Eliminating Monitor Overuse Trial (EMO Trial)

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05132322
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), University of Pennsylvania (Other), Boston Children's Hospital (Other), Children's Hospital Medical Center, Cincinnati (Other), Pediatric Research in Inpatient Settings (PRIS) Network (Other)
6,480
56
2
56
115.7
2.1

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
  • Behavioral: Educational Outreach
  • Behavioral: Audit & Feedback (unit level)
  • Behavioral: Audit & Feedback (real time, individual-level)
  • Behavioral: Clinical Pathway Integrated into Electronic Health Record
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6480 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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

Ages Eligible for Study:
2 Months and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Population 1a: Hospital staff who complete study questionnaires.

Inclusion Criteria:
  • Nurse or physician fluent in English and employed full-time by the hospital, affiliated practice, or affiliated university who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season

  • Hospital administrator fluent in English who oversaw the care of bronchiolitis on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)

Exclusion Criteria:

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

Population 1b: Hospital staff who participate in qualitative interviews

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:
  • Infants and children 2 months through 23 months old

  • Hospitalized on non-ICU wards participating in the trial

  • Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)

  • Primary diagnosis of bronchiolitis in most recent physician progress note

  • Not actively receiving supplemental oxygen ("in room air")

  • Last documented receipt of supplemental oxygen >1 hour prior to direct observational data collection

Exclusion Criteria:
  • Documented apnea or cyanosis during the current illness

  • Extreme prematurity (<28 weeks completed gestation)

  • Cardiac disease

  • Pulmonary hypertension

  • Chronic lung disease

  • Home oxygen requirement

  • Neuromuscular disease

  • Immunodeficiency

  • Cancer

  • Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19 / SARS-CoV-2)-related illness (known or suspected, including multisystem inflammatory syndrome in children multi-system inflammatory syndrome in children (MIS-C)

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

Inclusion Criteria:
  • Infants and children 2 months through 23 months old

  • Hospitalized on non-ICU wards participating in the trial

  • Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)

  • Primary diagnosis of bronchiolitis in most recent physician progress note

  • Actively receiving ≥2 Liters/minute (2L/min) supplemental oxygen or 21% room air flow

Exclusion Criteria:
  • Extreme prematurity (<28 weeks completed gestation)

  • Cardiac disease

  • Pulmonary hypertension

  • Chronic lung disease

  • Home oxygen requirement

  • Neuromuscular disease

  • Immunodeficiency

  • Cancer

  • Severe Acute Respiratory Syndrome Coronavirus 2 [Covid-19 / SARS-CoV-2 (known or suspected)]

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

Inclusion Criteria:
  • Their child was hospitalized for bronchiolitis on a unit participating in the trial during the most recent bronchiolitis season

  • Their child was found to be continuously SpO2-monitored while in room air during Aim 1 data collection

  • Fluent in English

Exclusion criteria:
  • Does not recall being present while child was continuously SpO2-monitored

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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT05132322
Other Study ID Numbers:
  • 21-018560
  • U01HL159880
First Posted:
Nov 24, 2021
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Children's Hospital of Philadelphia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022