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Burnout, ProfessionalWISERNCT02603133

Web-based Implementation for the Science of Enhancing Resilience Study

A study testing Three Good Things, Gratitude and Random Acts of Kindess in people with Burnout, Professional and Resilience, Psychological, run by Stanford University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
Three Good Things, Gratitude and Random Acts of Kindess
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,650 participants
Where
9 sitesUnited States
Study dates
Jul 2016to Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 20Show fewer
  • 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
  • Newborn Center Clerks
  • Newborn Center Pharmacists
  • Newborn Center Physical, Occupational, Speech, and Developmental Therapists
  • Newborn Center Nutritionists
  • Newborn Center Lactation Consultants

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Beth Israel Deconness Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill Children's Hospital

    Chapel Hill, North Carolina, 27599

  • Duke University Health System

    Durham, North Carolina, 27705

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas, Houston

    Houston, Texas, 77030

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • Stanford University Medical Center

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the detailed description

Optimizing provider well-being is critical to the delivery of safe and high quality care to the most vulnerable of patients: very preterm babies.

Major innovative objectives of this proposal include testing the Web-based Implementation for the Science of Enhancing Resilience (WISER) program's effectiveness in enhancing resilience among Neonatal Intensive Care Unit (NICU) health workers, evaluating its effect on unit safety culture, and examining its effect on clinical outcomes in preterm infants. The WISER program is an established but low-intensity yet engaging intervention, which integrates education and behavior modification to boost provider well-being and resilience in order to create an organizational environment which prevents patient harm.

Care for the more than 50,000 very low birth weight (VLBW; < 1500 gm) infants born annually in the United States is challenging and expensive. Quality of care and outcomes vary widely. Increasing technical demands and patient acuity have pushed burnout among health workers to the breaking point. The few tested interventions that improve caregiver resilience lack feasibility for widespread adoption. This study is designed to achieve the following aims:

  1. Test the effectiveness of WISER in improving NICU health professional resilience;
  2. Test the effectiveness of WISER in improving patient safety and organizational outcomes;
  3. Test the sustainability of WISER; and
  4. Describe the barriers and facilitators of the WISER program.

The investigators will test the efficacy of the WISER Program in the NICU setting using a stepped-wedge mixed-methods randomized controlled trial (swRCT) at six tertiary care NICUs. The results of this trial will also provide insights into the causal relations between health worker resilience, the organizational environment, and clinical outcomes among infants born VLBW.

Two blocks with 3 NICUs each will be randomly assigned to one of two intervention cohorts. The WISER NICUs program consists of six 10-minute videos delivered over the course of a six-month period. Following the end of the initial intervention, each NICU will receive individualized feedback/refresher webinar at 12 months, and a final follow-up at 24 months. The investigators will use measures of perception (surveys of health professional's perceptions) and quantifiable measures (clinical measures) to assess the efficacy of the intervention in different domains (resilience, organizational environment, and health). Qualitative methods will provide further insights into facilitators and barriers of the efficacy of WISER.

Being tested
Three Good Things, Gratitude, Random Acts of Kindess, Awe, 1 Good Chat
Keywords
healthcare, burnout, resilience, fatigue, NICU, safety culture, quality of care
Medical subject headings
Burnout, Professional, Burnout, Psychological, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Three Good ThingsBehavioural

    Also called 3GT Tool

    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.

  • GratitudeBehavioural

    Also called Grat Tool

    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.

  • Random Acts of KindessBehavioural

    Also called RAK Tool

    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.

  • AweBehavioural

    Also called Awe Tool

    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.

