<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/NCT03834428</url>
  </required_header>
  <id_info>
    <org_study_id>H-38265</org_study_id>
    <nct_id>NCT03834428</nct_id>
  </id_info>
  <brief_title>IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging</brief_title>
  <official_title>IText For ICOUGH: Improving Ambulation of Surgical Patients Through Text Messaging</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 plan to conduct a study that evaluates if text messaging increases&#xD;
      patients' adherence to ambulation (specifically reminding patients to get out of bed three or&#xD;
      more times daily) which is one component of a protocol called ICOUGH, which is a mnemonic&#xD;
      that stands for: Incentive spirometry (a breathing device that expands the lungs), Coughing&#xD;
      and deep breathing, Oral hygiene (using a toothbrush for example),Understanding (patient and&#xD;
      family education), Getting out of bed at least three times daily, and Head-of-bed elevation&#xD;
      to prevent choking; each letter representing steps of a protocol developed at Boston Medical&#xD;
      Center (BMC) shown to decrease lung-related complications of surgery. Other outcomes,&#xD;
      including frequency of ambulation, pain score, number of visitors per day, head-of-bed&#xD;
      elevation, education on importance of ambulation, and falls will also be assessed. The&#xD;
      hypothesis is that a reminder text message to ambulate will improve these outcomes over time.&#xD;
&#xD;
      While beneficial to patients and health care facilities, the ICOUGH protocol is sometimes&#xD;
      both difficult to implement and sustain at an acute care hospital, because: (1) patient&#xD;
      motivation fluctuates and is the key determinant of patient ambulation (2) it relies heavily&#xD;
      on nurses to both educate patients and then keep them accountable to the protocol, (3) an&#xD;
      unfavorable nurse-to-patient ratio, (4) high inpatient turnover for elective surgical cases,&#xD;
      and (5) an aging baby boomer population-a higher volume of older, higher- risk patients will&#xD;
      require more time and attention per nurse. Therefore, utilization of text message reminders&#xD;
      may promote better patient, family, and provider engagement and adherence to ambulation which&#xD;
      can improve outcomes and decrease healthcare spending.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary complications (e.g., pneumonia, unplanned intubation, and prolonged duration of&#xD;
      ventilatory support) occur after about 1-2% of operations in the United States, leading to&#xD;
      significant morbidity, lengths of hospital stay and cost, perhaps as much as $50,000 in&#xD;
      expenses for the necessary additional care. However, many of these complications are&#xD;
      preventable and the ICOUGH protocol has been demonstrated to impact pulmonary post operative&#xD;
      complications. It has been shown to improve patient outcomes by decreasing postoperative&#xD;
      pneumonia by 38%, unplanned intubations by 40%, and all adverse outcomes by 40%; over $5&#xD;
      million in cost savings for BMC in a two-year period has accompanied improved patient&#xD;
      outcomes.&#xD;
&#xD;
      But despite its efficacy, the acute care hospital setting, specifically a safety-net hospital&#xD;
      setting, presents challenges to ICOUGH protocol sustainability. ICOUGH requires education of&#xD;
      patients over a number of time points and holds them accountable to adhere to the protocol.&#xD;
      Nurses represent one source of education, although other clinical demands compete for nurses'&#xD;
      time and attention. Acute care hospitals face high inpatient turnover for elective operations&#xD;
      and must contend with an aging population that translates to a higher volume of older,&#xD;
      higher-risk patients who may require more time and attention per nurse. Additionally,&#xD;
      non-elective surgery patients, such as those admitted from the emergency department, would&#xD;
      not have received ICOUGH protocol education. However, patients who are admitted to the&#xD;
      hospital after emergency and trauma operations are at greatest risk of suffering pulmonary&#xD;
      complications and stand to benefit the most from these interventions. These patients are not&#xD;
      always optimized for surgery due to their acute circumstances, and they do not ordinarily&#xD;
      receive the ICOUGH education that patients have prior to elective operations. In addition,&#xD;
      patients also lack significant motivation due to the seriousness of their presentation and&#xD;
      pain level to ambulate unless reminded.&#xD;
&#xD;
      To address these challenges within BMC and facilitate ambulation protocol implementation,&#xD;
      sustainability, and scaling in other institutions, the research team developed a&#xD;
      point-of-care, patient-centric way to promote better patient, family, and provider engagement&#xD;
      with and adherence to the ICOUGH protocol, specifically ambulation. In this pilot study,&#xD;
      patients will be randomized to receive a text message once a day to remind them to ambulate&#xD;
      three or more times each day in addition to the ICOUGH education or to receive the ICOUGH&#xD;
      education without text reminders. All participants will be contacted daily by a research team&#xD;
      member to collect data on the outcome measures and each participant in the experimental text&#xD;
      message arm will be interviewed at hospital discharge to solicit their opinion abut the text&#xD;
      message reminders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2019</start_date>
  <completion_date type="Actual">July 13, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the frequency of ambulation daily while hospitalized</measure>
    <time_frame>baseline and 10 days</time_frame>
    <description>The frequency of ambulation will be tracked for each participant each day of their hospitalization after ICOUGH education. Ambulation is defined as leaving a patient's room.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Level Scale twice daily while hospitalized</measure>
