Trial Outcomes & Findings for Aligning Pulse Oximetry With Guidelines (NCT NCT04178941)

NCT ID: NCT04178941

Last Updated: 2023-09-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1898 participants

Primary outcome timeframe

1 month after intervention

Results posted on

2023-09-08

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
1051
847
Overall Study
COMPLETED
1051
847
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1049/1051 patients had sex data available in the medical record 818/847 survey respondents chose to disclose their sex

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PATIENTS OBSERVED - Intervention (Single Arm)
n=1051 Participants
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.
STAFF SURVEYED - Intervention (Single Arm)
n=847 Participants
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.
Total
n=1898 Participants
Total of all reporting groups
Age, Customized
Age category · 8 weeks - 5 months old
534 Participants
n=1051 Participants
0 Participants
n=847 Participants
534 Participants
n=1898 Participants
Age, Customized
Age category · 6 months - 11 months old
284 Participants
n=1051 Participants
0 Participants
n=847 Participants
284 Participants
n=1898 Participants
Age, Customized
Age category · 12 months - 17 months old
153 Participants
n=1051 Participants
0 Participants
n=847 Participants
153 Participants
n=1898 Participants
Age, Customized
Age category · 18 months - 23 months old
80 Participants
n=1051 Participants
0 Participants
n=847 Participants
80 Participants
n=1898 Participants
Age, Customized
Age category · Unknown age
0 Participants
n=1051 Participants
847 Participants
n=847 Participants
847 Participants
n=1898 Participants
Sex: Female, Male
Female
438 Participants
n=1049 Participants • 1049/1051 patients had sex data available in the medical record 818/847 survey respondents chose to disclose their sex
695 Participants
n=818 Participants • 1049/1051 patients had sex data available in the medical record 818/847 survey respondents chose to disclose their sex
1133 Participants
n=1867 Participants • 1049/1051 patients had sex data available in the medical record 818/847 survey respondents chose to disclose their sex
Sex: Female, Male
Male
611 Participants
n=1049 Participants • 1049/1051 patients had sex data available in the medical record 818/847 survey respondents chose to disclose their sex
123 Participants
n=818 Participants • 1049/1051 patients had sex data available in the medical record 818/847 survey respondents chose to disclose their sex
734 Participants
n=1867 Participants • 1049/1051 patients had sex data available in the medical record 818/847 survey respondents chose to disclose their sex
Ethnicity (NIH/OMB)
Hispanic or Latino
305 Participants
n=1051 Participants
77 Participants
n=847 Participants
382 Participants
n=1898 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
609 Participants
n=1051 Participants
703 Participants
n=847 Participants
1312 Participants
n=1898 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
137 Participants
n=1051 Participants
67 Participants
n=847 Participants
204 Participants
n=1898 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=1051 Participants
4 Participants
n=847 Participants
5 Participants
n=1898 Participants
Race (NIH/OMB)
Asian
38 Participants
n=1051 Participants
161 Participants
n=847 Participants
199 Participants
n=1898 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
5 Participants
n=1051 Participants
9 Participants
n=847 Participants
14 Participants
n=1898 Participants
Race (NIH/OMB)
Black or African American
236 Participants
n=1051 Participants
26 Participants
n=847 Participants
262 Participants
n=1898 Participants
Race (NIH/OMB)
White
354 Participants
n=1051 Participants
515 Participants
n=847 Participants
869 Participants
n=1898 Participants
Race (NIH/OMB)
More than one race
15 Participants
n=1051 Participants
30 Participants
n=847 Participants
45 Participants
n=1898 Participants
Race (NIH/OMB)
Unknown or Not Reported
402 Participants
n=1051 Participants
102 Participants
n=847 Participants
504 Participants
n=1898 Participants

PRIMARY outcome

Timeframe: 1 month after intervention

Population: 659 of the 847 overall respondents to the survey responded to this question.

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.

