NCT02603133

Brief Summary

Resilience means a healthcare provider's ability to cope, recover, and learn from stressful events, as well as their access to resources that promote health and well-being. Neonatal intensive care unit (NICU) health professionals' need to have particularly good resilience, because their work is extremely stressful and their patients, fragile preterm infants, require their undivided attention. The investigators propose a feasible and engaging intervention to enhance resilience among NICU health professionals promoting their ability to provide safe care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

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

November 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

November 6, 2015

Last Update Submit

February 8, 2023

Conditions

Burnout, ProfessionalResilience, Psychological

Keywords

healthcareburnoutresiliencefatigueNICUsafety culturequality of care

Outcome Measures

Primary Outcomes (1)

  • NICU health professional resilience

    Burnout (emotional exhaustion) is the primary resilience outcome. The Maslach Burnout Inventory (MBI) has been the gold standard tool in the field of burnout research. In our investigations, the Emotional Exhaustion subscale, in particular, is consistently associated with variables such as staff turnover, disruptive behavior, productivity, delays, and teamwork. When used as a "percent agree" metric, we have shown it to be a very effective indicator of emotional exhaustion at the group level for a clinical area or work setting. We will use a shortened 4-item version of this subscale from the Maslach Burnout Inventory, which we validated in the NICU setting. The response scale ranges from 1 (disagree strongly) to 5 (agree strongly). Resilience will be calculated as the percentage of NICU providers who disagree slightly or strongly with the 4 items assessing features of emotional exhaustion.

    10 days, 1 month, 6 months, 12 months

Secondary Outcomes (3)

  • Work-Life Balance

    10 days, 1 month, 6 months, 12 months

  • Depressive symptoms

    10 days, 1 month, 6 months, 12 months

  • Happiness

    10 days, 1 month, 6 months, 12 months

Other Outcomes (5)

  • Safety and teamwork climate

    6 months and 12 months

  • Clinical delays in patient care

    6 month, 12 months

  • Any health care associated infection

    12 months

  • +2 more other outcomes

Study Arms (3)

Cohort 1

OTHER

The intervention will begin for all NICUs, with baseline surveys as necessary pre-work. For those unable to attend, a link to the baseline survey will be emailed with site champion instructions to complete in groups at staff meetings and during shift change. Two weeks later, three randomly (random number generator) assigned NICUs (block 1) included in the first block webinar will then receive Module 1 of the intervention with Modules 2-6 being rolled out monthly. The second block of three NICUs starts approximately six-month later.

Behavioral: Three Good ThingsBehavioral: GratitudeBehavioral: Random Acts of KindessBehavioral: AweBehavioral: 1 Good Chat

Cohort 2

OTHER

This second block of 3 NICUs will start approximately six-months after roll-out of group 1. At time point 0 this NICUs in this group will receive a lecture on safety culture, unrelated to the burnout intervention.

Behavioral: Three Good ThingsBehavioral: GratitudeBehavioral: Random Acts of KindessBehavioral: AweBehavioral: 1 Good Chat

Cohort 3 (July cohort) WISER 2.0

EXPERIMENTAL

Individually randomized to one of two cohorts. Cohort 1 to start will serve as the waitlist control 1 before starting their version of the intervention. Each cohort will experience modified versions of WISER, which only differ by the spacing of intervention. Participants will receive 10-day sequential or 10-day non-sequential rollout of the resilience tools. Seq will receive the tools on ten consecutive days. NSeq will receive messages daily noThursdays, Fridays and Saturdays. Days 1 through 3 will be offered 3GT. Day 4 will continue with 3GT but add a single day activity for Gratitude. Day 5 adds a single activity for Awe. Day 6 adds a single day activity for RAK. Days 7 -10 the participant is offered the choice of Gratitude, Awe or RAK to accompany their daily 3GT. At 1 month follow-up time point, participants will receive 8 days of the 1 Good Chat tool, as a booster. At 6 month follow-up, participants will receive a gratitude exercise.

Behavioral: Three Good ThingsBehavioral: GratitudeBehavioral: Random Acts of KindessBehavioral: AweBehavioral: 1 Good Chat

Interventions

Three Good ThingsBEHAVIORAL

In this tool participants reflect on "good things" that happened that day during evenings across 10 days. Participants are also able to voluntarily share their good things and read other participants' good things through the nightly anonymous log. By savoring good moments from earlier that day, participants are thought to shift from the natural focus on "what went poorly" due to negativity bias1 to an appreciation for what went well. This shift in focus is thought to reduce rumination and depression symptoms. In prior research, 3GTs was found to increase happiness and decrease depression in internet participants.2 In prior cohorts of 3GTs, we saw improvements in burnout, depression symptoms, work-life balance, and happiness. Participants also report benefiting from viewing nightly Three Good Things logs of others.

