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Digital Support Intervention on Newly Licensed Nurses

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: NCT04100629
Recruitment Status : Terminated (Lack of enrollment (and due to pandemic))
First Posted : September 24, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
West Penn Allegheny Health System
University of California, San Diego
El Centro Medical Center
Pioneers Hospital
Information provided by (Responsible Party):
Lisa A Concilio, Duquesne University

Tracking Information
First Submitted Date  ICMJE September 19, 2019
First Posted Date  ICMJE September 24, 2019
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE December 13, 2019
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • Reported levels of perceived stress will change; predicted to decrease. [ Time Frame: prior to intervention, 3 weeks, and 6 weeks ]
    The Perceived Stress Scale (PSS) will be used to measure stress (Cohen, Kamarck, & Mermelstein, 1983). Participant stress will measured prior to intervention, at 3 weeks, and 6 weeks. It is a 10-item, Likert-type scale with five points. Scores are obtained by using the item responses that range from 0 to 4 (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often) with items 4, 5, 7, and 8 reversely scored. The summed scores of the PSS will be used for one of the dependent variables and will be discussed further as a key variable. Participants will be asked to think about their current work situation when answering survey questions. The possible range of scores, after adding all points, will range from 0 to 40, with higher scores signifying greater perceived stress.
  • Report levels of resiliency will change; predicted to increase. [ Time Frame: prior to intervention, 3 weeks, and 6 weeks ]
    The Connor-Davidson Resiliency Scale (CD-RISC-25) will be used to measure resiliency (Connor & Davidson, 2003). Participant resilience will measured prior to intervention, at 3 weeks, and 6 weeks. The CD-RISC-25 is a 25-item self-report scale that uses a five-point Likert-type scale ranging from 0 (not true at all) to 4 (true nearly all the time). Total scores, ranging from 0-100, assess resilience and a score of 100 denotes the highest level of resiliency; the tool takes 5-10 minutes to complete (CD RISC, 2011). The summed scores of the CD-RISC 25 will be used for one of the dependent variables and will be discussed further as a key variable.
  • Reported levels of participants Sense of Support will change; predicted to increase. [ Time Frame: prior to intervention, 3 weeks, and 6 weeks ]
    The Social Support Scale (SSS) will be used to measure perceived social support scores (Dolbier & Steinhardt, 2000). Participant perceived social support will measured prior to intervention, at 3 weeks, and 6 weeks. Respondents answer 21 items on a 4-option Likert-type scale labeled between 0 (not true at all) to 3 (completely true) (Dolbier & Steinhardt, 2000) and will take 20-25 minutes to complete (Versta, 2011). The summed scores of the SSS will be used for one of the dependent variables and will be discussed further as a key variable.
  • Intentions to Leave current job will change; predicted to decrease. [ Time Frame: 6 weeks ]
    An "Intention to Leave," investigator designed survey will be used to measure the participants' Intention to Leave their current jobs. Participant intention to leave their current job will measured at 6 weeks. Participants will be asked what percentage, if any, represents their ITL their current position and also what percentage represents their ITL to leave their current organization.
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Reported levels of stress will change [ Time Frame: prior to intervention, 3 weeks, and 6 weeks ]
    The Perceived Stress Scale (PSS) will be used to measure stress (Cohen, Kamarck, & Mermelstein, 1983). Participant stress will measured prior to intervention, at 3 weeks, and 6 weeks.
  • Report levels of resiliency will change [ Time Frame: prior to intervention, 3 weeks, and 6 weeks ]
    The Connor-Davidson Resiliency Scale (CD-RISC-25) will be used to measure resiliency (Connor & Davidson, 2003). Participant resilience will measured prior to intervention, at 3 weeks, and 6 weeks.
  • Reported levels of participants Sense of Support will change [ Time Frame: prior to intervention, 3 weeks, and 6 weeks ]
    The Social Support Scale (SSS) will be used to measure perceived social support scores (Dolbier & Steinhardt, 2000). Participant perceived social support will measured prior to intervention, at 3 weeks, and 6 weeks.
  • Intentions to Leave current job will change [ Time Frame: 6 weeks ]
    An "Intention to Leave," investigator designed survey will be used to measure the participants' Intention to Leave their current jobs. Participant intention to leave their current job will measured at 6 weeks.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Digital Support Intervention on Newly Licensed Nurses
Official Title  ICMJE The Impact of a Digital Support Intervention on Stress, Resiliency, Perceived Social Support, and Intention to Leave Among Newly Licensed Nurses: A Randomized Controlled Trial
Brief Summary Brief Description of the Study: Text messages will be sent to participants and responses will be surveyed to ascertain if using a social, digital intervention can influence NLNs' (newly licensed nurses') stress, resiliency, perceived sense of social support, and/or the intention to stay at current jobs. Newly licensed nurses (within their first year of hire) will be asked to participate. A series of four text messages will be sent to all study participants (experimental and control groups) by the PI every Monday, Wednesday, Friday, and Saturday (M, W, F, S) at 1pm for six weeks, for a total of 24 different texts for each group. Participants will fill out surveys before the study begins, at week 3 and at the end of the study (week 6).The control group will receive medical facts. Texts sent to the experimental group will be based on SSBC nurturant support messages and are intended to decrease stress intention to leave (ITL), increase resilience, and perceived sense of support. The SSBC nurturant support texts are comprised of three themes of support: emotional, network, and esteem. The experimental group's supportive text messages were created by the PI and require content validation. A gatekeeper at your facility will be asked to send an email to "Experts" (MSN educators) and ask them to complete the validation survey using a Qualtrics Survey Platform then the PI will place ratings into a table and calculate the results. There are 3 other facilities enrolled in this study: University California, San Diego, El Centro Medical Center, and Pioneer Hospital (all located in southern California).
Detailed Description

