Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 2
- 主要终点
- Severity of dialysis-associated symptoms (Effectiveness)
研究概览
简要总结
The SMaRRT-HD trial is a cluster randomized trial of symptom monitoring with supported clinician follow-up using the SMaRRT-HD electronic patient reported outcome measure (ePROM) system versus Usual Care. Approximately 2400 patients at up to 36 geographically and racially diverse US hemodialysis clinics will be enrolled. The primary trial hypothesis is that regular symptom patient reported outcome measure (PROM) administration with supported clinician follow-up in dialysis care will reduce suffering and improve outcomes by prompting treatment of unrecognized symptoms, and enhancing patient-care team communication. Clinics randomized to the SMaRRT-HD group will adopt the use of SMaRRT-HD for 12 months. SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a PROM and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a Health Related Quality of Life survey that includes questions about symptoms.
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
- 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
- •Treatment with hemodialysis at a participating dialysis clinic
- •English or Spanish speaking
排除标准
- •Not willing to report their symptoms using the SMaRRT-HD platform
- •Not willing to share clinically acquired data with the research team
- •Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)
- •Incarceration
结局指标
主要结局
Severity of dialysis-associated symptoms (Effectiveness)
时间窗: Baseline, 6 months, 12 months
This outcome will be assessed as change in the Dialysis Symptom Index-Severity Score over 12 months (primary endpoint). Participants are asked whether or not they experienced symptoms during the past week. If the response is yes, the participant is asked to indicate "How much did it bother you?". Lowest score - 0; Highest score - 150. A higher score indicates a worse outcome.
次要结局
- Depression (Effectiveness)(Baseline, 6 months, 12 months)
- Anxiety (Effectiveness)(Baseline, 6 months, 12 months)
- Health-related quality of life (Effectiveness)(Baseline, 6 months, 12 months)
- Mortality (Effectiveness)(Duration of active 12 month study participation plus 6 months; 18 months total)
- Missed dialysis sessions (Effectiveness)(Duration of active 12 month study participation)
- Penetration (Implementation)(Duration of active 12 month study participation)
- Post-dialysis recovery time (Effectiveness)(Baseline, 6 months, 12 months)
- Fatigue (Effectiveness)(Baseline, 6 months, 12 months)
- Pain interference (Effectiveness)(Baseline, 6 months, 12 months)
- Healthcare Engagement (Effectiveness)(Baseline, 6 months, 12 months)
- Hospitalizations (Effectiveness)(Duration of active 12 month study participation plus 6 months; 18 months total)
- Shortened dialysis sessions (Effectiveness)(Duration of active 12 month study participation)
- Fidelity (Implementation); Clinical action after PROM use; All Clinics(Duration of active 12 month study participation)
- Fidelity (Implementation); Patient-reported clinician follow-up; All Clinics(Baseline, 6 months, and 12 months)
- Fidelity (Implementation); Patient/clinician-reported follow-up activities; All Clinics(6 months, and 12 months)
- Fidelity (Implementation); Clinician access of symptom guidances; SMaRRT-HD Clinics(Duration of active 12 month study participation)
- Fidelity (Implementation); Clinician access of symptom reports; SMaRRT-HD Clinics(Duration of active 12 month study participation)
- Fidelity (Implementation); Patient-reported receipt of symptom summary; All Clinics(Baseline, 6 months, and 12 months)
- Acceptability (Implementation); Surveys; All Clinics(6 months and 12 months)
- Acceptability (Implementation); Interviews; All Clinics(6 months and 12 months)
- Acceptability (Implementation); Surveys; SMaRRT-HD Clinics(6 months and 12 months)
- Acceptability (Implementation); Interviews; SMaRRT-HD Clinics(6 months and 12 months)
- Appropriateness (Implementation); Surveys; All Clinics(6 months and 12 months)
- Appropriateness (Implementation); Interviews; All Clinics(6 months and 12 months)
- Appropriateness (Implementation); Surveys; SMaRRT-HD Clinics(6 months and 12 months)
- Appropriateness (Implementation); Interviews; SMaRRT-HD Clinics(6 months and 12 months)
- Feasibility (Implementation); Surveys; All Clinics(6 months and 12 months)
- Feasibility (Implementation); Interviews; All Clinics(6 months and 12 months)
- Feasibility (Implementation); Interviews; Dialysis provider organization corporate leaders(Interviews will be conducted before the optimization phase and after the end of the trial.)
- Feasibility (Implementation); Surveys; SMaRRT-HD Clinics(6 months and 12 months)
- Feasibility (Implementation); Interviews; SMaRRT-HD Clinics(6 months and 12 months)
研究者
Laura Dember, MD
Professor of Medicine and Epidemiology
University of Pennsylvania