Outcome measures

Outcome measures
Measure
STAFF SURVEYED - Intervention (Single Arm)
n=659 Participants
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.
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
Completely agree
222 Participants
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
Agree
331 Participants
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
Neither agree nor disagree
86 Participants
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
Disagree
20 Participants
Audit & Feedback Feasibility Using Adapted Item From Feasibility of Intervention Measure (FIM)
Completely diagree
0 Participants

PRIMARY outcome

Timeframe: 1 month after intervention

Population: 659/847 survey respondents answered this question.

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.

Outcome measures

Outcome measures
Measure
STAFF SURVEYED - Intervention (Single Arm)
n=659 Participants
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.
Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
Completely agree
305 Participants
Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
Agree
305 Participants
Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
Neither agree nor disagree
46 Participants
Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
Disagree
2 Participants
Audit & Feedback Acceptability Using Adapted Item From Acceptability of Intervention Measure (FIM)
Completely disagree
1 Participants

PRIMARY outcome

Timeframe: 1 month after intervention

Population: 659/847 survey respondents answered this question.

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.

Outcome measures

Outcome measures
Measure
STAFF SURVEYED - Intervention (Single Arm)
n=659 Participants
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.
Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
Completely agree
280 Participants
Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
Agree
337 Participants
Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
Neither agree nor disagree
37 Participants
Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
Disagree
4 Participants
Audit & Feedback Appropriateness Using Adapted Item From Intervention Appropriateness Measure (IAM)
Completely disagree
1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
STAFF SURVEYED - Intervention (Single Arm)
n=1051 Participants
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.
Hospital-level Percentage of Patients Continuously Monitored When Not Receiving Supplemental Oxygen
236 Participants

SECONDARY outcome

Timeframe: 4 months

Population: The denominator of sensitivity is those patients who were truly monitored, which for this analysis was 102.

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.

Outcome measures

Outcome measures
Measure
STAFF SURVEYED - Intervention (Single Arm)
n=102 Participants
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.
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 outcome

Timeframe: 4 months

Population: The denominator for specificity in this analysis was the number of patients who were truly not monitored, which was 566 patients.

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.

Outcome measures

Outcome measures
Measure
STAFF SURVEYED - Intervention (Single Arm)
n=566 Participants
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.
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
STAFF SURVEYED - Intervention (Single Arm)
n=104 Participants
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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
STAFF SURVEYED - Intervention (Single Arm)
n=564 Participants
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.
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

Adverse Events

PATIENTS OBSERVED - Intervention (Single Arm)

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

STAFF SURVEYED - Intervention (Single Arm)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
PATIENTS OBSERVED - Intervention (Single Arm)
n=1051 participants at risk
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.
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.
Respiratory, thoracic and mediastinal disorders
a code blue or rapid response team activation - unmonitored patient
0.38%
4/1051 • Number of events 4 • During 4-month active deimplementation study period.
Systematic surveillance for PATIENTS: * Monitor for code blue /rapid response team activations in unmonitored bronchiolitis patients * Investigators determine whether the Adverse Event meets Serious Adverse Event (SAE)/unanticipated problem (UAP) criteria 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.
0/0 • During 4-month active deimplementation study period.
Systematic surveillance for PATIENTS: * Monitor for code blue /rapid response team activations in unmonitored bronchiolitis patients * Investigators determine whether the Adverse Event meets Serious Adverse Event (SAE)/unanticipated problem (UAP) criteria 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.
Respiratory, thoracic and mediastinal disorders
a code blue or rapid response team activation - monitored patient
0.10%
1/1051 • Number of events 1 • During 4-month active deimplementation study period.
Systematic surveillance for PATIENTS: * Monitor for code blue /rapid response team activations in unmonitored bronchiolitis patients * Investigators determine whether the Adverse Event meets Serious Adverse Event (SAE)/unanticipated problem (UAP) criteria 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.
0/0 • During 4-month active deimplementation study period.
Systematic surveillance for PATIENTS: * Monitor for code blue /rapid response team activations in unmonitored bronchiolitis patients * Investigators determine whether the Adverse Event meets Serious Adverse Event (SAE)/unanticipated problem (UAP) criteria 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.

Additional Information

Chris Bonafide, MD, MSCE

Children's Hospital of Philadelphia

Phone: 267-426-2901

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place