<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/NCT03786978</url>
  </required_header>
  <id_info>
    <org_study_id>150118</org_study_id>
    <nct_id>NCT03786978</nct_id>
  </id_info>
  <brief_title>Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus</brief_title>
  <official_title>Impact of a Pharmaceutical Care Model in the Reduction of Readmission Rate in Diabetes Melitus Patients in a Public University Hospital, South Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Diabetes mellitus (DM) is associated with the frequent use of polypharmacy at different times&#xD;
      of administration and requires special attention from the patient or caregivers in order to&#xD;
      properly treatment performed. The degree of Functional Literacy in Health is defined as the&#xD;
      ability to apply literacy skills to health-related materials, including prescriptions,&#xD;
      package inserts, and home care instructions. Several questionnaires are used in research and&#xD;
      clinical practice to assess the pronunciation and understanding of commonly used medical&#xD;
      terms, as the SAHLPA-18 (Short Assessment of Health Literacy for Portuguese Speaking Adults).&#xD;
      The Brief Medication Questionnaire (BMQ) evaluates adherence to medication use from a&#xD;
      patient's perspective.&#xD;
&#xD;
      During the basal visit, after the characterization of the sample (n= 100), inpatients from&#xD;
      Hospital de Clínicas de Porto Alegre (HCPA) were randomized to interventional or comparator&#xD;
      group. The interventional group was follow up during a year after basal discharge. Comparator&#xD;
      group received only a phone call, 30 days after the basal discharge, to question how was&#xD;
      their healthy status. Readmission rates were evaluated for both groups. Also, a economic&#xD;
      evaluation was made to measure the readmission rates in terms of costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first outcome of the clinical study was to measure the readmission rate through a&#xD;
      structured pharmaceutical care model after basal hospital discharge and measure the effect of&#xD;
      this intervention in terms of readmission reduction in a short term period of 30 days,&#xD;
      regardless of the hospitalization reason.&#xD;
&#xD;
      As secondary outcomes the investigators measured the readmission rates after basal hospital&#xD;
      discharge and the effect of the intervention in terms of readmission reduction in 60, 90,180&#xD;
      and 365 days after basal hospital discharge. Also, the readmission costs in terms of&#xD;
      cost-effectiveness were evaluate.&#xD;
&#xD;
      The sample consisted of 100 patients with DM associated with other comorbidities,&#xD;
      hospitalized for any reason in the HCPA, of both sexes, older than 18 years.&#xD;
&#xD;
      Informed consent, demographic and validated questionnaires data were collected in the basal&#xD;
      visit. After that, patients were randomized to:&#xD;
&#xD;
      Group 1: comparator; Group 2: structured pharmaceutical intervention.&#xD;
&#xD;
      Seven days after basal hospital discharge, drugs adherence was verified.&#xD;
&#xD;
      The interventional group received pharmaceutical care at basal hospitalization stay, after&#xD;
      randomization, have their prescription reviewed until 7 days after discharge of basal&#xD;
      hospitalization and also received structured phone calls and mobile SMS (Short Message&#xD;
      Service) during one year follow up (30, 60, 180 and 365 days).&#xD;
&#xD;
      Electronic medical records of the included patients (intervention and comparator groups) were&#xD;
      reviewed monthly for 12 months, aiming to identify access to emergency services or hospital&#xD;
      readmissions at the HCPA and, consequently, the reasons for readmissions and outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2015</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Randomized clinical trial study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor made a blind evaluation from the study outcomes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Short term readmission rate</measure>
    <time_frame>30 days after basal hospital discharge</time_frame>
    <description>Hospital readmissions after basal hospital discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission rate - 60 days</measure>
    <time_frame>60 days after basal hospital discharge</time_frame>
    <description>Hospital readmissions after basal hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate - 90 days</measure>
    <time_frame>90 days after basal hospital discharge</time_frame>
    <description>Hospital readmissions after basal hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term readmission rate- 180 days</measure>
    <time_frame>180 days after basal hospital discharge</time_frame>
    <description>Hospital readmissions after basal hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term readmission rate- 365 days</measure>
    <time_frame>365 days after basal hospital discharge</time_frame>
    <description>Hospital readmissions after basal hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic evaluation</measure>
    <time_frame>365 days</time_frame>
    <description>Comparison between costs from readmission in both randomized groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Structured pharmaceutical care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive a structured pharmaceutical care until one year after hospital discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient received a single phone call 30 days after basal hospital discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured pharmaceutical care</intervention_name>
    <description>Patients receive a structured pharmaceutical care from one year after basal hospital discharge</description>
    <arm_group_label>Structured pharmaceutical care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comparator</intervention_name>
    <description>Patient received a single phone call 30 days after basal hospital discharge.</description>
    <arm_group_label>Comparator group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with DM and other comorbidities hospitalized for any reason at HCPA&#xD;
&#xD;
          -  Patients who are literate or have a literate caregiver;&#xD;
&#xD;
          -  Signature in the Term of Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Limited ability to communicate and read in Portuguese and absence of responsible&#xD;
             caregiver at the patient room;&#xD;
&#xD;
          -  Neuropsychiatric diseases (psychosis, delirium or severe dementia);&#xD;
&#xD;
          -  Terminal illness;&#xD;
&#xD;
          -  Transplanted patients or users of warfarin, as these patients receive formal guidance&#xD;
             from the HCPA pharmaceutical team;&#xD;
&#xD;
          -  Auditory or visual impairment that, at the discretion of the investigator, prevents&#xD;
             the patient from participating in the study;&#xD;
&#xD;
          -  Do not have own mobile number or a close family member living in the same household.&#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>Ticiana C Rodrigues, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Health Science of Porto Alegre</affiliation>
  </overall_official>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes mellitus</keyword>
  <keyword>Pharmaceutical care</keyword>
  <keyword>Educational intervention</keyword>
  <keyword>Pharmacoeconomic evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <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/NCT03786978
org study id: 150118
nct id: NCT03786978
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes mellitus (DM) is associated with the frequent use of polypharmacy at different times
      of administration and requires special attention from the patient or caregivers in order to
      properly treatment performed. The degree of Functional Literacy in Health is defined as the
      ability to apply literacy skills to health-related materials, including prescriptions,
      package inserts, and home care instructions. Several questionnaires are used in research and
      clinical practice to assess the pronunciation and understanding of commonly used medical
      terms, as the SAHLPA-18 (Short Assessment of Health Literacy for Portuguese Speaking Adults).
      The Brief Medication Questionnaire (BMQ) evaluates adherence to medication use from a
      patient's perspective.

