Web-based Implementation for the Science of Enhancing Resilience Study

Burnout, Professional Clinical Trial

— WISER  

Official title:

Web-based Implementation for the Science of Enhancing Resilience Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603133
• Other study ID #: IRB-34547
• Secondary ID: R01HD084679
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: February 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2650
• Est. completion date: July 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• Resilience, Psychological

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.
• 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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Beth Israel Deconness Medical Center	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill Children's Hospital	Chapel Hill	North Carolina
United States	Duke University Health System	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas, Houston	Houston	Texas
United States	Vanderbilt University	Nashville	Tennessee
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (77)

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* Note: There are 77 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and teamwork climate	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
Other	Clinical delays in patient care	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
Other	Any health care associated infection	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
Other	Voluntary Nursing Turnover	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 (a=.915)). We have found these items responsive to intervention in our work with the Comprehensive Unit Based Safety Program.	12 months
Other	Conflicts with co-professionals	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
Primary	NICU health professional resilience	Burnout (emotional exhaustion) is the primary resilience outcome. The Maslach Burnout Inventory (MBI) has been the gold standard tool in the field of burnout research. In our investigations, the Emotional Exhaustion subscale, in particular, is consistently associated with variables such as staff turnover, disruptive behavior, productivity, delays, and teamwork. When used as a "percent agree" metric, we have shown it to be a very effective indicator of emotional exhaustion at the group level for a clinical area or work setting. We will use a shortened 4-item version of this subscale from the Maslach Burnout Inventory, which we validated in the NICU setting. The response scale ranges from 1 (disagree strongly) to 5 (agree strongly). Resilience will be calculated as the percentage of NICU providers who disagree slightly or strongly with the 4 items assessing features of emotional exhaustion.	10 days, 1 month, 6 months, 12 months
Secondary	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 a = 0.82 in our large resilience database.	10 days, 1 month, 6 months, 12 months
Secondary	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.	10 days, 1 month, 6 months, 12 months
Secondary	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.	10 days, 1 month, 6 months, 12 months