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Digital Support Intervention on Newly Licensed Nurses

Primary Purpose

Stress, Job Stress

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
digital support: text messages
Sponsored by
Duquesne University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress

Eligibility Criteria

19 Years - 37 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pioneer Hospital
  • El Centro Regional Medical Center
  • University of California, San Diego
  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reported levels of perceived stress will change; predicted to decrease.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2019
Last Updated
June 1, 2020
Sponsor
Duquesne University
Collaborators
West Penn Allegheny Health System, University of California, San Diego, El Centro Medical Center, Pioneers Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04100629
Brief Title
Digital Support Intervention on Newly Licensed Nurses
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment (and due to pandemic)
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duquesne University
Collaborators
West Penn Allegheny Health System, University of California, San Diego, El Centro Medical Center, Pioneers Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Job Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
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).
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
digital support: text messages
Other Intervention Name(s)
text messages
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reported levels of perceived stress will change; predicted to decrease.
Description
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.
Time Frame
prior to intervention, 3 weeks, and 6 weeks
Title
Report levels of resiliency will change; predicted to increase.
Description
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.
Time Frame
prior to intervention, 3 weeks, and 6 weeks
Title
Reported levels of participants Sense of Support will change; predicted to increase.
Description
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.
Time Frame
prior to intervention, 3 weeks, and 6 weeks
Title
Intentions to Leave current job will change; predicted to decrease.
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Delmonico, PhD
Organizational Affiliation
Chair of the Duquesne University IRB
Official's Role
Study Director
Facility Information:
Facility Name
Pioneer Hospital
City
Brawley
State/Province
California
ZIP/Postal Code
92227
Country
United States
Facility Name
El Centro Regional Medical Center
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://drive.google.com/open?id=1vNjwT5j9Y32e7vdayZAMBp-3PvJWCiSK

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Digital Support Intervention on Newly Licensed Nurses

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