<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/NCT04476355</url>
  </required_header>
  <id_info>
    <org_study_id>2019-533</org_study_id>
    <nct_id>NCT04476355</nct_id>
  </id_info>
  <brief_title>Implementation of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients Using the CAN-IMPLEMENT Framework</brief_title>
  <official_title>Development of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients and Implementation Study Using the CAN-IMPLEMENT Framework</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
      Physical restraints (PR) are widely used in ICU around the world. Many institutions have&#xD;
      suggested that the use of PR should be reduced. Clinical practice guidelines (CPGs) are a&#xD;
      convenient way of packaging evidence and presenting recommendations to healthcare decision&#xD;
      makers. There are currently no CPGs on PR in China, while other countries had, so we hope to&#xD;
      be able to adapt existing guidelines to apply in Chinese context. We use the CAN-IMPLEMENT&#xD;
      approach to adapt and implement the guidelines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Critically ill patients admitted to intensive care units (ICU) often need more invasive&#xD;
      operations (e.g.mechanical ventilation and hemodialysis), due to the needs from their&#xD;
      condition, which can also lead to acute pain, discomfort, sleep deprivation, agitation and&#xD;
      delirium. Agitation, for example, can propel patients to resist the ventilator, thus&#xD;
      increasing the oxygen consumption, causing them to accidentally remove various devices and&#xD;
      catheters on them and even posing life-threatening risks. Therefore, the main reason for the&#xD;
      use of physical restraints (PR) around ICU is to prevent patients from accidentally removing&#xD;
      the catheters or devices needed to protect their safety.&#xD;
&#xD;
      Although PR was used to prevent Unplanned extubation (UE), there were many studies proved&#xD;
      that PR is one of the risk factors that account for UE and can not protect patient safety.&#xD;
      Indeed, its use has been proven to cause pressure injuries, worsen agitation, delirium and&#xD;
      neurovascular complications. But PR is widely used in ICU around the world.&#xD;
&#xD;
      Many institutions have suggested that the use of PR should be reduced, for example, the&#xD;
      Government of Ontario released the Patient Restraints Minimization Act in 2001 to &quot;minimize&#xD;
      the use of restraints on patients and to encourage hospitals and facilities to use&#xD;
      alternative methods, whenever possible, when it is necessary to prevent serious bodily harm&#xD;
      by a patient to himself or herself or to others. Registered Nurses Association of Ontario&#xD;
      (RNAO) issued clinical practice guidelines on the alternatives to PR in February 2012, aimed&#xD;
      to help nurses reduce the use of PR, or use it in a more reasonable and standardized way, and&#xD;
      to provide effective alternatives of PR.&#xD;
&#xD;
      Clinical practice guidelines (CPGs) are a convenient way of packaging evidence and presenting&#xD;
      recommendations to healthcare decision makers. But the development and updating of&#xD;
      high-quality CPGs require substantial time, expertise and resources. Guideline adaptation is&#xD;
      the systematic approach to the endorsement and/or modification of a guideline(s) produced in&#xD;
      one cultural and organisational setting for application in a different context. Where high&#xD;
      quality guidelines are already available, adaptation may be used as an alternative to de novo&#xD;
      guideline development to customise the existing guideline to the needs of local users. There&#xD;
      are currently no CPGs on PR in China, while other countries had, so we hope to be able to&#xD;
      adapt existing guidelines to apply in Chinese context. We use the CAN-IMPLEMENT approach to&#xD;
      adapt and implement the guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>In the same ICU, the patients in the study period were the experimental group and the former patients were the control group.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of utilization of physical restraints</measure>
    <time_frame>2 years</time_frame>
    <description>Length of utilization of physical restraints / length of stay in ICU</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">204</enrollment>
  <condition>Restraint, Physical</condition>
  <condition>Intensive Care Units</condition>
  <condition>Practice Guideline</condition>
  <condition>Health Plan Implementation</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the same ICU, the former(2019-12~2020-12) patients were the control group, data collected through case system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the same ICU, the patients in the study period were the experimental group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Select and Tailor implementation interventions</intervention_name>
    <description>Based on previously adapted guidelines and the assessment of innovation, adopters and practice environment for barriers and supports, the interventions mainly include patients education, practioners education and system changes.</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient him/herself or the patient's authorized agent signed the informed consent&#xD;
             to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of basic mental illness or cognitive impairment before&#xD;
             admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data analyzed in this study is not included in a repository because it contains interview transcripts.</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/NCT04476355
org study id: 2019-533
nct id: NCT04476355
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Physical restraints (PR) are widely used in ICU around the world. Many institutions have
      suggested that the use of PR should be reduced. Clinical practice guidelines (CPGs) are a
      convenient way of packaging evidence and presenting recommendations to healthcare decision
      makers. There are currently no CPGs on PR in China, while other countries had, so we hope to
      be able to adapt existing guidelines to apply in Chinese context. We use the CAN-IMPLEMENT
      approach to adapt and implement the guidelines.
Critically ill patients admitted to intensive care units (ICU) often need more invasive
      operations (e.g.mechanical ventilation and hemodialysis), due to the needs from their
      condition, which can also lead to acute pain, discomfort, sleep deprivation, agitation and
      delirium. Agitation, for example, can propel patients to resist the ventilator, thus
      increasing the oxygen consumption, causing them to accidentally remove various devices and
      catheters on them and even posing life-threatening risks. Therefore, the main reason for the
      use of physical restraints (PR) around ICU is to prevent patients from accidentally removing
      the catheters or devices needed to protect their safety.

      Although PR was used to prevent Unplanned extubation (UE), there were many studies proved
      that PR is one of the risk factors that account for UE and can not protect patient safety.
      Indeed, its use has been proven to cause pressure injuries, worsen agitation, delirium and
      neurovascular complications. But PR is widely used in ICU around the world.

      Many institutions have suggested that the use of PR should be reduced, for example, the
      Government of Ontario released the Patient Restraints Minimization Act in 2001 to "minimize
      the use of restraints on patients and to encourage hospitals and facilities to use
      alternative methods, whenever possible, when it is necessary to prevent serious bodily harm
      by a patient to himself or herself or to others. Registered Nurses Association of Ontario
      (RNAO) issued clinical practice guidelines on the alternatives to PR in February 2012, aimed
      to help nurses reduce the use of PR, or use it in a more reasonable and standardized way, and
      to provide effective alternatives of PR.

      Clinical practice guidelines (CPGs) are a convenient way of packaging evidence and presenting
      recommendations to healthcare decision makers. But the development and updating of
      high-quality CPGs require substantial time, expertise and resources. Guideline adaptation is
      the systematic approach to the endorsement and/or modification of a guideline(s) produced in
      one cultural and organisational setting for application in a different context. Where high
      quality guidelines are already available, adaptation may be used as an alternative to de novo
      guideline development to customise the existing guideline to the needs of local users. There
      are currently no CPGs on PR in China, while other countries had, so we hope to be able to
      adapt existing guidelines to apply in Chinese context. We use the CAN-IMPLEMENT approach to
      adapt and implement the guidelines.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: In the same ICU, the patients in the study period were the experimental group and the former patients were the control group.
primary purpose: Supportive Care
masking: None (Open Label)
measure: rate of utilization of physical restraints
time frame: 2 years
description: Length of utilization of physical restraints / length of stay in ICU
arm group label: control group
arm group type: No Intervention
description: In the same ICU, the former(2019-12~2020-12) patients were the control group, data collected through case system.
arm group label: experimental group
arm group type: Experimental
description: In the same ICU, the patients in the study period were the experimental group
intervention type: Other
intervention name: Select and Tailor implementation interventions
description: Based on previously adapted guidelines and the assessment of innovation, adopters and practice environment for barriers and supports, the interventions mainly include patients education, practioners education and system changes.
arm group label: experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No
ipd description: The data analyzed in this study is not included in a repository because it contains interview transcripts.