<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/NCT02209558</url>
  </required_header>
  <id_info>
    <org_study_id>14-305B</org_study_id>
    <nct_id>NCT02209558</nct_id>
  </id_info>
  <brief_title>The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions</brief_title>
  <acronym>Sternal</acronym>
  <official_title>The Effect of Visual Sternal Precautions on Behavioral Intentions and Readmissions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Shore University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sternal precautions are standard patient education protocol disseminated to post-operative&#xD;
      open heart surgery patients . While this &quot;best practice&quot; safety measure is widely distributed&#xD;
      to patients, the origin of said precautions is unknown. Statewide hospitals vary on their&#xD;
      parameters for sternal precautions using a myriad of restrictions, i.e. weighted activities,&#xD;
      biomechanical movements to be avoided. In addition, the medium in which sternal precautions&#xD;
      are taught varies, thus complicating patient adherence to these vital post-operative&#xD;
      measures.&#xD;
&#xD;
      The primary objective of this study is to use a randomized pre-post test design to compare&#xD;
      two different training procedures. One training group examines current standard of care&#xD;
      (providing verbal instruction using teach back and written sternal precautions). The second&#xD;
      training group provides subjects with visual depiction of sternal precautions, in addition to&#xD;
      standard of care. The study will analyze 30 and 60 day readmission rates for aforementioned&#xD;
      patients. Finally, the study will assess changes in behavior intentions from before training&#xD;
      to after training in both groups via behavioral analysis survey consisting of 8 questions.&#xD;
&#xD;
      Hypothesis 1: The investigators hypothesize that subjects provided with visual sternal&#xD;
      precautions, in addition to standard of care, will have a lower 30 and 60 day readmission&#xD;
      rate when compared to subjects in the standard of care group&#xD;
&#xD;
      Hypothesis 2: The investigators hypothesize that changes in behavior intentions toward&#xD;
      sternal precautions will be greater from before training to after training in the visual SPs&#xD;
      in addition to standard of care group than the standard of care only group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible subjects will be identified by the Senior Cardiothoracic Physical Therapist (Dr.&#xD;
      Craig D. Feinman, PT, DPT) on staff at North Shore University Hospital. Dr. Feinman will&#xD;
      provide basic study information to potential subjects and refer those that are interested in&#xD;
      the study to the research team who will then provide a copy of the consent form and more&#xD;
      information about the study. Inclusion Criteria represents post-surgical adult patients who&#xD;
      had a median or midline sternotomy incision during cardiac surgery at North-Shore University&#xD;
      Hospital. Exclusion Criteria represents patients with dementia or those that are cognitively&#xD;
      impaired will be excluded from the study.&#xD;
&#xD;
      A T-test or Mann Whitney U test will be use to compare group differences on continuous&#xD;
      variables, e.g. age. Beta regression or logistic regression model will be developed for the&#xD;
      outcomes of adherence and readmission proportions/rates. To assess changes from pre to post&#xD;
      training on behavioral intentions a paired t-test or Wilcoxon signed rank for matched pairs&#xD;
      will be used. A result will be considered statistically significant at the p&lt;0.05 level of&#xD;
      significance. All analyses will be performed using SAS version 9.3 (SAS Institute, Cary, NC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Patient behavioral intentions post visual training strategies</measure>
    <time_frame>Post-operative day one when patient medically cleared for PT evaluation, 2nd session, and prior to discharge from hospital (approximately 1-10 days)</time_frame>
    <description>The intervention group will receive &quot;standard of care&quot; sternal precautions delivered via written medium. In addition, printed visual depictions of sternal precautions will be provided. During completion of the initial Physical Therapy evaluation, patients will be asked to provide baseline knowledge of sternal precautions via &quot;teach back,&quot; an important tool in assessing patients' knowledge of important points delivered during clinical practice. Patients will then perform teach back of sternal precautions upon second Physical Therapy encounter to ensure understanding and post-operative anesthesia effects have waned. Prior to discharge (when patient deemed medically appropriate by the medical/surgical team), the patient will receive a survey consisting of 8 behavioral intention questions with &quot;yes,&quot; &quot;no,&quot; or &quot;not sure&quot; responses. Questions posed on the surveys assess if patients will/will not perform certain behaviors that may/may not predispose a risk to the patient's sternum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30 and 60 day readmission rates</measure>
