xml: <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/NCT06040151</url>
    </required_header>
    <id_info>
      <org_study_id>10624</org_study_id>
      <nct_id>NCT06040151</nct_id>
    </id_info>
    <brief_title>Evaluating Mobile-based Medication Reconciliation by Patients at Home</brief_title>
    <acronym>PILLS@HOME</acronym>
    <official_title>Evaluating Mobile-based Medication Reconciliation by Patients at Home: Feasibility, Quality and Time Investments by Pharmacy Technicians</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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>
        Medication reconciliation (MR) is essential to limit drug-related problems that occur during&#xD;
        care transitions in and out of care institutions. Pharmacy-led medication reconciliation has&#xD;
        been shown to reduce medication discrepancies, preventable harm and hospital readmissions.&#xD;
        However, these consultations are time-consuming. The Erasmus Medical Center is currently&#xD;
        developing a mobile-based patient portal. After receiving an invitation to perform medication&#xD;
        reconciliation in the app, patients can review their medication and allergies at home. Next,&#xD;
        pharmacy technicians manually verify all patient-entered data on completeness and quality.&#xD;
        The investigators hypothesize that mobile-based medication reconciliation results in&#xD;
        increased patient insight. Yet, it is unknown if mobile-based medication reconciliation is&#xD;
        feasible, saves time, and is of high quality.&#xD;
  &#xD;
        Therefore, the primary study objectives are to assess (1) the feasibility of patients&#xD;
        performing medication reconciliation using a mobile-based patient portal, (2) the time&#xD;
        investment of pharmacy technicians in mobile-based medication reconciliation (and related&#xD;
        costs), in comparison to standard practice, and (3) the quality of patients' pre-verified&#xD;
        medication lists. The secondary study objective is to assess patients' and pharmacy&#xD;
        technicians' acceptability of performing medication reconciliation using a mobile-based&#xD;
        patient portal.&#xD;
  &#xD;
        This is a prospective quality evaluation study assessing mobile-based medication&#xD;
        reconciliation. All adult patients (18 years or older) who are admitted to (a selection of)&#xD;
        clinical ward in Erasmus Medical Center and who are asked to complete medication&#xD;
        reconciliation are eligible. In the patient app, patients review ('pre-verify') their&#xD;
        medications and allergies, after which pharmacy technicians check and manually approve&#xD;
        ('verify') all patient-entered data and determine whether a follow-up interview is needed.&#xD;
  &#xD;
        Feasibility is defined as the successful completion rate of digital medication&#xD;
        reconciliation, and the need for additional interviews. Time investment by pharmacy&#xD;
        technicians (and related costs) are determined by timing the duration of all patient-bound&#xD;
        medication reconciliation-related tasks, both in standard care and when using mobile-based&#xD;
        reconciliation. The quality of verification is determined by comparing patients' pre-verified&#xD;
        medication list to pharmacy technician-verified lists. Acceptability is defined as the&#xD;
        perceived usability of medication reconciliation by patients and by pharmacy technicians.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility (1/4): completion rate of digital MR by patients</measure>
      <time_frame>During quality evaluation of the patient app, an average of 3 months</time_frame>
      <description>The fraction of all patients who were invited to participate that participated</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility (2/4): the time it takes patients to perform digital MR (in minutes)</measure>
      <time_frame>During quality evaluation of the patient app, an average of 3 months</time_frame>
      <description>To assess the ease-of-use of performing medication reconciliation in the patient app</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility (3/4): the need for live, follow-up interviews after performing digital MR</measure>
      <time_frame>During quality evaluation of the patient app, an average of 3 months</time_frame>
      <description>The fraction of all patients who were invited to participate in digital MR who needed a live interview</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility (4/4): how often the helpdesk was contacted</measure>
      <time_frame>During quality evaluation of the patient app, an average of 3 months</time_frame>
      <description>The fraction of all patients who were invited to participate in digital MR who contact the helpdesk</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The time investment by pharmacy technicians per patient in the digital MR process, compared to the current situation (in minutes)</measure>
      <time_frame>Before launch of the patient app, during an average of 2 months, and during quality evaluation of the patient app, an average of 3 months</time_frame>
      <description>The time investment by pharmacy technicians per patient in the new workflow vs. the current situation, in which all patients are invited for a live interview</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The quality of a patient's pre-verified medication list, compared to the pharmacy technician's verified medication list</measure>
      <time_frame>During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months</time_frame>
      <description>The number of discrepancies between the patient-reported medication list and the pharmacy-verified medication list (the number of changes made by a pharmacy technician in the MR process)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability (1/2): defined as the perceived usability of mobile-based MR by patients, assessed using short in-app questionnaires (VAS 1-5)</measure>
      <time_frame>During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months</time_frame>
      <description>To assess to what extent digital medication reconciliation is accepted by patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability (2/2): defined as the perceived usability of mobile-based MR by patients and pharmacy technicians, assessed using short qualitative interviews with both patients and pharmacy technicians</measure>
      <time_frame>During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months</time_frame>
      <description>To assess to what extent digital medication reconciliation is accepted by patients and pharmacy technicians</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">39</enrollment>
    <condition>Patients</condition>
    <arm_group>
      <arm_group_label>Users of mobile-based medication-reconciliation app</arm_group_label>
      <description>Adult patients (18 years or older) who are asked to complete medication reconciliation before a planned admission to the clinical ward of selected pilot departments in Erasmus Medical Center</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Digizorg mobile app (quality evaluation study)</intervention_name>
      <description>Erasmus Medical Center is developing a state-of-the-art, mobile-based patient portal that combines up-to-date medication lists from all healthcare providers involved in a patient's care. Other functionalities include: accessing health information, viewing and planning appointments, teleconsulting, sending messages, filling in questionnaires, reporting self-measurements, and reading background information on diseases, medication, and other interventions. The patient portal will primarily be implemented in Erasmus Medical Center, and is ultimately intended for every patient, regardless of underlying condition.</description>
      <arm_group_label>Users of mobile-based medication-reconciliation app</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All adult patients (18 years or older) who are asked to complete medication reconciliation&#xD;
          before a planned admission to the clinical ward of selected pilot departments in Erasmus MC&#xD;
          are eligible to participate in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  Planned admission to the clinical ward of participating pilot departments in Erasmus&#xD;
               MC&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No potential subject will be excluded from participation in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Martijn Brands, MD</last_name>
      <phone>0031205665675</phone>
      <email>m.r.brands@erasmusmc.nl</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Alan Abdulla</investigator_full_name>
      <investigator_title>dr. Alan Abdulla, Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Patients with all conditions are eligible</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040151
  org study id: 10624
  nct id: NCT06040151
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Medication reconciliation (MR) is essential to limit drug-related problems that occur during
        care transitions in and out of care institutions. Pharmacy-led medication reconciliation has
        been shown to reduce medication discrepancies, preventable harm and hospital readmissions.
        However, these consultations are time-consuming. The Erasmus Medical Center is currently
        developing a mobile-based patient portal. After receiving an invitation to perform medication
        reconciliation in the app, patients can review their medication and allergies at home. Next,
        pharmacy technicians manually verify all patient-entered data on completeness and quality.
        The investigators hypothesize that mobile-based medication reconciliation results in
        increased patient insight. Yet, it is unknown if mobile-based medication reconciliation is
        feasible, saves time, and is of high quality.
  
        Therefore, the primary study objectives are to assess (1) the feasibility of patients
        performing medication reconciliation using a mobile-based patient portal, (2) the time
        investment of pharmacy technicians in mobile-based medication reconciliation (and related
        costs), in comparison to standard practice, and (3) the quality of patients' pre-verified
        medication lists. The secondary study objective is to assess patients' and pharmacy
        technicians' acceptability of performing medication reconciliation using a mobile-based
        patient portal.
