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/NCT06016140</url>
    </required_header>
    <id_info>
      <org_study_id>2022-04430-01</org_study_id>
      <nct_id>NCT06016140</nct_id>
    </id_info>
    <brief_title>A Medication Plan for Safer Medication Treatment in Older Persons</brief_title>
    <official_title>Applying a Medication Plan for Safer Medication Treatment in Older Persons - a Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Jönköping County</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jonkoping University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Region Jönköping County</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>
        Harm from medications is still a concern in an aged population. As medication treatment for&#xD;
        older persons many times are complex, a feasibility study can be helpful to support decisions&#xD;
        about future evaluation and implementation of an intervention.&#xD;
  &#xD;
        In this study, the overall aim is to assess feasibility, acceptability and potential effects&#xD;
        of usage of a co-designed medication plan for older persons with medication treatment.&#xD;
  &#xD;
        The study will take place in the primary care setting in Sweden, and involve persons 75 years&#xD;
        or older using five or more medications on daily basis, physicians at primary care centers&#xD;
        and persons supporting the older person in their medication use a home.&#xD;
  &#xD;
        During an appointment, the physician and older person will agree on a medication plan, that&#xD;
        will be documented in the older person's electronic health record and printed out on paper.&#xD;
  &#xD;
        After three month, the potential outcomes of a medication plan will be collected, together&#xD;
        with data about feasibility and acceptability of the intervention. Two questionnaires will be&#xD;
        used, addressing usability and patient safety. Moreover, remote interviews with participants&#xD;
        will be performed to address usability and patient safety. Information about the medication&#xD;
        plan will be collected from the electronic health record. Data analysis will be done with&#xD;
        descriptive statistics and qualitative content analysis.&#xD;
  &#xD;
        Expected outcomes are an assessment of feasibility and acceptability, and potential outcomes,&#xD;
        to support decision on a future evaluation of the medication plan.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</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>Feasibility of the intervention</measure>
      <time_frame>Three months</time_frame>
      <description>For feasibility of the intervention, the secondary outcome measures will be analyzed together to address the feasibility of chosen study methods and of the intervention of using a co-designed medication plan</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Usability of the medication plan</measure>
      <time_frame>Three months</time_frame>
      <description>A modified version of Brookes &quot;The System Usability Scale, SUS&quot; will be used to measure usability of the medication plan. SUS is a widely used questionnaire for measuring the perception of the user experience and has been translated and evaluated in Swedish. The questions will be distributed by e-mail or mail (which is preferred of the participants) at the end of the three-month follow-up period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability of the medication plan</measure>
      <time_frame>Three months</time_frame>
      <description>Semi-structured interviews, with questions addressing usability will be conducted with participants (older persons, next-of-kin, physicians, nurses) at the end of the three-month follow-up period. The interview guide will be guided by topics addressed in SUS. A strategic selection of all participants will be used to gather different experiences. The interviews will be audio-recorded and then will be transcribed verbatim.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient safety</measure>
      <time_frame>Three months</time_frame>
      <description>We will use a selected number of questions, which addresses concerns related to safety, from the Swedish National Patient survey in primary care, and ask the older persons to complete the questionnaire. No similar measurement will be used for healthcare professionals and next-of-kin.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient safety</measure>
      <time_frame>Three months</time_frame>
      <description>We will complement the questionnaire with semi-structured interviews performed with older persons, nurses, next-of-kin and physicians. Questions addressing patient safety will be asked to the same population and at the same occasion as the interviews about usability. The interview guide will be guided by questions in the Swedish National Patient survey and inspired by indicators for safety monitoring in healthcare as proposed by Vincent et al.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of the intervention</measure>
      <time_frame>Three months</time_frame>
      <description>Acceptability of the intervention will be assessed by collecting the number of completed and adjusted medication plans, the content in the medication plans and medications prescribed for each older person during the follow up period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare utilisation</measure>
      <time_frame>Three months</time_frame>
      <description>Healthcare utilisation will be measured as number and cause, of hospital admission, emergency visits and unplanned physician visits during the follow up period</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Patient Safety</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Medication Plan Prototype</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Medication plan</intervention_name>
      <description>Involved participants will jointly agreed on continued medication treatment (treatment aim, planned monitring and evaluation and responsibility, and the physician will document the plan in the electronic health record</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Physicians and nurses: regular contact with the older person regarding medications,&#xD;
               employment at a primary care center and ability to understand and communicate in&#xD;
               Swedish&#xD;
  &#xD;
            -  Older persons: age &gt;75 years old, five or more medications on a regular basis and&#xD;
               ability to understand and communicate in Swedish&#xD;
  &#xD;
            -  Next-of-kin: age &gt; 18 years old, regular contact with the older person regarding&#xD;
               medications, ability to understand and communicate in Swedish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Older persons: impaired cognitive ability affecting the ability to provide informed&#xD;
               consent (Diagnosis code for dementia) and late palliative phase, here defined as&#xD;
               estimated life expectancy shorter than six months&#xD;
  &#xD;
            -  Next-of-kin: impaired cognitive ability affecting the ability to provide informed&#xD;
               consent&#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>Malin Holmqvist</last_name>
      <role>Principal Investigator</role>
      <affiliation>Region Jönköping County</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Region Jonkoping County</name>
        <address>
          <city>Jönköping</city>
          <zip>55185</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Region Jönköping County</investigator_affiliation>
      <investigator_full_name>Malin Holmqvist</investigator_full_name>
      <investigator_title>PhD student, pharmacist</investigator_title>
    </responsible_party>
    <keyword>aged</keyword>
    <keyword>medication</keyword>
    <keyword>feasibility study</keyword>
    <keyword>primary care</keyword>
    <patient_data>
      <sharing_ipd>No</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/NCT06016140
  org study id: 2022-04430-01
  nct id: NCT06016140
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Harm from medications is still a concern in an aged population. As medication treatment for
        older persons many times are complex, a feasibility study can be helpful to support decisions
        about future evaluation and implementation of an intervention.
  
        In this study, the overall aim is to assess feasibility, acceptability and potential effects
        of usage of a co-designed medication plan for older persons with medication treatment.
  
        The study will take place in the primary care setting in Sweden, and involve persons 75 years
        or older using five or more medications on daily basis, physicians at primary care centers
        and persons supporting the older person in their medication use a home.
  
        During an appointment, the physician and older person will agree on a medication plan, that
        will be documented in the older person's electronic health record and printed out on paper.
  
        After three month, the potential outcomes of a medication plan will be collected, together
        with data about feasibility and acceptability of the intervention. Two questionnaires will be
        used, addressing usability and patient safety. Moreover, remote interviews with participants
        will be performed to address usability and patient safety. Information about the medication
        plan will be collected from the electronic health record. Data analysis will be done with
        descriptive statistics and qualitative content analysis.
  
        Expected outcomes are an assessment of feasibility and acceptability, and potential outcomes,
        to support decision on a future evaluation of the medication plan.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Feasibility of the intervention
  time frame: Three months
  description: For feasibility of the intervention, the secondary outcome measures will be analyzed together to address the feasibility of chosen study methods and of the intervention of using a co-designed medication plan
  measure: Usability of the medication plan
  time frame: Three months
  description: A modified version of Brookes "The System Usability Scale, SUS" will be used to measure usability of the medication plan. SUS is a widely used questionnaire for measuring the perception of the user experience and has been translated and evaluated in Swedish. The questions will be distributed by e-mail or mail (which is preferred of the participants) at the end of the three-month follow-up period.
  measure: Usability of the medication plan
  time frame: Three months
  description: Semi-structured interviews, with questions addressing usability will be conducted with participants (older persons, next-of-kin, physicians, nurses) at the end of the three-month follow-up period. The interview guide will be guided by topics addressed in SUS. A strategic selection of all participants will be used to gather different experiences. The interviews will be audio-recorded and then will be transcribed verbatim.
  measure: Patient safety
  time frame: Three months
  description: We will use a selected number of questions, which addresses concerns related to safety, from the Swedish National Patient survey in primary care, and ask the older persons to complete the questionnaire. No similar measurement will be used for healthcare professionals and next-of-kin.
  measure: Patient safety
  time frame: Three months
  description: We will complement the questionnaire with semi-structured interviews performed with older persons, nurses, next-of-kin and physicians. Questions addressing patient safety will be asked to the same population and at the same occasion as the interviews about usability. The interview guide will be guided by questions in the Swedish National Patient survey and inspired by indicators for safety monitoring in healthcare as proposed by Vincent et al.
  measure: Acceptability of the intervention
  time frame: Three months
  description: Acceptability of the intervention will be assessed by collecting the number of completed and adjusted medication plans, the content in the medication plans and medications prescribed for each older person during the follow up period
  measure: Healthcare utilisation
  time frame: Three months
  description: Healthcare utilisation will be measured as number and cause, of hospital admission, emergency visits and unplanned physician visits during the follow up period
  arm group label: Intervention group
  arm group type: Experimental
  description: Medication Plan Prototype
  intervention type: Other
  intervention name: Medication plan
  description: Involved participants will jointly agreed on continued medication treatment (treatment aim, planned monitring and evaluation and responsibility, and the physician will document the plan in the electronic health record
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Malin Holmqvist
  role: Principal Investigator
  affiliation: Region Jönköping County
  facility: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Region Jönköping County
  investigator full name: Malin Holmqvist
  investigator title: PhD student, pharmacist
  sharing ipd: No