    <time_frame>30-60 days post patient discharge from hospital setting</time_frame>
    <description>Re-admission rates of enrolled subjects is integral in determining if patients adhere to sternal precautions after discharge. Resumption of regular activities is cleared by the medical/surgical team. The study team will review the medical records of the subjects 60 days after enrollment to determine if and why they were re-admitted to the hospital. Since there is a possibility for subjects to be re-admitted to facilities outside of the health system, the study team will also call the enrolled subjects 60 days after enrollment to obtain this information.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Intention - Mental Process</condition>
  <condition>Readmission Rates</condition>
  <arm_group>
    <arm_group_label>Standard Written Sternal Precautions</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive education that is the &quot;standard of care&quot; at North Shore Long Island Jewish Health Systems in their post-operative sternal precautions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Visual Sternal Precautions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive both &quot;standard of care&quot; written sternal precautions, as well as visual sternal precautions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Visual Sternal Precautions</intervention_name>
    <description>Visual depiction of SPs in addition to &quot;standard of care&quot; written precautions</description>
    <arm_group_label>Visual Sternal Precautions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Post-surgical adult patients who had a median or midline sternotomy incision during&#xD;
             cardiac surgery at North-Shore University Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with dementia or those that are cognitively impaired will be excluded from&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Craig D Feinman, Doctor of Physical Therapy</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Shore University Hospital, NSLIJ Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Renee Pekmezaris, PhD</last_name>
    <role>Study Director</role>
    <affiliation>North Shore University Hospital, NSLIJ Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrzej Kozikowski, PhD</last_name>
    <role>Study Director</role>
    <affiliation>North Shore University Hospital, NSLIJ Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jonathan Dropkin, ScD, PT</last_name>
    <role>Study Director</role>
    <affiliation>North Shore University Hospital, NSLIJ Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joanna Steinn, MPH</last_name>
    <role>Study Director</role>
    <affiliation>North Shore University Hospital, NSLIJ Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alan Hartman, MD</last_name>
    <role>Study Director</role>
    <affiliation>North Shore University Hospital, NSLIJ Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>April 13, 2015</last_update_submitted>
  <last_update_submitted_qc>April 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Craig Feinman</investigator_full_name>
    <investigator_title>Senior Cardiothoraic Physical Therapist, Physical Therapy</investigator_title>
  </responsible_party>
  <!-- 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/NCT02209558
org study id: 14-305B
nct id: NCT02209558
lead sponsor: 
collaborator: 
has dmc: Yes
Sternal precautions are standard patient education protocol disseminated to post-operative
      open heart surgery patients . While this "best practice" safety measure is widely distributed
      to patients, the origin of said precautions is unknown. Statewide hospitals vary on their
      parameters for sternal precautions using a myriad of restrictions, i.e. weighted activities,
      biomechanical movements to be avoided. In addition, the medium in which sternal precautions
      are taught varies, thus complicating patient adherence to these vital post-operative
      measures.

      The primary objective of this study is to use a randomized pre-post test design to compare
      two different training procedures. One training group examines current standard of care
      (providing verbal instruction using teach back and written sternal precautions). The second
      training group provides subjects with visual depiction of sternal precautions, in addition to
      standard of care. The study will analyze 30 and 60 day readmission rates for aforementioned
      patients. Finally, the study will assess changes in behavior intentions from before training
      to after training in both groups via behavioral analysis survey consisting of 8 questions.

      Hypothesis 1: The investigators hypothesize that subjects provided with visual sternal
      precautions, in addition to standard of care, will have a lower 30 and 60 day readmission
      rate when compared to subjects in the standard of care group

      Hypothesis 2: The investigators hypothesize that changes in behavior intentions toward
      sternal precautions will be greater from before training to after training in the visual SPs
      in addition to standard of care group than the standard of care only group.
