<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/NCT03829995</url>
  </required_header>
  <id_info>
    <org_study_id>H-18003889</org_study_id>
    <nct_id>NCT03829995</nct_id>
  </id_info>
  <brief_title>Effect of Pharmacist Provided Drug Information Services After Hospital Discharge</brief_title>
  <official_title>Effect of Pharmacist Provided Drug Information Services After Hospital Discharge: Patient Satisfaction and Sense Of Security Regarding Drug Treatment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Hovedstadens Apotek</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospitals Pharmacies' and Amgros' Research Development Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Hovedstadens Apotek</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective:&#xD;
&#xD;
      The aim of this study is to evaluate if offering drug counseling from a hospital pharmacy&#xD;
      increases patient satisfaction and sense of security regarding drug treatment after hospital&#xD;
      discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Method and design:&#xD;
&#xD;
      This study was estimated to include 250 participants in a clinical randomized controlled&#xD;
      trial. The participants were included from the Acute Medical Ward and the Department of&#xD;
      Respiratory Medicine at Bispebjerg Hospital when discharged. The participants were randomized&#xD;
      to one of two groups with unequal sizes: the control (50 participants) or intervention group&#xD;
      (200 participants). This study used blocked randomization with block sizes of 5/10/15/20/25.&#xD;
      The control group received the normal care following the Danish standard procedure.&#xD;
      Participants in the intervention group also received the normal care but was also offered the&#xD;
      possibility to contact a hospital pharmacy department by phone or mail and ask questions&#xD;
      regarding drug-related issues.&#xD;
&#xD;
      Data for the primary outcome measures was collected 14 days after discharge through&#xD;
      structured phone interviews. An interview guide with a semi-structured questionnaire and&#xD;
      already validated questions were developed, pre-tested and optimized. The participants were&#xD;
      asked to answer open-ended questions, closed-ended question and rate statements or questions&#xD;
      on a five-point scale.&#xD;
&#xD;
      The participants in the control group were asked to answer 13 items (seven questions or&#xD;
      statements on a five-point scale, four closed-ended questions and two open-ended questions).&#xD;
&#xD;
      The participants in the intervention group who did not make any queries were asked the same&#xD;
      questions as the participants in the control group and additionally three closed-ended&#xD;
      questions. A total of 16 items.&#xD;
&#xD;
      The participants in the intervention group who made queries were asked the same questions as&#xD;
      the participants in the intervention group who did not make any queries and additionally five&#xD;
      questions on a five-point scale, four closed-ended and one open-ended question. A total of 27&#xD;
      items.&#xD;
&#xD;
      The effect of the drug counseling regarding patient safety was evaluated by a pharmaceutical&#xD;
      assessment in which it was assessed whether the drug counseling had potentially prevented a&#xD;
      drug-related problem.&#xD;
&#xD;
      Quantitative data from the phone interviews will be analyzed in Microsoft excel with&#xD;
      descriptive statistics and simple parametric statistics. An analysis will determine whether&#xD;
      there is a difference in the primary outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2018</start_date>
  <completion_date type="Actual">June 3, 2019</completion_date>
  <primary_completion_date type="Actual">June 3, 2019</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>
    <intervention_model_description>The intervention group is compared with the control group.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The study is a open-label trial. The pharmacist know, whether the patient is randomized to the intervention group or the control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Sense of security regarding drug treatment and satisfaction with drug counseling.</measure>
    <time_frame>2-4 weeks after discharge.</time_frame>
    <description>The questionnaire comprised closed-ended questions, open-ended questions and questions or statements where the respondents were asked to rate the questions or statements on a five-point scale. The scale used is a attitude measurement scale that assess attitudes by presenting respondents with sentences that state beliefs about the particular attitude being measured. The respondents then decide to what extent he or she agrees with the statement. The responses are divided numerically into a series of ordered responses. Ratings: 1 = not at all, 2 = to a small extent, 3 = to some extent, 4 = to a great extent, 5 = to a very great extent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of medications by admission.</measure>
    <time_frame>Within one week after discharge.</time_frame>
    <description>Number of medications will be read in admission report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of medications by discharge.</measure>
    <time_frame>Within one week after discharge.</time_frame>
    <description>Number of medications will be read in discharge report..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients that received medication review by pharmacist during admission.</measure>
    <time_frame>Within one week after discharge.</time_frame>
    <description>The patient's journal will be searched for a medication review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients that received help with medication at home after discharge.</measure>
    <time_frame>Within one week after discharge.</time_frame>
    <description>The patient's journal will be searched for information regarding help with medication at home.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of enquiries.</measure>
    <time_frame>Directly after the patient received drug counseling.</time_frame>
    <description>Patient enquiries will be classified to one of the predefined categories: adverse effects, choice of therapy, dosage and administration, interactions, product information, storage and handling, indication or other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of potentially prevented drug-related problems.</measure>
    <time_frame>Directly after the patient received drug counseling.</time_frame>
    <description>The pharmacist that performed the drug counseling assessed whether the drug counseling had potentially prevented a drug-related problem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cause of hospitalization.</measure>
    <time_frame>Within one week after discharge.</time_frame>
    <description>The patient's journal will be searched for cause of hospitalization.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Drug Counseling</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group received the normal care following the Danish standard procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the intervention group received the normal care following the Danish stadard procedure. Additionally the participants was also offered the possibility to contact a hospital pharmacy department by phone or mail for drug counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Drug counseling</intervention_name>
    <description>Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients discharged from the acute medical ward and department of respiratory medicine&#xD;
             at Bispebjerg Hospital.&#xD;
&#xD;
          -  Patients discharged to own home.&#xD;
&#xD;
          -  Can speak the danish language.&#xD;
&#xD;
          -  ≥18 years old.&#xD;
&#xD;
          -  Can be contacted by phone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive and communicative problems (e.g. dementia, aphasia, suicidal) or other&#xD;
             barriers that unable the participant to use the intervention service.&#xD;
&#xD;
          -  Patient does not answer phone within five attempts on five different days, when trying&#xD;
             to conduct patient interview.&#xD;
&#xD;
          -  Cognitive and communicative problems that unable the participant to answer questions&#xD;
             in the patient interview.&#xD;
&#xD;
          -  Deceased or readmitted before patient interview.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tim E Vejborg, M.Sc.Pharm</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Hovedstadens Apotek</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Capital Regions Hospital Pharmacy</name>
      <address>
        <city>Copenhagen</city>
        <state>København NV</state>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>June 4, 2019</last_update_submitted>
  <last_update_submitted_qc>June 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Hovedstadens Apotek</investigator_affiliation>
    <investigator_full_name>Tim Emil Vejborg</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03829995
org study id: H-18003889
nct id: NCT03829995
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective:

      The aim of this study is to evaluate if offering drug counseling from a hospital pharmacy
      increases patient satisfaction and sense of security regarding drug treatment after hospital
      discharge.
Method and design:

      This study was estimated to include 250 participants in a clinical randomized controlled
      trial. The participants were included from the Acute Medical Ward and the Department of
      Respiratory Medicine at Bispebjerg Hospital when discharged. The participants were randomized
      to one of two groups with unequal sizes: the control (50 participants) or intervention group
      (200 participants). This study used blocked randomization with block sizes of 5/10/15/20/25.
      The control group received the normal care following the Danish standard procedure.
      Participants in the intervention group also received the normal care but was also offered the
      possibility to contact a hospital pharmacy department by phone or mail and ask questions
      regarding drug-related issues.

      Data for the primary outcome measures was collected 14 days after discharge through
      structured phone interviews. An interview guide with a semi-structured questionnaire and
      already validated questions were developed, pre-tested and optimized. The participants were
      asked to answer open-ended questions, closed-ended question and rate statements or questions
      on a five-point scale.

      The participants in the control group were asked to answer 13 items (seven questions or
      statements on a five-point scale, four closed-ended questions and two open-ended questions).

      The participants in the intervention group who did not make any queries were asked the same
      questions as the participants in the control group and additionally three closed-ended
      questions. A total of 16 items.

      The participants in the intervention group who made queries were asked the same questions as
      the participants in the intervention group who did not make any queries and additionally five
      questions on a five-point scale, four closed-ended and one open-ended question. A total of 27
      items.

      The effect of the drug counseling regarding patient safety was evaluated by a pharmaceutical
      assessment in which it was assessed whether the drug counseling had potentially prevented a
      drug-related problem.

      Quantitative data from the phone interviews will be analyzed in Microsoft excel with
      descriptive statistics and simple parametric statistics. An analysis will determine whether
      there is a difference in the primary outcome measures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The intervention group is compared with the control group.
primary purpose: Health Services Research
masking: None (Open Label)
masking description: The study is a open-label trial. The pharmacist know, whether the patient is randomized to the intervention group or the control group.
measure: Sense of security regarding drug treatment and satisfaction with drug counseling.
time frame: 2-4 weeks after discharge.
description: The questionnaire comprised closed-ended questions, open-ended questions and questions or statements where the respondents were asked to rate the questions or statements on a five-point scale. The scale used is a attitude measurement scale that assess attitudes by presenting respondents with sentences that state beliefs about the particular attitude being measured. The respondents then decide to what extent he or she agrees with the statement. The responses are divided numerically into a series of ordered responses. Ratings: 1 = not at all, 2 = to a small extent, 3 = to some extent, 4 = to a great extent, 5 = to a very great extent.
measure: Number of medications by admission.
time frame: Within one week after discharge.
description: Number of medications will be read in admission report.
measure: Number of medications by discharge.
time frame: Within one week after discharge.
description: Number of medications will be read in discharge report..
measure: Number of patients that received medication review by pharmacist during admission.
time frame: Within one week after discharge.
description: The patient's journal will be searched for a medication review.
measure: Number of patients that received help with medication at home after discharge.
time frame: Within one week after discharge.
description: The patient's journal will be searched for information regarding help with medication at home.
measure: Number of enquiries.
time frame: Directly after the patient received drug counseling.
description: Patient enquiries will be classified to one of the predefined categories: adverse effects, choice of therapy, dosage and administration, interactions, product information, storage and handling, indication or other.
measure: Number of potentially prevented drug-related problems.
time frame: Directly after the patient received drug counseling.
description: The pharmacist that performed the drug counseling assessed whether the drug counseling had potentially prevented a drug-related problem.
measure: Cause of hospitalization.
time frame: Within one week after discharge.
description: The patient's journal will be searched for cause of hospitalization.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group received the normal care following the Danish standard procedure.
arm group label: Intervention group
arm group type: Active Comparator
description: Participants in the intervention group received the normal care following the Danish stadard procedure. Additionally the participants was also offered the possibility to contact a hospital pharmacy department by phone or mail for drug counseling.
intervention type: Other
intervention name: Drug counseling
description: Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tim E Vejborg, M.Sc.Pharm
role: Principal Investigator
affiliation: Region Hovedstadens Apotek
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Region Hovedstadens Apotek
investigator full name: Tim Emil Vejborg
investigator title: Principal Investigator