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/NCT05988229</url>
    </required_header>
    <id_info>
      <org_study_id>H-43873</org_study_id>
      <nct_id>NCT05988229</nct_id>
    </id_info>
    <brief_title>Tools to Improve Discharge Equity (TIDE) Pilot RCT</brief_title>
    <acronym>TIDE</acronym>
    <official_title>Tools to Improve Discharge Equity (TIDE) at Hospital Discharge for Patients With Limited English Proficiency: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boston 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>
        The investigators will test the impact of a package of linguistically appropriate discharge&#xD;
        teaching tools against current standard of care for patients with Limited English proficiency&#xD;
        (LEP) in an unblinded randomized controlled trial. The tools include an expanded medication&#xD;
        calendar in English and the patients' preferred language, pictographics to illustrate return&#xD;
        precautions (what signs/symptoms require further evaluation), an audio recording of the nurse&#xD;
        reviewing the After Visit Summary (composed by providers) to allow for review by patients and&#xD;
        caretakers after discharge.&#xD;
  &#xD;
        The investigators will evaluate the effectiveness of the package of discharge teaching tools&#xD;
        on patients' understanding/recall, key implementation outcomes, and secondary clinical&#xD;
        outcomes via a structured interview 1-2 weeks after discharge and chart review 30 days after&#xD;
        discharge.&#xD;
  &#xD;
        The objectives of this research study are:&#xD;
  &#xD;
          1. test the effectiveness of a linguistically appropriate toolkit for improving patient&#xD;
             understanding of discharge instruction content&#xD;
  &#xD;
          2. Assess the feasibility and fidelity of the intervention in anticipation of a multi-site&#xD;
             implementation trial&#xD;
  &#xD;
          3. assess the feasibility and appropriateness of the linguistically appropriate toolkit to&#xD;
             nurses and in-person interpreters&#xD;
  &#xD;
          4. to assess the acceptability of the intervention to patients and their satisfaction with&#xD;
             it&#xD;
  &#xD;
          5. to collect data on implementation context in anticipation for a multi-site trial&#xD;
  &#xD;
          6. to collect preliminary data on the toolkit's impact on clinical outcomes including&#xD;
             medication adherence and hospital re-utilization.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>Block randomization stratified by language and level of care (observation unit versus inpatient floor)</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient understanding of discharge instructions</measure>
      <time_frame>1-2 weeks post discharge</time_frame>
      <description>Assessed by a composite score of six key domains of discharge instructions (primary diagnosis, self-care instructions, return precautions, medication changes, medication indications, follow-up) as determined by two physician adjudicators (1=poor, 4 = near perfect). Higher scores demonstrate better understanding.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient understanding of primary diagnosis of hospitalization</measure>
      <time_frame>1-2 weeks post discharge</time_frame>
      <description>Determined by two physician adjudicators (1=poor, 4 = near perfect). Higher scores demonstrate better understanding.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Implementation effectiveness</measure>
      <time_frame>18 months</time_frame>
      <description>Effectiveness will be assessed by observations of and comments from patients, nurses and visitors from qualitative interviews related to the adoption, acceptability, appropriateness, and feasibility of the discharge process</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medication adherence</measure>
      <time_frame>1-2 weeks</time_frame>
      <description>This outcome will be assessed using the modified Morisky Medication Adherence Scale (MMAS-8) which is an 8 item instrument. Each scale comprises five items that are scored on a Likert-type scale, where 1 = strongly disagree, 2 = disagree, 3 = uncertain, 4 = agree and 5 = strongly agree. Higher scores indicate stronger beliefs in the necessity of medication and greater concerns about taking it.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital re-utilization</measure>
      <time_frame>30 days</time_frame>
      <description>Assessed by a combined outcome of admission or emergency department (ED) visit within 30 days of index discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with completion of primary care follow-up</measure>
      <time_frame>30 days</time_frame>
      <description>Assessed from participants' medical records</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant participation in discharge teaching</measure>
      <time_frame>1-2 weeks</time_frame>
      <description>Participants are observed by a research team member during discharge teaching and will document the number of questions asked.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">196</enrollment>
    <condition>Hospital Discharge</condition>
    <arm_group>
      <arm_group_label>Discharge equity tools</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized into this arn will receive the toolkit of linguistically appropriate discharge teaching aids at hospital discharge.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of hospital discharge care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants randomized into this arm will receive the standard of care at hospital discharge.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Toolkit to improve discharge equity</intervention_name>
      <description>Linguistically appropriate discharge teaching aids: a medication calendar, pictographics added to the after visit summary (AVS), and an audio recording of the discharge teaching.</description>
      <arm_group_label>Discharge equity tools</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients&#xD;
  &#xD;
            -  Labeled in medical record as preferring one of the following four languages: Spanish,&#xD;
               Haitian Creole, Cape Verdean Creole, or Vietnamese&#xD;
  &#xD;
            -  Admitted to medicine team at BMC&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Being discharged home (to the community)&#xD;
  &#xD;
            -  Admitted to Boston Medical Center (BMC) hospital units (Menino 7 East, 7 West, and&#xD;
               Menino Observation)&#xD;
  &#xD;
          Nurses and Interpreters&#xD;
  &#xD;
            -  Caring for patient enrolled in trial&#xD;
  &#xD;
          Family/Visitors&#xD;
  &#xD;
            -  Present at time of discharge for patient enrolled in trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients&#xD;
  &#xD;
            -  On airborne infections precautions&#xD;
  &#xD;
            -  On clostridium difficile (C diff) precautions&#xD;
  &#xD;
            -  On suicide precautions&#xD;
  &#xD;
            -  Nurse report of participant displaying cognitive impairment, delirium, or aggression&#xD;
  &#xD;
            -  Enrolled in trial during a prior admission&#xD;
  &#xD;
          Nurses and Interpreters&#xD;
  &#xD;
            -  None&#xD;
  &#xD;
          Family/Visitors&#xD;
  &#xD;
            -  None&#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>Kirsten Austad, MD MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Boston Medical Center, Family Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kirsten Austad, MD MPH</last_name>
      <phone>(617) 414-4459</phone>
      <email>kirsten.austad@bmc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Brian Jack, MD</last_name>
      <email>brian.jack@bmc.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Boston Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02118</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kirsten Austad, MD MPH</last_name>
        <phone>817-414-4459</phone>
        <email>kirsten.austad@bmc.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Limited English proficiency</keyword>
    <keyword>Hospital Discharge Teaching</keyword>
    <keyword>Spanish speaking</keyword>
    <keyword>Haitian Creole speaking</keyword>
    <keyword>Cape Verdean Creole speaking</keyword>
    <keyword>Vietnamese speaking</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/NCT05988229
  org study id: H-43873
  nct id: NCT05988229
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators will test the impact of a package of linguistically appropriate discharge
        teaching tools against current standard of care for patients with Limited English proficiency
        (LEP) in an unblinded randomized controlled trial. The tools include an expanded medication
        calendar in English and the patients' preferred language, pictographics to illustrate return
        precautions (what signs/symptoms require further evaluation), an audio recording of the nurse
        reviewing the After Visit Summary (composed by providers) to allow for review by patients and
        caretakers after discharge.
  
