Bronchiolitis
Conditions
Brief summary
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.
Detailed description
Continuous pulse oximetry (SpO2) monitoring has revolutionized detection of oxygen desaturation in operating rooms and other high-risk areas, improving outcomes in those settings. 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. Despite national guidelines discouraging continuous pulse oximetry use in stable bronchiolitis patients, 46% of those infants and children are continuously monitored. This pragmatic, prospective, non-randomized, single-arm feasibility pilot will be performed on non-Intensive Care Unit (ICU) hospital units that care for bronchiolitis patients. 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.
Interventions
BEHAVIORALAudit and Feedback
The audit and feedback intervention includes providing each hospital's own continuous pulse oximetry use data back to them on a weekly basis for review and action.
BEHAVIORALEducational outreach
Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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. * Secondary subjects - Patients 1. Males or females 8 weeks through 23 months old hospitalized on non-Intensive Care Unit (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 fraction of inspired oxygen in the air (FiO2) of 21% (room air flow)
Exclusion criteria
* 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. * 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 Coronavirus disease 2019 (COVID-19)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM) | 1 month after intervention | The participant rates the feasibility of the intervention based on this statement: Data feedback about our use of continuous pulse oximetry in patients with bronchiolitis is easy to implement. Data was only collected from the STAFF SURVEYED - Intervention (Single Arm) Arm/Group for this Outcome Measure. |
| Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM) | 1 month after intervention | The participant rates the acceptability of the intervention based on this statement: I like the data feedback. Data was only collected from the STAFF SURVEYED - Intervention (Single Arm) Arm/Group for this Outcome Measure. |
| Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM) | 1 month after intervention | The participant rates the appropriateness of the intervention based on this statement: Data feedback about our use of continuous pulse oximetry in bronchiolitis seems like a good match for our non-ICU floors that care for bronchiolitis. Data was only collected from the STAFF SURVEYED - Intervention (Single Arm) Arm/Group for this Outcome Measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) of the Presence of Electronic Health Record Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. | 4 months | This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients who were continuously monitored at the bedside. The denominator is the number of patients who had EHR data suggesting that they were continuously monitored. |
| Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen | 4 months | Continuous pulse oximetry use rates in children with bronchiolitis who are not requiring supplemental oxygen administration. This is calculated as the number of patients continuously monitored when not receiving supplemental oxygen divided by the total number of patients observed when not receiving supplemental oxygen. |
| Negative Predictive Value of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. | 4 months | This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients who were not observed to be continuously monitored at the bedside. The denominator is the number of patients who had EHR data suggesting that they were NOT continuously monitored. |
| Sensitivity of the Presence of Electronic Health Record (EHR) Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. Sensitivity is Also Referred to as the True Positive Rate. | 4 months | This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients with EHR data from the medical monitoring device. The denominator is the number of patients who were truly monitored. |
| Specificity of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. Specificity is Also Referred to as the True Negative Rate. | 4 months | This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients with absence of EHR data from the medical monitoring device. The denominator is the number of patients who were truly not monitored. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PATIENTS OBSERVED - Intervention (Single Arm) This arm refers to patients who were exposed to the intervention described below and who had their clinical data collected prospectively during the trial.
The intervention is a combined educational outreach and 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.
Audit and Feedback: The audit and feedback intervention includes providing each hospital's own continuous pulse oximetry use data back to them on a weekly basis for review and action.
Educational outreach: Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis. | 1,051 |
| STAFF SURVEYED - Intervention (Single Arm) This arm refers to staff who were exposed to the intervention described below and who responded to the surveys administered for the feasibility, acceptability, and appropriateness outcome measures.
The intervention is a combined educational outreach and 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.
Audit and Feedback: The audit and feedback intervention includes providing each hospital's own continuous pulse oximetry use data back to them on a weekly basis for review and action.
Educational outreach: Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis. | 847 |
| Total | 1,898 |
Baseline characteristics
| Characteristic | Total | STAFF SURVEYED - Intervention (Single Arm) | PATIENTS OBSERVED - Intervention (Single Arm) |
|---|---|---|---|
| Age, Customized Age category 12 months - 17 months old | 153 Participants | 0 Participants | 153 Participants |
| Age, Customized Age category 18 months - 23 months old | 80 Participants | 0 Participants | 80 Participants |
| Age, Customized Age category 6 months - 11 months old | 284 Participants | 0 Participants | 284 Participants |
| Age, Customized Age category 8 weeks - 5 months old | 534 Participants | 0 Participants | 534 Participants |
| Age, Customized Age category Unknown age | 847 Participants | 847 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 382 Participants | 77 Participants | 305 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1312 Participants | 703 Participants | 609 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 204 Participants | 67 Participants | 137 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 199 Participants | 161 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 262 Participants | 26 Participants | 236 Participants |
| Race (NIH/OMB) More than one race | 45 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 14 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 504 Participants | 102 Participants | 402 Participants |
| Race (NIH/OMB) White | 869 Participants | 515 Participants | 354 Participants |
| Sex: Female, Male Female | 1133 Participants | 695 Participants | 438 Participants |
| Sex: Female, Male Male | 734 Participants | 123 Participants | 611 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,051 | 0 / 0 |
| other Total, other adverse events | 5 / 1,051 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1,051 | 0 / 0 |
Outcome results
Primary
Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
The participant rates the acceptability of the intervention based on this statement: I like the data feedback. Data was only collected from the STAFF SURVEYED - Intervention (Single Arm) Arm/Group for this Outcome Measure.