The purpose of this randomized control study (RCT) is to determine the impact of a 6-week digital support intervention (text messaging) on NLNs' levels of stress, resiliency, perceived social support, and ITL (intention to leave) their current jobs. The long-term objective is to examine if a 6-week digital support intervention impacts NLNs' (newly licensed nurses') ITL during the first year of hire. The central hypothesis is that a digital support intervention plays a critical role in NLNs' levels of stress, resilience, perceived sense of social support, and ITL their current jobs. In order to be included in this proposed study, participants must agree to not use their Smartphones while providing direct patient care but may access text messages while in designated break areas or when off duty.

Research Questions: RQ1: What is the effect of a digital support intervention upon NLNs' stress? RQ2: What is the effect of a digital support intervention upon NLNs' resiliency? RQ3: What is the effect of a digital support intervention upon NLNs' perceived social support? RQ4: What is the effect of a digital support intervention upon NLNs' ITL their first jobs during their first year of hire?

Design (Description of research plan, intervention(s) and time frame): A prospective, RCT design with an experimental and control group is proposed for this study to determine if a digital support intervention impacts NLNs' stress, resiliency, perceived sense of support, and Intention to Leave.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
A prospective, RCT design with an experimental and control group is proposed for this study to determine if a digital support intervention impacts Newly Licensed Nurses' stress, resiliency, perceived sense of support, and Intention To Leave their current jobs.
Masking: Single (Participant)
Masking Description:
participants' unique numeric identifiers will be separated into two groups by the random generator with the exception of male participants. To enhance similarity among the control and experimental groups, male participants will be evenly distributed between groups (every other male, in sequential order of data collection, will be placed into each group) and not randomized (Polit & Beck, 2017).
Primary Purpose: Supportive Care
Condition  ICMJE
  • Stress
  • Job Stress
Intervention  ICMJE Behavioral: digital support: text messages
In this study, the text messages are intended to be one-directional, from the PI to the participant. Participants are not expected to reply. If participants reply to any of the text messages, the PI will screen the content and only reply if it is a question regarding the study or a request to seek counseling. Additionally, participants will be instructed by the PI to access their Smartphones to read texts while on a break, after their shift, or when not at work; participants will be instructed to not use Smartphones to read texts while working. A series of four text messages will be sent to all study participants (experimental and control groups) by the PI every Monday, Wednesday, Friday, and Saturday (M, W, F, S) at 1pm for six weeks, for a total of 24 different texts for each group.
Other Name: text messages
Study Arms  ICMJE
  • Placebo Comparator: Control Group
    The control group will receive medical facts and are not meant to support newly licensed nurses and are not known to affect stress, resilience, perceived social support, or Intention To Leave one's job.
    Intervention: Behavioral: digital support: text messages
  • Experimental: Experimental Group
    Texts sent to the experimental group will be based on nurturant support messages and are intended to decrease stress, Intention To Leave, increase resilience, and perceived sense of support.
    Intervention: Behavioral: digital support: text messages
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 19, 2020)
23
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2019)
100
Actual Study Completion Date  ICMJE May 14, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Newly Licensed Nurses,
  • ages 19-37 years,
  • proficient in English,
  • working in an acute care facility as a RN during the first year of hire,
  • have a working personal Smartphone,
  • have the ability to send and receive text messages,
  • have an active and working personal email account, and
  • be willing to participate for six weeks,
  • complete a demographic survey before the study, survey instruments at 3 weeks, 6 weeks, and at the conclusion of the study
  • agree to not use or carry their Smartphone while performing direct patient care and
  • assume any data charges for text messages, if incurred.

Exclusion Criteria:

  • Newly Licensed Nurses who have worked in the role of a RN on another floor or
  • NLNs who have worked as an RN at another organization, or
  • NLNs not 19-37 years of age.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 37 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04100629
Other Study ID Numbers  ICMJE 2019/06/10
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 Lisa A Concilio, Duquesne University
Study Sponsor  ICMJE Duquesne University
Collaborators  ICMJE
  • West Penn Allegheny Health System
  • University of California, San Diego
  • El Centro Medical Center
  • Pioneers Hospital
Investigators  ICMJE
Study Director: David Delmonico, PhD Chair of the Duquesne University IRB
PRS Account Duquesne University
Verification Date June 2020

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