<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01688141</url>
  </required_header>
  <id_info>
    <org_study_id>Shelton</org_study_id>
    <nct_id>NCT01688141</nct_id>
  </id_info>
  <brief_title>A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease</brief_title>
  <official_title>A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals, Leicester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals, Leicester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%.&#xD;
      The study hypothesis is to ascertain if intensive primary care led disease management&#xD;
      programmes for CKD, supported by input from secondary care specialists will slow progression&#xD;
      of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD&#xD;
      registers.&#xD;
&#xD;
      The investigators have partnered with Nene commissioning, a practice based commissioning&#xD;
      group representing approximately 80 GP practices in Northamptonshire, to run this study. This&#xD;
      will be a cluster randomised trial of an intensive, secondary care supported, CKD management&#xD;
      programme in primary care vs normal CKD care. Randomisation will be at the level of the&#xD;
      individual general practice. All general practices associated with Nene commissioning will be&#xD;
      invited to participate. Randomisation of practices will be performed by the University of&#xD;
      Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking&#xD;
      randomised cluster trials.&#xD;
&#xD;
      The aims of the study are:&#xD;
&#xD;
        1. To determine whether reinforcement of best practice in the management of key aspects of&#xD;
           CKD care by clinical nurse specialists based in primary care, but with close links to&#xD;
           colleagues from secondary care, improves clinical outcomes.&#xD;
&#xD;
        2. To foster excellence in CKD care&#xD;
&#xD;
        3. To improve coding of CKD and prevalence on chronic disease registers.&#xD;
&#xD;
        4. To increase interest in, and capacity for primary care research in Northamptonshire.&#xD;
&#xD;
        5. To implement and evaluate a new model of partnership working between primary and&#xD;
           secondary care.&#xD;
&#xD;
      The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR).&#xD;
      Secondary outcome measures will be blood pressure control, proteinuria, incidence of&#xD;
      cardiovascular events,other biochemical parameters, referrals to secondary care and&#xD;
      hospitalisations and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      see above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">October 11, 2018</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study</measure>
    <time_frame>Baseline and 3.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure Control</measure>
    <time_frame>Baseline and 3.5 years</time_frame>
    <description>Observation of blood pressure control over the study period via blood pressure targets</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proteinuria</measure>
    <time_frame>3.5 years</time_frame>
    <description>Proteinuria coding in practices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Cardiovascular Events</measure>
    <time_frame>3.5 years</time_frame>
    <description>Observation of incidence of cardiovascular events over the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Biochemical Parameters</measure>
    <time_frame>3.5 years</time_frame>
    <description>Nature and incidence over the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Referrals to Secondary Care and Hospitalisations</measure>
    <time_frame>3.5 years</time_frame>
    <description>Data coillected from secondary care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>3.5 years</time_frame>
    <description>data collected from secondary care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28304</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced management</intervention_name>
    <description>Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
    <arm_group_label>Enhanced Management</arm_group_label>
    <other_name>CKD management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  measurement of serum creatinine&#xD;
&#xD;
          -  eGFR &lt; 60 ml/min/1.73m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nigel Brunskill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leicester General Hospital</name>
      <address>
        <city>Leicester</city>
        <state>Leics</state>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Leicester</name>
      <address>
        <city>Leicester</city>
        <state>Leics</state>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Leicester</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>31097609</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 20, 2009</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>June 19, 2019</results_first_submitted>
  <results_first_submitted_qc>March 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 8, 2020</results_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CKD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Usual care</description>
        </group>
        <group group_id="P2">
          <title>Enhanced Management</title>
          <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11706"/>
                <participants group_id="P2" count="11651"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11706"/>
                <participants group_id="P2" count="11651"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Usual care</description>
        </group>
        <group group_id="B2">
          <title>Enhanced Management</title>
          <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11706"/>
            <count group_id="B2" value="11651"/>
            <count group_id="B3" value="23357"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11706"/>
                    <measurement group_id="B2" value="11651"/>
                    <measurement group_id="B3" value="23357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.4" spread="11.3"/>
                    <measurement group_id="B2" value="75.1" spread="11.4"/>
                    <measurement group_id="B3" value="75.3" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7285"/>
                    <measurement group_id="B2" value="7234"/>
                    <measurement group_id="B3" value="14519"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4421"/>
                    <measurement group_id="B2" value="4417"/>
                    <measurement group_id="B3" value="8838"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11706"/>
                    <measurement group_id="B2" value="11651"/>
                    <measurement group_id="B3" value="23357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study</title>
        <time_frame>Baseline and 3.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Management</title>
            <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study</title>
          <units>mean average eGFR change/mL/min/1.73 m^2</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11706"/>
