<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/NCT04458428</url>
  </required_header>
  <id_info>
    <org_study_id>98177</org_study_id>
    <nct_id>NCT04458428</nct_id>
  </id_info>
  <brief_title>Short Message Service Based Patient Education in Spine Patients</brief_title>
  <acronym>SMS</acronym>
  <official_title>The Role of Postoperative SMS Based Patient Education in Spine Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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 primary objective is to evaluate whether an SMS based patient education&#xD;
      program improves patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Back and neck related complaints effect as much as 11% of the U.S. population and are one of&#xD;
      the most common presenting complaints at health care visits. A small subset of these patients&#xD;
      receive spine surgery of various types in the hopes of alleviating symptoms that are&#xD;
      recalcitrant to conservative management. The utilization of spine surgery has been rapidly&#xD;
      increasing.2 An estimated 413,000 spinal fusions were performed in the U.S. in 2008&#xD;
      accounting for almost $34 billion in charges.&#xD;
&#xD;
      Patient satisfaction has become an increasingly important measure of healthcare quality. This&#xD;
      paradigm shift is evident in the changing reimbursement models used by the Centers for&#xD;
      Medicare and Medicaid Services (CMS). Hospital Consumer Assessment of Healthcare Providers&#xD;
      and Systems (HCAHPS) is a survey-based assessment of patient satisfaction that was initially&#xD;
      developed in 2002. Currently, HCAHPS provides the ability to compare patient satisfaction&#xD;
      with the care they receive at various healthcare systems across the country. These scores are&#xD;
      used as part of a value-based purchasing initiative that can lead to a hospital gaining or&#xD;
      losing as much as 1.5% of their annual medicare revenue as a result of patient satisfaction&#xD;
      based incentives. This presents an important opportunity to optimize patient satisfaction in&#xD;
      order to both improve patient care and preserve hospital income.&#xD;
&#xD;
      A number of novel text-message based applications have been developed for healthcare use in&#xD;
      various settings. In the surgical setting text messaging has been used to provide&#xD;
      pre-operative education modules, as well as to track medication adherence after transplant.&#xD;
      This study aims to develop and critically evaluate, a text-messaging based patient education&#xD;
      system aimed at improving patient satisfaction with the post-operative course after spine&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SpineFriend Postoperative Questionnaire</measure>
    <time_frame>Follow Up Visits at 2 or 6 weeks</time_frame>
    <description>Patient satisfaction will consist of the SpineFriend Postoperative Questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">608</enrollment>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No other non-standard of care activities will be performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will be signed up for the automated short message service (SMS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS</intervention_name>
    <description>Patients who are randomized to the intervention arm will be signed up for the automated SMS program. This cohort will receive text messages after surgery, timed from the day of discharge through 14 days post-op. Patients in this cohort will receive text messages each day. The number of text messages varies on patient interest and &quot;yes&quot; responses to see additional information.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years and over undergoing spine surgery at the University of Utah&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Spiker, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah Orthopedics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Ryan Spiker</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Spine Surgery</keyword>
  <keyword>Short Message Service (SMS)</keyword>
  <keyword>Patient Satisfaction</keyword>
  <!-- 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/NCT04458428
org study id: 98177
nct id: NCT04458428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators primary objective is to evaluate whether an SMS based patient education
      program improves patient satisfaction.
Back and neck related complaints effect as much as 11% of the U.S. population and are one of
      the most common presenting complaints at health care visits. A small subset of these patients
      receive spine surgery of various types in the hopes of alleviating symptoms that are
      recalcitrant to conservative management. The utilization of spine surgery has been rapidly
      increasing.2 An estimated 413,000 spinal fusions were performed in the U.S. in 2008
      accounting for almost $34 billion in charges.

      Patient satisfaction has become an increasingly important measure of healthcare quality. This
      paradigm shift is evident in the changing reimbursement models used by the Centers for
      Medicare and Medicaid Services (CMS). Hospital Consumer Assessment of Healthcare Providers
      and Systems (HCAHPS) is a survey-based assessment of patient satisfaction that was initially
      developed in 2002. Currently, HCAHPS provides the ability to compare patient satisfaction
      with the care they receive at various healthcare systems across the country. These scores are
      used as part of a value-based purchasing initiative that can lead to a hospital gaining or
      losing as much as 1.5% of their annual medicare revenue as a result of patient satisfaction
      based incentives. This presents an important opportunity to optimize patient satisfaction in
      order to both improve patient care and preserve hospital income.

      A number of novel text-message based applications have been developed for healthcare use in
      various settings. In the surgical setting text messaging has been used to provide
      pre-operative education modules, as well as to track medication adherence after transplant.
      This study aims to develop and critically evaluate, a text-messaging based patient education
      system aimed at improving patient satisfaction with the post-operative course after spine
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: SpineFriend Postoperative Questionnaire
time frame: Follow Up Visits at 2 or 6 weeks
description: Patient satisfaction will consist of the SpineFriend Postoperative Questionnaire
arm group label: Control
arm group type: No Intervention
description: No other non-standard of care activities will be performed
arm group label: Intervention
arm group type: Experimental
description: Will be signed up for the automated short message service (SMS)
intervention type: Other
intervention name: SMS
description: Patients who are randomized to the intervention arm will be signed up for the automated SMS program. This cohort will receive text messages after surgery, timed from the day of discharge through 14 days post-op. Patients in this cohort will receive text messages each day. The number of text messages varies on patient interest and "yes" responses to see additional information.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ryan Spiker, M.D.
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Ryan Spiker
investigator title: Principle Investigator