<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/NCT03832595</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19060280</org_study_id>
    <secondary_id>R18DK118460</secondary_id>
    <secondary_id>1R01DK116957-01A1</secondary_id>
    <nct_id>NCT03832595</nct_id>
  </id_info>
  <brief_title>Kidney Coordinated Health Management Partnership</brief_title>
  <acronym>Kidney-CHAMP</acronym>
  <official_title>Kidney Coordinated Health Management Partnership</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As part of a 42-month pragmatic, cluster randomized trial in 1,650 primary care patients with&#xD;
      high-risk Chronic Kidney Disease (CKD), the investigators will test the effectiveness of a&#xD;
      multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM)&#xD;
      intervention that targets improvements in the delivery of evidence-based CKD care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population&#xD;
      Health Management (PHM) intervention to improve the delivery of evidence-based Chronic Kidney&#xD;
      Disease (CKD) care in patients with high-risk CKD. Investigators will perform a 42-month&#xD;
      pragmatic, cluster randomized (at the practice level) controlled trial in 1,650 patients with&#xD;
      high-risk CKD (as defined by validated risk prediction models or by current estimated&#xD;
      Glomerular Filtration Rate (eGFR) value or recent decline in eGFR values) managed by their&#xD;
      Primary Care Physicians (PCPs) to determine whether EHR-based PHM improves key processes of&#xD;
      care and clinical outcomes.&#xD;
&#xD;
      The investigators hypothesize that EHR-based PHM will improve hypertension control, use of&#xD;
      renin angiotensin aldosterone system inhibitors (RAASi), and avoidance of renally&#xD;
      contraindicated medications (Aim 1a-1c) and delay CKD progression (Aim 2).&#xD;
&#xD;
      Investigators will also characterize the acceptability and experience of Primary Care&#xD;
      Physicians (PCPs) in the intervention arm of the CKD PHM study (Aim 3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</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>
    <intervention_model_description>Cluster randomized controlled trial with randomization occurring at the Primary Care Physician practice level</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>outcomes are ascertained by data programmers who are blinded to study arm assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Decline in estimated Glomerular Filtration Rate (eGFR) or End Stage Renal Disease (ESRD)</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>A greater than or equal to 40% decline in eGFR or ESRD. eGFR decline will be adjudicated based on the baseline creatinine and eGFR determined from the CKD-epidemiology (CKD-EPI) equation and measured routinely in clinical practice.&#xD;
ESRD will be defined as an eGFR less than or equal to 10ml/min to account for patients with markedly reduced baseline eGFR values (i.e., 16-20ml/min).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypertension (HTN) Control</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi)</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite medication safety: Inappropriate use of Non-Steroidal Anti-inflammatory Drugs (NSAIDs), glyburide, metformin, gemfibrozil</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Investigators will examine the composite rate of use of these high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication safety: Use of Non-Steroidal Anti-inflammatory Drugs (NSAIDS)</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).&#xD;
NSAIDS use will be examined for all study patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Safety: Use of glyburide</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).&#xD;
Glyburide use will be examined for all study patients with diabetes at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Safety: Use of Metformin</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).&#xD;
Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Safety: Use of gemfibrozil</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).&#xD;
Use of gemfibrozil will be examined for all study patients with eGFR less than 30</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subgroup analysis: Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi) (outcome 3) in participants who are baseline non-users of RAASi</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Outcome 3 will be repeated in the subgroup of participants not receiving RAASi at baseline (i.e., In patients not receiving RAASi at study enrollment, RAASi use will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup analysis hypertension (HTN) control (outcome 2) in participants with uncontrolled BP at baseline (i.e., BP &gt;130/80 at baseline).</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Outcome 2 will be repeated in the subgroup of patients with suboptimal BP control (i.e., BP &gt;130/80) at baseline using outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup analysis of composite medication safety (outcome 4) in the subgroup of participants receiving at least 1 of the following medications inappropriately at study enrollment: NSAIDs, glyburide, metformin, gemfibrozil</measure>
    <time_frame>Through study completion, an average of 24 months</time_frame>
    <description>Outcome 4 will be repeated in the subgroup of patients who were receiving at least 1 high-risk medication at study enrollment (baseline). Investigators will examine the composite rate of use of these high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1596</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a care bundle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EHR-based PHM</intervention_name>
    <description>An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:&#xD;
Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every ~6 months,&#xD;
Medication therapy management: PharmD led telephonic medication therapy management with the patient every ~6 months,&#xD;
and Nurse led CKD patient education, every ~6-12 months&#xD;
unless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology).</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for PCPs: presence of an ambulatory continuity clinic in the University&#xD;
        of Pittsburgh Medical Center (UPMC) community medicine practice.&#xD;
&#xD;
        Inclusion criteria for patients:&#xD;
&#xD;
          1. age greater than or equal to 18, and less than or equal to 85&#xD;
&#xD;
          2. most recent eGFR less than 60 ml/min/yr&#xD;
&#xD;
          3. established care with UPMC PCP&#xD;
&#xD;
          4. high risk CKD based on validated external and internal risk prediction models or&#xD;
             severe reduction in eGFR, or substantial loss in eGFR in prior 18 months.&#xD;
&#xD;
        Exclusion Criteria for PCPs: none&#xD;
&#xD;
        Exclusion Criteria for patients:&#xD;
&#xD;
          1. history of kidney transplant&#xD;
&#xD;
          2. receiving maintenance dialysis&#xD;
&#xD;
          3. recent (within 12 months) outpatient nephrology visit&#xD;
&#xD;
          4. baseline eGFR less than 15ml/min&#xD;
&#xD;
          5. expected survival less than 6 months or hospice enrollee (e.g., stage IV heart&#xD;
             failure, metastatic cancer, oxygen dependent Chronic Obstructive Pulmonary Disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khaled Abdel-Kader, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manisha Jhamb, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Presbyterian</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <disposition_first_submitted>May 10, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>May 25, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 30, 2023</disposition_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Manisha Jhamb</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>electronic health record</keyword>
  <keyword>population health management</keyword>
  <keyword>patient education</keyword>
  <keyword>medication therapy management</keyword>
  <keyword>electronic consultation</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>pragmatic 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03832595
org study id: STUDY19060280
secondary id: R18DK118460
secondary id: 1R01DK116957-01A1
nct id: NCT03832595
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As part of a 42-month pragmatic, cluster randomized trial in 1,650 primary care patients with
      high-risk Chronic Kidney Disease (CKD), the investigators will test the effectiveness of a
      multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM)
      intervention that targets improvements in the delivery of evidence-based CKD care.