    <time_frame>Twice daily until hospital discharge or for 10 days maximum</time_frame>
    <description>Participants will be asked twice daily (in the morning and evening) until discharge, &quot;On a scale of 1-10, with 10 being the worst pain imaginable, what is your pain now?&quot; Lower scores are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants that received ambulation education during hospitalization</measure>
    <time_frame>At hospital discharge or hospital day #10</time_frame>
    <description>Participants will be asked whether they received any education on the importance of ambulation while hospitalized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily chair usage during hospitalization</measure>
    <time_frame>Daily until hospital discharge or for 10 days maximum</time_frame>
    <description>Participants will be asked about the number of times they sit in the chair in their room each day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of daily visitors while hospitalized</measure>
    <time_frame>Daily until hospital discharge or for 10 days maximum</time_frame>
    <description>Participants will be asked how many visitors they had while hospitalized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of visitors who helped participants ambulate</measure>
    <time_frame>Daily until hospital discharge or for 10 days maximum</time_frame>
    <description>Participants will be asked how many visitors helped them ambulate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usefulness of the text messages in the experimental group</measure>
    <time_frame>At hospital discharge or hospital day #10</time_frame>
    <description>At discharge participants in the experimental arm will be interviewed as to their opinions about the text messages. The qualitative answers will be analyzed for themes and content.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Ambulation Difficulty</condition>
  <arm_group>
    <arm_group_label>No Text Message Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm will receive education about the ICOUGH protocol which includes the importance of ambulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Text Message Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will receive daily text message reminders to ambulate in the hospital in addition to education about the ICOUGH protocol which includes the importance of ambulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text Message Intervention</intervention_name>
    <description>A text message will be sent once daily (between noon and 3p) to remind participants to ambulate at least 3 times each day while hospitalized.</description>
    <arm_group_label>Text Message Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ICOUGH protocol</intervention_name>
    <description>Education will be provided about the ICOUGH protocol which includes: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (for example using a toothbrush), Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking.</description>
    <arm_group_label>No Text Message Control</arm_group_label>
    <arm_group_label>Text Message Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of all genders on any surgical service at Boston Medical Center&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Ability to read at 5th grade level&#xD;
&#xD;
          -  Able to ambulate, with or without assistance&#xD;
&#xD;
          -  Possession of a personal cell phone that can receive text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visually impaired or blind&#xD;
&#xD;
          -  Presence of neuromuscular disease or inability to perform all the measures in the&#xD;
             ICOUGH protocol&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women&#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>Pamela Rosenkranz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>July 14, 2019</last_update_submitted>
  <last_update_submitted_qc>July 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Text message reminder</keyword>
  <keyword>ICOUGH protocol</keyword>
  <keyword>IText</keyword>
  <keyword>Safety net hospital</keyword>
  <keyword>Inpatient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mobility Limitation</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/NCT03834428
org study id: H-38265
nct id: NCT03834428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators plan to conduct a study that evaluates if text messaging increases
      patients' adherence to ambulation (specifically reminding patients to get out of bed three or
      more times daily) which is one component of a protocol called ICOUGH, which is a mnemonic
      that stands for: Incentive spirometry (a breathing device that expands the lungs), Coughing
      and deep breathing, Oral hygiene (using a toothbrush for example),Understanding (patient and
      family education), Getting out of bed at least three times daily, and Head-of-bed elevation
      to prevent choking; each letter representing steps of a protocol developed at Boston Medical
      Center (BMC) shown to decrease lung-related complications of surgery. Other outcomes,
      including frequency of ambulation, pain score, number of visitors per day, head-of-bed
      elevation, education on importance of ambulation, and falls will also be assessed. The
      hypothesis is that a reminder text message to ambulate will improve these outcomes over time.

      While beneficial to patients and health care facilities, the ICOUGH protocol is sometimes
      both difficult to implement and sustain at an acute care hospital, because: (1) patient
      motivation fluctuates and is the key determinant of patient ambulation (2) it relies heavily
      on nurses to both educate patients and then keep them accountable to the protocol, (3) an
      unfavorable nurse-to-patient ratio, (4) high inpatient turnover for elective surgical cases,
      and (5) an aging baby boomer population-a higher volume of older, higher- risk patients will
      require more time and attention per nurse. Therefore, utilization of text message reminders
      may promote better patient, family, and provider engagement and adherence to ambulation which
      can improve outcomes and decrease healthcare spending.
