Feasibility Pilot of Audit and Feedback With Educational Outreach to Align Continuous Pulse Oximetry Use in Stable Bronchiolitis With Evidence and Guideline Recommendations
Phase: NA
Conditions: Bronchiolitis
Sponsor: Children's Hospital of Philadelphia

Offi ci al Titl e:  F e a si bilit y  Pil ot of Au dit  a n d F e e d b a c k  Wit h E d u c ati o n al Outr e a c h  t o Ali g n 
C o nti n u o u s  Pul s e O xi m etr y  Us e i n St a bl e Br o n c hi oliti s  Wit h E vi d e n c e a n d G ui d eli n e 
R e c o m m e n d ati o n s  
N C T N u m b er:  NC T 0 4 1 7 8 9 4 1 
D o c u m e nt  d at e:  3/ 1 1/ 2 0 2 0

 
 
  
Title: 
Feasibility pilot of audit and feedback with educational outreach to 
align continuous pulse oximetry use in stable bronchiolitis patients 
with evidence and guideline recommendations 
Short Title 
Aligning pulse oximetry with guidelines  
eIRB Number 
19-016718 
Protocol Date: 
3/11/2020 
Amendment 1 Date:  
Amendment 3 Date:  
Amendment 2 Date: 
Amendment 4 Date: 
Study Principal Investigator 
Christopher P. Bonafide, MD, MSCE 
Children’s Hospital of Philadelphia 
 
 
 

  
 
 
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms ............................................................................. iv 
Abstract .................................................................................................................................. v 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
RELEVANT LITERATURE AND DATA ..................................................................................................... 1 
1.2.1 
Bronchiolitis SpO2 monitoring guidelines .............................................................................. 1 
1.2.2 
Research published since bronchiolitis SpO2 monitoring guidelines ................................ 1 
1.2.3 
Unpublished trials of continuous versus intermittent SpO2 monitoring in bronchiolitis .. 2 
1.2.4 
Results of Best Evidence for Effective Pediatric (BEEP) Monitoring Study .................... 2 
1.2.5 
Measurement of pulse oximetry use using direct observation during the 2018-19 
bronchiolitis season ................................................................................................................................... 3 
1.2.6 
Effective strategies for implementing practice guidelines .................................................. 4 
1.3 
COMPLIANCE STATEMENT .................................................................................................................... 4 
2 
STUDY OBJECTIVES .............................................................................................................................. 4 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 4 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 4 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 4 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 4 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ........................................................................ 5 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 5 
3.3.1 
Duration of Study Participation ............................................................................................... 5 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected ................................... 5 
3.4 
STUDY POPULATION ............................................................................................................................. 6 
3.4.1 
Inclusion Criteria ....................................................................................................................... 6 
3.4.2 
Exclusion Criteria ..................................................................................................................... 6 
4 
STUDY PROCEDURES ............................................................................................................................ 7 
4.1 
PRE-INTERVENTION PERIOD .................................................................................................................. 7 
4.2 
INTERVENTION PERIOD ......................................................................................................................... 7 
4.3 
AT CONCLUSION OF THE INTERVENTION PERIOD ................................................................................... 7 
5 
STUDY EVALUATIONS AND MEASUREMENTS .............................................................................. 7 
5.1 
OVERVIEW ........................................................................................................................................... 7 
5.2 
CHART REVIEW .................................................................................................................................... 8 
5.2.1 
Site investigators will provide the following contextual information about audit and 
feedback and educational outreach delivery events, using a framework previously described:29 8 
5.2.2 
The following data elements will be abstracted from the chart and stored in the study 
database: 8 
5.2.3 
The following data elements will be abstracted from the chart and stored in the 
individual site’s separate master list alongside the coded ID, admission date, and data collection 
rounds date but NOT entered into the study database and NOT transmitted outside of the 
institution where the patient is hospitalized: .......................................................................................... 9 
5.3 
BEDSIDE VISUAL OBSERVATION “ROUNDS” ........................................................................................ 10 
5.3.1 
COVID-19 related accommodations .................................................................................... 10 
5.4 
STAFF QUESTIONNAIRES (SEE APPENDIX FOR INSTRUMENT) ............................................................... 10 
5.4.1 
Site PIs will submit to CHOP for recruitment ..................................................................... 10 
5.4.2 
The questionnaires will include the following elements: ................................................... 10 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 11 

 
 
 
 
 
 
 
 
iii 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 11 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 11 
6.3 
STATISTICAL METHODS ...................................................................................................................... 11 
6.3.1 
Questionnaire-based methods (AIM, IAM, FIM) ................................................................ 11 
6.3.2 
Pulse oximetry use rates ....................................................................................................... 11 
6.3.3 
Medical device integration test characteristics .................................................................. 11 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 11 
7 
SAFETY MANAGEMENT ..................................................................................................................... 11 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 11 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 12 
8 
STUDY ADMINISTRATION ................................................................................................................. 12 
8.1 
TREATMENT ASSIGNMENT METHODS ................................................................................................. 12 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 12 
8.2.1 
Data sources ........................................................................................................................... 12 
8.3 
CONFIDENTIALITY .............................................................................................................................. 12 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS .................................................................................. 13 
8.4.1 
Data and Safety Monitoring Plan ......................................................................................... 13 
8.4.2 
Risk Assessment .................................................................................................................... 14 
8.4.3 
Potential Benefits of Trial Participation ............................................................................... 14 
8.4.4 
Risk-Benefit Assessment ...................................................................................................... 14 
8.5 
RECRUITMENT STRATEGY .................................................................................................................. 15 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 15 
8.6.1 
Informed consent and HIPAA for the primary measure (questionnaires) ...................... 15 
8.6.2 
Waiver of Consent and Assent for all other aspects of the study ................................... 15 
8.6.3 
Waiver of Assent .................................................................................................................... 16 
8.6.4 
Waiver of HIPAA Authorization ............................................................................................ 16 
8.7 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................................... 17 
9 
PUBLICATION ........................................................................................................................................ 17 
10 
APPENDIX ............................................................................................................................................... 18 
10.1 
CONSENT LANGUAGE FOR QUESTIONNAIRE ........................................................................................ 18 
10.2 
DRAFT QUESTIONNAIRE ITEMS ........................................................................................................... 18 
11 
REFERENCES ......................................................................................................................................... 19 
 

  
 
 
 
 
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
AAP 
 
American Academy of Pediatrics 
AIM 
 
Acceptability of Intervention Measure 
BEEP 
 
Best Evidence for Effective Pediatric Monitoring Study 
BIDS 
 
Bronchiolitis of Infancy Discharge Study 
EHR 
 
Electronic health record 
FIM 
 
Feasibility of Intervention Measure 
IAM 
 
Intervention Appropriateness Measure 
ICU 
 
Intensive care unit 
PRIS 
 
Pediatric Research in Inpatient Settings Network 
SpO2 
 
Pulse oximetry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
 
 
 
