Clinical trial NCT05132322: Eliminating Monitor Overuse Trial (EMO Trial)
Official title: Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiolitis Acute Viral
Keywords: pulse oximetry
deimplementation
cluster-randomized trial
effectiveness-implementation hybrid trial
implementation science
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Pennsylvania
name: Boston Children's Hospital
name: Children's Hospital Medical Center, Cincinnati
name: Pediatric Research in Inpatient Settings (PRIS) Network
First posted: 2021-11-24
Enrollment: 32357
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.


Eligibility criteria: Population 1a: Hospital staff who complete study questionnaires.

Inclusion Criteria:

* Nurse or physician fluent in English and employed full-time by the hospital, affiliated practice, or affiliated university who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season
* Hospital administrator fluent in English who oversaw the care of bronchiolitis on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)

Exclusion Criteria:

• Under the direct supervision of study or site principal investigator(s)

Population 1b: Hospital staff who participate in qualitative interviews

In Aim 2, we will conduct semi-structured interviews with physicians and nurses who provide care to bronchiolitis patients in participating units at the 5 hospitals with the highest and 3 hospitals with the lowest sustainability (8 hospitals total; up to maximum of 8 interviews/hospital). Maximum anticipated enrollment 64.

Inclusion criteria:

* Nurses or Physicians who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season
* Employed full-time by the hospital, affiliated practice, or affiliated university
* Fluent in English

Exclusion criteria:

• No exclusion criteria

Population 2a: Bronchiolitis patients directly observed while not receiving supplemental oxygen ("in room air," for primary trial outcome)

Inclusion Criteria:

* Infants and children 2 months through 23 months old
* Hospitalized on non-ICU wards participating in the trial
* Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
* Primary diagnosis of bronchiolitis in most recent physician progress note
* Not actively receiving supplemental oxygen ("in room air")
* Last documented receipt of supplemental oxygen \>1 hour prior to direct observational data collection

Exclusion Criteria:

* Documented apnea or cyanosis during the current illness
* Extreme prematurity (\<28 weeks completed gestation)
* Cardiac disease
* Pulmonary hypertension
* Chronic lung disease
* Home oxygen requirement
* Neuromuscular disease
* Immunodeficiency
* Cancer
* Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19 / SARS-CoV-2)-related illness (known or suspected, including multisystem inflammatory syndrome in children multi-system inflammatory syndrome in children (MIS-C)

Population 2b: Bronchiolitis patients directly observed while receiving supplemental oxygen (for underuse evaluation).

Inclusion Criteria:

* Infants and children 2 months through 23 months old
* Hospitalized on non-ICU wards participating in the trial
* Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
* Primary diagnosis of bronchiolitis in most recent physician progress note
* Actively receiving ≥2 Liters/minute (2L/min) supplemental oxygen or 21% room air flow

Exclusion Criteria:

* Extreme prematurity (\<28 weeks completed gestation)
* Cardiac disease
* Pulmonary hypertension
* Chronic lung disease
* Home oxygen requirement
* Neuromuscular disease
* Immunodeficiency
* Cancer
* Severe Acute Respiratory Syndrome Coronavirus 2 \[Covid-19 / SARS-CoV-2 (known or suspected)\]

Population 3: Parents or guardians of bronchiolitis patients who participate in qualitative interviews.

Inclusion Criteria:

* Their child was hospitalized for bronchiolitis on a unit participating in the trial during the most recent bronchiolitis season
* Their child was found to be in room air during Aim 1 data collection
* Fluent in English

Exclusion criteria:

• They are an employee of the hospital or a hospital volunteer

Primary outcomes:
measure: Sustainability of guideline-concordant deimplementation of continuous pulse oximetry monitoring
timeFrame: 3 years
Secondary outcomes:
measure: Penetration
timeFrame: Up to 4 years
measure: Acceptability of deimplementation
timeFrame: Up to 3 years
measure: Feasibility of deimplementation
timeFrame: Up to 3 years
measure: Appropriateness of deimplementation
timeFrame: Up to 3 years
measure: Perceived safety of deimplementation
timeFrame: Up to 3 years
measure: Cost of deimplementation strategies
timeFrame: Up to 3 years
measure: Length of Hospital Stay
timeFrame: Up to 4 years
measure: Duration of Oxygen Supplementation
timeFrame: Up to 4 years
Other outcomes:
measure: Exploratory long-term sustainability
timeFrame: 4 years
measure: Routinization of guideline-concordant deimplementation
timeFrame: Up to 3 years
measure: Institutionalization of guideline-concordant deimplementation
timeFrame: Up to 3 years
measure: Implementation Climate
timeFrame: Up to 3 years
measure: Implementation Leadership
timeFrame: Up to 3 years
measure: Psychological reactance
timeFrame: Up to 3 years
measure: Underuse of Pulse Oximetry Monitoring in High Risk Patients
timeFrame: Up to 4 years
measure: Number of Bronchiolitis Patients with Emergency Hypoxemic Events
timeFrame: Up to 4 years
measure: Number of Bronchiolitis Patients with Readmissions Featuring Hypoxemia Upon Re-Presentation
timeFrame: Up to 4 years
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Tucson
country: United States
facility: Banner University Medical Center- Diamond Children's
state: Arizona
city: Davis
country: United States
facility: University of California Davis
state: California
city: Encinitas
country: United States
facility: Rady Children's Hospital/UCSD
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Orange
country: United States
facility: Children's Hospital Orange County
state: California
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Children's Hospital
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: CS Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Children's Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: Lebanon
country: United States
facility: Children's Hospital at Dartmouth-Hitchcock
state: New Hampshire
city: Princeton
country: United States
facility: CHOP Pediatric Care at Penn Medicine/Princeton Health
state: New Jersey
city: Voorhees
country: United States
facility: CHOP Care Network at Virtua
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
city: New York
country: United States
facility: NYP-Morgan Stanley Children's Hospital
state: New York
city: New York
country: United States
facility: Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester Golisano Children's Hospital
state: New York
city: Syracuse
country: United States
facility: Upstate Golisano Children's Hospital
state: New York
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Children's Hospital at Oklahoma University Medical Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Hershey Children's Hospital
state: Pennsylvania
city: King Of Prussia
country: United States
facility: CHOP King of Prussia Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital, Tower Health
state: Pennsylvania
city: Sellersville
country: United States
facility: CHOP Grand View Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Houston
country: United States
facility: Children's Memorial Hermann
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital West Campus
state: Texas
city: The Woodlands
country: United States
facility: Texas Children's Hospital The Woodlands
state: Texas
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Riverton
country: United States
facility: Riverton Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Burlington
country: United States
facility: University of Vermont Children's Hospital
state: Vermont
city: Falls Church
country: United States
facility: Inova Children's Hospital
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters
state: Virginia
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Huntington
country: United States
facility: Hoops Family Children's Hospital at Marshall University
state: West Virginia
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Alberta Children's Hospital
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Christopher P Bonafide, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Rinad S Beidas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonafide CP, Xiao R, Schondelmeyer AC, Pettit AR, Brady PW, Landrigan CP, Wolk CB, Cidav Z, Ruppel H, Muthu N, Williams NJ, Schisterman E, Brent CR, Albanowski K, Beidas RS; Pediatric Research in Inpatient Settings (PRIS) Network. Sustainable deimplementation of continuous pulse oximetry monitoring in children hospitalized with bronchiolitis: study protocol for the Eliminating Monitor Overuse (EMO) type III effectiveness-deimplementation cluster-randomized trial. Implement Sci. 2022 Oct 21;17(1):72. doi: 10.1186/s13012-022-01246-z.