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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01HL143475-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Single Arm) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audit and Feedback | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month after intervention |
| 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. | 1 month after intervention |
| 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. | 1 month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Primary subjects - Hospital staff
Secondary subjects - Patients
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
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| Name | Affiliation | Role |
|---|---|---|
| Chris Bonafide, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37380625 | Derived | Faerber JA, Xiao R, Makeneni S, Schisterman EF, Brady PW, Schondelmeyer AC, Landrigan CP, Lucey K, Lee V, Gregory PF, Prasto J, Parthasarathy P, Greenfield M, Solomon C, Brent CR, Albanowski K, Beidas RS, Bonafide CP; Pediatric Research in Inpatient Settings (PRIS) Network. Sustainment of continuous pulse oximetry deimplementation: Analysis of Eliminating Monitor Overuse study data from six hospitals. J Hosp Med. 2023 Aug;18(8):724-729. doi: 10.1002/jhm.13154. Epub 2023 Jun 28. | |
| 34473258 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
For the patients observed, 1051 matches the participant flow. For the staff surveyed, we include 847 which is the total number of surveys received and analyzed for the outcome measures specified.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 659 of the 847 overall respondents to the survey responded to this question. | Posted | Count of Participants | Participants | 1 month after intervention |
|
During 4-month active deimplementation study period.
Systematic surveillance for PATIENTS:
We did not conduct systematic assessment for Serious Adverse Events, Other (Not Including Serious) Adverse Events, code blue events, rapid response events, or all-cause mortality in STAFF SURVEYED.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| a code blue or rapid response team activation - unmonitored patient | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | a code blue or rapid response team call to a study unit for bronchiolitis in an unmonitored patient, determined not to be related to trial interventions. This AE does NOT apply to STAFF surveyed. Zero STAFF are at risk of this event. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Bonafide, MD, MSCE | Children's Hospital of Philadelphia | 267-426-2901 | bonafide@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2020 | Jun 22, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 3, 2019 | Jun 22, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| Educational outreach | Behavioral | Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis. |
|
| 4 months |
| 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. | 4 months |
| 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. | 4 months |
| 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. | 4 months |
| 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. | 4 months |
| Schondelmeyer AC, Bettencourt AP, Xiao R, Beidas RS, Wolk CB, Landrigan CP, Brady PW, Brent CR, Parthasarathy P, Kern-Goldberger AS, Sergay N, Lee V, Russell CJ, Prasto J, Zaman S, McQuistion K, Lucey K, Solomon C, Garcia M, Bonafide CP; Pediatric Research in Inpatient Settings (PRIS) Network. Evaluation of an Educational Outreach and Audit and Feedback Program to Reduce Continuous Pulse Oximetry Use in Hospitalized Infants With Stable Bronchiolitis: A Nonrandomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2122826. doi: 10.1001/jamanetworkopen.2021.22826. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | 1049/1051 patients had sex data available in the medical record 818/847 survey respondents chose to disclose their sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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. | 659/847 survey respondents answered this question. | Posted | Count of Participants | Participants | 1 month after intervention |
|
|
|
| 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. | 659/847 survey respondents answered this question. | Posted | Count of Participants | Participants | 1 month after intervention |
|
|
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| 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. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| 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. | The denominator of sensitivity is those patients who were truly monitored, which for this analysis was 102. | Posted | Count of Participants | Participants | 4 months |
|
|
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| 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. | The denominator for specificity in this analysis was the number of patients who were truly not monitored, which was 566 patients. | Posted | Count of Participants | Participants | 4 months |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | 4 months |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| 0 |
| 1,051 |
| 0 |
| 1,051 |
| 5 |
| 1,051 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
|
| a code blue or rapid response team activation - monitored patient | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | a code blue or rapid response team call to a study unit for bronchiolitis in a monitored patient, determined not to be related to trial interventions. This AE does NOT apply to STAFF surveyed. Zero STAFF are at risk of this event. |
|
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Disagree |
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| Completely disagree |
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| Disagree |
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| Completely disagree |
|