Eligible subjects will be identified by the Senior Cardiothoracic Physical Therapist (Dr.
      Craig D. Feinman, PT, DPT) on staff at North Shore University Hospital. Dr. Feinman will
      provide basic study information to potential subjects and refer those that are interested in
      the study to the research team who will then provide a copy of the consent form and more
      information about the study. Inclusion Criteria represents post-surgical adult patients who
      had a median or midline sternotomy incision during cardiac surgery at North-Shore University
      Hospital. Exclusion Criteria represents patients with dementia or those that are cognitively
      impaired will be excluded from the study.

      A T-test or Mann Whitney U test will be use to compare group differences on continuous
      variables, e.g. age. Beta regression or logistic regression model will be developed for the
      outcomes of adherence and readmission proportions/rates. To assess changes from pre to post
      training on behavioral intentions a paired t-test or Wilcoxon signed rank for matched pairs
      will be used. A result will be considered statistically significant at the p<0.05 level of
      significance. All analyses will be performed using SAS version 9.3 (SAS Institute, Cary, NC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Patient behavioral intentions post visual training strategies
time frame: Post-operative day one when patient medically cleared for PT evaluation, 2nd session, and prior to discharge from hospital (approximately 1-10 days)
description: The intervention group will receive "standard of care" sternal precautions delivered via written medium. In addition, printed visual depictions of sternal precautions will be provided. During completion of the initial Physical Therapy evaluation, patients will be asked to provide baseline knowledge of sternal precautions via "teach back," an important tool in assessing patients' knowledge of important points delivered during clinical practice. Patients will then perform teach back of sternal precautions upon second Physical Therapy encounter to ensure understanding and post-operative anesthesia effects have waned. Prior to discharge (when patient deemed medically appropriate by the medical/surgical team), the patient will receive a survey consisting of 8 behavioral intention questions with "yes," "no," or "not sure" responses. Questions posed on the surveys assess if patients will/will not perform certain behaviors that may/may not predispose a risk to the patient's sternum.
measure: 30 and 60 day readmission rates
time frame: 30-60 days post patient discharge from hospital setting
description: Re-admission rates of enrolled subjects is integral in determining if patients adhere to sternal precautions after discharge. Resumption of regular activities is cleared by the medical/surgical team. The study team will review the medical records of the subjects 60 days after enrollment to determine if and why they were re-admitted to the hospital. Since there is a possibility for subjects to be re-admitted to facilities outside of the health system, the study team will also call the enrolled subjects 60 days after enrollment to obtain this information.
arm group label: Standard Written Sternal Precautions
arm group type: No Intervention
description: Patients will receive education that is the "standard of care" at North Shore Long Island Jewish Health Systems in their post-operative sternal precautions.
arm group label: Visual Sternal Precautions
arm group type: Experimental
description: Patients will receive both "standard of care" written sternal precautions, as well as visual sternal precautions.
intervention type: Behavioral
intervention name: Visual Sternal Precautions
description: Visual depiction of SPs in addition to "standard of care" written precautions
arm group label: Visual Sternal Precautions
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Craig D Feinman, Doctor of Physical Therapy
role: Principal Investigator
affiliation: North Shore University Hospital, NSLIJ Health System
last name: Renee Pekmezaris, PhD
role: Study Director
affiliation: North Shore University Hospital, NSLIJ Health System
last name: Andrzej Kozikowski, PhD
role: Study Director
affiliation: North Shore University Hospital, NSLIJ Health System
last name: Jonathan Dropkin, ScD, PT
role: Study Director
affiliation: North Shore University Hospital, NSLIJ Health System
last name: Joanna Steinn, MPH
role: Study Director
affiliation: North Shore University Hospital, NSLIJ Health System
last name: Alan Hartman, MD
role: Study Director
affiliation: North Shore University Hospital, NSLIJ Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Craig Feinman
investigator title: Senior Cardiothoraic Physical Therapist, Physical Therapy