<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/NCT02229110</url>
  </required_header>
  <id_info>
    <org_study_id>13-039/C</org_study_id>
    <nct_id>NCT02229110</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Computerised Prompt for Primary and Secondary Care Physicians to Refer or Refer Back Type 2 Diabetes Patients</brief_title>
  <official_title>Effectiveness of a Computerised Prompt for Primary and Secondary Care Physicians to Refer or Refer Back Type 2 Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with type 2 diabetes mellitus can receive care in the general practice or at the&#xD;
      outpatient clinic. In the region of Amersfoort in The Netherlands, primary care practices and&#xD;
      the hospital are connected through Diamuraal to organize the diabetes care in that region.&#xD;
      They work in the same electronic medical record, and patients can request access to their own&#xD;
      record (called a patient web portal). They set up Diamuraal guidelines, based on the&#xD;
      guidelines of the Dutch College of General Practitioners and Internists, on where the patient&#xD;
      care needs to be allocated (primary or secondary care), depending on the amount of specific&#xD;
      care a patient needs. Despite guidelines, not all patients are treated in the correct place.&#xD;
&#xD;
      Our hypotheses is that when we improve triage we can cause a major shift from treatment in&#xD;
      secondary care to primary care and from primary care to self-care by using the patient web&#xD;
      portal. Furthermore, patients who needs extra attention due to problems with their diabetes&#xD;
      or complications can receive this extra attention due to increased e-consultation between&#xD;
      primary care and secondary care and if necessary actually can, during a short time, be&#xD;
      treated by an internist. We hope to achieve this by introducing a signal in the electronic&#xD;
      medical record. This signal allocates patients according to the guidelines and warns a&#xD;
      physician if their patients is not treated according to that guideline. The health care&#xD;
      provider can then discuss this situation with his patient. We believe that this leads to&#xD;
      shift in allocation of care, in which optimal care is provided and patients are made more&#xD;
      aware of their situation which hopefully leads to better self-management and satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">October 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of participants with change in allocation of care after intervention</measure>
    <time_frame>One year</time_frame>
    <description>One of the following:&#xD;
shift from primary care to secondary care&#xD;
shift from secondary care to primary care&#xD;
continuation of treatment in primary care but with addition of e-consultation with secondary care&#xD;
continuation of treatment in primary care but with replacement of one or more office visits in self-control</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assembly of reasons by health care providers for not following the guidelines</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of diabetes care</measure>
    <time_frame>One year</time_frame>
    <description>Measured with Quality of Care and Outcomes in Type 2 Diabetes scoring system (QuED) containing scores for biomedical data (HbA1c, blood pressure, lipids, medication regimen, number of measurements)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes treatment satisfaction</measure>
    <time_frame>One year</time_frame>
    <description>Measured with the diabetes treatment satisfaction questionnaire (DTSQ): six questions on satisfaction with treatment regimen and two questions on perceived frequency of hyperglycemia and hypoglycemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who meet their treatment goals</measure>
    <time_frame>One year</time_frame>
    <description>Measured in number of goals that are met</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2779</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Signal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to usual care, there will be an automatic signal in the electronic medical record (EMR) upon opening that will show the reader that the patient is currently not treated in the correct treatment setting and it simultaneously will give advice to which treatment allocation this patient should be transferred to.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No signal</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients receive usual care, consisting of 4 office visits yearly</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Signal</intervention_name>
    <description>Automatic signal in the electronic medical record</description>
    <arm_group_label>Signal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with type 2 diabetes mellitus&#xD;
&#xD;
          -  health care provider work within Diamuraal setting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - none&#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>Guy EH Rutten, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lioe-Ting Dijkhorst-Oei, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maaike CM Ronda, MD</last_name>
    <role>Study Director</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diamuraal-associated GP practices</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meander Medical Center</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://www.diamuraal.nl</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Ronda MC, Dijkhorst-Oei LT, Gorter KJ, Beulens JW, Rutten GE. Differences between diabetes patients who are interested or not in the use of a patient Web portal. Diabetes Technol Ther. 2013 Jul;15(7):556-63. doi: 10.1089/dia.2013.0023. Epub 2013 Jun 18.</citation>
    <PMID>23777369</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>June 15, 2015</last_update_submitted>
  <last_update_submitted_qc>June 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>Prof. G.E.H.M. Rutten</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>type 2 diabetes mellitus</keyword>
  <keyword>e-Health</keyword>
  <keyword>allocation of care</keyword>
  <keyword>clinical inertia</keyword>
  <keyword>quality of care</keyword>
  <keyword>patient satisfaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02229110
org study id: 13-039/C
nct id: NCT02229110
lead sponsor: 
has dmc: No
Patients with type 2 diabetes mellitus can receive care in the general practice or at the
      outpatient clinic. In the region of Amersfoort in The Netherlands, primary care practices and
      the hospital are connected through Diamuraal to organize the diabetes care in that region.
