<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/NCT03254407</url>
  </required_header>
  <id_info>
    <org_study_id>S58200</org_study_id>
    <nct_id>NCT03254407</nct_id>
  </id_info>
  <brief_title>Switch Timely to Oral Medication</brief_title>
  <acronym>STORM</acronym>
  <official_title>Comparison of Cost-effectiveness Between Electronic Notes Versus Telephone Calls to Alert the Prescriber of a Possible IV to Oral Switch.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      The goal of this study compare the effectiveness of an electronic note versus a telephone&#xD;
      call to alert the prescriber of a possible IV to oral switch. Secondary endpoints are the&#xD;
      time-to-switch and the economic impact of earlier IV to oral switch.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods&#xD;
&#xD;
      o Study design&#xD;
&#xD;
      A prospective, mono-centric, interrupted time series interventional study will be carried out&#xD;
      starting in August 2015. Patients will be recruited hospital wide, except for patients&#xD;
      admitted at the ICU or pediatric wards. The study protocol will be send for approval to the&#xD;
      Clinical Trial Centre and Ethics Committee. Based on the NIH, Code of Federal Regulations&#xD;
      Chapter 45-46, an exemption on informed consent is requested at Ethics Committee in order to&#xD;
      prevent bias by informing physicians and/or patients; as there's only a suggestion to alter&#xD;
      therapy to the treating physician and no clinical intervention is planned and data are&#xD;
      processed anonymously and retrospectively, patient safety and patient rights are guaranteed.&#xD;
      The study protocol will be registered in the public registry ClinicalTrials.gov.&#xD;
&#xD;
      o Inclusion and exclusion criteria and general assessment process&#xD;
&#xD;
      All prescriptions for levofloxacin (J01MA12), moxifloxacin (J01MA14), clarithromycin&#xD;
      (J01FA09), fluconazole (J02AC01), clindamycin (J01FF01), acetaminophen (N02BE01), rifampicin&#xD;
      (J04AB02), ornidazole (J01XD03) and metronidazole (J01XD01) in the hospitals CPOE from&#xD;
      01-08-2015 until 30-11-2015 for all hospitalized patients will be included.&#xD;
&#xD;
      The following prescription-related information will be requested from the HIS: unique&#xD;
      hospitalisation number, patient name (needed for contact with prescriber), date of&#xD;
      prescription, identification of prescriber, ward number, discipline, medication, route of&#xD;
      administration, dose.&#xD;
&#xD;
      The sample size of the dataset is not limited in order to provide the maximum power to the&#xD;
      study. The number of patients is estimated at 4000 per month.&#xD;
&#xD;
      o Building the dataset&#xD;
&#xD;
      A daily stored query, as presented in Figure 1, will the CPOE for therapies with at least one&#xD;
      of the nine bio-equivalent drugs and fulfillment of the other criteria, such as presence of&#xD;
      an order of a meal or prescription for other oral solid drugs and absence of a prescription&#xD;
      of parenteral nutrition or an order for enteral feeding . The working procedure and the&#xD;
      stored query are validated by 3 senior staff hospital pharmacists with expertise in the&#xD;
      domain and approved by the Pharmacy&amp;Therapeutics Committee (MFC).&#xD;
&#xD;
      The time scheme of the study is presented in Figure 2, and consists of the following blocks:&#xD;
&#xD;
        -  Baseline monitoring periods: During month 1 and 3, the query will be run without&#xD;
           intervention. The results of the query are captured in a database in order to have&#xD;
           baseline data before starting both the intervention periods.&#xD;
&#xD;
        -  Intervention period 1: During month 2, a team of trained staff pharmacists, who are&#xD;
           assisted under close supervision by master students of the Faculty of Pharmaceutical&#xD;
           Sciences, contact the prescribers by telephone, guided by the suggestions and&#xD;
           information of the operating procedure. The number of contacted prescribers and their&#xD;
           responses (acceptance or not) are recorded in the database. To do so, a standard&#xD;
           operating procedure for telephone contact with the prescribers will be available for the&#xD;
           co-investigators.&#xD;
&#xD;
        -  Intervention period 2: During month 4, a computer algorithm will leave an electronic&#xD;
           follow-up note suggesting the potential IV to oral switch, along with the argument to do&#xD;
           so, in the medical record.&#xD;
&#xD;
      Due to dispensing of the medication and his interdisciplinary task in optimizing therapy the&#xD;
      hospital pharmacist is related to the patient and has access to the necessary data; the&#xD;
      pharmaceutical record is part of the patients' medical record. Nevertheless the access to the&#xD;
      medical records is, as always, subject to approval by the medical council. Use of data is&#xD;
      subject to a confidentiality agreement, an official confidentiality agreement between&#xD;
      hospital and each co-investigator will be signed.&#xD;
&#xD;
      The solely intend of the access to the medical record is to gather data on the potential&#xD;
      IV/PO switch and possible contra-indications. There will be no intervention in any way in the&#xD;
      therapy nor the patient - physicians relationship. Reporting will be anonymous, never on an&#xD;
      individual patient or physician.&#xD;
