Chronic Kidney Disease
Conditions
Keywords
CKD
Brief summary
Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD registers. The investigators have partnered with Nene commissioning, a practice based commissioning group representing approximately 80 GP practices in Northamptonshire, to run this study. This will be a cluster randomised trial of an intensive, secondary care supported, CKD management programme in primary care vs normal CKD care. Randomisation will be at the level of the individual general practice. All general practices associated with Nene commissioning will be invited to participate. Randomisation of practices will be performed by the University of Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking randomised cluster trials. The aims of the study are: 1. To determine whether reinforcement of best practice in the management of key aspects of CKD care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes. 2. To foster excellence in CKD care 3. To improve coding of CKD and prevalence on chronic disease registers. 4. To increase interest in, and capacity for primary care research in Northamptonshire. 5. To implement and evaluate a new model of partnership working between primary and secondary care. The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR). Secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.
Detailed description
see above
Interventions
OTHEREnhanced management
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Sponsors
University Hospitals, Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* measurement of serum creatinine * eGFR \< 60 ml/min/1.73m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study | Baseline and 3.5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proteinuria | 3.5 years | Proteinuria coding in practices |
| Incidence of Cardiovascular Events | 3.5 years | Observation of incidence of cardiovascular events over the study period |
| Blood Pressure Control | Baseline and 3.5 years | Observation of blood pressure control over the study period via blood pressure targets |
| Referrals to Secondary Care and Hospitalisations | 3.5 years | Data coillected from secondary care |
| Mortality | 3.5 years | data collected from secondary care |
| Other Biochemical Parameters | 3.5 years | Nature and incidence over the study period |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Usual care | 11,706 |
| Enhanced Management Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed.
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care. | 11,651 |
| Total | 23,357 |
Baseline characteristics
| Characteristic | Total | Control | Enhanced Management |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23357 Participants | 11706 Participants | 11651 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 75.3 years STANDARD_DEVIATION 11.3 | 75.4 years STANDARD_DEVIATION 11.3 | 75.1 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United Kingdom | 23357 participants | 11706 participants | 11651 participants |
| Sex: Female, Male Female | 14519 Participants | 7285 Participants | 7234 Participants |
| Sex: Female, Male Male | 8838 Participants | 4421 Participants | 4417 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11,706 | 0 / 11,651 |
| serious Total, serious adverse events | 0 / 11,706 | 0 / 11,651 |
Outcome results
Primary
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
Time frame: Baseline and 3.5 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study | -2.00 mean average eGFR change/mL/min/1.73 m^2 |
| Enhanced Management | Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study | -2.29 mean average eGFR change/mL/min/1.73 m^2 |
Secondary
Blood Pressure Control
Observation of blood pressure control over the study period via blood pressure targets
Time frame: Baseline and 3.5 years
Population: Denominator change due to loss to follow-up and death.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Blood Pressure Control | Baseline | 6834 Participants |
| Control | Blood Pressure Control | 3.5 Years | 7460 Participants |
| Enhanced Management | Blood Pressure Control | Baseline | 7137 Participants |
| Enhanced Management | Blood Pressure Control | 3.5 Years | 7295 Participants |
Secondary
Incidence of Cardiovascular Events
Observation of incidence of cardiovascular events over the study period
Time frame: 3.5 years
Population: Data not available for analysis.
Secondary
Mortality
data collected from secondary care
Time frame: 3.5 years
Population: Data not available for analysis.
Secondary
Other Biochemical Parameters
Nature and incidence over the study period
Time frame: 3.5 years
Population: Data not available for analysis.
Secondary
Proteinuria
Proteinuria coding in practices
Time frame: 3.5 years
Population: Loss to follow-up and death
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Proteinuria | Baseline | 627 participants |
| Control | Proteinuria | 3.5 Years | 1947 participants |
| Enhanced Management | Proteinuria | 3.5 Years | 2110 participants |
| Enhanced Management | Proteinuria | Baseline | 982 participants |
Secondary
Referrals to Secondary Care and Hospitalisations
Data coillected from secondary care
Time frame: 3.5 years
Population: Data not available for analysis.