 
v
ABSTRACT 
Context:   
Continuous pulse oximetry (SpO2) monitoring has revolutionized detection of oxygen desaturation in 
operating rooms and other high-risk areas, improving outcomes in those settings.1,2 However, 
research suggests that overuse of continuous SpO2 monitoring in stable children with bronchiolitis 
who are unlikely to benefit from it is low-value care that places some children at risk of adverse 
outcomes.3–12 Despite national guidelines13,14 discouraging continuous pulse oximetry use in stable 
bronchiolitis patients, 46% of those infants and children are continuously monitored.  
Objectives:  
The primary objective is to measure the feasibility, acceptability, and appropriateness of audit and 
feedback with educational outreach as a strategy to align continuous pulse oximetry use in stable 
bronchiolitis patients with evidence and guideline recommendations. 
Study Design:  
Pragmatic, prospective, non-randomized, single-arm feasibility pilot implementation with the 
intervention delivered at the hospital unit level. 
Setting/Participants: 
The pilot will be performed on non-ICU hospital units that care for bronchiolitis patients at up to 10 
total hospitals in the United States. The primary subjects are hospital staff who order or manage 
continuous pulse oximetry monitoring for bronchiolitis patients. Secondary subjects are patients age 
2 through 23 months with a primary diagnosis of bronchiolitis. 
Study Interventions and Measures:  
The intervention is an audit and feedback strategy that includes providing the hospital’s own 
continuous pulse oximetry use data back to them on a weekly basis. The data will be accompanied 
by staff-targeted educational materials and outreach sessions summarizing the current evidence and 
guideline recommendations for continuous pulse oximetry use in bronchiolitis.  
Primary measurements include measures of feasibility, acceptability, and appropriateness of the 
audit and feedback strategy. Secondarily, we will analyze continuous pulse oximetry use rates and 
validate an alternative semi-automated data collection strategy. 
 

 
  
 
 
 
1 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 
Introduction 
Continuous pulse oximetry (SpO2) monitoring has revolutionized detection of oxygen desaturation in 
operating rooms and other high-risk areas, improving outcomes in those settings.1,2 However, 
research suggests that overuse of continuous SpO2 monitoring in stable children with bronchiolitis 
who are unlikely to benefit from it is low-value care that places some children at risk of adverse 
outcomes.3–12 
Despite national guidelines13,14 discouraging continuous pulse oximetry use in stable bronchiolitis 
patients, 46% of those infants and children are continuously monitored (not yet published data from a 
multicenter study performed in 56 hospitals led by investigators on this proposal).  
This study aims to pilot an audit and feedback strategy to align continuous pulse oximetry use in 
stable bronchiolitis patients with evidence and guideline recommendations in preparation for a 
multicenter cluster-randomized hybrid trial. 
1.2 
Relevant Literature and Data 
1.2.1 
Bronchiolitis SpO2 monitoring guidelines 
Appropriate use of SpO2 monitoring in children with bronchiolitis is guided by the American Academy 
of Pediatrics (AAP) Clinical Practice Guideline for the Diagnosis, Management, and Prevention of 
Bronchiolitis13 and Society of Hospital Medicine Choosing Wisely recommendations.14 The AAP 
Guideline was published by Ralston (Advisory Committee member) and colleagues in 2014.13 The 
Guideline states that “Clinicians may choose not to use continuous pulse oximetry for children with a 
diagnosis of bronchiolitis,” citing intermittent monitoring benefits including shorter length of stay, 
decreased alarm fatigue, and decreased cost. The Society of Hospital Medicine Choosing Wisely in 
Pediatric Hospital Medicine workgroup took a stronger stance against monitoring, stating “Do not use 
continuous pulse oximetry routinely in children with acute respiratory illness unless they are on 
supplemental oxygen.”14 
1.2.2 
Research published since bronchiolitis SpO2 monitoring guidelines 
Since publication of the AAP Guideline and Choosing Wisely recommendations, 3 randomized 
trials,3–5 2 nonrandomized studies,6,7 and 1 expert commentary15 have further strengthened the 
evidence base against using continuous SpO2 monitoring in favor of intermittent SpO2 measurement 
in children with bronchiolitis not requiring supplemental oxygen. The research below demonstrates 
that intermittent SpO2 monitoring is a safe alternative,3,7 those who are continuously monitored 
unnecessarily are at risk of adverse outcomes including prolonged length of stay,5,8,9 iatrogenic 
harm,10 and increased costs,5 and false SpO2 monitor alarms contribute to alarm fatigue.11,12 
McCulloh et al performed a randomized trial comparing continuous versus intermittent SpO2 
monitoring among children with bronchiolitis at 4 hospitals who had stable oxygen saturations of 90% 
or higher off supplemental oxygen.3 They found that patients who underwent intermittent SpO2 
measurement did not have increased urgent care escalation or respiratory interventions, confirming 
its safety. 
Schuh et al performed a randomized trial among infants presenting to an emergency department 
with bronchiolitis.4 Infants were randomized to have their SpO2 measured either with an oximeter 
with true SpO2 displayed or a modified oximeter with falsely elevated SpO2 displayed (+3 percentage 
points). Patients whose SpO2 was artificially elevated were less likely to be hospitalized but had no 
significant differences in other clinical outcomes, including no difference in subsequent unscheduled 
follow up visits for bronchiolitis. We interpret these findings as indicating that continuous pulse 
oximetry likely identifies minor desaturations that do not impact outcomes but are over weighted in 
clinical decision making (in this study, the decision to admit). 
In the Bronchiolitis of Infancy Discharge Study (BIDS), a randomized controlled trial of hospitalized 
infants with bronchiolitis, Cunningham et al randomized infants to be continuously monitored using 
either a standard pulse oximeter or a modified oximeter that falsely inflated SpO2, displaying a 
measured value of 90% as 94%.5 They found that supplemental oxygen was provided less often and 

 
  
 
 
 
2 
for shorter periods of time in the group with SpO2 values falsely inflated, an expected outcome. 
However, they also found that infants were discharged 10 hours sooner in the group with SpO2 
values falsely inflated, and yet there were no differences in any adverse effects of the falsely inflated 
oxygen saturation value, including readmission or time until return to daycare. In an economic 
analysis of BIDS, the standard oximeter group had significantly greater hospital costs than the 
modified group, primarily driven by costs of the hospital bed, supplemental oxygen, and oximeter 
probes.16 Like Schuh’s study, we interpret these findings as indicating that continuous pulse oximetry 
likely identifies minor desaturations that do not impact patient outcomes but are over weighted in 
clinical decision making, unnecessarily prolonging oxygen administration and length of hospital stay 
and increasing costs.  
Principi et al performed a cohort study of infants presenting to an emergency department with 
bronchiolitis who were well enough to be discharged home.6 Prior to discharge, researchers applied 
pulse oximeters to the infants. The oximeters had alarms disabled and their displays did not show 
SpO2 values. They collected the oximeters 72 hours later. They found that half of these infants 
deemed well enough for discharge had desaturations to 80% or less for at least 1 minute and one-
quarter had desaturation to 70% or less for at least 1 minute. There were no differences in rates of 
return medical visits or subsequent hospitalizations between infants who experienced desaturations 
and those who did not. We interpret these findings as indicating that brief desaturations to levels that 
would likely have been treated if they occurred in hospital are common in patients with bronchiolitis 
at home, but are not associated with adverse outcomes. 
Schondelmeyer et al evaluated a quality improvement intervention targeting reduction of continuous 
pulse oximetry in children with bronchiolitis and asthma when they no longer required supplemental 
oxygen.7 Their intervention included staff education, checklists, and electronic health record clinical 
decision support. They found a reduction of median time on continuous pulse oximetry from 10.7 to 
3.1 hours without a difference in rapid response team activations, ICU transfers, or readmissions. 
This study confirms the safety of the AAP Guideline and Choosing Wisely recommendations, and 
supports the practice of removing continuous pulse oximetry after supplemental oxygen is 
discontinued and replacing it with intermittent SpO2 monitoring. 
In a 2017 BMJ expert commentary, “When technology creates uncertainty: pulse oximetry and 
overdiagnosis of hypoxaemia in bronchiolitis,”15 Quinonez et al reviewed the literature above and 
argue that the widespread use of pulse oximetry in stable bronchiolitis patients leads to 
overdiagnosis of hypoxemia. Overdiagnosis is when a true abnormality is discovered, but awareness 
of the abnormality does not benefit the patient.17 The authors conclude that “current body of 
evidence suggests that we should challenge assumptions regarding the detection and aggressive 
management of borderline hypoxemia in non-critically ill infants with bronchiolitis,” because current 
overuse of continuous pulse oximetry has led to overdiagnosis of clinically insignificant hypoxemia 
that contributes to unnecessary resource utilization and risk of patient harm. 
1.2.3 
Unpublished trials of continuous versus intermittent SpO2 monitoring in bronchiolitis 
We identified 2 randomized controlled trials of continuous versus intermittent SpO2 monitoring in 
bronchiolitis led by Mahant in Toronto. The first trial is a single center pilot that has been 
completed.18 The second is a 6-center trial that is ongoing.19 While results of the intervention on the 
primary outcome (length of stay) are not yet available, in a personal communication the Principal 
Investigator reported that among the 89 patients randomized to intermittent (as opposed to 
continuous) SpO2 monitoring to date, none have experienced adverse safety events attributable to 
the less intensive intermittent monitoring intervention.20  
1.2.4 
Results of Best Evidence for Effective Pediatric (BEEP) Monitoring Study 
The BEEP study, performed in 2018 (not yet published) and led by Amanda Schondelmeyer, MD, 
MSc used the RAND/UCLA Appropriateness method and a panel of experts nominated by leaders of 
national nursing, physician, human factors, and respiratory therapy organizations as well as a family 
advocacy organization to develop consensus guidelines for physiologic monitoring in hospitalized 
children in non-ICU settings. Pertinent to this proposal, the expert panel determined the following 
scenarios to be appropriate and necessary: 

