<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/NCT03017469</url>
  </required_header>
  <id_info>
    <org_study_id>SMH30Dec2016</org_study_id>
    <nct_id>NCT03017469</nct_id>
  </id_info>
  <brief_title>Achieving Resilience in Acute Care Nurses (ARISE).</brief_title>
  <official_title>Achieving Resilience in Acute Care Nurses (ARISE): A Randomized Controlled Trial of a Multi-component Intervention for Nurses in Critical Care and Trauma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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>
      Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives,&#xD;
      which can lead to adverse personal and professional outcomes. While workplace stress cannot&#xD;
      be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease&#xD;
      fatigue. Organizational employee health, wellness, and assistance programs are all&#xD;
      intentioned to provide this type of support; however, nurses often lack awareness of options&#xD;
      and opportunities, and access can be a challenge. The purpose of the proposed study is to&#xD;
      assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance&#xD;
      resilience and promote awareness of organizational resources for health, wellness, and&#xD;
      employee assistance. We will evaluate the impact of participation in ARISE on resilience and&#xD;
      other outcomes in nurses in critical care and trauma settings. As a Best Practice Spotlight&#xD;
      Organization designated by the Registered Nurses Association of Ontario (RNAO), this project&#xD;
      will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to&#xD;
      Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse&#xD;
      Fatigue in Health Care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">October 15, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>Connor Davidson Resilience Scale (CD-RISC)</measure>
    <time_frame>1 month post intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Connor Davidson Resilience Scale (CD-RISC)</measure>
    <time_frame>3 months post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occupational fatigue and recovery (OFER) scale</measure>
    <time_frame>1 month post intervention</time_frame>
    <description>Acute fatigue and inter-shift recovery scales only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occupational fatigue and recovery (OFER) scale</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Acute fatigue and inter-shift recovery scales only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Professional Quality of Life (ProQOL5) scale</measure>
    <time_frame>1 month post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Professional Quality of Life (ProQOL5) scale</measure>
    <time_frame>3 months post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>1 month post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>3 months post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).</measure>
    <time_frame>1 month post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).</measure>
    <time_frame>3 months post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness Attention Awareness Scale (MASS)</measure>
    <time_frame>1 month post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness Attention Awareness Scale (MASS)</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Mindfulness attention awareness will be measured using the Mindfulness Attention Awareness Scale (MASS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program Evaluation Outcomes for ARISE participants</measure>
    <time_frame>1 month post intervention</time_frame>
    <description>For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program Evaluation Outcomes for ARISE participants</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Compassion Fatigue</condition>
  <arm_group>
    <arm_group_label>ARISE Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nurses who participate in the 1.5 day ARISE Intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Nurses who do not participate in the ARISE Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ARISE</intervention_name>
    <description>Full day (7.5 hours) workshop consisting of a resilience-focused seminar facilitated by our Employee Assistance Provider (EAP) [Shepell], an introduction to hospital based resources including EAP and health and wellness offerings, and an introduction to self-care and self-care techniques including yoga and stretches, stress relief using the senses and mindfulness&#xD;
Half day (3.75 hours) workshop focusing on the following self-care techniques: mindfulness, yoga and stretching, and creative and reflective reading and writing&#xD;
Peer support through social media engagement (closed Facebook group) for 3 months post-intervention participation&#xD;
Five online, instructor-guided mindfulness sessions (Zoom)</description>
    <arm_group_label>ARISE Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nurse in the medical-surgical and trauma-neurosurgical intensive care units (MSICU and&#xD;
             TNICU) and the medical/surgical floor (9CCN),&#xD;
&#xD;
          -  full-time or part-time employment status,&#xD;
&#xD;
          -  approval of clinical leader manager (CLM),&#xD;
&#xD;
          -  receipt of written informed consent.&#xD;
&#xD;
        Exclusion Crieria:&#xD;
&#xD;
          -  casual employment status&#xD;
&#xD;
          -  inability to attend intervention days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.mindgarden.com/documents/PerceivedStressScale.pdf</url>
    <description>Cohen, S. (1994). Perceived Stress Scale.</description>
  </link>
  <link>
    <url>http://rnao.ca/bpg/guidelines/preventing-and-mitigating-nurse-fatigue-health-care</url>
    <description>Registered Nurses' Association of Ontario [RNAO]. (2011). Preventing and Mitigating Nurse Fatigue in Health Care Toronto, Canada Registered Nurses' Association of Ontario</description>
  </link>
  <link>
    <url>http://www.compassionfatigue.org/pages/ProQOLManualOct05.pdf</url>
    <description>Stamm, B. (2005 ). The ProQOL Manual: THE PROFESSIONAL QUALITY OF LIFE SCALE: Compassion Satisfaction, Burnout &amp; Compassion Fatigue/Secondary Trauma Scales. Pocatello, ID.</description>
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    <citation>Songprakun W, McCann TV. Using bibliotherapy to assist people to recover from depression in Thailand: Relationship between resilience, depression and psychological distress. Int J Nurs Pract. 2015 Dec;21(6):716-24. doi: 10.1111/ijn.12250. Epub 2014 Mar 12.</citation>
    <PMID>24621304</PMID>
  </reference>
  <reference>
    <citation>Sorenson C, Bolick B, Wright K, Hamilton R. Understanding Compassion Fatigue in Healthcare Providers: A Review of Current Literature. J Nurs Scholarsh. 2016 Sep;48(5):456-65. doi: 10.1111/jnu.12229. Epub 2016 Jun 28.</citation>
    <PMID>27351469</PMID>
  </reference>
  <reference>
    <citation>Steege LM, Pinekenstein B. Addressing Occupational Fatigue in Nurses: A Risk Management Model for Nurse Executives. J Nurs Adm. 2016 Apr;46(4):193-200. doi: 10.1097/NNA.0000000000000325.</citation>
    <PMID>27011153</PMID>
  </reference>
  <reference>
    <citation>Wei W, Taormina RJ. A new multidimensional measure of personal resilience and its use: Chinese nurse resilience, organizational socialization and career success. Nurs Inq. 2014 Dec;21(4):346-357. doi: 10.1111/nin.12067. Epub 2014 Apr 8.</citation>
    <PMID>24707977</PMID>
  </reference>
  <reference>
    <citation>Weidlich CP, Ugarriza DN. A pilot study examining the impact of care provider support program on resiliency, coping, and compassion fatigue in military health care providers. Mil Med. 2015 Mar;180(3):290-5. doi: 10.7205/MILMED-D-14-00216.</citation>
    <PMID>25735019</PMID>
  </reference>
  <reference>
    <citation>Windle G, Bennett KM, Noyes J. A methodological review of resilience measurement scales. Health Qual Life Outcomes. 2011 Feb 4;9:8. doi: 10.1186/1477-7525-9-8.</citation>
    <PMID>21294858</PMID>
  </reference>
  <reference>
    <citation>Winwood PC, Colon R, McEwen K. A practical measure of workplace resilience: developing the resilience at work scale. J Occup Environ Med. 2013 Oct;55(10):1205-12. doi: 10.1097/JOM.0b013e3182a2a60a.</citation>
    <PMID>24064782</PMID>
  </reference>
  <reference>
    <citation>Winwood PC, Winefield AH, Dawson D, Lushington K. Development and validation of a scale to measure work-related fatigue and recovery: the Occupational Fatigue Exhaustion/Recovery Scale (OFER). J Occup Environ Med. 2005 Jun;47(6):594-606. doi: 10.1097/01.jom.0000161740.71049.c4.</citation>
    <PMID>15951720</PMID>
  </reference>
  <reference>
    <citation>Winwood PC, Winefield AH, Lushington K. Work-related fatigue and recovery: the contribution of age, domestic responsibilities and shiftwork. J Adv Nurs. 2006 Nov;56(4):438-49. doi: 10.1111/j.1365-2648.2006.04011.x.</citation>
    <PMID>17042823</PMID>
  </reference>
  <reference>
    <citation>Wittenberg-Lyles E, Goldsmith J, Reno J. Perceived benefits and challenges of an oncology nurse support group. Clin J Oncol Nurs. 2014 Aug;18(4):E71-6. doi: 10.1188/14.CJON.E71-E76.</citation>
    <PMID>25095307</PMID>
  </reference>
  <reference>
    <citation>Yates PJ, Benson EV, Harris A, Baron R. An investigation of factors supporting the psychological health of staff in a UK emergency department. Emerg Med J. 2012 Jul;29(7):533-5. doi: 10.1136/emj.2010.099630. Epub 2011 Jun 27.</citation>
    <PMID>21708961</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Unity Health Toronto</investigator_affiliation>
    <investigator_full_name>Orla Smith</investigator_full_name>
    <investigator_title>Director, Nursing/Clinical research, research manager, Critical Care Department, and associate scientist at the Li Ka Shing Knowledge Institute</investigator_title>
  </responsible_party>
  <keyword>Resilience</keyword>
  <keyword>Workplace Stress</keyword>
  <keyword>Occupational Fatigue</keyword>
  <keyword>Compassion Fatigue</keyword>
  <keyword>Peer Support</keyword>
  <keyword>Self-Care</keyword>
  <keyword>Employee Assistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Compassion Fatigue</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT03017469
org study id: SMH30Dec2016
nct id: NCT03017469
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives,
      which can lead to adverse personal and professional outcomes. While workplace stress cannot
      be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease
      fatigue. Organizational employee health, wellness, and assistance programs are all
      intentioned to provide this type of support; however, nurses often lack awareness of options
      and opportunities, and access can be a challenge. The purpose of the proposed study is to
      assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance
      resilience and promote awareness of organizational resources for health, wellness, and
      employee assistance. We will evaluate the impact of participation in ARISE on resilience and
      other outcomes in nurses in critical care and trauma settings. As a Best Practice Spotlight
      Organization designated by the Registered Nurses Association of Ontario (RNAO), this project
      will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to
      Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse
      Fatigue in Health Care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Connor Davidson Resilience Scale (CD-RISC)
time frame: 1 month post intervention
measure: Connor Davidson Resilience Scale (CD-RISC)
time frame: 3 months post intervention
measure: Occupational fatigue and recovery (OFER) scale
time frame: 1 month post intervention
description: Acute fatigue and inter-shift recovery scales only
measure: Occupational fatigue and recovery (OFER) scale
time frame: 3 months post intervention
description: Acute fatigue and inter-shift recovery scales only
measure: Professional Quality of Life (ProQOL5) scale
time frame: 1 month post intervention
measure: Professional Quality of Life (ProQOL5) scale
time frame: 3 months post intervention
measure: Perceived Stress Scale (PSS)
time frame: 1 month post intervention
measure: Perceived Stress Scale (PSS)
time frame: 3 months post intervention
measure: Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).
