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Web-based Implementation for the Science of Enhancing Resilience Study (WISER)

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ClinicalTrials.gov Identifier: NCT02603133
Recruitment Status : Enrolling by invitation
First Posted : November 11, 2015
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Duke University
Information provided by (Responsible Party):
Jochen Profit, Stanford University

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.

Condition or disease Intervention/treatment Phase
Burnout, Professional Resilience, Psychological Behavioral: Three Good Things Behavioral: Gratitude Behavioral: Random Acts of Kindess Behavioral: Awe Behavioral: 1 Good Chat Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Web-based Implementation for the Science of Enhancing Resilience Study
Actual Study Start Date : July 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
No Intervention: Cohort 1
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.
No Intervention: Cohort 2
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.
Experimental: Cohort 3 (July cohort) WISER 2.0

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 Things
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.
Other Name: 3GT Tool

Behavioral: Gratitude
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.
Other Name: Grat Tool

Behavioral: Random Acts of Kindess
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.
Other Name: RAK Tool

Behavioral: Awe
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.
Other Name: Awe Tool

Behavioral: 1 Good Chat
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
Other Name: Good Chat Tool




Primary Outcome Measures :
  1. NICU health professional resilience [ Time Frame: 10 days, 1 month, 6 months, 12 months ]
    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.


Secondary Outcome Measures :
  1. Work-Life Balance [ Time Frame: 10 days, 1 month, 6 months, 12 months ]
    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.

  2. Depressive symptoms [ Time Frame: 10 days, 1 month, 6 months, 12 months ]
    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.

  3. Happiness [ Time Frame: 10 days, 1 month, 6 months, 12 months ]
    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.


Other Outcome Measures:
  1. Safety and teamwork climate [ Time Frame: 6 months and 12 months ]
    These two scales of the Safety Attitudes Questionnaire (SAQ) to assess health professionals' perceptions of these dimensions. Response scales range from 1 (disagree strongly) to 5 (agree strongly). These scales have been linked most closely with burnout, clinical, and operational outcomes. Scale scores will be calculated according to published methods.

  2. Clinical delays in patient care [ Time Frame: 6 month, 12 months ]
    All participants will receive a question on the survey regarding clinical delays in patient care. The response scale matches the SAQ.

  3. Any health care associated infection [ Time Frame: 12 months ]
    We will use standardized Vermont Oxford Network (VON) data definitions for all clinical data during the birth hospitalization. We chose this outcome because we have found it to be modifiable, and sensitive to health professional participation and unit safety culture. The VON addresses measurement bias through data collection procedures designed to minimize error and maximize accuracy. Data are abstracted from the medical record locally, using standardized protocols. Throughout this study, we will be able to collect routine clinical data collected for the VON database directly from participating NICUs.

  4. Voluntary Nursing Turnover [ Time Frame: 12 months ]
    This measure will be collected through a 3-item intention to leave index (I would like to find a better job; I often think about leaving this job; and I have plans to leave this job within the next year (α=.915)). We have found these items responsive to intervention in our work with the Comprehensive Unit Based Safety Program.

  5. Conflicts with co-professionals [ Time Frame: 6 months, 12 months ]
    Conflicts will be measured using a disruptive behavior index that assesses the prevalence of 15 distinct types of disruptive behaviors, as well as the extent to which they are managed well in a given work setting.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Location: newborn center, i.e. the NICU or a step down unit
  2. Provider:

    1. Primary work place is the Newborn Center
    2. Full time equivalent of >=40%
    3. Date of hire more than 4 weeks prior to start of the intervention
  3. Provider groups:

    1. Attendings that identify your newborn center as their primary site of work (not physicians from satellite NICUs)
    2. NICU fellows
    3. Nurse practitioners
    4. Physician Assistants
    5. Nurses, including nurse leadership (managers, educators)
    6. Nurse Assistant
    7. Respiratory care providers
    8. Transport specialists if primarily neonatal transport team
    9. Newborn Center Social workers
    10. Newborn Center Clerks
    11. Newborn Center Pharmacists
    12. Newborn Center Physical, Occupational, Speech, and Developmental Therapists
    13. Newborn Center Nutritionists
    14. Newborn Center Lactation Consultants

Exclusion Criteria:

  1. Location: Labor and delivery or the newborn nursery
  2. 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)
  3. Float personnel
  4. Does not speak english
  5. Cannot operate computer or smart phone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603133


Locations
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United States, California
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Massachusetts
Beth Israel Deconness Medical Center
Boston, Massachusetts, United States, 02215
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
University of North Carolina at Chapel Hill Children's Hospital
Chapel Hill, North Carolina, United States, 27599
Duke University Health System
Durham, North Carolina, United States, 27705
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas, Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Duke University
Investigators
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Principal Investigator: Jochen Profit, MD, MPH Stanford University
Principal Investigator: J. Bryan Sexton, PhD Duke University

Publications:
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
Maslach C, Jackson SE. Maslach Burnout Inventory. Palo Alto, CA: Consulting Psychologists Press, Inc.; 1981
Cherniss C. Staff Burnout: Job Stress in the Human Services. Beverly Hills, CA: Sage Publications; 1980
Jarvis P. Adult Education and Lifelong Learning: Theory and Practice. 4th ed. New York, NY: Routledge; 2010
Profit J, Weiss K, Clarke A, Gest AL, Sexton JB. NICU Caregiver Burnout, Happiness, and Three Good Things. Pediatric Academic Societies' Annual Meeting 2014;E-PAS 3844.652
Maslach C, Jackson S. The measurement of experienced burnout. J Occ Behav 1981;2:99-113
Hudson DW, Berenholtz SM, Thomas EJ, Sexton BJ. A safety culture primer for the critical care clinician: the role of culture in patient safety and quality improvement. Contemp Crit Care 2009;7:1-12
Pronovost P, Weast B. Implementing and validating a comprehensive unit-based safety program. J Patient Saf 2005:33-40
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
Profit J, Lee HC, Sharek PJ, et al. NICU Safety Culture: The Effect of Choice of Instrument on Benchmarking. Pediatrics 2014;Under review
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
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
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

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Responsible Party: Jochen Profit, Associate Professor of Pediatrics, Director of Perinatal Health Systems Research, Stanford University
ClinicalTrials.gov Identifier: NCT02603133     History of Changes
Other Study ID Numbers: IRB-34547
R01HD084679 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only research team will be accessing the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jochen Profit, Stanford University:
healthcare
burnout
resilience
fatigue
NICU
safety culture
quality of care

Additional relevant MeSH terms:
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Burnout, Psychological
Burnout, Professional
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases