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

February 8, 2023 updated by: Jochen Profit, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital at Stanford
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deconness Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill Children's Hospital
      • Durham, North Carolina, United States, 27705
        • Duke University Health System
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • University of Texas, Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days, 1 month, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days, 1 month, 6 months, 12 months
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.
10 days, 1 month, 6 months, 12 months
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.
10 days, 1 month, 6 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months and 12 months
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.
6 month, 12 months
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.
12 months
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.
12 months
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.
6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (ESTIMATE)

November 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-34547
  • R01HD084679 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

only research team will be accessing the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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