months)
- General Anxiety Disorder (GAD-7)(Baseline, 6 months and 12 months)
研究者
Kimberly R Jacob Arriola
Vice Provost for Graduate Studies
Emory University