A Pragmatic, Registry-based, International, Cluster-randomized Controlled Trial Examining the Use of TEACH-PD Training Modules for Incident PD Patients Versus Existing Practices on the Rate of PD-related Infections
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 67
- 主要终点
- Time to the first occurrence of any PD-related infection
研究概览
简要总结
For many patients peritoneal dialysis (PD) is the preferred form of dialysis to treat kidney disease as it provides greater flexibility and the ability to dialyse at home. However, PD use in Australia has been decreasing over the last 10 years. A big reason for this drop is the risk of infection. The best way to prevent PD related infections is to make sure that patients have good training in PD techniques. The researchers of this study have developed TEACH-PD, a new education package for training both PD nurses and PD patients.
The aim of this study is to find out whether TEACH-PD training reduces the number of PD related infections.
详细描述
End stage kidney disease is fatal unless treated with dialysis or transplant. Peritoneal dialysis (PD) is a core dialysis modality offering home-based care for patients. PD utilization is frequently threatened beyond 5 years for most patients due to PD-related infections. Patient training is a critical cornerstone of mitigating infection risk and maximizing PD durability (technique survival), but training practices are characterized by a lack of standardization and severe heterogeneity.
There is no high-level evidence to inform PD training. Accordingly, a structured program encompassing how and what to teach PD patients at the inception of PD treatment has the potential to reduce serious PD-related infections, extend the longevity of PD, support cost-effective home-based dialysis care, and reduce costs and health service utilization associated with hospitalization and transition to haemodialysis. TEACH-PD is a standardised modular curriculum for both PD nurse trainers and patients that has been collaboratively developed by renal nurses, doctors, educationalists and patients, aligned to current International Society for Peritoneal Dialysis (ISPD) guidelines, utilizing modern adult learning principles. The TEACH-PD program is feasible and acceptable, as demonstrated in a successful pilot study.
The primary objective of TEACH-PD CRCT (Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes - a Cluster Randomised Controlled Trial) is to determine whether implementation of standardised training modules based on ISPD guidelines targeting both PD trainers and patients results in a longer time to the composite end-point of exit site infections, tunnel infections and peritonitis in incident PD patients compared to existing training practices.
TEACH-PD is a registry-based, pragmatic, multi-center, multinational trial, randomising PD units to implementing TEACH-PD training modules targeted at PD trainers and incident PD patients versus standard existing practices.
An estimated 1,500 patient new to PD will be recruited from at least approximately 42-44 PD units in Australia and New Zealand.The study is being coordinated by the University of Queensland (operating through the Australasian Kidney Trial Network).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients new to PD;
- •Patients > 18 years of age,
- •Need to undergo PD training;
- •Are able to provide informed consent
排除标准
- 未提供
结局指标
主要结局
Time to the first occurrence of any PD-related infection
时间窗: From the PD start date until first PD-related infection, assessed up to 4 years
Time to the first occurrence of any PD-related infection including exit site infection, tunnel infection or peritonitis
次要结局
- Time to first exit site infection(From the PD start date until first exit site infection, assessed up to 4 years)
- Time to first episode of peritonitis(From the PD start date until first peritonitis episode, assessed up to 4 years)
- Participant Quality of Life questionnaire(Completed at baseline, 6, 12, 18 and 24 months)
- Time to first tunnel infection(From the PD start date until first tunnel infection, assessed up to 4 years)
- Time to infection-associated catheter removal(From the PD start date until first infection-associated catheter removal, assessed up to 4 years)
- Incidence of technique failure - 180 days(Assessed at 180 days after transfer to HD or if death occurs within this period)
- Incidence of technique failure - 30 days(Assessed at 30 days after transfer to HD or if death occurs within this period)
- Incidence of all-cause hospitalization(Assessed from the PD start date, over up to 4 years)
- Incidence of all-cause mortality(Assessed from the PD start date, over up to 4 years)
- Health-care cost-effectiveness analysis(Assessed from the PD start date, over up to 4 years)