Eliminating Monitor Overuse Trial (EMO Trial)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Unlearning Only Includes educational outreach and audit & feedback. |
Behavioral: Educational Outreach
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.
Behavioral: Audit & 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.
Behavioral: Audit & 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.
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Experimental: Unlearning + Substitution Includes educational outreach, audit & feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry. |
Behavioral: Educational Outreach
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for pulse oximetry use in bronchiolitis.
Behavioral: Audit & 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.
Behavioral: Audit & 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.
Behavioral: Clinical 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.
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Outcome Measures
Primary Outcome Measures
- Sustainability of guideline-concordant deimplementation of continuous pulse oximetry monitoring [3 years]
Sustainability of guideline-concordant deimplementation of continuous pulse oximetry (SpO2) monitoring is the primary trial outcome. It is calculated based on penetration (outcome 2). Sustainability will be measured longitudinally based on calculating the differences in the penetration of guideline-concordant practice at baseline, compared to the penetration during the sustainability phase.
Secondary Outcome Measures
- Penetration [Up to 4 years]
Penetration is calculated as the percentage of bronchiolitis patients who are in room air (not receiving any supplemental oxygen) and are receiving guideline-concordant care (this means they are not being continuously SpO2-monitored). The continuous monitoring status is determined using direct observation on hospital units.
- Acceptability of deimplementation [Up to 3 years]
Acceptability of deimplementation among staff measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better acceptability. The items are analyzed individually and not summed to a total score.
- Feasibility of deimplementation [Up to 3 years]
Feasibility of deimplementation among staff measured by questionnaire. Items are adapted from the validated Feasibility of Implementation Measure (FIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.
- Appropriateness of deimplementation [Up to 3 years]
Appropriateness of deimplementation among staff measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.
- Perceived safety of deimplementation [Up to 3 years]
Perceived safety of deimplementation among staff measured by questionnaire. Items are adapted from those used in the pilot study preceding this trial and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better agreement with each question.
- Cost of deimplementation strategies [Up to 3 years]
Cost of delivering each of the strategies will be assessed using a pragmatic Time-Driven Activity Based Costing method developed specifically for economic analysis of implementation strategies.
- 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.
- 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.
Other Outcome Measures
- Exploratory long-term sustainability [4 years]
Exploratory long-term sustainability is calculated based on penetration. Penetration is the percentage of bronchiolitis patients who are in room air (not receiving any supplemental oxygen) and are receiving guideline-concordant care (this means they are not being continuously SpO2-monitored). The continuous monitoring status is determined using direct observation on hospital units. In this exploratory outcome investigators are using an alternative definition of sustainability in which, in order to meet criteria for having successfully sustained a practice change, hospitals must first (a) experience a significant increase in penetration between baseline and active deimplementation, and then (b) maintain the increased penetration at ≥90% of the active deimplementation phase level through the end of the sustainability period.
- Routinization of guideline-concordant deimplementation [Up to 3 years]
Routinization is a dimension of the Slaghuis Measurement Instrument for Sustainability of Work Practices. Routinization is the process in which clinicians develop new routines such that the intended practice changes become part of their everyday work.
- Institutionalization of guideline-concordant deimplementation [Up to 3 years]
Institutionalization is a dimension of the Slaghuis Measurement Instrument for Sustainability of Work Practices. Institutionalization is the process in which the organization embeds the intended practice change into its existing systems and structures.
- Implementation Climate [Up to 3 years]
Implementation Climate is whether the environment expects, supports, and rewards deimplementation of continuous SpO2 monitoring. Investigators will measure Implementation Climate using items from the Implementation Climate Scale. This is an 18-item scale with each item having 5 response options from 0 through 4. Higher total scores indicate better implementation climate.
- Implementation Leadership [Up to 3 years]
Implementation Leadership is leader behaviors that include being proactive, knowledgeable, supportive, and persevering around deimplementation of continuous SpO2 monitoring. Implementation Leadership will be measured using items from the Implementation Leadership Scale. This is a 12-item scale with each item having 5 response options from 0 through 4. Higher total scores indicate better implementation leadership.
- Psychological reactance [Up to 3 years]
Assessment of psychological reactance by questionnaire will be performed using validated items from seminal research in psychological reactance in health communication. This includes dimensions of freedom threat, emotional response, and cognitive response to deimplementation. Items are rated on 5-point Likert scales ranging from 0 through 4 with higher scores indicating more reactance for some items, and less reactance on other items. The items are analyzed individually and not summed to a total score.
