Clinical trial NCT02603133: Web-based Implementation for the Science of Enhancing Resilience Study
Official title: Web-based Implementation for the Science of Enhancing Resilience Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Resilience, Psychological
Keywords: healthcare
burnout
resilience
fatigue
NICU
safety culture
quality of care
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Duke University
First posted: 2015-11-11
Enrollment: 2650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: NICU health professional resilience
timeFrame: 10 days, 1 month, 6 months, 12 months
Secondary outcomes:
measure: Work-Life Balance
timeFrame: 10 days, 1 month, 6 months, 12 months
measure: Depressive symptoms
timeFrame: 10 days, 1 month, 6 months, 12 months
measure: Happiness
timeFrame: 10 days, 1 month, 6 months, 12 months
Other outcomes:
measure: Safety and teamwork climate
timeFrame: 6 months and 12 months
measure: Clinical delays in patient care
timeFrame: 6 month, 12 months
measure: Any health care associated infection
timeFrame: 12 months
measure: Voluntary Nursing Turnover
timeFrame: 12 months
measure: Conflicts with co-professionals
timeFrame: 6 months, 12 months
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Boston
country: United States
facility: Beth Israel Deconness Medical Center
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Children's Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas, Houston
state: Texas
Study officials:
affiliation: Stanford University
name: Jochen Profit, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: J. Bryan Sexton, PhD
role: PRINCIPAL_INVESTIGATOR
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