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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT02603133
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Duke University (Other)
2,650
Enrollment
9
Locations
3
Arms
36
Actual Duration (Months)
294.4
Patients Per Site
8.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Three Good Things
  • Behavioral: Gratitude
  • Behavioral: Random Acts of Kindess
  • Behavioral: Awe
  • Behavioral: 1 Good Chat
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2650 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.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 :
Jul 1, 2016
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Good Chat Tool

    		•
    Other: 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.

    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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Good Chat Tool

    		•
    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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Good Chat Tool

    		•

    Outcome Measures

    Primary Outcome Measures

    1. NICU health professional resilience [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 [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

    2. Provider:

    3. Primary work place is the Newborn Center

    4. Full time equivalent of >=40%

    5. Date of hire more than 4 weeks prior to start of the intervention

    6. Provider groups:

    7. Attendings that identify your newborn center as their primary site of work (not physicians from satellite NICUs)

    8. NICU fellows

    9. Nurse practitioners

    10. Physician Assistants

    11. Nurses, including nurse leadership (managers, educators)

    12. Nurse Assistant

    13. Respiratory care providers

    14. Transport specialists if primarily neonatal transport team

    15. Newborn Center Social workers

    16. Newborn Center Clerks

    17. Newborn Center Pharmacists

    18. Newborn Center Physical, Occupational, Speech, and Developmental Therapists

    19. Newborn Center Nutritionists

    20. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lucile Packard Children's Hospital at Stanford Palo Alto California United States 94304
    2 Stanford University Medical Center Stanford California United States 94305
    3 Beth Israel Deconness Medical Center Boston Massachusetts United States 02215
    4 University of New Mexico Albuquerque New Mexico United States 87131
    5 University of North Carolina at Chapel Hill Children's Hospital Chapel Hill North Carolina United States 27599
    6 Duke University Health System Durham North Carolina United States 27705
    7 Vanderbilt University Nashville Tennessee United States 37232
    8 Baylor College of Medicine Houston Texas United States 77030
    9 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

    • Principal Investigator: Jochen Profit, MD, MPH, Stanford University
    • Principal Investigator: J. Bryan Sexton, PhD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jochen Profit, Associate Professor of Pediatrics, Director of Perinatal Health Systems Research, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02603133
    Other Study ID Numbers:
    • IRB-34547
    • R01HD084679
    First Posted:
    Nov 11, 2015
    Last Update Posted:
    Sep 2, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jochen Profit, Associate Professor of Pediatrics, Director of Perinatal Health Systems Research, Stanford University
    healthcare
    burnout
    resilience
    fatigue
    NICU
    safety culture
    quality of care
    Additional relevant MeSH terms:
    Burnout, Professional
    Burnout, Psychological

    Study Results

    No Results Posted as of Sep 2, 2020