- Underuse of Pulse Oximetry Monitoring in High Risk Patients [Up to 4 years]
Underuse is defined as failing to continuously SpO2 -monitor bronchiolitis patients receiving ≥2L/min supplemental oxygen (a marker of more severe disease). It is calculated as the percentage of bronchiolitis patients who are receiving ≥2L/min supplemental oxygen, and are not being continuously SpO2-monitored. It is measured using direct observation.
- Number of Bronchiolitis Patients with Emergency Hypoxemic Events [Up to 4 years]
Investigators will collect data on emergency events occurring in bronchiolitis patients as a potential unintended consequence of deimplementation efforts. Investigators will identify code blue and rapid response team activations in bronchiolitis patients who were unmonitored at the time of the event and were subsequently found to be hypoxemic to <85% at the time of the event when SpO2 monitors were applied. These outcomes will be extracted from local patient safety databases (e.g., local rapid response team activation logs).
- Number of Bronchiolitis Patients with Readmissions Featuring Hypoxemia Upon Re-Presentation [Up to 4 years]
Investigators will collect data on readmissions occurring in bronchiolitis patients as a potential unintended consequence of deimplementation efforts. Investigators will identify readmissions of bronchiolitis patients to the hospital within 7 days of discharge who were found to be hypoxemic to <85% upon re-presentation to the emergency department.
Eligibility Criteria
Criteria
Population 1a: Hospital staff who complete study questionnaires.
Inclusion Criteria:
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Nurse or physician fluent in English and employed full-time by the hospital, affiliated practice, or affiliated university who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season
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Hospital administrator fluent in English who oversaw the care of bronchiolitis on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)
Exclusion Criteria:
• Under the direct supervision of study or site principal investigator(s)
Population 1b: Hospital staff who participate in qualitative interviews
Inclusion Criteria:
• Nurse or physician fluent in English and employed full-time by the hospital, affiliated practice, or affiliated university who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season
Exclusion Criteria:
• Under the direct supervision of study or site principal investigator(s)
Population 2a: Bronchiolitis patients directly observed while not receiving supplemental oxygen ("in room air," for primary trial outcome)
Inclusion Criteria:
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Infants and children 2 months through 23 months old
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Hospitalized on non-ICU wards participating in the trial
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Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
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Primary diagnosis of bronchiolitis in most recent physician progress note
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Not actively receiving supplemental oxygen ("in room air")
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Last documented receipt of supplemental oxygen >1 hour prior to direct observational data collection
Exclusion Criteria:
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Documented apnea or cyanosis during the current illness
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Extreme prematurity (<28 weeks completed gestation)
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Cardiac disease
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Pulmonary hypertension
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Chronic lung disease
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Home oxygen requirement
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Neuromuscular disease
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Immunodeficiency
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Cancer
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Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19 / SARS-CoV-2)-related illness (known or suspected, including multisystem inflammatory syndrome in children multi-system inflammatory syndrome in children (MIS-C)
Population 2b: Bronchiolitis patients directly observed while receiving supplemental oxygen (for underuse evaluation).
Inclusion Criteria:
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Infants and children 2 months through 23 months old
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Hospitalized on non-ICU wards participating in the trial
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Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
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Primary diagnosis of bronchiolitis in most recent physician progress note
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Actively receiving ≥2 Liters/minute (2L/min) supplemental oxygen or 21% room air flow
Exclusion Criteria:
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Extreme prematurity (<28 weeks completed gestation)
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Cardiac disease
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Pulmonary hypertension
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Chronic lung disease
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Home oxygen requirement
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Neuromuscular disease
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Immunodeficiency
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Cancer
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Severe Acute Respiratory Syndrome Coronavirus 2 [Covid-19 / SARS-CoV-2 (known or suspected)]
Population 3: Parents or guardians of bronchiolitis patients who participate in qualitative interviews.
