<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/NCT03301610</url>
  </required_header>
  <id_info>
    <org_study_id>17-004771</org_study_id>
    <nct_id>NCT03301610</nct_id>
  </id_info>
  <brief_title>Mobile Educations Effect on Pain Outcomes</brief_title>
  <official_title>The Impact of Mobile Education Delivery on Postoperative Pain Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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 purpose of this study is to explore the clinical impact of pain management education&#xD;
      using a mobile web-based education delivery system compared to standard education delivery.&#xD;
      This study seeks to understand the difference between two different education delivery&#xD;
      methodologies and the effect on the postoperative pain experience, including participation in&#xD;
      treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing&#xD;
      major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time,&#xD;
      interactive, mobile education system will demonstrate improved pain associated outcomes and&#xD;
      higher patient participation when compared to the current standard education delivery method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">January 24, 2018</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>This prospective study has been designed as quasi-experimental study. This study seeks to explore both a treatment and control group in efforts to compare outcomes which are dependent on the type of intervention. Study participants will be assigned into one of two study arms, intervention or control, based on random assignment determined by the location they are bedded in hospital. One of two patient care units will offer standard education, the other unit will offer the mobile, iPad based education. The patient care unit to offer the mobile, iPad based education will be selected at random.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in self-reported pain scores</measure>
    <time_frame>Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)</time_frame>
    <description>Scores are measured using a 10 point (Lickert) pain rating scale. The scale ranges from 0 to 10 with the lower score indicating less pain and the higher score indicating greater pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain management knowledge</measure>
    <time_frame>Pre-intervention (between 1 and 5 days before surgical procedure) and post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)</time_frame>
    <description>Scores are measured using a modified Patient Pain Questionnaire; 9 knowledge based questions use a ten-point (0-10) ordinal scale to assess patients' agreement or disagreement with specific statements. All items have been formatted so that zero indicates the most positive outcome and a ten indicates the most negative outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in self-reported participation in pain management</measure>
    <time_frame>Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)</time_frame>
    <description>Scores are measured using a 10 point Lickert scale measuring patients perception of participation in pain management/treatment decisions. The scale ranges from 0 to 10 with the lower score indicating less perceived participation and the higher score indicating greater perceived participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in post-operative opioid requirements</measure>
    <time_frame>Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)</time_frame>
    <description>Total opioid requirements, converted to morphine milligram equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in usefulness of education</measure>
    <time_frame>Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)</time_frame>
    <description>Scores are measured using a 10 point Lickert rating scale. The scale ranges from 0 to 10 with the lower score indicating lower perceived usefulness and the higher score indicating greater perceived usefulness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in use of non-pharmacologic pain modalities</measure>
    <time_frame>Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)</time_frame>
    <description>Results are tabulated for a descriptive selection list for patients to report what interventions were used.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Total Joint Arthroplasty</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Mobile Education Delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in the study arm will receive comprehensive pain management education delivered using mobile iPads at the point of care. The mobile based education modules will be inclusive of the use of the pain rating scale and assessment of pain; communication with healthcare providers; daily expectations for pain and pain management; pharmacologic and non-pharmacologic treatment options; medication side effects and safety; and discharge instructions including safe handling of opioids, disposal, tapering, and when to call the provider. It will also include an interactive pain and discomfort menu, knowledge based questions, and medication tracking log.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard verbal and written education</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will receive the current standard of care which consists of verbal instruction and pain management educational pamphlets. At a minimum, the patients will receive two educational pamphlets titled Your Pain and Discomfort Management Menu and Communicating About Your Pain. Verbal instruction is nurse dependent. At a minimum the nurse will provide the two pamphlets to the patient and follow-up with the patient to address any questions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Education Delivery</intervention_name>
    <description>Patients will be provided with an iPad on admission to the post-surgical unit and will remain with the patient until discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient care experience. The RN will use the iPad to engage patients in their pain management.</description>
    <arm_group_label>Mobile Education Delivery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Verbal and Written Education</intervention_name>
    <description>Patients will be provided with two pamphlets on pain management on admission to the post-surgical unit. Nurses will follow-up with verbal instruction based on patient need. This will continue through hospital stay. Additional printed education materials are available through the department of patient education and verbal instruction may be tailored based on nursing assessment and patient need.</description>
    <arm_group_label>Standard verbal and written education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  over the age of 18 years&#xD;
&#xD;
          -  undergoing surgical intervention and inpatient care for one of the following&#xD;
             procedures:&#xD;
&#xD;
          -  total hip arthroplasty (THA) (primary, bilateral, and revision)&#xD;
&#xD;
          -  total knee arthroplasty (TKA) (primary, bilateral, unicompartmental, and revision)&#xD;
&#xD;
          -  Fluent in the English language&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Undergoing more complex hip and knee procedures such as:&#xD;
&#xD;
          -  implant resections with or without spacer placement&#xD;
&#xD;
          -  liner exchange&#xD;
&#xD;
          -  THA or unipolar hip arthroplasty related to repair of hip fracture.&#xD;
&#xD;
          -  Preexisting physical or cognitive limitations that would hinder their ability to use&#xD;
             the mobile application&#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>Amber M Stitz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>February 28, 2018</last_update_submitted>
  <last_update_submitted_qc>February 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Amber M. Stitz</investigator_full_name>
    <investigator_title>Clinical Nurse Specialist</investigator_title>
  </responsible_party>
  <keyword>Pain Education</keyword>
  <keyword>Information Delivery</keyword>
  <keyword>Mobile Application</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03301610/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03301610/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03301610
org study id: 17-004771
nct id: NCT03301610
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the clinical impact of pain management education
      using a mobile web-based education delivery system compared to standard education delivery.