time frame: 1 month post intervention
measure: Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).
time frame: 3 months post intervention
measure: Mindfulness Attention Awareness Scale (MASS)
time frame: 1 month post intervention
measure: Mindfulness Attention Awareness Scale (MASS)
time frame: 3 months post intervention
description: Mindfulness attention awareness will be measured using the Mindfulness Attention Awareness Scale (MASS).
measure: Program Evaluation Outcomes for ARISE participants
time frame: 1 month post intervention
description: For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.
measure: Program Evaluation Outcomes for ARISE participants
time frame: 3 months post intervention
description: For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.
arm group label: ARISE Intervention
arm group type: Experimental
description: Nurses who participate in the 1.5 day ARISE Intervention
arm group label: Control Group
arm group type: No Intervention
description: Nurses who do not participate in the ARISE Intervention
intervention type: Other
intervention name: ARISE
description: Full day (7.5 hours) workshop consisting of a resilience-focused seminar facilitated by our Employee Assistance Provider (EAP) [Shepell], an introduction to hospital based resources including EAP and health and wellness offerings, and an introduction to self-care and self-care techniques including yoga and stretches, stress relief using the senses and mindfulness
Half day (3.75 hours) workshop focusing on the following self-care techniques: mindfulness, yoga and stretching, and creative and reflective reading and writing
Peer support through social media engagement (closed Facebook group) for 3 months post-intervention participation
Five online, instructor-guided mindfulness sessions (Zoom)
arm group label: ARISE Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
url: http://www.mindgarden.com/documents/PerceivedStressScale.pdf
description: Cohen, S. (1994). Perceived Stress Scale.
url: http://rnao.ca/bpg/guidelines/preventing-and-mitigating-nurse-fatigue-health-care
description: Registered Nurses' Association of Ontario [RNAO]. (2011). Preventing and Mitigating Nurse Fatigue in Health Care Toronto, Canada Registered Nurses' Association of Ontario
url: http://www.compassionfatigue.org/pages/ProQOLManualOct05.pdf
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citation: Steege LM, Pinekenstein B. Addressing Occupational Fatigue in Nurses: A Risk Management Model for Nurse Executives. J Nurs Adm. 2016 Apr;46(4):193-200. doi: 10.1097/NNA.0000000000000325.
PMID: 27011153
citation: Wei W, Taormina RJ. A new multidimensional measure of personal resilience and its use: Chinese nurse resilience, organizational socialization and career success. Nurs Inq. 2014 Dec;21(4):346-357. doi: 10.1111/nin.12067. Epub 2014 Apr 8.
PMID: 24707977
citation: Weidlich CP, Ugarriza DN. A pilot study examining the impact of care provider support program on resiliency, coping, and compassion fatigue in military health care providers. Mil Med. 2015 Mar;180(3):290-5. doi: 10.7205/MILMED-D-14-00216.
PMID: 25735019
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PMID: 21294858
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PMID: 24064782
citation: Winwood PC, Winefield AH, Dawson D, Lushington K. Development and validation of a scale to measure work-related fatigue and recovery: the Occupational Fatigue Exhaustion/Recovery Scale (OFER). J Occup Environ Med. 2005 Jun;47(6):594-606. doi: 10.1097/01.jom.0000161740.71049.c4.
PMID: 15951720
citation: Winwood PC, Winefield AH, Lushington K. Work-related fatigue and recovery: the contribution of age, domestic responsibilities and shiftwork. J Adv Nurs. 2006 Nov;56(4):438-49. doi: 10.1111/j.1365-2648.2006.04011.x.
PMID: 17042823
citation: Wittenberg-Lyles E, Goldsmith J, Reno J. Perceived benefits and challenges of an oncology nurse support group. Clin J Oncol Nurs. 2014 Aug;18(4):E71-6. doi: 10.1188/14.CJON.E71-E76.
PMID: 25095307
citation: Yates PJ, Benson EV, Harris A, Baron R. An investigation of factors supporting the psychological health of staff in a UK emergency department. Emerg Med J. 2012 Jul;29(7):533-5. doi: 10.1136/emj.2010.099630. Epub 2011 Jun 27.
PMID: 21708961
responsible party type: Principal Investigator
investigator affiliation: Unity Health Toronto
investigator full name: Orla Smith
investigator title: Director, Nursing/Clinical research, research manager, Critical Care Department, and associate scientist at the Li Ka Shing Knowledge Institute
mesh term: Fatigue
mesh term: Compassion Fatigue
mesh term: Stress, Psychological
sharing ipd: No