<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/NCT03826056</url>
  </required_header>
  <id_info>
    <org_study_id>D19046</org_study_id>
    <nct_id>NCT03826056</nct_id>
  </id_info>
  <brief_title>Neurology Inpatient Clinical Education Trial</brief_title>
  <official_title>Neurology Inpatient Clinical Education Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the effectiveness of a personalized patient&#xD;
      education program to the current hospital education and evaluate its impact using patient&#xD;
      satisfaction scores.&#xD;
&#xD;
      The investigators hypothesize that a personalized patient education intervention will&#xD;
      increase patient's understanding of their diagnosis and satisfaction with the care as&#xD;
      reflected in the survey results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 7, 2021</completion_date>
  <primary_completion_date type="Actual">December 7, 2021</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>Study team members will randomize patients to receive either the current standard hospital education material or the new personalized education material. Investigators will use a stratified randomization process to allocate the patients from different categories including age range, gender, and discharge diagnosis into each group. Thereby the investigators will achieve equal distribution of diagnoses and other demographics among groups in real time. They will review the two groups when performing statistical analysis near the end of the study to ensure heterogeneity of distribution.&#xD;
A study team member who has also been a member of the care team will use the either the current hospital standard or the new personalized education materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The patient will not be informed of whether he or she is receiving the current hospital standard or the new personalized patient education intervention. The study team member will known which intervention is being used for patient education. The intervention arm will not be blinded in the data analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction scores</measure>
    <time_frame>Subjects will be expected to mail the feedback forms within 2 weeks of discharge. Investigators will mail a single reminder prepaid return mail with a copy of the questionnaire to patients who do not respond within this time allowing 1 month total time.</time_frame>
    <description>The patients will answer a survey consisting of seven multiple-choice questions regarding their perception of the education intervention. Each questions will be scored on a scale of one to four for a total possible score of 28 for all 7 questions. A score of 1 indicates a negative perception of the education whereas 4 indicates the most positive impression. Therefore the lowest possible score is 7 for a severely negative perception of the education and the highest score is 28 for a very positive impression of the education program. Only the total scores will be compared for statistical analysis. Scores from patients in the current standard and new personalized education intervention groups will be compared.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Myasthenia Gravis</condition>
  <condition>Guillain-Barre Syndrome</condition>
  <condition>Multiple Sclerosis</condition>
  <condition>Seizures</condition>
  <condition>Parkinsonism</condition>
  <condition>Meningitis</condition>
  <condition>Encephalitis</condition>
  <condition>Headache</condition>
  <condition>Vestibular Disorder</condition>
  <condition>Spondylosis</condition>
  <condition>Normal Pressure Hydrocephalus</condition>
  <arm_group>
    <arm_group_label>Current standard education group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A study team member will use the current hospital standard educational material to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>New personalized education group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A study team member will use the new personalized educational materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Current standard discharge educational intervention</intervention_name>
    <description>The patients will receive the current hospital standard discharge educational material which explains the diagnosis, new medications, follow up and any activity/diet restrictions. A member of the study team will explain this material to the patient and answer any questions.</description>
    <arm_group_label>Current standard education group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized discharge educational intervention</intervention_name>
    <description>The patients will receive a new personalized discharge educational material which will explain the specifics of their disorder, the treatment, and prognosis. The materials will contain simple, organized explanations and graphics. A member of the study team will explain this material to the patient and answer any questions.</description>
    <arm_group_label>New personalized education group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over the age of 18&#xD;
&#xD;
          -  Must have the capacity to consent and understand the study related activities and&#xD;
             education materials.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18&#xD;
&#xD;
          -  Have a condition that impairs the ability to understand the study, its risks, and&#xD;
             appropriately consent for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vijay Renga, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth- Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Vijay Renga</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>clinical education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myasthenia Gravis</mesh_term>
    <mesh_term>Spondylosis</mesh_term>
    <mesh_term>Vestibular Diseases</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Meningitis</mesh_term>
    <mesh_term>Encephalitis</mesh_term>
    <mesh_term>Hydrocephalus</mesh_term>
    <mesh_term>Parkinsonian Disorders</mesh_term>
    <mesh_term>Hydrocephalus, Normal Pressure</mesh_term>
    <mesh_term>Guillain-Barre Syndrome</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Investigators will protect patients' identity by using identification numbers that do not correspond to any personal identification information. They will enter the survey results to the institution's safely encrypted database.</ipd_description>
  </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/NCT03826056
org study id: D19046
nct id: NCT03826056
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to compare the effectiveness of a personalized patient
      education program to the current hospital education and evaluate its impact using patient
      satisfaction scores.