To test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population
      Health Management (PHM) intervention to improve the delivery of evidence-based Chronic Kidney
      Disease (CKD) care in patients with high-risk CKD. Investigators will perform a 42-month
      pragmatic, cluster randomized (at the practice level) controlled trial in 1,650 patients with
      high-risk CKD (as defined by validated risk prediction models or by current estimated
      Glomerular Filtration Rate (eGFR) value or recent decline in eGFR values) managed by their
      Primary Care Physicians (PCPs) to determine whether EHR-based PHM improves key processes of
      care and clinical outcomes.

      The investigators hypothesize that EHR-based PHM will improve hypertension control, use of
      renin angiotensin aldosterone system inhibitors (RAASi), and avoidance of renally
      contraindicated medications (Aim 1a-1c) and delay CKD progression (Aim 2).

      Investigators will also characterize the acceptability and experience of Primary Care
      Physicians (PCPs) in the intervention arm of the CKD PHM study (Aim 3).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomized controlled trial with randomization occurring at the Primary Care Physician practice level
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: outcomes are ascertained by data programmers who are blinded to study arm assignment
measure: Decline in estimated Glomerular Filtration Rate (eGFR) or End Stage Renal Disease (ESRD)
time frame: Through study completion, an average of 24 months
description: A greater than or equal to 40% decline in eGFR or ESRD. eGFR decline will be adjudicated based on the baseline creatinine and eGFR determined from the CKD-epidemiology (CKD-EPI) equation and measured routinely in clinical practice.
ESRD will be defined as an eGFR less than or equal to 10ml/min to account for patients with markedly reduced baseline eGFR values (i.e., 16-20ml/min).
measure: Hypertension (HTN) Control
time frame: Through study completion, an average of 24 months
description: Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR.
measure: Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi)
time frame: Through study completion, an average of 24 months
description: Will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).
measure: Composite medication safety: Inappropriate use of Non-Steroidal Anti-inflammatory Drugs (NSAIDs), glyburide, metformin, gemfibrozil
time frame: Through study completion, an average of 24 months
description: Investigators will examine the composite rate of use of these high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).
measure: Medication safety: Use of Non-Steroidal Anti-inflammatory Drugs (NSAIDS)
time frame: Through study completion, an average of 24 months
description: Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).
NSAIDS use will be examined for all study patients
measure: Medication Safety: Use of glyburide
time frame: Through study completion, an average of 24 months
description: Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).
Glyburide use will be examined for all study patients with diabetes at baseline
measure: Medication Safety: Use of Metformin
time frame: Through study completion, an average of 24 months
description: Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).
Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30
measure: Medication Safety: Use of gemfibrozil
time frame: Through study completion, an average of 24 months
description: Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).
Use of gemfibrozil will be examined for all study patients with eGFR less than 30
measure: Subgroup analysis: Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi) (outcome 3) in participants who are baseline non-users of RAASi
time frame: Through study completion, an average of 24 months
description: Outcome 3 will be repeated in the subgroup of participants not receiving RAASi at baseline (i.e., In patients not receiving RAASi at study enrollment, RAASi use will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).
measure: Subgroup analysis hypertension (HTN) control (outcome 2) in participants with uncontrolled BP at baseline (i.e., BP >130/80 at baseline).
time frame: Through study completion, an average of 24 months
description: Outcome 2 will be repeated in the subgroup of patients with suboptimal BP control (i.e., BP >130/80) at baseline using outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR.
measure: Subgroup analysis of composite medication safety (outcome 4) in the subgroup of participants receiving at least 1 of the following medications inappropriately at study enrollment: NSAIDs, glyburide, metformin, gemfibrozil
time frame: Through study completion, an average of 24 months
description: Outcome 4 will be repeated in the subgroup of patients who were receiving at least 1 high-risk medication at study enrollment (baseline). Investigators will examine the composite rate of use of these high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study).
arm group label: Usual care
arm group type: Active Comparator
description: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).
arm group label: Intervention Arm
arm group type: Experimental
description: Patients will receive a care bundle
intervention type: Other
intervention name: EHR-based PHM
description: An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:
Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every ~6 months,
Medication therapy management: PharmD led telephonic medication therapy management with the patient every ~6 months,
and Nurse led CKD patient education, every ~6-12 months
unless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology).
arm group label: Intervention Arm
intervention type: Other
intervention name: Usual Care
description: Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Khaled Abdel-Kader, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Manisha Jhamb, MD MPH
role: Principal Investigator
affiliation: University of Pittsburgh Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Manisha Jhamb
investigator title: Assistant Professor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No