      They work in the same electronic medical record, and patients can request access to their own
      record (called a patient web portal). They set up Diamuraal guidelines, based on the
      guidelines of the Dutch College of General Practitioners and Internists, on where the patient
      care needs to be allocated (primary or secondary care), depending on the amount of specific
      care a patient needs. Despite guidelines, not all patients are treated in the correct place.

      Our hypotheses is that when we improve triage we can cause a major shift from treatment in
      secondary care to primary care and from primary care to self-care by using the patient web
      portal. Furthermore, patients who needs extra attention due to problems with their diabetes
      or complications can receive this extra attention due to increased e-consultation between
      primary care and secondary care and if necessary actually can, during a short time, be
      treated by an internist. We hope to achieve this by introducing a signal in the electronic
      medical record. This signal allocates patients according to the guidelines and warns a
      physician if their patients is not treated according to that guideline. The health care
      provider can then discuss this situation with his patient. We believe that this leads to
      shift in allocation of care, in which optimal care is provided and patients are made more
      aware of their situation which hopefully leads to better self-management and satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: The number of participants with change in allocation of care after intervention
time frame: One year
description: One of the following:
shift from primary care to secondary care
shift from secondary care to primary care
continuation of treatment in primary care but with addition of e-consultation with secondary care
continuation of treatment in primary care but with replacement of one or more office visits in self-control
measure: Assembly of reasons by health care providers for not following the guidelines
time frame: One year
measure: Change in quality of diabetes care
time frame: One year
description: Measured with Quality of Care and Outcomes in Type 2 Diabetes scoring system (QuED) containing scores for biomedical data (HbA1c, blood pressure, lipids, medication regimen, number of measurements)
measure: Change in diabetes treatment satisfaction
time frame: One year
description: Measured with the diabetes treatment satisfaction questionnaire (DTSQ): six questions on satisfaction with treatment regimen and two questions on perceived frequency of hyperglycemia and hypoglycemia.
measure: Number of participants who meet their treatment goals
time frame: One year
description: Measured in number of goals that are met
arm group label: Signal
arm group type: Active Comparator
description: In addition to usual care, there will be an automatic signal in the electronic medical record (EMR) upon opening that will show the reader that the patient is currently not treated in the correct treatment setting and it simultaneously will give advice to which treatment allocation this patient should be transferred to.
arm group label: No signal
arm group type: No Intervention
description: Patients receive usual care, consisting of 4 office visits yearly
intervention type: Other
intervention name: Signal
description: Automatic signal in the electronic medical record
arm group label: Signal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guy EH Rutten, MD PhD
role: Principal Investigator
affiliation: UMC Utrecht
last name: Lioe-Ting Dijkhorst-Oei, MD, PhD
role: Study Director
affiliation: UMC Utrecht
last name: Maaike CM Ronda, MD
role: Study Director
affiliation: UMC Utrecht
facility: 
facility: 
country: Netherlands
url: http://www.diamuraal.nl
description: Related Info
citation: Ronda MC, Dijkhorst-Oei LT, Gorter KJ, Beulens JW, Rutten GE. Differences between diabetes patients who are interested or not in the use of a patient Web portal. Diabetes Technol Ther. 2013 Jul;15(7):556-63. doi: 10.1089/dia.2013.0023. Epub 2013 Jun 18.
PMID: 23777369
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: Prof. G.E.H.M. Rutten
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2