  • 1 Good ChatBehavioural

    Also called Good Chat Tool

    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

Study groups in NCT02603133
Study groupRoleWhat they receive
Cohort 1OtherThe 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.
Receives: Behavioral: Three Good Things; Behavioral: Gratitude; Behavioral: Random Acts of Kindess; Behavioral: Awe; Behavioral: 1 Good Chat
Cohort 2OtherThis 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.
Receives: Behavioral: Three Good Things; Behavioral: Gratitude; Behavioral: Random Acts of Kindess; Behavioral: Awe; Behavioral: 1 Good Chat
Cohort 3 (July cohort) WISER 2.0ExperimentalIndividually 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.
Receives: Behavioral: Three Good Things; Behavioral: Gratitude; Behavioral: Random Acts of Kindess; Behavioral: Awe; Behavioral: 1 Good Chat

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 days, 1 month, 6 months, 12 months

Secondary outcomes (3)

  1. Work-Life Balance

    Work-Life Balance (WLB). WLB items were adopted from the College Activities and Behavior Questionnaire. These items that can be interpreted at face-value. All items are prefaced with, "during the past week, how often did this occur" and include items such as "argued with a co-professional" and "arrived home late from work"; they are answered on a four-point scale (0 = rarely or none; 3 = all of the time). Each of these items individually is face-valid and interpretable, but together they make for robust debriefings and discussions linking QI to work-life balance. They are internally consistent, with a Cronbach's alpha of α = 0.82 in our large resilience database.

    Measured: 10 days, 1 month, 6 months, 12 months

  2. Depressive symptoms

    The Center for Epidemiological Studies Depression Scale-10-item version (CES-D10), a psychometrically sound tool for screening respondents for clinical depression, consists of ten items. All items are prefaced with, "during the past week, how often did this occur," include items such as "I could not 'get going'" and "my sleep was restless," and are answered on a four-point scale (0 = rarely or none; 3 = all of the time). Each participant's responses are summed together to achieve a 0- to 30-point scale. A score of 10 or higher is considered a positive screen. We have used the CES-D10 in several WISER and three good things studies without any problems under the existing IRB. The CES-D10 is not a suicide screening tool, it is explicitly used to screen for depression without a suicide item.

    Measured: 10 days, 1 month, 6 months, 12 months

  3. Happiness

    Rather than to solely focus on negative outcomes, we will also measure happiness via the well-validated Subjective Happiness Scale. This 4-item measure of global subjective happiness was developed and validated 15 years ago using 14 studies with a total of 2732 participants, and has high internal consistency, test-retest, self-peer correlations, as well as excellent convergent and discriminant validity. The strong psychometrics and brevity of this scale have made it very popular in positive psychology interventions that require more precision in the assessment of subjective happiness.

    Measured: 10 days, 1 month, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2015 (estimated)
  2. Study startJul 2016
  3. Primary completionAug 2018
  4. Study completionJul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
2,650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603133
Sponsor's protocol ID
IRB-34547
Other IDs
R01HD084679
Acronym
WISER
Status last verified
Feb 2023
First submitted
6 Nov 2015
Last updated
10 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: only research team will be accessing the data.

Publications

  • Dyrbye LN, Shanafelt TD. Physician burnout: a potential threat to successful health care reform. JAMA. 2011 May 18;305(19):2009-10. doi: 10.1001/jama.2011.652. No abstract available.

    PubMed 21586718

  • Aiken LH, Sermeus W, Van den Heede K, Sloane DM, Busse R, McKee M, Bruyneel L, Rafferty AM, Griffiths P, Moreno-Casbas MT, Tishelman C, Scott A, Brzostek T, Kinnunen J, Schwendimann R, Heinen M, Zikos D, Sjetne IS, Smith HL, Kutney-Lee A. Patient safety, satisfaction, and quality of hospital care: cross sectional surveys of nurses and patients in 12 countries in Europe and the United States. BMJ. 2012 Mar 20;344:e1717. doi: 10.1136/bmj.e1717.

    PubMed 22434089

  • West CP, Tan AD, Shanafelt TD. Association of resident fatigue and distress with occupational blood and body fluid exposures and motor vehicle incidents. Mayo Clin Proc. 2012 Dec;87(12):1138-44. doi: 10.1016/j.mayocp.2012.07.021.

    PubMed 23218084

  • Fahrenkopf AM, Sectish TC, Barger LK, Sharek PJ, Lewin D, Chiang VW, Edwards S, Wiedermann BL, Landrigan CP. Rates of medication errors among depressed and burnt out residents: prospective cohort study. BMJ. 2008 Mar 1;336(7642):488-91. doi: 10.1136/bmj.39469.763218.BE. Epub 2008 Feb 7.