Time frame: 1 month after intervention
Population: 659/847 survey respondents answered this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM) | Completely disagree | 1 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM) | Completely agree | 305 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM) | Agree | 305 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM) | Neither agree nor disagree | 46 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM) | Disagree | 2 Participants |
Primary
Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
The participant rates the appropriateness of the intervention based on this statement: Data feedback about our use of continuous pulse oximetry in bronchiolitis seems like a good match for our non-ICU floors that care for bronchiolitis. Data was only collected from the STAFF SURVEYED - Intervention (Single Arm) Arm/Group for this Outcome Measure.
Time frame: 1 month after intervention
Population: 659/847 survey respondents answered this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM) | Completely agree | 280 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM) | Agree | 337 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM) | Neither agree nor disagree | 37 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM) | Disagree | 4 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM) | Completely disagree | 1 Participants |
Primary
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
The participant rates the feasibility of the intervention based on this statement: Data feedback about our use of continuous pulse oximetry in patients with bronchiolitis is easy to implement. Data was only collected from the STAFF SURVEYED - Intervention (Single Arm) Arm/Group for this Outcome Measure.
Time frame: 1 month after intervention
Population: 659 of the 847 overall respondents to the survey responded to this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM) | Completely agree | 222 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM) | Agree | 331 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM) | Neither agree nor disagree | 86 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM) | Disagree | 20 Participants |
| STAFF SURVEYED - Intervention (Single Arm) | Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM) | Completely diagree | 0 Participants |
Secondary
Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen
Continuous pulse oximetry use rates in children with bronchiolitis who are not requiring supplemental oxygen administration. This is calculated as the number of patients continuously monitored when not receiving supplemental oxygen divided by the total number of patients observed when not receiving supplemental oxygen.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAFF SURVEYED - Intervention (Single Arm) | Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen | 236 Participants |
Secondary
Negative Predictive Value of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis.
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients who were not observed to be continuously monitored at the bedside. The denominator is the number of patients who had EHR data suggesting that they were NOT continuously monitored.
Time frame: 4 months
Population: The denominator for negative predictive value calculation was the total number of patients who had EHR data suggesting that they were NOT continuously monitored, which was 564 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAFF SURVEYED - Intervention (Single Arm) | Negative Predictive Value of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. | 554 Participants |
Secondary
Positive Predictive Value (PPV) of the Presence of Electronic Health Record Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis.
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients who were continuously monitored at the bedside. The denominator is the number of patients who had EHR data suggesting that they were continuously monitored.
Time frame: 4 months
Population: The denominator for PPV calculation was the total number of patients who had EHR data suggesting that they were continuously monitored, which was 104 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAFF SURVEYED - Intervention (Single Arm) | Positive Predictive Value (PPV) of the Presence of Electronic Health Record Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. | 92 Participants |
Secondary
Sensitivity of the Presence of Electronic Health Record (EHR) Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. Sensitivity is Also Referred to as the True Positive Rate.
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients with EHR data from the medical monitoring device. The denominator is the number of patients who were truly monitored.
Time frame: 4 months
Population: The denominator of sensitivity is those patients who were truly monitored, which for this analysis was 102.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAFF SURVEYED - Intervention (Single Arm) | Sensitivity of the Presence of Electronic Health Record (EHR) Data From the Medical Monitoring Device for Actual Monitoring at the Bedside in Bronchiolitis. Sensitivity is Also Referred to as the True Positive Rate. | 92 Participants |
Secondary
Specificity of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. Specificity is Also Referred to as the True Negative Rate.
This measure will be calculated using chart review (to determine presence of electronic health record data from the medical monitoring device) and direct observation (to determine actual monitoring at the bedside). This outcome compared EHR data at minute 0 (same minute as direct observation occurred). The numerator is the number of patients with absence of EHR data from the medical monitoring device. The denominator is the number of patients who were truly not monitored.
Time frame: 4 months
Population: The denominator for specificity in this analysis was the number of patients who were truly not monitored, which was 566 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAFF SURVEYED - Intervention (Single Arm) | Specificity of the Absence of Electronic Health Record Data From the Medical Monitoring Device for Absence of Monitoring at the Bedside in Bronchiolitis. Specificity is Also Referred to as the True Negative Rate. | 554 Participants |