Pulmonary complications (e.g., pneumonia, unplanned intubation, and prolonged duration of
      ventilatory support) occur after about 1-2% of operations in the United States, leading to
      significant morbidity, lengths of hospital stay and cost, perhaps as much as $50,000 in
      expenses for the necessary additional care. However, many of these complications are
      preventable and the ICOUGH protocol has been demonstrated to impact pulmonary post operative
      complications. It has been shown to improve patient outcomes by decreasing postoperative
      pneumonia by 38%, unplanned intubations by 40%, and all adverse outcomes by 40%; over $5
      million in cost savings for BMC in a two-year period has accompanied improved patient
      outcomes.

      But despite its efficacy, the acute care hospital setting, specifically a safety-net hospital
      setting, presents challenges to ICOUGH protocol sustainability. ICOUGH requires education of
      patients over a number of time points and holds them accountable to adhere to the protocol.
      Nurses represent one source of education, although other clinical demands compete for nurses'
      time and attention. Acute care hospitals face high inpatient turnover for elective operations
      and must contend with an aging population that translates to a higher volume of older,
      higher-risk patients who may require more time and attention per nurse. Additionally,
      non-elective surgery patients, such as those admitted from the emergency department, would
      not have received ICOUGH protocol education. However, patients who are admitted to the
      hospital after emergency and trauma operations are at greatest risk of suffering pulmonary
      complications and stand to benefit the most from these interventions. These patients are not
      always optimized for surgery due to their acute circumstances, and they do not ordinarily
      receive the ICOUGH education that patients have prior to elective operations. In addition,
      patients also lack significant motivation due to the seriousness of their presentation and
      pain level to ambulate unless reminded.

      To address these challenges within BMC and facilitate ambulation protocol implementation,
      sustainability, and scaling in other institutions, the research team developed a
      point-of-care, patient-centric way to promote better patient, family, and provider engagement
      with and adherence to the ICOUGH protocol, specifically ambulation. In this pilot study,
      patients will be randomized to receive a text message once a day to remind them to ambulate
      three or more times each day in addition to the ICOUGH education or to receive the ICOUGH
      education without text reminders. All participants will be contacted daily by a research team
      member to collect data on the outcome measures and each participant in the experimental text
      message arm will be interviewed at hospital discharge to solicit their opinion abut the text
      message reminders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in the frequency of ambulation daily while hospitalized
time frame: baseline and 10 days
description: The frequency of ambulation will be tracked for each participant each day of their hospitalization after ICOUGH education. Ambulation is defined as leaving a patient's room.
measure: Pain Level Scale twice daily while hospitalized
time frame: Twice daily until hospital discharge or for 10 days maximum
description: Participants will be asked twice daily (in the morning and evening) until discharge, "On a scale of 1-10, with 10 being the worst pain imaginable, what is your pain now?" Lower scores are more favorable.
measure: Number of participants that received ambulation education during hospitalization
time frame: At hospital discharge or hospital day #10
description: Participants will be asked whether they received any education on the importance of ambulation while hospitalized.
measure: Daily chair usage during hospitalization
time frame: Daily until hospital discharge or for 10 days maximum
description: Participants will be asked about the number of times they sit in the chair in their room each day.
measure: Number of daily visitors while hospitalized
time frame: Daily until hospital discharge or for 10 days maximum
description: Participants will be asked how many visitors they had while hospitalized
measure: Number of visitors who helped participants ambulate
time frame: Daily until hospital discharge or for 10 days maximum
description: Participants will be asked how many visitors helped them ambulate.
measure: Usefulness of the text messages in the experimental group
time frame: At hospital discharge or hospital day #10
description: At discharge participants in the experimental arm will be interviewed as to their opinions about the text messages. The qualitative answers will be analyzed for themes and content.
arm group label: No Text Message Control
arm group type: Active Comparator
description: Participants randomized to this arm will receive education about the ICOUGH protocol which includes the importance of ambulation.
arm group label: Text Message Intervention
arm group type: Experimental
description: Participants randomized to this arm will receive daily text message reminders to ambulate in the hospital in addition to education about the ICOUGH protocol which includes the importance of ambulation.
intervention type: Behavioral
intervention name: Text Message Intervention
description: A text message will be sent once daily (between noon and 3p) to remind participants to ambulate at least 3 times each day while hospitalized.
arm group label: Text Message Intervention
intervention type: Behavioral
intervention name: ICOUGH protocol
description: Education will be provided about the ICOUGH protocol which includes: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (for example using a toothbrush), Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking.
arm group label: No Text Message Control
arm group label: Text Message Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pamela Rosenkranz
role: Principal Investigator
affiliation: Boston University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mobility Limitation
sharing ipd: No