 
  
 
 
 
3 
• 
Children hospitalized with routine bronchiolitis and an SpO2 value of >=90% without 
supplemental oxygen in the absence of witnessed apnea or cyanosis should NOT receive 
continuous pulse oximetry monitoring, instead they should receive intermittent pulse 
oximetry measurement 
• 
Children weaned from supplemental oxygen should be transitioned to intermittent oximetry 
measurement within 1 hour if oxygen saturations are stable at >=90% unless otherwise 
indicated by diagnosis or condition. 
 
1.2.5 
Measurement of pulse oximetry use using direct observation during the 2018-19 
bronchiolitis season 
From December 2018 through March 2019, our team performed a 56-center observational study 
within the Pediatric Research in Inpatient Settings (PRIS) Network measuring pulse oximetry use in 
stable infants and children not requiring supplemental oxygen.21 This is the population for whom the 
AAP and Choosing Wisely support avoiding the use of continuous pulse oximetry. 
The study aimed to include exclusively patients for whom continuous pulse oximetry is not indicated 
according the AAP and Choosing Wisely guidelines: Children 8 weeks-23 months old with primary 
diagnosis of bronchiolitis on most recent physician note, hospitalized on generalist services in non-
ICU areas, and not currently on any supplemental oxygen or room air flow support. We excluded 
infants born at <28 weeks, those receiving home oxygen or positive pressure ventilation, and those 
with major cardiac, respiratory, neuromuscular, immunologic, and oncologic comorbidities. This 
project was funded by NHLBI and was approved by the CHOP IRB as the reviewing IRB (CHOP 
IRB# 18-015070). 
In this study that included over 3600 in-person assessments of pulse oximetry monitoring status, we 
found that the overall monitoring rate across all hospitals was 46%, with a very wide range of 
variation, ranging from hospitals that monitor <5% of these patients to hospitals that monitor >85% of 
these patients (results not yet published; see figure below). These results support efforts to reduce 
continuous pulse oximetry in stable bronchiolitis patients in outlier hospitals with high use rates.  
Prior to submitting a subsequent grant that will aim to de-implement continuous pulse oximetry in a 
well-defined stable bronchiolitis population, we must establish the feasibility of a foundational audit 
and feedback strategy for addressing continuous pulse oximetry overuse. 
 
 

 
  
 
 
 
4 
1.2.6 
Effective strategies for implementing practice guidelines 
In a recent report from the American College of Cardiology/American Heart Association Task Force 
on Clinical Practice Guidelines, evidence from the published implementation science literature was 
presented describing effective strategies to enhance the adoption and implementation of clinical 
practice guidelines.22 The review concluded that audit and feedback and educational outreach 
strategies were the most effective in improving outcomes measuring processes of care as well as 
clinical outcomes. However, the specific aspects of audit and feedback that make this strategy 
effective (e.g. who the feedback data are delivered to, what information is delivered, is comparison 
data provided, are data presented graphically, what is the lag time between data collection and 
feedback, etc) are not well established, but are an active area of inquiry in the field of implementation 
science. The subsequent trial that we will plan based upon the results of this pilot will secondarily 
aim to elucidate mechanisms that contribute to the effectiveness of differing configurations of audit 
and feedback. 
1.3 
Compliance Statement 
This study will be conducted in full accordance with all applicable Children’s Hospital of Philadelphia 
Research Policies and Procedures and all applicable Federal and state laws and regulations. All 
episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol and will report unanticipated 
problems involving risks to subjects or others in accordance with Children’s Hospital of Philadelphia 
IRB Policies and Procedures and all federal requirements. Collection, recording, and reporting of 
data will be accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study. 
 
2 
STUDY OBJECTIVES 
2.1 
Primary Objective (or Aim) 
The primary objective of this study is to measure the feasibility, acceptability, and appropriateness of 
audit and feedback with educational outreach as a strategy to align continuous pulse oximetry use in 
stable bronchiolitis patients with evidence and guideline recommendations. 
2.2 
Secondary Objectives (or Aim) 
The secondary objectives are to: 
• 
Measure continuous pulse oximetry use rates in children with bronchiolitis who are not requiring 
supplemental oxygen administration. 
• 
In hospitals with “medical device integration” in which data from physiologic monitors are sent 
directly to the electronic health records, we will: 
• 
Validate that the medical device integration data in the electronic health record reflects the 
findings of direct in-person observation described above as the gold standard. 
 
3 
INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
This is a pragmatic,23 prospective, non-randomized, single-arm feasibility pilot implementation with 
the audit and feedback plus educational outreach intervention delivered at the hospital unit (i.e. 
ward) level. 
This study does not directly involve making any changes to patient care – it only involves presenting 
data, guidelines, and evidence to clinical staff who make independent decisions about their own 
actions related to pulse oximetry monitoring in bronchiolitis. Any individual clinicians who do not wish 

 
  
 
 