  
        This is a prospective quality evaluation study assessing mobile-based medication
        reconciliation. All adult patients (18 years or older) who are admitted to (a selection of)
        clinical ward in Erasmus Medical Center and who are asked to complete medication
        reconciliation are eligible. In the patient app, patients review ('pre-verify') their
        medications and allergies, after which pharmacy technicians check and manually approve
        ('verify') all patient-entered data and determine whether a follow-up interview is needed.
  
        Feasibility is defined as the successful completion rate of digital medication
        reconciliation, and the need for additional interviews. Time investment by pharmacy
        technicians (and related costs) are determined by timing the duration of all patient-bound
        medication reconciliation-related tasks, both in standard care and when using mobile-based
        reconciliation. The quality of verification is determined by comparing patients' pre-verified
        medication list to pharmacy technician-verified lists. Acceptability is defined as the
        perceived usability of medication reconciliation by patients and by pharmacy technicians.
  observational model: Cohort
  time perspective: Prospective
  measure: Feasibility (1/4): completion rate of digital MR by patients
  time frame: During quality evaluation of the patient app, an average of 3 months
  description: The fraction of all patients who were invited to participate that participated
  measure: Feasibility (2/4): the time it takes patients to perform digital MR (in minutes)
  time frame: During quality evaluation of the patient app, an average of 3 months
  description: To assess the ease-of-use of performing medication reconciliation in the patient app
  measure: Feasibility (3/4): the need for live, follow-up interviews after performing digital MR
  time frame: During quality evaluation of the patient app, an average of 3 months
  description: The fraction of all patients who were invited to participate in digital MR who needed a live interview
  measure: Feasibility (4/4): how often the helpdesk was contacted
  time frame: During quality evaluation of the patient app, an average of 3 months
  description: The fraction of all patients who were invited to participate in digital MR who contact the helpdesk
  measure: The time investment by pharmacy technicians per patient in the digital MR process, compared to the current situation (in minutes)
  time frame: Before launch of the patient app, during an average of 2 months, and during quality evaluation of the patient app, an average of 3 months
  description: The time investment by pharmacy technicians per patient in the new workflow vs. the current situation, in which all patients are invited for a live interview
  measure: The quality of a patient's pre-verified medication list, compared to the pharmacy technician's verified medication list
  time frame: During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
  description: The number of discrepancies between the patient-reported medication list and the pharmacy-verified medication list (the number of changes made by a pharmacy technician in the MR process)
  measure: Acceptability (1/2): defined as the perceived usability of mobile-based MR by patients, assessed using short in-app questionnaires (VAS 1-5)
  time frame: During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
  description: To assess to what extent digital medication reconciliation is accepted by patients
  measure: Acceptability (2/2): defined as the perceived usability of mobile-based MR by patients and pharmacy technicians, assessed using short qualitative interviews with both patients and pharmacy technicians
  time frame: During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
  description: To assess to what extent digital medication reconciliation is accepted by patients and pharmacy technicians
  arm group label: Users of mobile-based medication-reconciliation app
  description: Adult patients (18 years or older) who are asked to complete medication reconciliation before a planned admission to the clinical ward of selected pilot departments in Erasmus Medical Center
  intervention type: Device
  intervention name: Digizorg mobile app (quality evaluation study)
  description: Erasmus Medical Center is developing a state-of-the-art, mobile-based patient portal that combines up-to-date medication lists from all healthcare providers involved in a patient's care. Other functionalities include: accessing health information, viewing and planning appointments, teleconsulting, sending messages, filling in questionnaires, reporting self-measurements, and reading background information on diseases, medication, and other interventions. The patient portal will primarily be implemented in Erasmus Medical Center, and is ultimately intended for every patient, regardless of underlying condition.
  arm group label: Users of mobile-based medication-reconciliation app
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Martijn Brands, MD
  phone: 0031205665675
  email: m.r.brands@erasmusmc.nl
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Alan Abdulla
  investigator title: dr. Alan Abdulla, Principal Investigator
  sharing ipd: Undecided