&#xD;
      Impact of initiation time of the study At the University Hospitals Leuven, August is the&#xD;
      moment where most new prescribers enter the hospital. To avoid bias from this prescriber&#xD;
      switch, the switch period is excluded from the timing. Therefore, in concrete, baseline&#xD;
      monitoring period 1 will be started up in September 2015.&#xD;
&#xD;
      Avoidance of potential bias To avoid learning bias from the prescribers, a wash-out period is&#xD;
      included before each intervention period. A poster on possible IV-PO switch will distributed&#xD;
      in the hospital and published on the intranet webpage at the start of each period of the&#xD;
      study.&#xD;
&#xD;
      o Analysis of database&#xD;
&#xD;
      General analysis of the database will be done in Microsoft Access 2013. More in detail,&#xD;
      descriptive statistics will be carried out using appropriate parametric or non- parametric&#xD;
      tests (Student t-test, Mann-Whitney U-test or Chi square, based on distribution of data) to&#xD;
      describe the demographics of the included patients.&#xD;
&#xD;
      Statistical analysis will be carried out in SPSS or SAS by the investigator in collaboration&#xD;
      with L-Biostat (KU Leuven).&#xD;
&#xD;
      o Pharmacoeconomic analysis&#xD;
&#xD;
      Based on the dataset (time-to-switch and price of medication) the potential cost-saving from&#xD;
      a healthcare payer perspective will be calculated using the list price at 01-11-2015 of the&#xD;
      involved medication. Cost-avoidance due to lesser infections or lesser length of stay cannot&#xD;
      be calculated with this dataset.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of the type of alert</measure>
    <time_frame>4 months - August till November 2015 - calculated after each from 4 periods (=months)</time_frame>
    <description>Difference in number of switches and time to swich between electronic note and telephone alert of the prescriber.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of possible IV/PO switches, per discipline and per type of product</measure>
    <time_frame>4 months - August till November 2015 - calculated after each from 4 periods (=months)</time_frame>
    <description>number of potential IV to oral switches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacoeconomic impact of the intervention on time to switch</measure>
    <time_frame>4 months - August till November 2015 - calculated after each from 4 periods (=months)</time_frame>
    <description>Cost saving of switching to less expensive oral medication and cost saving due to lesser adverse events in relation to the cost of running the IV/oral switch service. Delta time to switch multiplied by days of inapproriate IV therapy --&gt; savings in euro</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence and motivation for overruling the switch</measure>
    <time_frame>4 months - August till November 2015 - calculated after each from 4 periods (=months)</time_frame>
    <description>Reasons and evidence background of the reasons for not following the advice to switch. descriptive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Learning curve over time and this for both methods of alerting on possible IV/PO switches</measure>
    <time_frame>4 months - August till November 2015 - calculated after each from 4 periods (=months)</time_frame>
    <description>Can there be a bias from a learning effect. Measured as time to switch in control and washout periods.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8000</enrollment>
  <condition>IV Oral Switch</condition>
  <condition>Appropriateness Review</condition>
  <arm_group>
    <arm_group_label>Screening medical record</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Screening medical record for possible IV-PO switch Possbile IV/PO switch communicated to prescriber by phone or e-note</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening medical record</intervention_name>
    <description>Communicating possible IV/PO switch to prescriber by phone or e-note in medical record</description>
    <arm_group_label>Screening medical record</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Therapy with prescriptions for levofloxacin (J01MA12), moxifloxacin (J01MA14),&#xD;
             clarithromycin (J01FA09), fluconazole (J02AC01), clindamycin (J01FF01), acetaminophen&#xD;
             (N02BE01), rifampicin (J04AB02), ornidazole (J01XD03) and metronidazole (J01XD01) in&#xD;
             the hospitals CPOE from 01-08-2015 until 30-11-2015 for hospitalized patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Therapy prescribed in PDMS (in casu: ICU)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas De Rijdt, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>May 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Thomas De Rijdt</investigator_full_name>
    <investigator_title>Assistant-head of Pharmacy</investigator_title>
  </responsible_party>
  <keyword>bioequivalent</keyword>
  <keyword>IV/PO switch</keyword>
  <keyword>appropriateness</keyword>
  <keyword>clinical pharmacy</keyword>
  <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/NCT03254407
org study id: S58200
nct id: NCT03254407
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study compare the effectiveness of an electronic note versus a telephone
      call to alert the prescriber of a possible IV to oral switch. Secondary endpoints are the
      time-to-switch and the economic impact of earlier IV to oral switch.
Methods