      The investigators hypothesize that a personalized patient education intervention will
      increase patient's understanding of their diagnosis and satisfaction with the care as
      reflected in the survey results.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study team members will randomize patients to receive either the current standard hospital education material or the new personalized education material. Investigators will use a stratified randomization process to allocate the patients from different categories including age range, gender, and discharge diagnosis into each group. Thereby the investigators will achieve equal distribution of diagnoses and other demographics among groups in real time. They will review the two groups when performing statistical analysis near the end of the study to ensure heterogeneity of distribution.
A study team member who has also been a member of the care team will use the either the current hospital standard or the new personalized education materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
primary purpose: Health Services Research
masking: Single (Participant)
masking description: The patient will not be informed of whether he or she is receiving the current hospital standard or the new personalized patient education intervention. The study team member will known which intervention is being used for patient education. The intervention arm will not be blinded in the data analysis.
measure: Patient satisfaction scores
time frame: Subjects will be expected to mail the feedback forms within 2 weeks of discharge. Investigators will mail a single reminder prepaid return mail with a copy of the questionnaire to patients who do not respond within this time allowing 1 month total time.
description: The patients will answer a survey consisting of seven multiple-choice questions regarding their perception of the education intervention. Each questions will be scored on a scale of one to four for a total possible score of 28 for all 7 questions. A score of 1 indicates a negative perception of the education whereas 4 indicates the most positive impression. Therefore the lowest possible score is 7 for a severely negative perception of the education and the highest score is 28 for a very positive impression of the education program. Only the total scores will be compared for statistical analysis. Scores from patients in the current standard and new personalized education intervention groups will be compared.
arm group label: Current standard education group
arm group type: Active Comparator
description: A study team member will use the current hospital standard educational material to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
arm group label: New personalized education group
arm group type: Experimental
description: A study team member will use the new personalized educational materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
intervention type: Behavioral
intervention name: Current standard discharge educational intervention
description: The patients will receive the current hospital standard discharge educational material which explains the diagnosis, new medications, follow up and any activity/diet restrictions. A member of the study team will explain this material to the patient and answer any questions.
arm group label: Current standard education group
intervention type: Behavioral
intervention name: Personalized discharge educational intervention
description: The patients will receive a new personalized discharge educational material which will explain the specifics of their disorder, the treatment, and prognosis. The materials will contain simple, organized explanations and graphics. A member of the study team will explain this material to the patient and answer any questions.
arm group label: New personalized education group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Vijay Renga, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Vijay Renga
investigator title: Principal Investigator
mesh term: Myasthenia Gravis
mesh term: Spondylosis
mesh term: Vestibular Diseases
mesh term: Multiple Sclerosis
mesh term: Seizures
mesh term: Meningitis
mesh term: Encephalitis
mesh term: Hydrocephalus
mesh term: Parkinsonian Disorders
mesh term: Hydrocephalus, Normal Pressure
mesh term: Guillain-Barre Syndrome
mesh term: Headache
sharing ipd: No
ipd description: Investigators will protect patients' identity by using identification numbers that do not correspond to any personal identification information. They will enter the survey results to the institution's safely encrypted database.