<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/NCT02990897</url>
  </required_header>
  <id_info>
    <org_study_id>0</org_study_id>
    <nct_id>NCT02990897</nct_id>
  </id_info>
  <brief_title>Pilot Study of Health Information Technology for Chronic Kidney Disease Management</brief_title>
  <official_title>Pilot Study of Health Information Technology for Chronic Kidney Disease Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers now know that treating chronic kidney disease (CKD) in its early stages can&#xD;
      prevent dialysis and reduce heart problems that go along with kidney disease. Computerized&#xD;
      tools may help primary care doctors to diagnose the disease earlier and computer reminders&#xD;
      may help doctors to prescribe the best treatments. In this project the investigators will&#xD;
      test computer reminders in primary care clinics to see if they improve treatment of early&#xD;
      chronic kidney disease and to see if it can promote referral to nephrology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are conducting a randomized trial to determine the effect of a health&#xD;
      information technology (HIT) application to calculate risk progression of end stage renal&#xD;
      disease (ESRD). The primary outcome is the completion of the necessary tests for the risk&#xD;
      prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum&#xD;
      albumin, and serum bicarbonate) for CKD patients in primary care. Secondary outcomes will&#xD;
      include nephrology referrals, doubling of serum creatinine, initiation of hemodialysis, and&#xD;
      primary care provider (PCP) satisfaction. In the analysis, all patients over the age of 18&#xD;
      who have a visit with one of physicians involved in the trial during the intervention period&#xD;
      will be eligible and patients with stage 3-5 CKD will be included. Physicians are the&#xD;
      subjects in this study, as the intervention is a behavioral intervention for physicians. The&#xD;
      physicians' patients will not actively be recruited and will only indirectly be affected by&#xD;
      the study. The application creates blocks of patient appointments for each physician and&#xD;
      randomly assigns patients to intervention and control arms within these blocks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">July 14, 2022</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Laboratory tests completed</measure>
    <time_frame>6 months following primary care visit</time_frame>
    <description>Dichotomous measure of whether laboratory tests necessary to calculate the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) were resulted in the electronic health record for patients who did not previously have all of these tests done in the prior year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urine microalbumin to creatinine ratio test completed</measure>
    <time_frame>6 months following primary care visit</time_frame>
    <description>Dichotomous measure of whether urine microalbumin to creatinine ratio test was completed for patients who did not previously have these tests done in the prior year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Referral of patient from PCP to nephrologist</measure>
    <time_frame>6 months following primary care visit</time_frame>
    <description>Dichotomous measure of whether a patient was seen by a nephrologist for patients who did not previously have these tests done in the prior year.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with Stage 3,4, or 5 CKD who are randomized to the control arm will receive standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Stage 3,4, or 5 CKD who are randomized to the intervention group will receive care from a physician who has been exposed to the intervention: a clinical decision support message. This clinical decision support message shows the patient's risk of kidney failure over the next 5 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>clinical decision support message</intervention_name>
    <description>The intervention patient's physician is shown an estimate of the patient's 5 year risk of ESRD with a link for further information.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are 18 years or older&#xD;
&#xD;
          -  patients of primary care providers who are included in the study&#xD;
&#xD;
          -  patients with CKD (defined as two estimated glomerular filtration rate (GFR) values&#xD;
             under 60 mL/min per 1.73 m^2 90 days apart)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients without CKD (defined as two GFR values under 60 mL/min per 1.73 m^2 90 days&#xD;
             apart)&#xD;
&#xD;
          -  patients under the age of 18&#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>Lipika Samal, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Shore Physicians Group</name>
      <address>
        <city>Danvers</city>
        <state>Massachusetts</state>
        <zip>01923</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Lipika Samal</investigator_full_name>
    <investigator_title>Associate Physician</investigator_title>
  </responsible_party>
  <keyword>Medical informatics</keyword>
  <keyword>Quality of care</keyword>
  <keyword>Referral</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 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/NCT02990897
org study id: 0
nct id: NCT02990897
lead sponsor: 
has dmc: No
Researchers now know that treating chronic kidney disease (CKD) in its early stages can
      prevent dialysis and reduce heart problems that go along with kidney disease. Computerized
      tools may help primary care doctors to diagnose the disease earlier and computer reminders
      may help doctors to prescribe the best treatments. In this project the investigators will
      test computer reminders in primary care clinics to see if they improve treatment of early
      chronic kidney disease and to see if it can promote referral to nephrology.
The investigators are conducting a randomized trial to determine the effect of a health
      information technology (HIT) application to calculate risk progression of end stage renal
      disease (ESRD). The primary outcome is the completion of the necessary tests for the risk
      prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum
      albumin, and serum bicarbonate) for CKD patients in primary care. Secondary outcomes will
      include nephrology referrals, doubling of serum creatinine, initiation of hemodialysis, and
      primary care provider (PCP) satisfaction. In the analysis, all patients over the age of 18
      who have a visit with one of physicians involved in the trial during the intervention period
      will be eligible and patients with stage 3-5 CKD will be included. Physicians are the
      subjects in this study, as the intervention is a behavioral intervention for physicians. The
      physicians' patients will not actively be recruited and will only indirectly be affected by
      the study. The application creates blocks of patient appointments for each physician and
      randomly assigns patients to intervention and control arms within these blocks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Laboratory tests completed
time frame: 6 months following primary care visit
description: Dichotomous measure of whether laboratory tests necessary to calculate the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) were resulted in the electronic health record for patients who did not previously have all of these tests done in the prior year.
measure: Urine microalbumin to creatinine ratio test completed
time frame: 6 months following primary care visit
description: Dichotomous measure of whether urine microalbumin to creatinine ratio test was completed for patients who did not previously have these tests done in the prior year.
measure: Referral of patient from PCP to nephrologist
time frame: 6 months following primary care visit
description: Dichotomous measure of whether a patient was seen by a nephrologist for patients who did not previously have these tests done in the prior year.
arm group label: Control Group
arm group type: No Intervention
description: Patients with Stage 3,4, or 5 CKD who are randomized to the control arm will receive standard care.
arm group label: Intervention Group
arm group type: Experimental
description: Patients with Stage 3,4, or 5 CKD who are randomized to the intervention group will receive care from a physician who has been exposed to the intervention: a clinical decision support message. This clinical decision support message shows the patient's risk of kidney failure over the next 5 years.
intervention type: Behavioral
intervention name: clinical decision support message
description: The intervention patient's physician is shown an estimate of the patient's 5 year risk of ESRD with a link for further information.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lipika Samal, MD, MPH
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Lipika Samal
investigator title: Associate Physician
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No