Transforming Hemodialysis-Related Vascular Access Education (THRiVE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)
研究概览
简要总结
The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches: 1) "Education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "Education-Plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "Usual Care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. Participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. Study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age 18 years or older
- •Nephrology visit for chronic kidney disease during the last 18 months
- •Most recent eGFR less than or equal to 20 ml/min/1.73 m2 or 2-year Kidney Failure Risk Equation score greater than 40%
- •Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis
排除标准
- •Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure
- •Previous placement of an AV access
- •Prior appointment with surgeon for AV access evaluation or creation
- •Cognitive dysfunction or severe visual impairment that prevents use of the education materials
- •Does not speak either English or Spanish
研究组 & 干预措施
Education
干预措施: Educational Materials (Behavioral)
Education
干预措施: Usual Care (Behavioral)
Education
干预措施: Patient Lists for Clinicians: System-Level Intervention (Other)
Education-Plus
干预措施: Educational Materials (Behavioral)
Education-Plus
干预措施: Motivational Interviewing (Behavioral)
Education-Plus
干预措施: Usual Care (Behavioral)
Education-Plus
干预措施: Patient Lists for Clinicians: System-Level Intervention (Other)
Usual Care
干预措施: Usual Care (Behavioral)
Usual Care
干预措施: Patient Lists for Clinicians: System-Level Intervention (Other)
结局指标
主要结局
Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)
时间窗: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
The proportion of participants who have arteriovenous access creation surgery.
次要结局
- Preparedness for Decision-Making (Effectiveness outcome)(12 weeks after randomization)
- Reasons for Participation - qualitative reach assessment (Implementation outcome)(12-16 weeks after randomization)
- Vascular Access Knowledge (Effectiveness outcome)(12 weeks after randomization)
- Characteristics of Enrolled Participants - quantitative reach assessment (Implementation outcome)(Baseline)
- Reasons Nephrologists Opt-Out on Behalf of Patients - qualitative reach assessment (Implementation outcome)(Up to 4 years after trial initiation (full duration of the trial))
- Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)(Within 12 months after randomization or before hemodialysis initiation, whichever comes first)
- Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome)(Within 12 months after randomization or before hemodialysis initiation, whichever comes first)
- Usable Arteriovenous Vascular Access (Effectiveness outcome)(Up to 4 years after randomization (full duration of the trial))
- Acceptability of Intervention Content, Delivery, and Accessibility - qualitative acceptability assessment (Implementation outcome)(12 to 16 weeks after randomization)
- Chronic Kidney Disease Class Attendance - quantitative fidelity assessment (Implementation outcome)(Within 12 months)
- Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)(Within 12 months after randomization or before hemodialysis initiation, whichever comes first)
- Decision Self-Efficacy (Effectiveness outcome)(12 weeks after randomization)
- Characteristics of Eligible Patients - quantitative reach assessment (Implementation outcome)(Pre-Enrollment)
- Characteristics of Participants who Withdraw from the Trial - quantitative reach assessment (Implementation outcome)(From eligibility until 12 months)
- Participant Contact Attempts for Motivational Interviewing - quantitative barriers/facilitators assessment (Implementation outcome)(12 month period after randomization)
- System-Level Barriers to Arteriovenous Access Creation From Clinical Staff Perspective - qualitative implementation/barriers assessment (Implementation outcome)(Up to 4 years after trial initiation (full duration of the trial))
- Receipt of Educational Materials - quantitative fidelity assessment (Implementation outcome)(Within 12 weeks after randomization)
- Completed Motivational Interviewing Sessions - quantitative fidelity assessment (Implementation outcome)(Within 12 months after randomization)
- Characteristics of Participants who Complete the Trial - quantitative reach assessment (Implementation outcome)(12 months)
- Declined Enrollment - quantitative reach assessment (Implementation outcome)(Pre-enrollment)
- Acceptability Intervention Measure - quantitative acceptability assessment (Implementation outcome)(12 -16 weeks after randomization)
- System-Level Barriers to Arteriovenous Access Creation From Participant Perspective - qualitative implementation/barriers assessment (Implementation outcome)(Within 12 months)
- Viewing of Video - quantitative fidelity assessment (Implementation outcome)(Within 12 weeks after randomization)
- Brochure Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)(Within 12 weeks after randomization)
- Video Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)(Within 12 weeks after randomization)
- Missed Motivational Interviewing Sessions - quantitative barriers/facilitators assessment (Implementation outcome)(12 month period after randomization)
研究者
Laura Dember, MD
Professor of Medicine and Epidemiology
University of Pennsylvania