        The investigators will evaluate the effectiveness of the package of discharge teaching tools
        on patients' understanding/recall, key implementation outcomes, and secondary clinical
        outcomes via a structured interview 1-2 weeks after discharge and chart review 30 days after
        discharge.
  
        The objectives of this research study are:
  
          1. test the effectiveness of a linguistically appropriate toolkit for improving patient
             understanding of discharge instruction content
  
          2. Assess the feasibility and fidelity of the intervention in anticipation of a multi-site
             implementation trial
  
          3. assess the feasibility and appropriateness of the linguistically appropriate toolkit to
             nurses and in-person interpreters
  
          4. to assess the acceptability of the intervention to patients and their satisfaction with
             it
  
          5. to collect data on implementation context in anticipation for a multi-site trial
  
          6. to collect preliminary data on the toolkit's impact on clinical outcomes including
             medication adherence and hospital re-utilization.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Block randomization stratified by language and level of care (observation unit versus inpatient floor)
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Patient understanding of discharge instructions
  time frame: 1-2 weeks post discharge
  description: Assessed by a composite score of six key domains of discharge instructions (primary diagnosis, self-care instructions, return precautions, medication changes, medication indications, follow-up) as determined by two physician adjudicators (1=poor, 4 = near perfect). Higher scores demonstrate better understanding.
  measure: Patient understanding of primary diagnosis of hospitalization
  time frame: 1-2 weeks post discharge
  description: Determined by two physician adjudicators (1=poor, 4 = near perfect). Higher scores demonstrate better understanding.
  measure: Implementation effectiveness
  time frame: 18 months
  description: Effectiveness will be assessed by observations of and comments from patients, nurses and visitors from qualitative interviews related to the adoption, acceptability, appropriateness, and feasibility of the discharge process
  measure: Medication adherence
  time frame: 1-2 weeks
  description: This outcome will be assessed using the modified Morisky Medication Adherence Scale (MMAS-8) which is an 8 item instrument. Each scale comprises five items that are scored on a Likert-type scale, where 1 = strongly disagree, 2 = disagree, 3 = uncertain, 4 = agree and 5 = strongly agree. Higher scores indicate stronger beliefs in the necessity of medication and greater concerns about taking it.
  measure: Hospital re-utilization
  time frame: 30 days
  description: Assessed by a combined outcome of admission or emergency department (ED) visit within 30 days of index discharge
  measure: Number of participants with completion of primary care follow-up
  time frame: 30 days
  description: Assessed from participants' medical records
  measure: Participant participation in discharge teaching
  time frame: 1-2 weeks
  description: Participants are observed by a research team member during discharge teaching and will document the number of questions asked.
  arm group label: Discharge equity tools
  arm group type: Experimental
  description: Participants randomized into this arn will receive the toolkit of linguistically appropriate discharge teaching aids at hospital discharge.
  arm group label: Standard of hospital discharge care
  arm group type: No Intervention
  description: Participants randomized into this arm will receive the standard of care at hospital discharge.
  intervention type: Other
  intervention name: Toolkit to improve discharge equity
  description: Linguistically appropriate discharge teaching aids: a medication calendar, pictographics added to the after visit summary (AVS), and an audio recording of the discharge teaching.
  arm group label: Discharge equity tools
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kirsten Austad, MD MPH
  role: Principal Investigator
  affiliation: Boston Medical Center, Family Medicine
  last name: Kirsten Austad, MD MPH
  phone: (617) 414-4459
  email: kirsten.austad@bmc.org
  last name: Brian Jack, MD
  email: brian.jack@bmc.org
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No