      o Study design

      A prospective, mono-centric, interrupted time series interventional study will be carried out
      starting in August 2015. Patients will be recruited hospital wide, except for patients
      admitted at the ICU or pediatric wards. The study protocol will be send for approval to the
      Clinical Trial Centre and Ethics Committee. Based on the NIH, Code of Federal Regulations
      Chapter 45-46, an exemption on informed consent is requested at Ethics Committee in order to
      prevent bias by informing physicians and/or patients; as there's only a suggestion to alter
      therapy to the treating physician and no clinical intervention is planned and data are
      processed anonymously and retrospectively, patient safety and patient rights are guaranteed.
      The study protocol will be registered in the public registry ClinicalTrials.gov.

      o Inclusion and exclusion criteria and general assessment process

      All prescriptions for levofloxacin (J01MA12), moxifloxacin (J01MA14), clarithromycin
      (J01FA09), fluconazole (J02AC01), clindamycin (J01FF01), acetaminophen (N02BE01), rifampicin
      (J04AB02), ornidazole (J01XD03) and metronidazole (J01XD01) in the hospitals CPOE from
      01-08-2015 until 30-11-2015 for all hospitalized patients will be included.

      The following prescription-related information will be requested from the HIS: unique
      hospitalisation number, patient name (needed for contact with prescriber), date of
      prescription, identification of prescriber, ward number, discipline, medication, route of
      administration, dose.

      The sample size of the dataset is not limited in order to provide the maximum power to the
      study. The number of patients is estimated at 4000 per month.

      o Building the dataset

      A daily stored query, as presented in Figure 1, will the CPOE for therapies with at least one
      of the nine bio-equivalent drugs and fulfillment of the other criteria, such as presence of
      an order of a meal or prescription for other oral solid drugs and absence of a prescription
      of parenteral nutrition or an order for enteral feeding . The working procedure and the
      stored query are validated by 3 senior staff hospital pharmacists with expertise in the
      domain and approved by the Pharmacy&Therapeutics Committee (MFC).

      The time scheme of the study is presented in Figure 2, and consists of the following blocks:

        -  Baseline monitoring periods: During month 1 and 3, the query will be run without
           intervention. The results of the query are captured in a database in order to have
           baseline data before starting both the intervention periods.