                <count group_id="O2" value="11651"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.00" lower_limit="-3.95" upper_limit="0.92"/>
                    <measurement group_id="O2" value="-2.29" lower_limit="-3.89" upper_limit="-0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Pressure Control</title>
        <description>Observation of blood pressure control over the study period via blood pressure targets</description>
        <time_frame>Baseline and 3.5 years</time_frame>
        <population>Denominator change due to loss to follow-up and death.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Management</title>
            <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure Control</title>
          <description>Observation of blood pressure control over the study period via blood pressure targets</description>
          <population>Denominator change due to loss to follow-up and death.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11551"/>
                <count group_id="O2" value="11473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11551"/>
                    <count group_id="O2" value="11473"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6834"/>
                    <measurement group_id="O2" value="7137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11129"/>
                    <count group_id="O2" value="10689"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7460"/>
                    <measurement group_id="O2" value="7295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proteinuria</title>
        <description>Proteinuria coding in practices</description>
        <time_frame>3.5 years</time_frame>
        <population>Loss to follow-up and death</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Management</title>
            <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
          </group>
        </group_list>
        <measure>
          <title>Proteinuria</title>
          <description>Proteinuria coding in practices</description>
          <population>Loss to follow-up and death</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11689"/>
                <count group_id="O2" value="11546"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11689"/>
                    <count group_id="O2" value="11546"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="627"/>
                    <measurement group_id="O2" value="982"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11228"/>
                    <count group_id="O2" value="10755"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1947"/>
                    <measurement group_id="O2" value="2110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Cardiovascular Events</title>
        <description>Observation of incidence of cardiovascular events over the study period</description>
        <time_frame>3.5 years</time_frame>
        <population>Data not available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Management</title>
            <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Cardiovascular Events</title>
          <description>Observation of incidence of cardiovascular events over the study period</description>
          <population>Data not available for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Other Biochemical Parameters</title>
        <description>Nature and incidence over the study period</description>
        <time_frame>3.5 years</time_frame>
        <population>Data not available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Management</title>
            <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
          </group>
        </group_list>
        <measure>
          <title>Other Biochemical Parameters</title>
          <description>Nature and incidence over the study period</description>
          <population>Data not available for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Referrals to Secondary Care and Hospitalisations</title>
        <description>Data coillected from secondary care</description>
        <time_frame>3.5 years</time_frame>
        <population>Data not available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Management</title>
            <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
          </group>
        </group_list>
        <measure>
          <title>Referrals to Secondary Care and Hospitalisations</title>
          <description>Data coillected from secondary care</description>
          <population>Data not available for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>data collected from secondary care</description>
        <time_frame>3.5 years</time_frame>
        <population>Data not available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Management</title>
            <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>data collected from secondary care</description>
          <population>Data not available for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Usual care</description>
        </group>
        <group group_id="E2">
          <title>Enhanced Management</title>
          <description>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.&#xD;
Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11706"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11651"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11706"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11651"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professor Nigel Brunskill</name_or_title>
      <organization>University of Leicester</organization>
      <phone>+44 116 258 8043</phone>
      <email>njb18@le.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688141
org study id: Shelton
nct id: NCT01688141
lead sponsor: 
has dmc: Yes
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.
see above
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
time frame: Baseline and 3.5 years
measure: Blood Pressure Control
time frame: Baseline and 3.5 years
description: Observation of blood pressure control over the study period via blood pressure targets
measure: Proteinuria
time frame: 3.5 years
description: Proteinuria coding in practices
measure: Incidence of Cardiovascular Events
time frame: 3.5 years
description: Observation of incidence of cardiovascular events over the study period
measure: Other Biochemical Parameters
time frame: 3.5 years
description: Nature and incidence over the study period
measure: Referrals to Secondary Care and Hospitalisations
time frame: 3.5 years
description: Data coillected from secondary care
measure: Mortality
time frame: 3.5 years
description: data collected from secondary care
arm group label: Control
arm group type: No Intervention
description: Usual care
arm group label: Enhanced Management
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Enhanced management
description: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
arm group label: Enhanced Management
other name: CKD management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nigel Brunskill, PhD
role: Principal Investigator
affiliation: Consultant
facility: 
facility: 
facility: 
country: United Kingdom
citation: 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.
PMID: 31097609
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 