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Achieving Resilience in Acute Care Nurses (ARISE).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017469
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Orla Smith, St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE January 9, 2017
First Posted Date  ICMJE January 11, 2017
Last Update Posted Date April 17, 2018
Actual Study Start Date  ICMJE February 21, 2017
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
Connor Davidson Resilience Scale (CD-RISC) [ Time Frame: 1 month post intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
  • Connor Davidson Resilience Scale (CD-RISC) [ Time Frame: 3 months post intervention ]
  • Occupational fatigue and recovery (OFER) scale [ Time Frame: 1 month post intervention ]
    Acute fatigue and inter-shift recovery scales only
  • Occupational fatigue and recovery (OFER) scale [ Time Frame: 3 months post intervention ]
    Acute fatigue and inter-shift recovery scales only
  • Professional Quality of Life (ProQOL5) scale [ Time Frame: 1 month post intervention ]
  • Professional Quality of Life (ProQOL5) scale [ Time Frame: 3 months post intervention ]
  • Perceived Stress Scale (PSS) [ Time Frame: 1 month post intervention ]
  • Perceived Stress Scale (PSS) [ Time Frame: 3 months post intervention ]
  • Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N). [ Time Frame: 1 month post intervention ]
  • Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N). [ Time Frame: 3 months post intervention ]
  • Mindfulness Attention Awareness Scale (MASS) [ Time Frame: 1 month post intervention ]
  • Mindfulness Attention Awareness Scale (MASS) [ Time Frame: 3 months post intervention ]
    Mindfulness attention awareness will be measured using the Mindfulness Attention Awareness Scale (MASS).
  • Program Evaluation Outcomes for ARISE participants [ Time Frame: 1 month post intervention ]
    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.
  • Program Evaluation Outcomes for ARISE participants [ Time Frame: 3 months post intervention ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Achieving Resilience in Acute Care Nurses (ARISE).
Official Title  ICMJE Achieving Resilience in Acute Care Nurses (ARISE): A Randomized Controlled Trial of a Multi-component Intervention for Nurses in Critical Care and Trauma.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Stress, Psychological
  • Compassion Fatigue
Intervention  ICMJE Other: ARISE
  1. 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
  2. Half day (3.75 hours) workshop focusing on the following self-care techniques: mindfulness, yoga and stretching, and creative and reflective reading and writing
  3. Peer support through social media engagement (closed Facebook group) for 3 months post-intervention participation
  4. Five online, instructor-guided mindfulness sessions (Zoom)
Study Arms  ICMJE
  • Experimental: ARISE Intervention
    Nurses who participate in the 1.5 day ARISE Intervention
    Intervention: Other: ARISE
  • No Intervention: Control Group
    Nurses who do not participate in the ARISE Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2017)
29
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2017)
40
Actual Study Completion Date  ICMJE October 15, 2017
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nurse in the medical-surgical and trauma-neurosurgical intensive care units (MSICU and TNICU) and the medical/surgical floor (9CCN),
  • full-time or part-time employment status,
  • approval of clinical leader manager (CLM),
  • receipt of written informed consent.

Exclusion Crieria:

  • casual employment status
  • inability to attend intervention days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03017469
Other Study ID Numbers  ICMJE SMH30Dec2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Orla Smith, St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Michael's Hospital, Toronto
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP