<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/NCT02208674</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0251</org_study_id>
    <nct_id>NCT02208674</nct_id>
  </id_info>
  <brief_title>Early Identification and Action in CKD</brief_title>
  <official_title>Early Identification and Action in CKD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Geisinger Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased&#xD;
      risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized&#xD;
      clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and&#xD;
      hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is&#xD;
      screened and treated according to recommended guidelines. Using a cluster-randomized,&#xD;
      controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize&#xD;
      6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a&#xD;
      pharmacist-directed &quot;CKD Action Plan&quot; (group 2). Determining the impact of the CKD Action&#xD;
      Plan on screening and treatment guideline adherence is the primary goal of this pilot study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Screening Urinary Albumin Excretion</measure>
    <time_frame>At 12 months</time_frame>
    <description>Completed test for urine albumin/creatinine (or urine protein/creatinine)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyslipidemia Screening</measure>
    <time_frame>At least once after eGFR &lt; 60 ml/min</time_frame>
    <description>One-time test for dyslipidemia (lipid panel)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACEI or ARB Treatment if urine ACR is &gt; 30 mg/g (diabetic) or &gt; 300 mg/g (non-diabetic)</measure>
    <time_frame>within 12 months of enrollment date</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statin Treatment</measure>
    <time_frame>Within 12 months of enrollment</time_frame>
    <description>If age &gt;= 50</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure Control-1</measure>
    <time_frame>Average of last two readings prior to 12 months post-enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure--II</measure>
    <time_frame>Average of all blood pressures within 12 month study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure--III</measure>
    <time_frame>at 12 months post enrollment</time_frame>
    <description>Target blood pressure attained (using KDIGO criteria) based on average of last 2 clinic readings within 12 month study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical Surveillance</measure>
    <time_frame>two weeks after initiation or titration of ACEI or ARB</time_frame>
    <description>Test order for serum creatinine, potassium, and sodium within two weeks of ACEI or ARB initiation or titration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic Adverse Drug Event</measure>
    <time_frame>At 12 months post-enrollment</time_frame>
    <description>Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and Provider Satisfaction</measure>
    <time_frame>9-12 months post study start date</time_frame>
    <description>Based on administered surveys</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cystatin C Supplementary Screening</measure>
    <time_frame>within 12 months of enrollment date</time_frame>
    <description>One-time serum cystatin C test for individuals with eGFR between 45 and 59 ml/min and urine albumin-creatinine &lt; 30 mg/g.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protocolized, pharmacist-delivered CKD Action Plan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protocolized, pharmacist-delivered CKD Action Plan</intervention_name>
    <description>The CKD Action plan protocolizes the screening and treatment of primary risk factors for CKD progression and cardiovascular disease among individuals with stage G3A CKD</description>
    <arm_group_label>Protocolized, pharmacist-delivered CKD Action Plan</arm_group_label>
    <other_name>Health care delivery procedure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  eGFRCR value between 45-59 ml/min/1.73m2 in the prior 12 months&#xD;
&#xD;
          -  scheduled laboratory appointment for serum creatinine testing within the next 30 days&#xD;
&#xD;
          -  average systolic or diastolic blood pressure reading of at least 150 or 85 mm Hg,&#xD;
             respectively, during the prior 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fewer than 2 blood pressure readings in the prior 12 months,&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  current hospitalization&#xD;
&#xD;
          -  life expectancy less than 6 months as determined by the study investigators&#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>Alex Chang, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geisinger Health System</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882-016-0383-7</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Chang AR, Evans M, Yule C, Bohn L, Young A, Lewis M, Graboski E, Gerdy B, Ehmann W, Brady J, Lawrence L, Antunes N, Green J, Snyder S, Kirchner HL, Grams M, Perkins R. Using pharmacists to improve risk stratification and management of stage 3A chronic kidney disease: a feasibility study. BMC Nephrol. 2016 Nov 8;17(1):168. doi: 10.1186/s12882-016-0383-7.</citation>