Inclusion Criteria:
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Their child was hospitalized for bronchiolitis on a unit participating in the trial during the most recent bronchiolitis season
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Their child was found to be continuously SpO2-monitored while in room air during Aim 1 data collection
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Fluent in English
Exclusion criteria:
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Does not recall being present while child was continuously SpO2-monitored
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They are an employee of the hospital or a hospital volunteer
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Children's of Alabama | Birmingham | Alabama | United States | 35233 |
2 | Banner University Medical Center- Diamond Children's | Tucson | Arizona | United States | 85719 |
3 | University of California Davis | Davis | California | United States | 95616 |
4 | Rady Children's Hospital/UCSD | Encinitas | California | United States | 92024 |
5 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
6 | Valley Children's Hospital | Madera | California | United States | 93636 |
7 | Children's Hospital Orange County | Orange | California | United States | 92868 |
8 | Lucile Packard Children's Hospital Stanford | Stanford | California | United States | 94304 |
9 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
10 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
11 | Yale-New Haven Children's Hospital | New Haven | Connecticut | United States | 06510 |
12 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
13 | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | United States | 60611 |
14 | Riley Hospital for Children at IU Health | Indianapolis | Indiana | United States | 46202 |
15 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
16 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
17 | CS Mott Children's Hospital | Ann Arbor | Michigan | United States | 48108 |
18 | Children's Minnesota | Minneapolis | Minnesota | United States | 55404 |
19 | Children's Mercy Kansas City | Kansas City | Missouri | United States | 64108 |
20 | Children's Hospital at Dartmouth-Hitchcock | Lebanon | New Hampshire | United States | 03756 |
21 | CHOP Pediatric Care at Penn Medicine/Princeton Health | Princeton | New Jersey | United States | 08536 |
22 | CHOP Care Network at Virtua | Voorhees | New Jersey | United States | 08043 |
23 | Albany Medical Center | Albany | New York | United States | 12208 |
24 | Children's Hospital at Montefiore | Bronx | New York | United States | 10467 |
25 | Cohen Children's Medical Center | New Hyde Park | New York | United States | 11040 |
26 | NYP-Morgan Stanley Children's Hospital | New York | New York | United States | 10032 |
27 | Komansky Children's Hospital/New York Presbyterian Medical Center /Weill Cornell Medicine | New York | New York | United States | 10065 |
28 | University of Rochester Golisano Children's Hospital | Rochester | New York | United States | 14642 |
29 | Upstate Golisano Children's Hospital | Syracuse | New York | United States | 13210 |
30 | Akron Children's Hospital | Akron | Ohio | United States | 44308 |
31 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
32 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
33 | Children's Hospital at Oklahoma University Medical Center | Oklahoma City | Oklahoma | United States | 73104 |
34 | Penn State Hershey Children's Hospital | Hershey | Pennsylvania | United States | 17033 |
35 | CHOP King of Prussia Hospital | King Of Prussia | Pennsylvania | United States | 19406 |
36 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
37 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
38 | Reading Hospital, Tower Health | Reading | Pennsylvania | United States | 19611 |
39 | CHOP Grand View Hospital | Sellersville | Pennsylvania | United States | 18960 |
40 | Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | United States | 37232 |
41 | Children's Medical Center Dallas | Dallas | Texas | United States | 75235 |
42 | Children's Memorial Hermann | Houston | Texas | United States | 77030 |
43 | Texas Children's Hospital | Houston | Texas | United States | 77030 |
44 | Texas Children's Hospital West Campus | Houston | Texas | United States | 77094 |
45 | Texas Children's Hospital The Woodlands | The Woodlands | Texas | United States | 77384 |
46 | Utah Valley Hospital | Provo | Utah | United States | 84604 |
47 | Riverton Hospital | Riverton | Utah | United States | 84065 |
48 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
49 | University of Vermont Children's Hospital | Burlington | Vermont | United States | 05401 |
50 | Inova Children's Hospital | Falls Church | Virginia | United States | 22042 |
51 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507 |
52 | Children's Hospital of Richmond at VCU | Richmond | Virginia | United States | 23298 |
53 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
54 | Hoops Family Children's Hospital at Marshall University | Huntington | West Virginia | United States | 25701 |
55 | Children's Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
56 | Alberta Children's Hospital | Calgary | Canada | AB T3B 6A8 |
Sponsors and Collaborators
- 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
Investigators
- Principal Investigator: Christopher P Bonafide, MD, MSCE, Children's Hospital of Philadelphia
- Principal Investigator: Rinad S Beidas, PhD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-018560
- U01HL159880