      This study seeks to understand the difference between two different education delivery
      methodologies and the effect on the postoperative pain experience, including participation in
      treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing
      major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time,
      interactive, mobile education system will demonstrate improved pain associated outcomes and
      higher patient participation when compared to the current standard education delivery method.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This prospective study has been designed as quasi-experimental study. This study seeks to explore both a treatment and control group in efforts to compare outcomes which are dependent on the type of intervention. Study participants will be assigned into one of two study arms, intervention or control, based on random assignment determined by the location they are bedded in hospital. One of two patient care units will offer standard education, the other unit will offer the mobile, iPad based education. The patient care unit to offer the mobile, iPad based education will be selected at random.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Difference in self-reported pain scores
time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
description: Scores are measured using a 10 point (Lickert) pain rating scale. The scale ranges from 0 to 10 with the lower score indicating less pain and the higher score indicating greater pain.
measure: Change in pain management knowledge
time frame: Pre-intervention (between 1 and 5 days before surgical procedure) and post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
description: Scores are measured using a modified Patient Pain Questionnaire; 9 knowledge based questions use a ten-point (0-10) ordinal scale to assess patients' agreement or disagreement with specific statements. All items have been formatted so that zero indicates the most positive outcome and a ten indicates the most negative outcome.
measure: Difference in self-reported participation in pain management
time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
description: Scores are measured using a 10 point Lickert scale measuring patients perception of participation in pain management/treatment decisions. The scale ranges from 0 to 10 with the lower score indicating less perceived participation and the higher score indicating greater perceived participation.
measure: Difference in post-operative opioid requirements
time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
description: Total opioid requirements, converted to morphine milligram equivalents
measure: Difference in usefulness of education
time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
description: Scores are measured using a 10 point Lickert rating scale. The scale ranges from 0 to 10 with the lower score indicating lower perceived usefulness and the higher score indicating greater perceived usefulness.
measure: Difference in use of non-pharmacologic pain modalities
time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)
description: Results are tabulated for a descriptive selection list for patients to report what interventions were used.
arm group label: Mobile Education Delivery
arm group type: Experimental
description: The participants in the study arm will receive comprehensive pain management education delivered using mobile iPads at the point of care. The mobile based education modules will be inclusive of the use of the pain rating scale and assessment of pain; communication with healthcare providers; daily expectations for pain and pain management; pharmacologic and non-pharmacologic treatment options; medication side effects and safety; and discharge instructions including safe handling of opioids, disposal, tapering, and when to call the provider. It will also include an interactive pain and discomfort menu, knowledge based questions, and medication tracking log.
arm group label: Standard verbal and written education
arm group type: Placebo Comparator
description: The control group will receive the current standard of care which consists of verbal instruction and pain management educational pamphlets. At a minimum, the patients will receive two educational pamphlets titled Your Pain and Discomfort Management Menu and Communicating About Your Pain. Verbal instruction is nurse dependent. At a minimum the nurse will provide the two pamphlets to the patient and follow-up with the patient to address any questions.
intervention type: Other
intervention name: Mobile Education Delivery
description: Patients will be provided with an iPad on admission to the post-surgical unit and will remain with the patient until discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient care experience. The RN will use the iPad to engage patients in their pain management.
arm group label: Mobile Education Delivery
intervention type: Other
intervention name: Standard Verbal and Written Education
description: Patients will be provided with two pamphlets on pain management on admission to the post-surgical unit. Nurses will follow-up with verbal instruction based on patient need. This will continue through hospital stay. Additional printed education materials are available through the department of patient education and verbal instruction may be tailored based on nursing assessment and patient need.
arm group label: Standard verbal and written education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amber M Stitz
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Amber M. Stitz
investigator title: Clinical Nurse Specialist
mesh term: Pain, Postoperative
provided document: 
provided document: 