    PubMed 18258931

  • Sexton JB, Helmreich RL, Neilands TB, Rowan K, Vella K, Boyden J, Roberts PR, Thomas EJ. The Safety Attitudes Questionnaire: psychometric properties, benchmarking data, and emerging research. BMC Health Serv Res. 2006 Apr 3;6:44. doi: 10.1186/1472-6963-6-44.

    PubMed 16584553

  • Profit J, Sharek PJ, Amspoker AB, Kowalkowski MA, Nisbet CC, Thomas EJ, Chadwick WA, Sexton JB. Burnout in the NICU setting and its relation to safety culture. BMJ Qual Saf. 2014 Oct;23(10):806-13. doi: 10.1136/bmjqs-2014-002831. Epub 2014 Apr 17.

    PubMed 24742780

  • Sexton JB, Sharek PJ, Thomas EJ, Gould JB, Nisbet CC, Amspoker AB, Kowalkowski MA, Schwendimann R, Profit J. Exposure to Leadership WalkRounds in neonatal intensive care units is associated with a better patient safety culture and less caregiver burnout. BMJ Qual Saf. 2014 Oct;23(10):814-22. doi: 10.1136/bmjqs-2013-002042. Epub 2014 May 13.

    PubMed 24825895

  • van Wyk BE, Pillay-Van Wyk V. Preventive staff-support interventions for health workers. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD003541. doi: 10.1002/14651858.CD003541.pub2.

    PubMed 20238322

  • Sexton JB, Chadwick WA, Weiss KJ, Clarke A, Gould JB, Profit J. Assessing and Improving Health Care Worker Resilience in the NICU. E-PAS 2013:4150.7

  • Ungar M. Researching and theorizing resilience across cultures and contexts. Prev Med. 2012 Nov;55(5):387-9. doi: 10.1016/j.ypmed.2012.07.021. Epub 2012 Aug 1. No abstract available.

    PubMed 22884666

  • Maslach C, Jackson SE. Maslach Burnout Inventory. Palo Alto, CA: Consulting Psychologists Press, Inc.; 1981

  • Profit J, Gould JB, Zupancic JA, Stark AR, Wall KM, Kowalkowski MA, Mei M, Pietz K, Thomas EJ, Petersen LA. Formal selection of measures for a composite index of NICU quality of care: Baby-MONITOR. J Perinatol. 2011 Nov;31(11):702-10. doi: 10.1038/jp.2011.12. Epub 2011 Feb 24.

    PubMed 21350429

  • Ahola K, Vaananen A, Koskinen A, Kouvonen A, Shirom A. Burnout as a predictor of all-cause mortality among industrial employees: a 10-year prospective register-linkage study. J Psychosom Res. 2010 Jul;69(1):51-7. doi: 10.1016/j.jpsychores.2010.01.002. Epub 2010 Mar 19.

    PubMed 20630263

  • Kitaoka-Higashiguchi K, Morikawa Y, Miura K, Sakurai M, Ishizaki M, Kido T, Naruse Y, Nakagawa H. Burnout and risk factors for arteriosclerotic disease: follow-up study. J Occup Health. 2009;51(2):123-31. doi: 10.1539/joh.l8104. Epub 2009 Feb 10.

    PubMed 19212087

  • Guest RS, Baser R, Li Y, Scardino PT, Brown AE, Kissane DW. Cancer surgeons' distress and well-being, II: modifiable factors and the potential for organizational interventions. Ann Surg Oncol. 2011 May;18(5):1236-42. doi: 10.1245/s10434-011-1623-5. Epub 2011 Mar 12.

    PubMed 21399883

Questions about this trial

What is this clinical trial studying?

A study testing Three Good Things, Gratitude and Random Acts of Kindess in people with Burnout, Professional and Resilience, Psychological, run by Stanford University at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NICU health professional resilience (time frame: 10 days, 1 month, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02603133, which also lists 80 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.

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