Trial Outcomes & Findings for Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience (NCT NCT02320175)

NCT ID: NCT02320175

Last Updated: 2020-09-01

Results Overview

Our primary outcome was the rate of medical errors, including harmful errors (preventable adverse events) and non-harmful errors. Medical errors and adverse events were measured per 1000 patient-days before and after implementation of Patient and Family Centered I-PASS using an established systematic safety surveillance methodology. Trained research clinicians reviewed patient medical charts, hospital incident reports, family safety interviews, and staff reports for potential errors and adverse events. Trained physician-reviewers blinded to pre- vs. post-intervention status then categorized all suspected incidents as either adverse events, non-harmful errors, or exclusions. Adverse events that were clearly caused by a medical error were subsequently deemed preventable and all other cases were categorized as non-preventable.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6478 participants

Primary outcome timeframe

6 months (3 months pre, 3 months post) per site (7 sites total)

Results posted on

2020-09-01

Participant Flow

Participant milestones

Participant milestones
Measure
Pre-intervention
Before implementation of Patient and Family Centered I-PASS.
Post-intervention
After implementation of Patient and Family Centered I-PASS.
Overall Study
STARTED
3538
2940
Overall Study
COMPLETED
3538
2940
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pre-intervention
n=3055 Participants
Before implementation of Patient and Family Centered I-PASS.
Post-intervention
n=2813 Participants
After implementation of Patient and Family Centered I-PASS.
Total
n=5868 Participants
Total of all reporting groups
Age, Continuous
Patient
6.9 Years
STANDARD_DEVIATION 1.7 • n=1540 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
7.3 Years
STANDARD_DEVIATION 1.7 • n=1492 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
7.1 Years
STANDARD_DEVIATION 1.7 • n=3032 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
Age, Continuous
Parent
36.0 Years
STANDARD_DEVIATION 1.2 • n=872 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
36.3 Years
STANDARD_DEVIATION 1.2 • n=787 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
36.2 Years
STANDARD_DEVIATION 1.2 • n=1659 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
Age, Continuous
Physician
28.5 Years
STANDARD_DEVIATION 0.3 • n=334 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
28.2 Years
STANDARD_DEVIATION 0.3 • n=249 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
28.4 Years
STANDARD_DEVIATION 0.3 • n=583 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
Age, Continuous
Nurse
34.4 Years
STANDARD_DEVIATION 0.8 • n=177 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
35.5 Years
STANDARD_DEVIATION 0.9 • n=132 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
34.8 Years
STANDARD_DEVIATION 0.9 • n=309 Participants • A total of 132 subjects (4.3%) were missing data on age in pre-intervention and a total of 153 subjects (5.4%) were missing data on age in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 1.2%-11.6%.
Sex: Female, Male
Patient · Female
767 Participants
n=1542 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
765 Participants
n=1492 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
1532 Participants
n=3034 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
Sex: Female, Male
Patient · Male
775 Participants
n=1542 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
727 Participants
n=1492 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
1502 Participants
n=3034 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
Sex: Female, Male
Parent · Female
731 Participants
n=895 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
648 Participants
n=811 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
1379 Participants
n=1706 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
Sex: Female, Male
Parent · Male
164 Participants
n=895 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
163 Participants
n=811 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
327 Participants
n=1706 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
Sex: Female, Male
Physician · Female
236 Participants
n=342 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
167 Participants
n=249 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
403 Participants
n=591 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
Sex: Female, Male
Physician · Male
106 Participants
n=342 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
82 Participants
n=249 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
188 Participants
n=591 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
Sex: Female, Male
Nurse · Female
171 Participants
n=187 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
124 Participants
n=139 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
295 Participants
n=326 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
Sex: Female, Male
Nurse · Male
16 Participants
n=187 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
15 Participants
n=139 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
31 Participants
n=326 Participants • A total of 89 subjects (2.9%) were missing data on sex in pre-intervention and a total of 122 subjects (4.3%) were missing data on sex in post-intervention. Missing data by subject type (e.g., patient, physician) ranged from 0%-8.9%.
Race/Ethnicity, Customized
Patient · Hispanic or Latino
NA Participants
n=1360 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
NA Participants
n=1279 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
NA Participants
n=2639 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Patient · Asian
74 Participants
n=1360 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
58 Participants
n=1279 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
132 Participants
n=2639 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Patient · Black
