Prepare for Kidney Care Trial: Comparing Responsive Management vs. Dialysis Preparation for Frail Elderly with Advanced CKD

The Prepare for Kidney Care trial is underway in the UK to compare two treatment pathways for frail, multimorbid, older people with advanced Chronic Kidney Disease (搜索)搜索该疾病 (CKD (搜索)搜索该疾病): 'prepare for responsive management' and 'prepare for renal dialysis查看药品详情'. This national, multi-center trial aims to determine the impact of these pathways on patients' quality of life and survival.

Study Design and Setting

The trial is recruiting patients from 31 secondary care kidney units across England, Scotland, Wales, and Northern Ireland. The intervention is delivered across primary care, secondary care, and community settings. The study targets patients known to kidney services who are considering their treatment options.

Eligibility Criteria

Inclusion criteria include patients with new or existing stage 5 CKD (搜索)搜索该疾病 (eGFR less than 15 mL/min/1.73 m2) who are:

• Aged 65 years and over with a World Health Organization (WHO) performance status of 3 or above.
• Aged 65 years and over with a comorbidity score of 2 or more.
• Aged 80 years and over.

Exclusion criteria include inability to consent, not being medically fit for dialysis查看药品详情, needing to start dialysis within 4 weeks, previous kidney transplant, or active status on the kidney transplant waiting list.

Interventions

The trial compares 'prepare for responsive management,' an optimized form of conservative kidney management, against 'prepare for renal dialysis查看药品详情,' representing routine NHS care for patients intending to start dialysis. The rationale for these comparators is based on the uncertainty regarding the superiority of one pathway over the other, reflecting community equipoise.

Prepare for Responsive Management

This intervention arm provides regular support from kidney unit staff, including assessment of symptoms and advance care planning. It aims to support patients in their preferred place of care, avoiding scans and surgery associated with dialysis查看药品详情 preparation. The intervention involves three stages: Assess, Responsive Management, and Supportive Care.

1. Assess: Comprehensive care assessment in the patient’s home, including symptom checklist (IPOS-renal or equivalent), symptom control, psychosocial needs assessment, information/communication needs, advance care planning, and caregiver assessment.
2. Responsive Management: Routine support (monthly telephone contacts, annual home visits) and responsive support tailored to the patient’s evolving situation, including options such as home visits from the kidney unit team or admission to a hospital/hospice if required. Triggers for senior clinical review include uncontrolled symptoms, concerning blood results, or patient/family doubts about continuing on the allocated treatment.
3. Supportive Care: Transition to this stage occurs when symptoms of kidney failure cannot be adequately controlled. The advance care plan is reviewed, and community and palliative care services are activated to ensure good end-of-life care, focusing on pain and symptom management, avoiding inappropriate prolongation of dying, achieving a sense of control, relieving burden on loved ones, and strengthening relationships.

Prepare for Renal Dialysis

This comparator arm represents routine NHS care for patients intending to start dialysis查看药品详情. It includes assessment, renal dialysis, and supportive care stages. The assessment stage may include information about dialysis options, preparation for dialysis (vascular access scans, surgical appointments), psychology support, dietary advice, advance care planning, and home visits.

Outcomes

The primary outcome is the mean total number of Quality-Adjusted Life Years (QALYs) observed in the two arms between first patient recruited and the end of data collection (August 31, 2025), using the EQ-5D-5L to derive health utility value. Secondary outcomes include all-cause mortality, cause-specific mortality, place of death, hospital-free days, and patient-reported outcomes such as generic quality of life (EQ-5D-5L), disease-specific symptom burden (IPOS-renal), and treatment burden (MTBQ).

Sample Size and Recruitment

The trial aims to recruit 446 participants to achieve 85% power to detect a clinically meaningful difference of 0.345 QALYs between the two pathways. Recruitment strategies include identifying eligible patients at referral, during clinical appointments, or by searching kidney clinic records. The Quintet Recruitment Intervention (QRI) is being used to optimize recruitment and address potential challenges.

Data Collection and Management

Data collection includes baseline assessments and follow-up data collected every 4 months. Data linkage to existing healthcare databases will provide additional information on hospital admissions, causes of death, and dialysis查看药品详情 modalities. Data is managed using REDCap, with data entry and validation rules to ensure data quality.

This trial will provide valuable evidence on the optimal management of frail, older adults with advanced CKD (搜索)搜索该疾病, informing clinical practice and improving patient outcomes.