NCT04100629

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 13, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

September 19, 2019

Last Update Submit

June 1, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    prior to intervention, 3 weeks, and 6 weeks

  • 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.

    prior to intervention, 3 weeks, and 6 weeks

  • 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.

    prior to intervention, 3 weeks, and 6 weeks

  • 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.

    6 weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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.

Behavioral: digital support: text messages

Experimental Group

EXPERIMENTAL

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.

Behavioral: digital support: text messages

Interventions

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.

Also known as: text messages
Control GroupExperimental Group

Eligibility Criteria

Age19 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pioneer Hospital

Brawley, California, 92227, United States

Location

El Centro Regional Medical Center

El Centro, California, 92243, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • David Delmonico, PhD

    Chair of the Duquesne University IRB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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).
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 24, 2019

Study Start

December 13, 2019

Primary Completion

April 30, 2020

Study Completion

May 14, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations