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REducing the PrOgression of diabetic kidney disease: A cluster Randomised (REPORT Study)

Effectiveness of a health-service development model in REducing the PrOgression of diabetic kidney disease: A cluster Randomised (REPORT Study)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000629336
Enrollment
2200
Registered
2026-05-22
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Type 2 diabetes mellitus is a global pandemic, affecting about 422 million people worldwide. One serious complication is diabetic kidney disease (DKD), which has become the leading cause of kidney failure. DKD is a disabling condition that can lead to early death without kidney replacement therapy, such as dialysis or transplant. While medications to prevent or slow DKD are available, they are most effective when started early, at the right doses, and taken consistently over time. General practice is often the first point of care and is accessible; however, system-level challenges, such as limited appointment availability, delayed follow-up, and increasing demands on general practice teams, can make it difficult to manage each patient’s care optimally. As a result, important treatment targets for DKD are often not met. This study is inspired by the successful London Kidney Network’s “3 in 3” program, which showed that a new integrated model of care can reduce the progression of DKD. The model involves primary care teams in the Auckland region being systematically supported by diabetes and kidney specialists. This model helps to ensure that people with diabetes and kidney problems receive the care they need, early and consistently. It provides extra support through nurses, Kai Manaaki, specialist advice, teamwork between doctors, and training for general doctors across Auckland.

Interventions

The REPORT study uses a health service development model implemented at the general practice level to support improved prevention and management of diabetic kidney disease (DKD). The intervention is delivered in two stages for general practices allocated to the intervention arm. In the first stage, intervention practices receive support to identify gaps in care for patients with DKD, update key clinical and laboratory parameters, optimise internal DKD care pathways, and identify patients who may

The REPORT study uses a health service development model implemented at the general practice level to support improved prevention and management of diabetic kidney disease (DKD). The intervention is delivered in two stages for general practices allocated to the intervention arm. In the first stage, intervention practices receive support to identify gaps in care for patients with DKD, update key clinical and laboratory parameters, optimise internal DKD care pathways, and identify patients who may face barriers to access or engagement. This stage is designed to enable practices to achieve the “4 in 3 months” targets. The second stage focuses on establishing sustainable long-term management. Practices are supported to maintain regular blood testing, prescribing, and appointment scheduling, with monthly clinical input from renal and diabetes specialists. Both stages of the intervention are supported by the following: 1) Practice-level actions and “4 in 3 months” targets Participating practices undertake structured, practice-level actions to achieve the regional “4 in 3 months” targets for patients with DKD. These targets aim to ensure that, within three months, eligible patients receive: a) initiation and up-titration of ACE inhibitors or ARBs to the maximum tolerated dose; b) blood pressure management to <130/80 mmHg; c) initiation of SGLT2 inhibitor therapy, when appropriate and in line with Special Authority criteria. Decisions regarding initiation are made by the general practitioner, informed by clinical assessment and eligibility criteria. Where appropriate, decisions may be supported through multidisciplinary case discussion or specialist input via enhanced referral pathways; d) glycaemic control with HbA1c <53 mmol/mol. 2) Funded Practice Nurse (PN) Time Funded practice nurse time is provided to support coordination of practice-level DKD care pathways. The PN role includes identifying patients with DKD using practice management software, coordinating recalls and follow-up, facilitating monitoring of blood pressure, renal function, and glycaemic control, and supporting delivery of evidence-based DKD care within the practice. The PN will identify patients with DKD who will benefit from General Practitioner review for medical optimisation as per existing regional guidelines, including treatment with angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor blockers (ARBs) to the maximum tolerated dose, initiation of sodium–glucose co-transporter 2 (SGLT2) inhibitors if appropriate, and achievement of optimal glycaemic control. The PN also delivers DKD-related patient education and liaises with Kai Manaaki and specialist services as required. 3) Kai Manaaki Support Funded Kai Manaaki time is provided to support patients who experience barriers to accessing or engaging with care. Kai Manaaki provide non-clinical navigation and support, including assisting patients to attend appointments, complete investigations, and access prescribed medications. The role focuses on addressing practical, social, and systemic barriers to care and supporting engagement with DKD management through culturally appropriate, whanau-centred support, working alongside the primary care team. 4) Practice Management Software (PMS) Automation The intervention includes the use of PMS automation to support DKD care, including automated identification of patients with DKD, recall and reminder systems for appointments and clinical reviews, and prescription reminders. PMS automation is accessed through existing general practice clinical systems and computers, and is integrated within routine practice workflows. 5) Training for Practice Nurses and Kai Manaaki Standardised education and training are provided for practice nurses and Kai Manaaki involved in the intervention. Training includes completion of the New Zealand adaptation of the Western Diabetes Education Program (NZ-WDEP) online training, which provides foundational education in diabetes management. This is supplemented by a full-day, face-to-face training programme involving diabetes and renal specialists and experienced nursing staff, covering DKD management, pharmacological therapy including ACE inhibitors, ARBs, and SGLT2 inhibitors, and delivery of DKD-related patient education aligned with the REPORT care pathway. Practice nurses and Kai Manaaki will also receive cultural training from representatives of Mana Whenua. Ongoing support is provided through monthly one-hour meetings with the study team to support implementation, reinforce learning, and address operational or clinical issues arising during the intervention period. 6) Monthly Case Conferencing Meetings Monthly case conferencing meetings are held to support optimal clinical decision-making for patients with DKD. These discussions involve general practitioners, nephrologists, diabetologists, Practice Nurses, and Kai Manaaki, and are conducted primarily via virtual meetings. Sessions focus on the review of challenges in DKD care, medication optimisation, and management planning, and typically last 60–90 minutes. 7) Enhanced Referral Pathways Enhanced referral pathways are implemented to support early access to renal and diabetes specialist advice for intervention practices in the REPORT study. These pathways are designed to streamline referral processes, facilitate access to clinical advice, and support shared care between primary care and specialist services. The intervention is implemented over a three-month period and managed and monitored for up to 2.5 years. Adherence to the intervention is monitored using routine clinical information, including electronic medical records, recall and appointment systems, prescription activity, and documentation of Practice Nurse and Kai Manaaki involvement.

Sponsors

Aotearoa Clinical Trials
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

General practices from participating PHOs with more than 100 PWD who have a urine albumin-to-creatinine ratio (uACR) exceeding 3.5 mg/mmol for females, or 2.5 mg/mmol for males, will be eligible for the study.

Exclusion criteria

General practices from participating PHO’s with less than 100 PWD who have uACR exceeding 3.5 mg/mmol for females, or 2.5 mg/mmol for males will be excluded from the study

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026