Also known as: 3GT Tool
Cohort 1Cohort 2Cohort 3 (July cohort) WISER 2.0
GratitudeBEHAVIORAL

In this tool participants are offered the opportunity to cultivate gratitude toward others through a guided gratitude letter writing exercise.2 Through expressing gratitude, we learn more about our vital connections to others, often in surprising and meaningful ways. Previous research has found that gratitude interventions increase well-being in a number of ways, particularly in boosting positive affect.

Also known as: Grat Tool
Cohort 1Cohort 2Cohort 3 (July cohort) WISER 2.0
Random Acts of KindessBEHAVIORAL

In this tool, participants report kind acts that they have committed, received, and/or witnessed, each day. By committing random acts of kindness participants experience a boost of positive emotions, and report lower negative affect. Recipients of acts of kindness benefit as well.

Also known as: RAK Tool
Cohort 1Cohort 2Cohort 3 (July cohort) WISER 2.0
AweBEHAVIORAL

This tool provides participants the opportunity to recount in detail one of their own experiences of awe, and encourages them to be on the lookout for new ones (even minor examples) over a few days. When we experience awe, our sense of time expands, we are kinder to others, we experience higher life satisfaction, and we prefer experiences over material things.

Also known as: Awe Tool
Cohort 1Cohort 2Cohort 3 (July cohort) WISER 2.0
1 Good ChatBEHAVIORAL

This tool uses the latest research on cultivating relationships and increasing social connection. Feeling socially connected is linked to health and well-being outcomes, including longevity.6 The 1 Good Chat tool asks participants to reflect on good conversations and to note the prosocial behaviors that he/she and the other person engaged in

Also known as: Good Chat Tool
Cohort 1Cohort 2Cohort 3 (July cohort) WISER 2.0

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Location: newborn center, i.e. the NICU or a step down unit
  • Provider:
  • Primary work place is the Newborn Center
  • Full time equivalent of \>=40%
  • Date of hire more than 4 weeks prior to start of the intervention
  • Provider groups:
  • Attendings that identify your newborn center as their primary site of work (not physicians from satellite NICUs)
  • NICU fellows
  • Nurse practitioners
  • Physician Assistants
  • Nurses, including nurse leadership (managers, educators)
  • Nurse Assistant
  • Respiratory care providers
  • Transport specialists if primarily neonatal transport team
  • Newborn Center Social workers
  • +5 more criteria

You may not qualify if:

  • Location: Labor and delivery or the newborn nursery
  • Provider: Work is delivered mostly outside the newborn center (this may affect providers who delivery services across the hospital such as residents, surgeons, anesthesia, consultants, nutritionists, PT/OT (these are included if they are mostly dedicated to the newborn center)
  • Float personnel
  • Does not speak english
  • Cannot operate computer or smart phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Beth Israel Deconness Medical Center

Boston, Massachusetts, 02215, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of North Carolina at Chapel Hill Children's Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Health System

Durham, North Carolina, 27705, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas, Houston

Houston, Texas, 77030, United States

Location

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  • Pettker CM, Thung SF, Norwitz ER, Buhimschi CS, Raab CA, Copel JA, Kuczynski E, Lockwood CJ, Funai EF. Impact of a comprehensive patient safety strategy on obstetric adverse events. Am J Obstet Gynecol. 2009 May;200(5):492.e1-8. doi: 10.1016/j.ajog.2009.01.022. Epub 2009 Feb 27.

    PMID: 19249729BACKGROUND

  • Wolf FA, Way LW, Stewart L. The efficacy of medical team training: improved team performance and decreased operating room delays: a detailed analysis of 4863 cases. Ann Surg. 2010 Sep;252(3):477-83; discussion 483-5. doi: 10.1097/SLA.0b013e3181f1c091.

    PMID: 20739848BACKGROUND

  • Pronovost PJ, Berenholtz SM, Goeschel C, Thom I, Watson SR, Holzmueller CG, Lyon JS, Lubomski LH, Thompson DA, Needham D, Hyzy R, Welsh R, Roth G, Bander J, Morlock L, Sexton JB. Improving patient safety in intensive care units in Michigan. J Crit Care. 2008 Jun;23(2):207-21. doi: 10.1016/j.jcrc.2007.09.002.