 
5 
to participate may choose not to interact with the electronic communications and may choose to not 
attend meetings where this intervention is discussed. 
On the Pragmatic-Explanatory Continuum,23 this study is highly pragmatic for the following 
reasons (see cited article for detailed explanation of domains): 
• 
Eligibility criteria: The same bronchiolitis patients who would likely be a candidate for the 
audit and feedback intervention if it was being provided in usual care are also eligible for this 
intervention since it is applied at the hospital unit level. 
• 
Recruitment: The audit and feedback intervention will be delivered to the same health care 
professionals who are involved in the decisions or actions surrounding the initiation or 
discontinuation of continuous pulse oximetry monitoring in usual care. 
• 
Setting: The pilot is being performed in hospital settings that are identical to the types of 
settings where we intend the results to be applied. 
• 
Organization: Given the highly pragmatic nature of this study, the intervention will be 
delivered into each hospital using the same structures of care used locally for making 
improvements in bronchiolitis care delivery. 
• 
Flexibility in intervention delivery: Consistent with the idea that interventions can be tailored 
to local context, we will allow for flexibility/adaptation/tailoring in the content and format of 
the educational materials and outreach sessions. Thus, the methodology of exactly how to 
deliver this intervention is not rigidly prescriptive in this protocol. In addition, it is possible that 
some sites will be performing concurrent quality improvement interventions targeting pulse 
oximetry overuse. We will seek to fully understand when and how any potential quality 
improvement interventions interact with this study but we will not restrict sites from 
performing separate improvement initiatives nor will we will regulate or oversee their 
concurrent quality improvement projects. 
• 
Flexibility in adherence to the intervention: While we will monitor health care professionals’ 
engagement with the interventions and the resulting pulse oximetry use that results at the 
patient level, as in usual care, there are no special measures in place beyond what would 
occur in the course of a practice change in the usual care of bronchiolitis. 
3.2 
Allocation to Treatment Groups and Blinding 
N/A: This is a single-arm study. 
3.3 
Study Duration, Enrollment and Number of Sites 
The intervention period will last between 2-4 months depending on the timing relative to the local 
epidemiology-dictated bronchiolitis season. 
The primary subjects are hospital staff. Secondary subjects are patients age 2 through 23 months 
with a primary diagnosis of bronchiolitis. 
3.3.1 
Duration of Study Participation 
• 
Hospital staff: 2-4 months. 
• 
Patients: minimum of 1 day, maximum of the duration of their entire hospitalization (maximum 4 
months; anticipated average of 1-3 days). 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted in up to 10 hospitals in the United States. 
Primary subjects exposed to the intervention (hospital staff): Since the intervention is occurring at a 
unit-wide level and we are not collecting any identifiers on these primary subjects, it is not possible to 
accurately measure the actual number of staff whose behavior could potentially have been impacted 
by the intervention. It also will not be possible to identify when hospital staff are exposed to the 
intervention repeatedly over time. In order to best estimate this number, we will “count” the 

 
  
 
 
 
6 
involvement of 100 hospital staff per unit during the entire intervention period. Based on an average 
of 5 available units per hospital in candidate hospitals, we can estimate 10 hospitals * 5 units per 
hospital * 100 staff per unit = 5,000 hospital staff subjects, acknowledging that this number will not 
be completely accurate but is a reasonable estimate. When we report the “actual” number of primary 
exposed subjects involved for continuing reviews and study closure, we will report 100 * the total 
number of units involved in the study. 
Primary subjects completing the questionnaires (hospital staff): We will aim for 100 completed 
questionnaires per hospital x 10 hospitals = 1,000 primary subjects completing the questionnaires. 
Since these 1,000 will be drawn from within the 5,000 listed above, they will not add to the overall 
subject total. 
Secondary subjects - Patients: We project collecting data on a maximum of 300 unique bronchiolitis 
patients per hospital * 10 hospitals = 3,000 patients. 
 
3.4 
Study Population 
3.4.1 
Inclusion Criteria 
3.4.1.1 
Primary subjects - Hospital staff 
1) Nurses, physicians, physician assistants, nursing assistants, or respiratory therapists  
2) Providing care to patients on units included in the study. 
3.4.1.2 
Secondary subjects - Patients 
1) Males or females 8 weeks through 23 months old hospitalized on non-ICU wards 
2) Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine) 
3) Primary diagnosis of acute bronchiolitis according to hospital chart 
4) Not currently requiring supplemental oxygen therapy or nasal cannula flow at an FiO2 of 21% 
(room air flow) 
3.4.2 
Exclusion Criteria 
3.4.2.1 
Primary subjects - Hospital staff 
1) None. Staff may self-exclude by choosing not to interact with the electronic communications and 
may choose to not attend meetings where the intervention is discussed. 
3.4.2.2 
Secondary subjects - Patients 
1) Premature birth: <28 weeks completed gestation 
2) Cyanotic congenital heart disease 
3) Pulmonary hypertension 
4) Home oxygen or positive pressure ventilation requirement 
5) Tracheostomy 
6) Neuromuscular disease 
7) Immunodeficiency 
8) Cancer  
9) Historical, current, or suspected diagnosis of heart failure, myocarditis, or arrhythmia 
10) Historical, current, or suspected diagnosis of COVID-19 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these 
criteria must be reported in accordance with IRB Policies and Procedures.  

 
  
 
 
 
7 
4 
STUDY PROCEDURES 
4.1 
Pre-intervention period 
• 
Implementation champions identified, local teams formed 
• 
Local team members will meet with leadership on each potential unit; unit leadership will be 
given the opportunity to opt their unit out of the study for any reason. 
• 
Implementation champions & teams perform educational outreach sessions on participating units 
• 
describing current guidelines 
• 
summarizing the evidence behind the guidelines 
• 
discussing potential alternatives to continuous pulse oximetry monitoring for patients in 
whom guidelines do not advise continuous pulse oximetry 
• 
Distribution/dissemination of educational materials (e.g. slide presentations, posters, flyers, 
videos) to hospital staff working on study units focused on the bullet points above 
• 
materials collaboratively developed by the CHOP team and local implementation teams, with 
site-specific tailoring by the local implementation teams 
4.2 
Intervention period 
• 
Implementation teams will conduct data collection rounds and supplemental chart review 
(see Section 5) to determine continuous pulse oximetry status on bronchiolitis patients not 
receiving supplemental oxygen or room air flow, targeting data collection at least twice per 
week in order to acquire sufficient data for audit and feedback intervention. 
• 
If any hospital staff responsible for the care of the patient are present and available on the 
unit, the data collector may perform real-time inquiry if feasible, briefly asking about the 
indications for monitoring individual patients, which will be documented in the study 
database as field notes without documenting any of the hospital staff member’s identifiers. 
• 
On a weekly basis, the data will be summarized in a dashboard and the dashboard along 
with the raw data will be returned to the site PI.  
• 
Local implementation team will then share that data in electronic and in-person settings 
appropriate and tailored to each site (e.g. email, safety huddles,24,25 staff meetings, rounds, 
staff messages in electronic health record systems) with key clinician stakeholders who 
order or manage continuous pulse oximetry monitoring for bronchiolitis patients. Data will be 
contextualized with (a) the hospital’s prior performance, (b) other hospitals’ prior 
performance, (c) the current performance of other units in the same hospital, (d) the current 
performance of other units in other hospitals. 
• 
Additional educational materials will be distributed and additional education/outreach 
sessions will be held by the local implementation team at a frequency determined by the site 
PI depending on local pulse oximetry use rates. 
4.3 
At conclusion of the intervention period 
• 
Administer questionnaire-based psychometrically valid measures to hospital staff assessing 
feasibility, acceptability, appropriateness,26 and perceived safety of the audit and feedback 
strategy. 
 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 
Overview 
Data collection will be operationalized at sites during periodic in-person observational “rounds” 
during the intervention period. During a data collection round, site investigators will first identify all 

 
  
 
 
 
8 
patients currently admitted to their hospital’s non-ICU pediatric wards with bronchiolitis by reviewing 
the census of each unit that cares for children with bronchiolitis and examining the charts of patients 
meeting age criteria to determine if they are eligible. They will then walk to the bedside of each 
eligible infant with bronchiolitis to confirm that supplemental oxygen and room air flow are off and 
determine the current continuous monitoring status (SpO2, electrocardiographic, neither, both). 
Inspired by ecological momentary assessment,27 this observational approach is the most feasible 
method to determine true continuous monitoring status across a wide range of hospitals with varying 
chart documentation and physiologic monitor data infrastructures. These in person observations are 
necessary even if monitor orders exist because the presence of orders for continuous SpO2 
monitoring are poorly predictive of actual monitoring status (data from current 56-hospital study led 
by same team conducting this study). Sites will transmit data using REDCap, a secure research data 
management tool.28 At the conclusion of the intervention period, questionnaires will be electronically 
distributed to hospital staff on each participating unit. 
5.2 
Chart review 
5.2.1 
Site investigators will provide the following contextual information about audit and 
feedback and educational outreach delivery events, using a framework previously 
described:29 
• 
Date of event 
• 
What type of session was held? (audit data review, educational outreach session, email, 
webinar, etc) 
• 
Who was the audience (role composition, (e.g. nurses and residents from the 3 East unit) 
• 
What information was delivered? 
• 
Were specific behavior changes in response to the data discussed? 
• 
Were structural changes discussed? 
• 
Were other changes discussed? 
• 
Were comparison data discussed? 
o 
The same hospital’s past season performance 
o 
Other hospitals’ past season performance 
o 
Other hospitals’ current season performance 
o 
Performance of other units in the same hospital during current season 
o 
Performance of other units in other hospitals during current season 
• 
Were graphs presented? 
• 
How fresh were the most recent data discussed? (e.g. from the previous week) 
• 
Implementation dates and details of any active quality improvement projects occurring 
concurrently 
5.2.2 
The following data elements will be abstracted from the chart and stored in the study 
database: 
• 
Hospital 
• 
Admission date and time 
• 
Coded patient-admission ID – this is an identifier for each unique patient-admission to allow 
the data analysis to account for clustering of observations within individual patient-
admissions. This is not an actual patient identifier assigned by the hospital; it is a study-
specific coded identifier with the linkage master list document held by the individual site (no 

 
  
 
 
 
9 
actual patient identifiers other than the dates listed here are transmitted to CHOP from other 
sites).  
• 
Unit name 
• 
Bed number 
• 
Patient age 
• 
Patient sex 
• 
Patient race and ethnicity 
• 
Patient primary diagnosis and chronic conditions 
• 
Forms of chronic neurologic impairment (e.g. static encephalopathy, cerebral palsy, 
hydrocephalus, spina bifida, epilepsy/seizure disorder, hypotonia, other form of neurologic 
impairment) 
• 
Technology dependence (e.g. short-term feeding tube, long-term feeding tube, central 
venous line, renal dialysis) 
• 
History of apnea or cyanosis during this illness 
• 
History of ICU stay earlier in this admission 
• 
Patient gestational age 
• 
How long have they been off respiratory support (e.g. supplemental oxygen or room air 
flow), according to the chart? 
• 
Are any pulse oximetry measurements documented in the chart since the patient has been 
off respiratory support (e.g. supplemental oxygen or room air flow)? 
• 
Do they have an active continuous pulse oximetry monitoring order in the chart right now?  
• 
Do they have an active continuous electrocardiographic/cardiorespiratory monitoring order in 
the chart right now?  
• 
For hospitals with integration of medical device data into electronic health records:  
• 
Is there at least 1 pulse oximetry data point visible in the chart from the same minute that 
rounds occurred? 
• 
Is there at least 1 pulse oximetry data point visible in the chart for each of the 15 minutes 
preceding when rounds occurred? 
• 
Is there at least 1 pulse oximetry data point visible in the chart for each of the 15 minutes 
following when rounds occurred? 
5.2.3 
The following data elements will be abstracted from the chart and stored in the 
individual site’s separate master list alongside the coded ID, admission date, and data 
collection rounds date but NOT entered into the study database and NOT transmitted 
outside of the institution where the patient is hospitalized: 
• 
Patient first name 
• 
Patient last name 
• 
Patient medical record number 
• 
Patient admission /account number (a hospital-specific identifier in the EHR that identifies 
the specific admission) 

 
  
 
 
 
10
5.3 
Bedside visual observation “rounds” 
• 
Date and time rounds occurred at this patient’s bedside (the exact time, to the minute, using 
the time displayed on the bedside monitor as the time of record) 
• 
Based on observing the patient at the bedside, are they currently receiving any respiratory 
support (e.g. supplemental oxygen or nasal cannula flow)? 
• 
Are they being continuously pulse oximetry monitored right now based on bedside 
observation? 
• 
Are they being continuously electrocardiographically/cardiorespiratory monitored (using 
chest leads to measure heart rate, heart rhythm, and/or respiratory rate) right now based on 
bedside observation? 
• 
Field notes based on brief real time inquiry of health care professionals, if performed, 
regarding why the patient is continuously monitored 
 
5.3.1 
COVID-19 related accommodations 
Due to hospitals experiencing shortages of personal protective equipment such as surgical 
masks, and the interest in protecting the health and safety of data collection staff, we will 
permit the following modifications to the observational rounds for hospitals actively limiting 
entry into patient rooms to only essential personnel: 
• 
The data collector may obtain the respiratory support status by asking the bedside 
nurse responsible for the care of the patient, so no room entry is required 
• 
The data collector may obtain the continuous monitoring status by any of the 
following methods, so no room entry is required: 
o 
Viewing the monitor from outside the patient room (e.g. through a door) 
o 
Viewing the monitor from a central station 
o 
Viewing the monitor using an existing remote continuous monitor viewing 
platform used by clinicians at the hospital for patient care (e.g. AirStrip) 
The method used for determining respiratory support status and continuous monitoring status will be 
noted in the data collection form. 
 
5.4 
Staff questionnaires (see appendix for instrument) 
5.4.1 
Site PIs will submit to CHOP for recruitment 
• 
Email addresses of potential health professional subjects 
5.4.2 
The questionnaires will include the following elements: 
• 
Hospital 
• 
Unit(s) where person worked during the intervention period 
• 
Profession (nurse, attending physician, etc.) 
• 
Did the person care for any patients with bronchiolitis on an intervention unit during the 
intervention period? 
• 
Gender, race, ethnicity of subject completing the questionnaire  
• 
Acceptability of Intervention Measure (AIM) 
• 
Intervention Appropriateness Measure (IAM) 
• 
Feasibility of Intervention Measure (FIM) 

 
  
 
 
 
11
• 
Supplemental items (see appendix) 
Please note that we may make minor changes to the items included in the questionnaire in the 
months between initial IRB submission and questionnaire administration based on ongoing 
discussion with the investigative team and site PIs. As long as the changes do not represent major 
changes in scope, we will not submit revised versions of the questionnaire to the IRB. 
 
6 
STATISTICAL CONSIDERATIONS 
This is a feasibility study preparatory to a clinical trial. Therefore, there is minimal emphasis on 
statistical power. 
6.1 
Primary Endpoint 
The primary endpoints are the resulting scores on the questionnaire measures above. 
6.2 
Secondary Endpoints 
Secondary endpoints will include the following: 
• 
Continuous pulse oximetry use rates in children with bronchiolitis who are not requiring 
supplemental oxygen administration. 
• 
The test characteristics (sensitivity, specificity, positive predictive value, negative predictive 
value) of the electronic health record data from the medical monitoring device for actual 
monitoring at the bedside in bronchiolitis 
6.3 
Statistical Methods 
6.3.1 
Questionnaire-based methods (AIM, IAM, FIM) 
We will generate average scores for each item and for each measure, stratified by hospital and role 
(e.g. nurse, physician). 
6.3.2 
Pulse oximetry use rates 
We will calculate the overall rate of SpO2 monitoring overuse within each hospital. The rate 
numerator is the number of patients with bronchiolitis who are breathing room air (not requiring any 
supplemental oxygen) and are continuously SpO2-monitored. The rate denominator is the total 
number of patients with bronchiolitis who are breathing room air. We will stratify these rates by key 
variables (e.g. time of day, amount of time off supplemental oxygen). 
6.3.3 
Medical device integration test characteristics 
We will calculate the sensitivity, specificity, positive predictive value, negative predictive value of the 
electronic health record data from the medical monitoring device for actual monitoring at the bedside 
in bronchiolitis. 
6.4 
Sample Size and Power 
By engaging 10 sites in a range of different settings, we expect to gain meaningful insight into the 
feasibility of performing a larger trial of this intervention. By collecting a total of approximately 100 
questionnaires on each of the AIM, FIM, and IAM per hospital, we will have 90% power to reject the 
null hypothesis response of “Neither agree nor disagree” (3.0) assuming a mean response of “Agree” 
(4.0), alpha=.05, standard deviation=3. A total of 73 responses would provide 80% power to detect 
the above conditions. 
 
7 
SAFETY MANAGEMENT 
7.1 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study. See details in section 8.4.1 
describing the proactive adverse event surveillance plan. 

 
  
 
 
 
12
7.2 
Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen during 
the course of this study (including SAEs), they will be reported to the IRB in accordance with CHOP 
IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. AEs that are not serious but that 
are notable and could involve risks to subjects will be summarized in narrative or other format and 
submitted to the IRB at the time of continuing review.  
 
8 
STUDY ADMINISTRATION 
8.1 
Treatment Assignment Methods 
This is a single arm study without randomization or blinding. 
8.2 
Data Collection and Management 
8.2.1 
Data sources 
8.2.1.1 
Chart review 
Data from chart review will be extracted from the medical record system used at the hospital site. 
This may include electronic medical records (e.g. the Epic system at CHOP) or paper medical 
records.  
8.2.1.2 
Bedside visual observation “rounds” 
Data will be obtained by visual observing and documenting the current state of respiratory support 
and physiologic monitoring occurring in patient rooms. See details of COVID-19 modifications in 
Section 5.3. 
8.2.1.3 
Staff questionnaires 
• 
As listed in Sections 5 and 6 
8.3 
Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. The Investigator and other site personnel will not 
use such data and records for any purpose other than conducting the study.  
The only PHI elements that documented in the study database are the admission date and the date 
the data collection rounds occurred (which by definition is a date during the patient’s hospitalization). 
Thus this is a limited dataset. 
The dataset is also coded to decrease the risk of breach of confidentiality. A patient-admission ID 
number not otherwise associated with the individual (not derived from any element of PHI) will be 
generated by each site and included in the study database allowing patients to be followed over time 
within the same admission. This is an identifier for each unique patient-admission to allow the data 
analysis to account for clustering of observations within individual patient-admissions. This is not an 
actual patient identifier assigned by the hospital; it is a study-specific coded identifier with the linkage 
master list document held by the individual site (no PHI other than the dates listed above are 
transmitted to CHOP from other sites).  
Hospitals that choose to maintain paper master lists will keep them in locked file cabinets. Hospitals 
that choose to maintain electronic master lists will store them either on hard drives owned by the 
institution or servers maintained/approved by their institution. The master list containing the key to 
decipher the coded dataset will be deleted/destroyed at the earliest possible date that complies with 
individual hospitals’ retention of records policies. 
Questionnaire data will not contain any PHI. 

 
  
 
 
 
13
No identifiable data will be used for future study without first obtaining IRB approval. The investigator 
will obtain a data use agreement between provider (the PI) and any recipient researchers (including 
others at CHOP) before sharing a limited dataset (dates and zip codes).  
8.4 
Regulatory and Ethical Considerations 
8.4.1 
Data and Safety Monitoring Plan 
The risks of this study are minimal as it involves an intervention intended to align clinical practice 
with established guidelines and recommendations for quality bronchiolitis care. The Principal 
Investigator is responsible for data and safety monitoring. The primary risk is breach of privacy and 
confidentiality. We will also perform proactive surveillance for threats to patient safety. 
8.4.1.1 
Plan for mitigating and monitoring risk of privacy and confidentiality breaches 
CHOP’s instance of REDCap will be used for all data collection and management in this study, 
including data collection performed at non-CHOP sites. For feasibility reasons, study sites will be 
permitted to use a temporary paper data collection worksheet as long as it is stored in a locked file 
cabinet and destroyed after abstraction into REDCap. Handling of the master list is described in the 
above section. 
After data collection, exported data for analysis will take place only on computers that meet CHOP IT 
standards for encryption and password protection as outlined in CHOP IT SOP A-3-6. Data will be 
stored on the CHOP research SAN and/or other secure servers maintained by CHOP IT. Only 
investigators and study staff approved by the IRB will have access to data containing PHI.  
In accordance with the current CHOP Retention of Records Policy A-3-9 in the Administrative Policy 
Manual, section on minimal risk human subjects research records, we will retain all information from 
this study for 6 years after the study is completed, after which PHI will be stripped from the data set. 
We recognize that other sites relying on the CHOP IRB have different record retention requirements. 
For this reason, we will: 
1. Provide all data submitted to CHOP back to the Site PI at the conclusion of the study using a 
CHOP IT approved secure method, allowing each site to meet local record retention 
requirements. We will not submit Site-Specific Amendments describing each site’s record 
retention requirement. 
2. Support other site-specific record retention or local IRB policy exceptions (such as a local 
requirement to retain data collection worksheets after the data are abstracted into REDCap) 
that may differ from what we have written above as long as they are described in the Site 
Survey or a Site-Specific Amendment.  
The CHOP PI will monitor and review the study progress, the accuracy and security of the data, and 
will ensure subject confidentiality and safety. 
8.4.1.2 
Plan for proactive surveillance for threats to patient safety 
In this study, we will regularly evaluate the safety of the intervention, since the intervention may lead 
to less intensive monitoring for some bronchiolitis patients. In order to monitor for threats to safety, 
we will: 
• 
Monitor for code blue team activations and rapid response team / medical emergency team / 
critical assessment team activations in all bronchiolitis patients hospitalized on units 
participating in the study during the intervention period. This includes patients who were not 
subjects of data collection, because the intervention is applied at the unit level and could 
impact the care of patients with bronchiolitis even if they are not reviewed during data 
collection rounds. 
• 
Investigators will review the chart of each patient meeting the above criteria to determine if 
the patient was unmonitored at the time of the event that led to the activation. 
• 
Events meeting the activation criteria in which the patient was unmonitored at the time of the 
event that led to the activation will be considered study adverse events, whether or not they 

 
  
 
 
 
14
are related to the research intervention, and be documented in research records as meeting 
those criteria. 
• 
Investigators will then determine, through chart review and speaking with staff present at the 
time of the event, if available, if the event was at least possibly related to the study 
intervention, defined as “there is a reasonable possibility that the adverse event may have 
been caused by the procedures involved in the research.” 
• 
Investigators will follow the CHOP IRB’s Unanticipated Problems Decision Tree 
(https://irb.research.chop.edu/unanticipated-problems) in order to determine whether the 
Adverse Event requires prompt reporting to the IRB or should be filed with the next 
continuing review. 
• 
Adverse Events that meet the definition of Unanticipated Problem Involving Risks to 
Subjects will be reported promptly to the IRB and the study will be suspended pending 
review of the event by the IRB. Following the review, we will work with the IRB and staff from 
the inpatient units to determine if the study should be modified to improve the safety of 
patients. 
• 
Sites other than CHOP will follow their IRB’s internal reporting requirements, if they differ 
from the procedures outlined above. 
 
8.4.2 
Risk Assessment 
Risks are not greater than minimal in this study. The primary risk is breach of privacy and 
confidentiality. Less likely are threats to patient safety. These risks will be minimized as described 
above. 
Given that there are national recommendations from Choosing Wisely and the AAP that support 
using less continuous monitoring in stable bronchiolitis, this study is not introducing any additional 
risk than would be introduced if clinical leaders initiated efforts into routine clinical care to align their 
hospitals’ practice with the existing national guidelines. The intervention simply aims to measure the 
feasibility of revealing how hospitals are doing with respect to these guidelines by showing them their 
own data, and providing information/education on the existing recommendations. All decisions about 
changes to monitoring are made by the primary medical team, not the researchers. 
8.4.3 
Potential Benefits of Trial Participation 
8.4.3.1 
Direct 
Patients, their families, and the health professionals caring for them have the potential to benefit from 
higher quality, guideline-concordant health care. This may produce fewer monitor alarms, and 
thereby fewer interruptions from alarms that may break the concentration of health professionals and 
contribute to errors, wake patients from sleep, or cause unnecessary anxiety in patients and their 
loved ones. The patients also may have a lower risk of harm due to a reduction in the probability of 
the clinicians caring for them experiencing the alarm fatigue that can result from high alarm rates. 
Patients may also benefit by not having their hospital stays prolonged unnecessarily due to the 
overdiagnosis of inconsequential mild hypoxemia. 
8.4.3.2 
Indirect 
The study outlined in this proposal will generate important knowledge that will advance (a) the 
science of audit and feedback and (b) plans for a future large-scale cluster-randomized trial of this 
intervention.  
8.4.4 
Risk-Benefit Assessment 
Based on the discussion above and the lack of deviation from standard clinical care, the benefits of 
this study far outweigh the minimal risks. Given that the risks of the study are minimal, it is 
reasonable to proceed with the project.  

 
  
 
 
 
15
8.5 
Recruitment Strategy 
The pragmatic approach to recruitment of health care professionals and patients for the intervention 
has been described in previous sections. 
For the data collection in-person observational rounds, site investigators will identify all patients 
currently admitted to their hospital’s non-ICU pediatric wards with bronchiolitis by reviewing the 
census of each unit that cares for children with bronchiolitis and examining the charts of patients 
meeting age criteria to determine if they are eligible. Eligibility screening does not involve recording 
any data until the patient is determined to be eligible and is enrolled. 
For the primary objective, measuring feasibility, acceptability, and appropriateness using the 
validated questionnaire instruments, site PIs will distribute the questionnaire to the following health 
care professional types who worked on an intervention unit in a role involving the care of patients 
with bronchiolitis during the intervention period: 
• 
Attending physicians 
• 
Resident physicians 
• 
Nurses 
• 
Nursing assistants 
• 
Physician assistants 
• 
Respiratory therapists 
• 
Other relevant staff (e.g. if a hospital’s bronchiolitis care team includes staff who educate 
parents about their child’s condition prior to discharge, we would include them here) 
 
Questionnaires will be distributed in paper and electronic formats. Paper questionnaires will be 
distributed during unit-based events such as safety huddles,24,25 staff meetings, and rounds and 
subsequently entered into a CHOP-based REDCap form by the site investigative team or scanned 
and emailed to the CHOP-based study email address. Electronic questionnaires will be distributed 
using CHOP-based REDCap survey distribution tools to track responses and nonresponses. In order 
to distribute, site PIs will work with unit leadership within each discipline listed above to identify 
potential eligible health professional subjects. Site PIs will submit a list of email addresses of these 
potential subjects to CHOP study leadership, who will enter these into the CHOP-based REDCap 
survey distribution system.  
8.6 
Informed Consent/Assent and HIPAA Authorization 
8.6.1 
Informed consent and HIPAA for the primary measure (questionnaires) 
Consent will be obtained for the questionnaires administered to health care professional; we request 
waiver of documentation. The waiver is appropriate under §46.117(c)(ii): the research presents no 
more than minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required outside of the research context. 
The first section of the questionnaire will include the required elements of consent and a statement 
that completion of the questionnaire indicates willingness and consent to participate. Specific 
language is included in the Appendix. HIPAA Authorization is not necessary for the questionnaire 
portion of the study; email addresses of health care professionals are being collected in order to 
distribute but are not considered PHI because they do not relate to the health of an individual. 
8.6.2 
Waiver of Consent and Assent for all other aspects of the study 
Waivers of consent and assent are being requested for this study, with the exception of the 
questionnaire portion described in the section above. If consent was obtained, the only central record 
directly linking the subject and the research data would be the informed consent form and the 
principal risk would be potential harm resulting from a breach of confidentiality. In addition, this 
project involves no procedures for which written consent is normally required outside of the research 

 
  
 
 
 
16
context. Any health care professional can opt out of study participation at any time simply by not 
participating in study-related activities. 
The research meets the criteria of 45 CFR 46.116(d), as illustrated below:  
(1) Risks are not greater than minimal in this study. The primary risk is breach of privacy and 
confidentiality. The risk will be minimized by keeping all data and records confidential in 
accordance with institutional policies on subject privacy. The investigators will not use data or 
records for any purpose other than conducting the study. Please see Section 8.3 for additional 
details. 
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects because 
PHI will only be accessed by IRB approved study staff performing data collection, and we are 
collecting a limited, coded dataset to minimize risk of PHI exposure. 
(3) The research could not practicably be carried out without the waiver or alteration. The intent is to 
obtain a large, unbiased sample of patients with bronchiolitis to obtain insights on hospital-level 
practices and systems of care related to pulse oximetry monitoring in bronchiolitis. The research 
could not practicably be carried out without the waiver or alteration, as it may not be feasible to 
locate and contact the families of all of the patients whose clinical records will be required in 
order for this to be an unbiased sample representative of the population with adequate sample 
size. If we fail to obtain all of the data due to families who cannot be located/contacted, this will 
threaten the statistical outcome, bias the sample, prohibit conclusions to be drawn or alter the 
sample such that conclusions would be skewed.   
(4) There will not be any pertinent patient-level information that would benefit the patient directly 
after participation so none of the subjects will be provided with additional information after 
participation.  
8.6.3 
Waiver of Assent 
Please refer to the justification for waiver of consent above. 
8.6.4 
Waiver of HIPAA Authorization 
We request a waiver of HIPAA Authorization. The study presents no more than minimal risk to the 
privacy of individuals. The research meets the criteria of 45 CFR 46.116(d), as illustrated below: 
 (A) The use or disclosure of protected health information involves no more than a 
minimal risk to the privacy of individuals, based on, at least, the presence of the following 
elements:  
(1) An adequate plan to protect the identifiers from improper use and disclosure;  
• 
We have provided an adequate plan to protect identifiers from improper 
use and disclosure above. 
(2) An adequate plan to destroy the identifiers at the earliest opportunity consistent 
with conduct of the research, unless there is a health or research justification for 
retaining the identifiers or such retention is otherwise required by law; and  
• 
We have provided a plan to destroy the identifiers, including those in the 
master list, at the earliest opportunity consistent with the conduct of the 
research that is also consistent with institutional record retention policies, 
described above. 
(3) Adequate written assurances that the protected health information will not be 
reused or disclosed to any other person or entity, except as required by law, for 
authorized oversight of the research project, or for other research for which the use 
or disclosure of protected health information would be permitted by this subpart;  
• 
Protected health information will not be reused or disclosed to any other 
entity except as required by law, for authorized oversight of the research 

 
  
 
 
 
17
project, or for other research for which the use or disclosure of protected 
health information would be permitted by this subpart. 
(B) The research could not practicably be conducted without the waiver or alteration; and  
• 
The research could not practicably be conducted without the waiver as 
described above in waiver of consent request. 
(C) The research could not practicably be conducted without access to and use of the 
protected health information. 
• 
The research could not practicably be conducted without access to and 
use of protected health information needed to track patients over time 
and to track the dates of admission and data collection at each site 
during the bronchiolitis season. 
8.7 
Payment to Subjects/Families 
None. 
 
9 
PUBLICATION 
Peer-reviewed publication is planned. No identifiable information will be used in publication. 
 
 

 
  
 
 
 
18
10 APPENDIX 
10.1 Consent language for questionnaire 
See eIRB application section 12.01 3.0. 
10.2 Draft questionnaire items 
See eIRB application section 12.02 2.0. 
 
 
 

 
  
 
 
 
19
11 REFERENCES 
1.  
Cullen DJ, Nemeskal AR, Cooper JB, Zaslavsky A, Dwyer MJ. Effect of pulse oximetry, age, and ASA physical status 
on the frequency of patients admitted unexpectedly to a postoperative intensive care unit and the severity of their 
anesthesia-related complications. Anesth Analg. 1992;74(2):181-188. 
2.  
Ochroch EA, Russell MW, Hanson WC, et al. The impact of continuous pulse oximetry monitoring on intensive care 
unit admissions from a postsurgical care floor. Anesth Analg. 2006;102(3):868-875. 
doi:10.1213/01.ane.0000195583.76486.c4 
3.  
McCulloh R, Koster M, Ralston S, et al. Use of intermittent vs continuous pulse oximetry for nonhypoxemic infants and 
young children hospitalized for bronchiolitis: a randomized clinical trial. JAMA Pediatr. 2015;169(10):898-904. 
doi:10.1001/jamapediatrics.2015.1746 
4.  
Schuh S, Freedman S, Coates A, et al. Effect of oximetry on hospitalization in bronchiolitis: a randomized clinical trial. 
JAMA. 2014;312(7):712-718. doi:10.1001/jama.2014.8637 
5.  
Cunningham S, Rodriguez A, Adams T, et al. Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-
blind, randomised, equivalence trial. Lancet. 2015;386(9998):1041. doi:10.1016/S0140-6736(15)00163-4 
6.  
Principi T, Coates AL, Parkin PC, Stephens D, DaSilva Z, Schuh S. Effect of oxygen desaturations on subsequent 
medical visits in infants discharged from the emergency department with bronchiolitis. JAMA Pediatr. 2016;170(6):602-
608. doi:10.1001/jamapediatrics.2016.0114 
7.  
Schondelmeyer AC, Simmons JM, Statile AM, et al. Using quality improvement to reduce continuous pulse oximetry 
use in children with wheezing. Pediatrics. 2015;135(4):e1044-e1051. doi:10.1542/peds.2014-2295 
8.  
Schroeder AR, Marmor AK, Pantell RH, Newman TB. Impact of pulse oximetry and oxygen therapy on length of stay in 
bronchiolitis hospitalizations. Arch Pediatr Adolesc Med. 2004;158(6):527. doi:10.1001/archpedi.158.6.527 
9.  
Cunningham S, McMurray A. Observational study of two oxygen saturation targets for discharge in bronchiolitis. Arch 
Dis Child. 2012;97(4):361-363. doi:10.1136/adc.2010.205211 
10.  
McBride SC, Chiang VW, Goldmann DA, Landrigan CP. Preventable adverse events in infants hospitalized with 
bronchiolitis. Pediatrics. 2005;116(3):603-608. doi:10.1542/peds.2004-2387 
11.  
Bonafide CP, Lin R, Zander M, et al. Association between exposure to nonactionable physiologic monitor alarms and 
response time in a children’s hospital. J Hosp Med. 2015;10(6):345-351. 
12.  
Bonafide CP, Localio AR, Holmes JH, et al. Video analysis of factors associated with response time to physiologic 
monitor alarms in a children’s hospital. JAMA Pediatr. 2017;171(6):524-531. 
13.  
Ralston SL, Lieberthal AS, Meissner HC, et al. Clinical practice guideline: the diagnosis, management, and prevention 
of bronchiolitis. Pediatrics. 2014;134(5):e1474-e1502. 
14.  
Quinonez RA, Garber MD, Schroeder AR, et al. Choosing wisely in pediatric hospital medicine: Five opportunities for 
improved healthcare value. J Hosp Med. 2013;8(9):479-485. 
15.  
Quinonez RA, Coon ER, Schroeder AR, Moyer VA. When technology creates uncertainty: pulse oximetry and 
overdiagnosis of hypoxaemia in bronchiolitis. BMJ. 2017;358:j3850. doi:10.1136/bmj.j3850 
16.  
Cunningham S, Rodriguez A, Boyd KA, McIntosh E, Lewis SC, on behalf of the BIDS Collaborators Group. 
Bronchiolitis of Infancy Discharge Study (BIDS): a multicentre, parallel-group, double-blind, randomised controlled, 
equivalence trial with economic evaluation. Health Technol Assess. 2015;19(71):1-172. doi:10.3310/hta19710 
17.  
Coon ER, Quinonez RA, Moyer VA, Schroeder AR. Overdiagnosis: how our compulsion for diagnosis may be harming 
children. Pediatrics. 2014;134(5):1013-1023. 
18.  
Monitoring OXYgen in Infants Hospitalized With Bronchiolitis: A Best Practices Trial (The MOXY Trial) - 
ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01646606. Accessed September 15, 2017. 
19.  
Oxygen Saturation Monitoring in Bronchiolitis - ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02947204. 
Accessed September 15, 2017. 

 
  
 
 
 
20
20.  
Sanjay Mahant, MD MSc, FRCPC. Bronchiolitis RCTs at The Hospital for Sick Children, Toronto. September 2017. 
21.  
Rasooly IR, Beidas RS, Wolk CB, et al. Measuring overuse of continuous pulse oximetry in bronchiolitis and 
developing strategies for large-scale deimplementation: study protocol for a feasibility trial. Pilot Feasibility Stud. 
2019;5(1):68. doi:10.1186/s40814-019-0453-2 
22.  
Chan WV, Pearson TA, Bennett GC, et al. ACC/AHA special report: Clinical practice guideline implementation 
strategies: A summary of systematic reviews by the NHLBI Implementation Science Work Group: A report of the 
American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. Circulation. 
2017;135(9):e122-e137. 
23.  
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are 
fit for purpose. BMJ. 2015;350:h2147. doi:10.1136/bmj.h2147 
24.  
Bonafide CP, Localio AR, Stemler S, et al. Safety huddle intervention for reducing physiologic monitor alarms: A hybrid 
effectiveness-implementation cluster randomized trial. J Hosp Med. February 2018:[Epub ahead of print]. 
25.  
Dewan M, Wolfe H, Lin R, et al. Impact of a safety huddle–based intervention on monitor alarm rates in low-acuity 
pediatric intensive care unit patients. J Hosp Med. 2017;12(8):652-657. 
26.  
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome 
measures. Implement Sci. 2017;12(1):108. doi:10.1186/s13012-017-0635-3 
27.  
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. 
28.  
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a 
metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed 
Inf. 2009;42:377-381. 
29.  
Colquhoun H, Michie S, Sales A, et al. Reporting and design elements of audit and feedback interventions: a 
secondary review. BMJ Qual Saf. 2017;26(1):54-60. doi:10.1136/bmjqs-2015-005004