Bronchiolitis Acute Viral
Conditions
Keywords
pulse oximetry, deimplementation, cluster-randomized trial, effectiveness-implementation hybrid trial, implementation science
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.
Interventions
BEHAVIORALEducational Outreach
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.
BEHAVIORALAudit & Feedback (unit level)
Weekly unit-level feedback of each hospital's guideline-concordant practice will be distributed to sites in the form of a visual dashboard that includes comparisons over time and between hospitals. The dashboard will then be shared locally on a weekly basis with clinicians in person and electronically.
BEHAVIORALAudit & Feedback (real time, individual-level)
Real-time feedback will occur at the individual clinician level. When collecting data on an individual patient, data collectors encountering guideline-discordant continuous monitoring are empowered to briefly ask any available clinician responsible for that patient's care, in a nonjudgmental way, about indications for monitoring that patient. The clinician is ultimately responsible for deciding if any changes are indicated.
BEHAVIORALClinical Pathway Integrated into Electronic Health Record
Clinical pathways guide clinicians step-by-step through evidence-based care. Based on the existing guidelines for physiologic monitoring in bronchiolitis, the pathway will clearly specify (a) situations when it is appropriate to initiate intermittent SpO2 measurement instead of continuous SpO2 monitoring, and (b) when it is appropriate to discontinue continuous SpO2 monitoring altogether, and transition to intermittent SpO2 measurement. In order to be visible to clinicians as they perform patient care, the pathway will be integrated into the electronic health record at sites randomized to this intervention.
Sponsors
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Boston Children's Hospital
Children's Hospital Medical Center, Cincinnati
Pediatric Research in Inpatient Settings (PRIS) Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Population a: 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 b: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deimplementation Sustainment | Data from the baseline phase (approximately 7 months) was compared to data from the sustainment phase (approximately 4 months). Only data from baseline and sustainment phases are used in this calculation. | The primary outcome specified in the protocol is deimplementation sustainment, a "difference in differences" outcome based on statistical comparisons based on pulse oximetry overuse across trial phases and arms. Pulse oximetry overuse is operationally defined as percent of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation). The least metabolized form of the data for pulse oximetry overuse, raw proportions across trial phases and arms, is reported here. Results of the specific analysis used to report the trial's pre-specified primary outcome of deimplementation sustainment is reported in Statistical Analysis 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Baseline Phase of the Trial | This measure used data from the baseline phase (approximately 7 months). | This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the baseline phase. In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system. |
| Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Active Deimplementation Phase of the Trial | Data from the active deimplementation phase (approximately 5 months). | This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the active deimplementation phase. In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system. |
| Count of Observations During Which the Patient Was Not Receiving Supplemental Oxygen and Yet Was Continuously Monitored Using Pulse Oximetry During the Sustainment Phase of the Trial | Data from the sustainment phase (approximately 4 months). | This measure is assessed as the count of patient observations monitored using continuous pulse oximetry while not receiving supplemental oxygen (measured using direct observation) in the sustainment phase. In order to assist in interpretation, this can also be viewed below as a proportion or a percent of the total number of observations. The denominator is the count of observations of patients not receiving supplemental oxygen. The numerator is the count of observations of patients not receiving supplemental oxygen who are also monitored using continuous pulse oximetry. The numerator count is divided by the denominator count to calculate a proportion. The proportion is multiplied by 100 to obtain a percent. This is expressed below as a count with the percentage automatically calculated by the clinicaltrials.gov system. |
| Duration of Oxygen Supplementation | Up to 4 years | The oxygen supplementation duration is the total duration of time during which a patient is documented as receiving supplemental oxygen during hospitalization. |
| Length of Hospital Stay | Up to 4 years | The length of hospital stay is the duration of time that elapses between the time a patient is admitted with bronchiolitis to an inpatient unit of the hospital until the time they are discharged from the hospital, using data manually abstracted from the electronic health record chart. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORChristopher P Bonafide, MD, MSCE
Children's Hospital of Philadelphia
PRINCIPAL_INVESTIGATORRinad S Beidas, PhD
Northwestern University
Participant flow
Recruitment details
This is a cluster-randomized trial with randomization at the hospital level. The trial had 4 phases: Baseline, Active Deimplementation, Sustainment, and Exploratory. Each phase had a mutually exclusive, separate group of participants enrolled - participants did not continue their participation across phases. For example, all of the patients in the baseline phase are different from all of the patients in the sustainment phase.