        -  Intervention period 1: During month 2, a team of trained staff pharmacists, who are
           assisted under close supervision by master students of the Faculty of Pharmaceutical
           Sciences, contact the prescribers by telephone, guided by the suggestions and
           information of the operating procedure. The number of contacted prescribers and their
           responses (acceptance or not) are recorded in the database. To do so, a standard
           operating procedure for telephone contact with the prescribers will be available for the
           co-investigators.

        -  Intervention period 2: During month 4, a computer algorithm will leave an electronic
           follow-up note suggesting the potential IV to oral switch, along with the argument to do
           so, in the medical record.

      Due to dispensing of the medication and his interdisciplinary task in optimizing therapy the
      hospital pharmacist is related to the patient and has access to the necessary data; the
      pharmaceutical record is part of the patients' medical record. Nevertheless the access to the
      medical records is, as always, subject to approval by the medical council. Use of data is
      subject to a confidentiality agreement, an official confidentiality agreement between
      hospital and each co-investigator will be signed.

      The solely intend of the access to the medical record is to gather data on the potential
      IV/PO switch and possible contra-indications. There will be no intervention in any way in the
      therapy nor the patient - physicians relationship. Reporting will be anonymous, never on an
      individual patient or physician.

      Impact of initiation time of the study At the University Hospitals Leuven, August is the
      moment where most new prescribers enter the hospital. To avoid bias from this prescriber
      switch, the switch period is excluded from the timing. Therefore, in concrete, baseline
      monitoring period 1 will be started up in September 2015.

      Avoidance of potential bias To avoid learning bias from the prescribers, a wash-out period is
      included before each intervention period. A poster on possible IV-PO switch will distributed
      in the hospital and published on the intranet webpage at the start of each period of the
      study.

      o Analysis of database

      General analysis of the database will be done in Microsoft Access 2013. More in detail,
      descriptive statistics will be carried out using appropriate parametric or non- parametric
      tests (Student t-test, Mann-Whitney U-test or Chi square, based on distribution of data) to
      describe the demographics of the included patients.

      Statistical analysis will be carried out in SPSS or SAS by the investigator in collaboration
      with L-Biostat (KU Leuven).

      o Pharmacoeconomic analysis

      Based on the dataset (time-to-switch and price of medication) the potential cost-saving from
      a healthcare payer perspective will be calculated using the list price at 01-11-2015 of the
      involved medication. Cost-avoidance due to lesser infections or lesser length of stay cannot
      be calculated with this dataset.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Effectiveness of the type of alert
time frame: 4 months - August till November 2015 - calculated after each from 4 periods (=months)
description: Difference in number of switches and time to swich between electronic note and telephone alert of the prescriber.
measure: The number of possible IV/PO switches, per discipline and per type of product
time frame: 4 months - August till November 2015 - calculated after each from 4 periods (=months)
description: number of potential IV to oral switches
measure: Pharmacoeconomic impact of the intervention on time to switch
time frame: 4 months - August till November 2015 - calculated after each from 4 periods (=months)
description: Cost saving of switching to less expensive oral medication and cost saving due to lesser adverse events in relation to the cost of running the IV/oral switch service. Delta time to switch multiplied by days of inapproriate IV therapy --> savings in euro
measure: Evidence and motivation for overruling the switch
time frame: 4 months - August till November 2015 - calculated after each from 4 periods (=months)
description: Reasons and evidence background of the reasons for not following the advice to switch. descriptive.
measure: Learning curve over time and this for both methods of alerting on possible IV/PO switches
time frame: 4 months - August till November 2015 - calculated after each from 4 periods (=months)
description: Can there be a bias from a learning effect. Measured as time to switch in control and washout periods.
arm group label: Screening medical record
arm group type: Other
description: Screening medical record for possible IV-PO switch Possbile IV/PO switch communicated to prescriber by phone or e-note
intervention type: Other
intervention name: Screening medical record
description: Communicating possible IV/PO switch to prescriber by phone or e-note in medical record
arm group label: Screening medical record
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas De Rijdt, PharmD
role: Principal Investigator
affiliation: UZ Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Thomas De Rijdt
investigator title: Assistant-head of Pharmacy
sharing ipd: No