Randomised control trials currently in progress
| Study | Healthcare setting, country | Study design | Population, N | KFRE details | Inclusion/exclusion criteria | Intervention | Control | End-points | Follow-up |
| Jhamb et al (2019) – The Kidney CHAMP Study29 | Primary care, Pittsburgh, USA | Cluster RCT | 1650 high-risk CKD patients | Not presented | Patients with high-risk CKD (as defined by validated risk prediction models or by current eGFR value or recent decline in eGFR values). Inclusion: age 18–85 years, eGFR <60 mL/min/1.73 m2. Exclusion: history of renal transplant, on maintenance dialysis, recent (within 12 months) outpatient nephrology visit, baseline eGFR less than 15 mL/min/1.73 m2, expected survival <6 months, active substance dependence or severe/uncontrolled psychiatric condition. | EHR-based PHM intervention: nephrologist-led E‐consults, pharmacist‐led medication reviews and nurse-led CKD education. | Usual care | Primary outcome is a composite of 40% reduction in eGFR or ESKD. Secondary outcomes: improved hypertension control, use of RAASi and avoidance of renally contraindicated medications. | 42 months |
| Harasemiw et al (2019)30 | 32 primary care clinics, Manitoba and Alberta, Canada | Multicentre cluster RCT | Estimate each clinic to have 185 patients with CKD | Not presented | Inclusion: aged 18 years and older with CKD G3-G5 attending the participating clinics | Active knowledge translation intervention: addition of KFRE and decision aids to clinics’ Data Presentation Tool, patient-facing visual aids, a medical detailing visit and sentinel feedback reports. | Usual care: exposed to current guidelines for CKD management, without active dissemination. | Primary outcomes: proportion of patients with measured urine ACR, and proportion of patients appropriately treated with ACEi or ARB. Secondary outcomes: the optimal management of diabetes, hypertension and cardiovascular risk; prescriptions of NSAIDs; and decline in eGFR. Substudy: measure patients’ CKD-specific health literacy and trust in physician care via surveys administered in the clinic postvisit; measure provider satisfaction with the risk prediction tools; at the health system level, outcomes including cost of CKD care, and appropriate referrals for patients at high risk of kidney failure. | Primary and secondary outcomes reviewed at 1 year after the intervention implementation. Exception for decline in eGFR, which will be measured 2 years postintervention. |
| Green et al (2018) – PREPARE NOW Study31 | Nephrology care, Geisinger Health System kidney specialty clinics, Pennsylvania, USA | Cluster RCT | 1572 participants | 8-variable KFRE 2-year risk score | Inclusion: patients currently receiving care at Geisinger nephrology practices, aged 18 years and older with advanced kidney disease determined by eGFR or presence of albuminuria. | Implement new electronic health information tools (disease registry and risk prediction tools) to help providers recognise patents in need of Kidney Transitions Care. Implement a Kidney Transitions Specialist who will provide and facilitate integrated delivery of patient support programmes. | Usual care | Primary outcomes: change in % patients feeling in control of their decision making, change in number of hospitalisations and change in % patients with advance directives for kidney care. Secondary outcomes: change in % self-care patients with biomedical care plans, change in % patients with values aligned care, change in % patients with preferences for renal replacement therapy documented, change in % patients with emergency dialysis initiation, change in months to kidney failure and change in % patients with vascular access (eg, fistula) in place at dialysis initiation. | 36 months |
| Hemmelgarn et al (2018)33 | Nephrology multidisciplinary CKD clinics, Alberta, Canada | Pre/post cohort | Not presented | Not presented | Inclusion: adults aged 18 years and older with sustained eGFR <30 mL/min/1.73 m2, who are followed by a nephrologist. Exclusion: patients receiving dialysis or with a kidney transplant prior to the study period. | Transition to CKD multidisciplinary clinic when KFRE 2-year risk ≥10% or eGFR ≤15 mL/min/1.73 m2. | Pretriage period | Clinical outcomes (hospitalisation and emergency department visits and death), use of modalities that improve patient experience and outcomes (home dialysis and kidney transplantation), resource use (physician visits and laboratory tests), process-based quality indicators for appropriate CKD care (assessment of albuminuria, use of ACE-I/ARBs in those with albuminuria, and statins), costs and proportion of patients risk stratified and appropriately managed. | Cohort accrual for the preperiod from April 2015 to April 2016. Postperiod, cohort accrual from April 2017 to April 2018, with follow-up to April 2019. |
ACEi, ACE inhibitor; ACR, albumin:creatinine ratio; ARB, angiotensin receptor blocker; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; EHR, electronic health record; ESKD, end-stage kidney disease; KFRE, Kidney Failure Risk Equation; NSAID, non-steroidal anti-inflammatory drugs; PHM, population health management; RAASi, renin–angiotensin–aldosterone system inhibitors; RCT, randomised control trial.