Eliminating Monitor Overuse Trial (EMO Trial)

Trial ID or NCT#

NCT05132322

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

Eliminating Monitor Overuse (EMO) Hybrid Effectiveness-Deimplementation Trial

Eligibility Criteria

Ages Eligible for Study: Older than 2 Months
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. • Under the direct supervision of study or site principal investigator(s)
    1. Population 1b: Hospital staff who participate in qualitative interviews
    2. In Aim 2, we will conduct semi-structured interviews with physicians and nurses who provide care to bronchiolitis patients in participating units at the 5 hospitals with the highest and 3 hospitals with the lowest sustainability (8 hospitals total; up to maximum of 8 interviews/hospital). Maximum anticipated enrollment 64.
    3. Inclusion criteria:
      1. * Nurses or Physicians who cared for bronchiolitis patients on a unit participating in the trial during at least 5 days of the most recent bronchiolitis season* Employed full-time by the hospital, affiliated practice, or affiliated university* Fluent in English
    4. Exclusion criteria:
  2. • No exclusion criteria
    1. Population 2a: Bronchiolitis patients directly observed while not receiving supplemental oxygen ("in room air," for primary trial outcome)
    2. Inclusion Criteria:
      1. * 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
    3. Exclusion Criteria:
      1. * 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)
    4. Population 2b: Bronchiolitis patients directly observed while receiving supplemental oxygen (for underuse evaluation).
    5. Inclusion Criteria:
      1. * 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
    6. Exclusion Criteria:
      1. * 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 \[Covid-19 / SARS-CoV-2 (known or suspected)\]
    7. Population 3: Parents or guardians of bronchiolitis patients who participate in qualitative interviews.
    8. Inclusion Criteria:
      1. * Their child was hospitalized for bronchiolitis on a unit participating in the trial during the most recent bronchiolitis season* Their child was found to be in room air during Aim 1 data collection* Fluent in English
    9. Exclusion criteria:
  3. • They are an employee of the hospital or a hospital volunteer
View All Criteria
Show Less

Investigator(s)

Alan Schroeder

Contact us to find out if this trial is right for you.

Contact

Alan Schroeder

SEND MESSAGE

View on ClinicalTrials.gov