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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:
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.
see above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual care | |
| Enhanced Management | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced management | Other | Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study | Baseline and 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Control | Observation of blood pressure control over the study period via blood pressure targets | Baseline and 3.5 years |
| Proteinuria | Proteinuria coding in practices |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nigel Brunskill, PhD | Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicester General Hospital | Leicester | Leics | LE5 4PW | United Kingdom | ||
| University Hospitals Leicester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31097609 | Background | Major RW, Brown C, Shepherd D, Rogers S, Pickering W, Warwick GL, Barber S, Ashra NB, Morris T, Brunskill NJ. The Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease (PSP-CKD) Study: A Cluster Randomized Trial in Primary Care. J Am Soc Nephrol. 2019 Jul;30(7):1261-1270. doi: 10.1681/ASN.2018101042. Epub 2019 May 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Usual care |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Usual care |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study | Posted | Mean | 95% Confidence Interval | mean average eGFR change/mL/min/1.73 m^2 | Baseline and 3.5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Usual care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Nigel Brunskill | University of Leicester | +44 116 258 8043 | njb18@le.ac.uk |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 3.5 years |
| Incidence of Cardiovascular Events | Observation of incidence of cardiovascular events over the study period | 3.5 years |
| Other Biochemical Parameters | Nature and incidence over the study period | 3.5 years |
| Referrals to Secondary Care and Hospitalisations | Data coillected from secondary care | 3.5 years |
| Mortality | data collected from secondary care | 3.5 years |
| Leicester |
| Leics |
| LE5 4PW |
| United Kingdom |
| University Hospitals of Leicester | Leicester | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Blood Pressure Control | Observation of blood pressure control over the study period via blood pressure targets | Denominator change due to loss to follow-up and death. | Posted | Count of Participants | Participants | Baseline and 3.5 years |
|
|
|
| Secondary | Proteinuria | Proteinuria coding in practices | Loss to follow-up and death | Posted | Number | participants | 3.5 years |
|
|
|
| Secondary | Incidence of Cardiovascular Events | Observation of incidence of cardiovascular events over the study period | Data not available for analysis. | Posted | 3.5 years |
|
|
| Secondary | Other Biochemical Parameters | Nature and incidence over the study period | Data not available for analysis. | Posted | 3.5 years |
|
|
| Secondary | Referrals to Secondary Care and Hospitalisations | Data coillected from secondary care | Data not available for analysis. | Posted | 3.5 years |
|
|
| Secondary | Mortality | data collected from secondary care | Data not available for analysis. | Posted | 3.5 years |
|
|
| 0 |
| 11,706 |
| 0 |
| 11,706 |
| EG001 | 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. | 0 | 11,651 | 0 | 11,651 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 3.5 Years |
|
|
| 3.5 Years |
|
|