    PMID: 18538214BACKGROUND

  • Profit J, Sexton JB, Thomas EJ, et al. Higher Safety Culture among Neonatal Intensive Care Units That Participate in Quality Improvement Collaboratives. E-PAS 2012:2920.350

    BACKGROUND

  • Profit J, Lee HC, Sharek PJ, et al. NICU Safety Culture: The Effect of Choice of Instrument on Benchmarking. Pediatrics 2014;Under review

    BACKGROUND

  • Profit J, Typpo KV, Hysong SJ, Woodard LD, Kallen MA, Petersen LA. Improving benchmarking by using an explicit framework for the development of composite indicators: an example using pediatric quality of care. Implement Sci. 2010 Feb 9;5:13. doi: 10.1186/1748-5908-5-13.

    PMID: 20181129BACKGROUND

  • Sexton JB, Sharek PJ, Gould JB, et al. Prevalence of Emotional Exhaustion in a Cohort of 21 Neonatal Intensive Care Units. E-PAS 2012:2920.351

    BACKGROUND

  • Profit J, Sharek PJ, Thomas EJ, et al. Clinical Outcomes among VLBW Infants and the Links to Subsequent Perceptions of NICU Safety Culture. E-PAS 2013:2922.356

    BACKGROUND

  • Chadwick WA, Fullwood C, Mullin L, Browning B, Schifer C, Pietrusik J. Webinar Implementation for the Science of Enhancing Resilience (WISER): the development and evaluation of WISER 1.0. Duke University Medical School Research Day. Durham, NC2012

    BACKGROUND

  • Timmel J, Kent PS, Holzmueller CG, Paine L, Schulick RD, Pronovost PJ. Impact of the Comprehensive Unit-based Safety Program (CUSP) on safety culture in a surgical inpatient unit. Jt Comm J Qual Patient Saf. 2010 Jun;36(6):252-60. doi: 10.1016/s1553-7250(10)36040-5.

    PMID: 20564886BACKGROUND

  • Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.

    PMID: 16045394BACKGROUND

  • Emmons RA, McCullough ME. Counting blessings versus burdens: an experimental investigation of gratitude and subjective well-being in daily life. J Pers Soc Psychol. 2003 Feb;84(2):377-89. doi: 10.1037//0022-3514.84.2.377.

    PMID: 12585811BACKGROUND

  • Profit J, Adair KC, Cui X, Mitchell B, Brandon D, Tawfik DS, Rigdon J, Gould JB, Lee HC, Timpson WL, McCaffrey MJ, Davis AS, Pammi M, Matthews M, Stark AR, Papile LA, Thomas E, Cotten M, Khan A, Sexton JB. Randomized controlled trial of the "WISER" intervention to reduce healthcare worker burnout. J Perinatol. 2021 Sep;41(9):2225-2234. doi: 10.1038/s41372-021-01100-y. Epub 2021 Aug 9.

    PMID: 34366432RESULT

  • Profit J, Cui X, Tawfik D, Adair KC, Sexton JB. "WISER" intervention to reduce healthcare worker burnout - 1 year follow up. J Perinatol. 2024 Dec;44(12):1719-1723. doi: 10.1038/s41372-024-01993-5. Epub 2024 May 11.

    PMID: 38734802DERIVED

  • Sexton JB, Adair KC, Cui X, Tawfik DS, Profit J. Effectiveness of a bite-sized web-based intervention to improve healthcare worker wellbeing: A randomized clinical trial of WISER. Front Public Health. 2022 Dec 8;10:1016407. doi: 10.3389/fpubh.2022.1016407. eCollection 2022.

    PMID: 36568789DERIVED

  • Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.

    PMID: 32627860DERIVED

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, PsychologicalFatigue

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jochen Profit, MD, MPH

    Stanford University

    PRINCIPAL INVESTIGATOR

  • J. Bryan Sexton, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Participants are individually randomized to one of two cohorts. 1 cohort will serve as the waitlist control for Cohort 1 before starting their version of the intervention. Each cohort will experience slightly different versions of WISER, which only differ by the spacing of the intervention. Cohort 1 will receive a 10-day sequential (Seq) and a 10-day non-sequential (NSeq) rollout of the resilience tools. Seq will receive the tools on ten consecutive days. NSeq will receive messages daily with the exception of Thursdays, Fridays and Saturdays. Our tracking of attrition in the first study showed marked declines in participation on Thursdays, Fridays, and to some extent on Saturdays, but an increase on Sundays, hence this design to test a new way of counteracting attrition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Director of Perinatal Health Systems Research

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 11, 2015

Study Start

July 1, 2016

Primary Completion

August 1, 2018

Study Completion

July 1, 2019

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

only research team will be accessing the data.

Locations

US(9)