      During the basal visit, after the characterization of the sample (n= 100), inpatients from
      Hospital de Clínicas de Porto Alegre (HCPA) were randomized to interventional or comparator
      group. The interventional group was follow up during a year after basal discharge. Comparator
      group received only a phone call, 30 days after the basal discharge, to question how was
      their healthy status. Readmission rates were evaluated for both groups. Also, a economic
      evaluation was made to measure the readmission rates in terms of costs.
The first outcome of the clinical study was to measure the readmission rate through a
      structured pharmaceutical care model after basal hospital discharge and measure the effect of
      this intervention in terms of readmission reduction in a short term period of 30 days,
      regardless of the hospitalization reason.

      As secondary outcomes the investigators measured the readmission rates after basal hospital
      discharge and the effect of the intervention in terms of readmission reduction in 60, 90,180
      and 365 days after basal hospital discharge. Also, the readmission costs in terms of
      cost-effectiveness were evaluate.

      The sample consisted of 100 patients with DM associated with other comorbidities,
      hospitalized for any reason in the HCPA, of both sexes, older than 18 years.

      Informed consent, demographic and validated questionnaires data were collected in the basal
      visit. After that, patients were randomized to:

      Group 1: comparator; Group 2: structured pharmaceutical intervention.

      Seven days after basal hospital discharge, drugs adherence was verified.

      The interventional group received pharmaceutical care at basal hospitalization stay, after
      randomization, have their prescription reviewed until 7 days after discharge of basal
      hospitalization and also received structured phone calls and mobile SMS (Short Message
      Service) during one year follow up (30, 60, 180 and 365 days).

      Electronic medical records of the included patients (intervention and comparator groups) were
      reviewed monthly for 12 months, aiming to identify access to emergency services or hospital
      readmissions at the HCPA and, consequently, the reasons for readmissions and outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial study
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor made a blind evaluation from the study outcomes.
measure: Short term readmission rate
time frame: 30 days after basal hospital discharge
description: Hospital readmissions after basal hospital discharge
measure: Readmission rate - 60 days
time frame: 60 days after basal hospital discharge
description: Hospital readmissions after basal hospital discharge
measure: Readmission rate - 90 days
time frame: 90 days after basal hospital discharge
description: Hospital readmissions after basal hospital discharge
measure: Long term readmission rate- 180 days
time frame: 180 days after basal hospital discharge
description: Hospital readmissions after basal hospital discharge
measure: Long term readmission rate- 365 days
time frame: 365 days after basal hospital discharge
description: Hospital readmissions after basal hospital discharge
measure: Economic evaluation
time frame: 365 days
description: Comparison between costs from readmission in both randomized groups
arm group label: Structured pharmaceutical care
arm group type: Experimental
description: Patients receive a structured pharmaceutical care until one year after hospital discharge
arm group label: Comparator group
arm group type: Active Comparator
description: Patient received a single phone call 30 days after basal hospital discharge.
intervention type: Behavioral
intervention name: Structured pharmaceutical care
description: Patients receive a structured pharmaceutical care from one year after basal hospital discharge
arm group label: Structured pharmaceutical care
intervention type: Behavioral
intervention name: Comparator
description: Patient received a single phone call 30 days after basal hospital discharge.
arm group label: Comparator group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ticiana C Rodrigues, PhD
role: Principal Investigator
affiliation: Federal University of Health Science of Porto Alegre
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: No