    <PMID>27825313</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>November 14, 2016</last_update_submitted>
  <last_update_submitted_qc>November 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Geisinger Clinic</investigator_affiliation>
    <investigator_full_name>Alexander Chang</investigator_full_name>
    <investigator_title>Clinical Investigator</investigator_title>
  </responsible_party>
  <keyword>chronic kidney disease</keyword>
  <keyword>albuminuria</keyword>
  <keyword>hypertension</keyword>
  <keyword>dyslipidemia</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>pragmatic trial</keyword>
  <keyword>cluster randomized trial</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>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data for this study may be obtained upon request, after permission to do so is granted by the Geisinger IRB and information security office. Readers should contact the principal investigator (achang@geisinger.edu) for further information.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02208674
org study id: 2014-0251
nct id: NCT02208674
lead sponsor: 
has dmc: Yes
Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased
      risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized
      clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and
      hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is
      screened and treated according to recommended guidelines. Using a cluster-randomized,
      controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize
      6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a
      pharmacist-directed "CKD Action Plan" (group 2). Determining the impact of the CKD Action
      Plan on screening and treatment guideline adherence is the primary goal of this pilot study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Screening Urinary Albumin Excretion
time frame: At 12 months
description: Completed test for urine albumin/creatinine (or urine protein/creatinine)
measure: Dyslipidemia Screening
time frame: At least once after eGFR < 60 ml/min
description: One-time test for dyslipidemia (lipid panel)
measure: ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic)
time frame: within 12 months of enrollment date
measure: Statin Treatment
time frame: Within 12 months of enrollment
description: If age >= 50
measure: Blood Pressure Control-1
time frame: Average of last two readings prior to 12 months post-enrollment
measure: Blood Pressure--II
time frame: Average of all blood pressures within 12 month study period
measure: Blood Pressure--III
time frame: at 12 months post enrollment
description: Target blood pressure attained (using KDIGO criteria) based on average of last 2 clinic readings within 12 month study period
measure: Biochemical Surveillance
time frame: two weeks after initiation or titration of ACEI or ARB
description: Test order for serum creatinine, potassium, and sodium within two weeks of ACEI or ARB initiation or titration.
measure: Symptomatic Adverse Drug Event
time frame: At 12 months post-enrollment
description: Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug
measure: Patient and Provider Satisfaction
time frame: 9-12 months post study start date
description: Based on administered surveys
measure: Cystatin C Supplementary Screening
time frame: within 12 months of enrollment date
description: One-time serum cystatin C test for individuals with eGFR between 45 and 59 ml/min and urine albumin-creatinine < 30 mg/g.
arm group label: Usual Care
arm group type: No Intervention
description: Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care.
arm group label: Protocolized, pharmacist-delivered CKD Action Plan
arm group type: Experimental
description: Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations.
intervention type: Other
intervention name: Protocolized, pharmacist-delivered CKD Action Plan
description: The CKD Action plan protocolizes the screening and treatment of primary risk factors for CKD progression and cardiovascular disease among individuals with stage G3A CKD
arm group label: Protocolized, pharmacist-delivered CKD Action Plan
other name: Health care delivery procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alex Chang, MD, MS
role: Principal Investigator
affiliation: Geisinger Clinic
facility: 
country: United States
url: https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882-016-0383-7
description: Related Info
citation: Chang AR, Evans M, Yule C, Bohn L, Young A, Lewis M, Graboski E, Gerdy B, Ehmann W, Brady J, Lawrence L, Antunes N, Green J, Snyder S, Kirchner HL, Grams M, Perkins R. Using pharmacists to improve risk stratification and management of stage 3A chronic kidney disease: a feasibility study. BMC Nephrol. 2016 Nov 8;17(1):168. doi: 10.1186/s12882-016-0383-7.
PMID: 27825313
responsible party type: Principal Investigator
investigator affiliation: Geisinger Clinic
investigator full name: Alexander Chang
investigator title: Clinical Investigator
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Hypertension
sharing ipd: No
ipd description: Data for this study may be obtained upon request, after permission to do so is granted by the Geisinger IRB and information security office. Readers should contact the principal investigator (achang@geisinger.edu) for further information.