Pre-assignment details
The trial had 4 phases: Baseline, Active Deimplementation, Sustainment, and Exploratory. The primary outcome uses data from bronchiolitis patients from the first 3 phases only. The fourth phase, labeled Exploratory, included a subset of sites and was used exclusively for exploratory outcome measurement in bronchiolitis patients. The trial also included other populations, including parents/guardians, and staff/coaches. These other populations were exclusively used for exploratory outcomes.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) 18-65 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) ≤2 years old | 720 Participants |
| Age, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) 3-17 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) >65 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Missing/declined to answer | 0 Participants |
| Age, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) 18-65 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) ≤2 years old | 982 Participants |
| Age, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) 3-17 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) >65 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Missing/declined to answer | 0 Participants |
| Age, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) 18-65 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) ≤2 years old | 345 Participants |
| Age, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) 3-17 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) >65 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Missing/declined to answer | 0 Participants |
| Age, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) 18-65 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) ≤2 years old | 701 Participants |
| Age, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) 3-17 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) >65 years old | 0 Participants |
| Age, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Missing/declined to answer | 0 Participants |
| Age, Customized Parents/Guardians (for exploratory outcomes) 18-65 years old | 14 Participants |
| Age, Customized Parents/Guardians (for exploratory outcomes) ≤2 years old | 0 Participants |
| Age, Customized Parents/Guardians (for exploratory outcomes) 3-17 years old | 1 Participants |
| Age, Customized Parents/Guardians (for exploratory outcomes) >65 years old | 0 Participants |
| Age, Customized Parents/Guardians (for exploratory outcomes) Missing/declined to answer | 0 Participants |
| Age, Customized Staff/Coaches (for exploratory outcomes) 18-65 years old | 1440 Participants |
| Age, Customized Staff/Coaches (for exploratory outcomes) ≤2 years old | 0 Participants |
| Age, Customized Staff/Coaches (for exploratory outcomes) 3-17 years old | 0 Participants |
| Age, Customized Staff/Coaches (for exploratory outcomes) >65 years old | 3 Participants |
| Age, Customized Staff/Coaches (for exploratory outcomes) Missing/declined to answer | 344 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Hispanic | 459 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Missing/declined to answer | 79 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Non-Hispanic Black | 143 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Non-Hispanic Other | 68 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Non-Hispanic White | 255 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Hispanic | 525 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Missing/declined to answer | 97 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Non-Hispanic Black | 108 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Non-Hispanic Other | 68 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Non-Hispanic White | 382 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Hispanic | 84 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Missing/declined to answer | 25 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Non-Hispanic Black | 53 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Non-Hispanic Other | 25 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Non-Hispanic White | 125 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Hispanic | 469 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Missing/declined to answer | 134 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Non-Hispanic Black | 76 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Non-Hispanic Other | 51 Participants |
| Race/Ethnicity, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Non-Hispanic White | 618 Participants |
| Race/Ethnicity, Customized Parents/guardians (for exploratory outcomes) Hispanic | 2 Participants |
| Race/Ethnicity, Customized Parents/guardians (for exploratory outcomes) Missing/declined to answer | 0 Participants |
| Race/Ethnicity, Customized Parents/guardians (for exploratory outcomes) Non-Hispanic Black | 2 Participants |
| Race/Ethnicity, Customized Parents/guardians (for exploratory outcomes) Non-Hispanic Other | 1 Participants |
| Race/Ethnicity, Customized Parents/guardians (for exploratory outcomes) Non-Hispanic White | 2 Participants |
| Race/Ethnicity, Customized Staff/coaches (for exploratory outcomes) Hispanic | 94 Participants |
| Race/Ethnicity, Customized Staff/coaches (for exploratory outcomes) Missing/declined to answer | 254 Participants |
| Race/Ethnicity, Customized Staff/coaches (for exploratory outcomes) Non-Hispanic Black | 53 Participants |
| Race/Ethnicity, Customized Staff/coaches (for exploratory outcomes) Non-Hispanic Other | 241 Participants |
| Race/Ethnicity, Customized Staff/coaches (for exploratory outcomes) Non-Hispanic White | 1008 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Female | 284 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Male | 520 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Missing/declined to answer | 0 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Active Deimplementation Phase, for primary outcome) Other Identity | 0 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Female | 317 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Male | 600 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Missing/declined to answer | 0 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Baseline Phase, for primary outcome) Other Identity | 0 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Female | 262 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Male | 217 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Missing/declined to answer | 0 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Exploratory Phase, for exploratory outcomes) Other Identity | 0 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Female | 688 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Male | 968 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Missing/declined to answer | 0 Participants |
| Sex/Gender, Customized Bronchiolitis patients (Sustainment Phase, for primary outcome) Other Identity | 0 Participants |
| Sex/Gender, Customized Parents/guardians (for exploratory outcomes) Female | 9 Participants |
| Sex/Gender, Customized Parents/guardians (for exploratory outcomes) Male | 1 Participants |
| Sex/Gender, Customized Parents/guardians (for exploratory outcomes) Missing/declined to answer | 0 Participants |
| Sex/Gender, Customized Parents/guardians (for exploratory outcomes) Other Identity | 0 Participants |
| Sex/Gender, Customized Staff/coaches (for exploratory outcomes) Female | 734 Participants |
| Sex/Gender, Customized Staff/coaches (for exploratory outcomes) Male | 352 Participants |
| Sex/Gender, Customized Staff/coaches (for exploratory outcomes) Missing/declined to answer | 1687 Participants |
| Sex/Gender, Customized Staff/coaches (for exploratory outcomes) Other Identity | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 861 | 0 / 720 | 0 / 955 | 0 / 701 | 0 / 309 | 0 / 345 |
| other Total, other adverse events | 6 / 861 | 6 / 720 | 2 / 955 | 10 / 701 | 3 / 309 | 0 / 345 |
| serious Total, serious adverse events | 0 / 861 | 0 / 720 | 0 / 955 | 0 / 701 | 0 / 309 | 0 / 345 |
Outcome results
None listed