266 Participants
n=1360 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
221 Participants
n=1279 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
487 Participants
n=2639 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Patient · White
708 Participants
n=1360 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
600 Participants
n=1279 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
1308 Participants
n=2639 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Patient · Other
312 Participants
n=1360 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
400 Participants
n=1279 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
712 Participants
n=2639 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Parent · Hispanic or Latino
193 Participants
n=899 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
181 Participants
n=807 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
374 Participants
n=1706 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Parent · Asian
62 Participants
n=899 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
50 Participants
n=807 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
112 Participants
n=1706 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Parent · Black
158 Participants
n=899 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
122 Participants
n=807 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
280 Participants
n=1706 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Parent · White
424 Participants
n=899 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
376 Participants
n=807 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
800 Participants
n=1706 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Parent · Other
62 Participants
n=899 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
78 Participants
n=807 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
140 Participants
n=1706 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Physician · Hispanic or Latino
23 Participants
n=331 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
9 Participants
n=248 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
32 Participants
n=579 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Physician · Asian
60 Participants
n=331 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
39 Participants
n=248 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
99 Participants
n=579 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Physician · Black
11 Participants
n=331 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
11 Participants
n=248 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
22 Participants
n=579 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Physician · White
226 Participants
n=331 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
176 Participants
n=248 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
402 Participants
n=579 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Physician · Other
11 Participants
n=331 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
13 Participants
n=248 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
24 Participants
n=579 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Nurse · Hispanic or Latino
13 Participants
n=184 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
5 Participants
n=133 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
18 Participants
n=317 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Nurse · Asian
26 Participants
n=184 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
23 Participants
n=133 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
49 Participants
n=317 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Nurse · Black
5 Participants
n=184 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
7 Participants
n=133 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
12 Participants
n=317 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Nurse · White
129 Participants
n=184 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
96 Participants
n=133 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
225 Participants
n=317 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Race/Ethnicity, Customized
Nurse · Other
11 Participants
n=184 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
2 Participants
n=133 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
13 Participants
n=317 Participants • Patient race derived from hospital administrative data. Parent, Physician, and Nurse race/ethnicity derived from self-reported survey data. For adult subjects, categories other than 'Hispanic or Latino' are non-Hispanic (e.g., Black = Black and Non-Hispanic). Missing data on race/ethnicity ranged from 1.6%-9.3%, except for patients (15.0% overall).
Region of Enrollment
United States
2781 Participants
n=3055 Participants
2407 Participants
n=2813 Participants
5188 Participants
n=5868 Participants
Region of Enrollment
Canada
274 Participants
n=3055 Participants
406 Participants
n=2813 Participants
680 Participants
n=5868 Participants

PRIMARY outcome

Timeframe: 6 months (3 months pre, 3 months post) per site (7 sites total)

Population: Patients admitted to study units.

Our primary outcome was the rate of medical errors, including harmful errors (preventable adverse events) and non-harmful errors. Medical errors and adverse events were measured per 1000 patient-days before and after implementation of Patient and Family Centered I-PASS using an established systematic safety surveillance methodology. Trained research clinicians reviewed patient medical charts, hospital incident reports, family safety interviews, and staff reports for potential errors and adverse events. Trained physician-reviewers blinded to pre- vs. post-intervention status then categorized all suspected incidents as either adverse events, non-harmful errors, or exclusions. Adverse events that were clearly caused by a medical error were subsequently deemed preventable and all other cases were categorized as non-preventable.

Outcome measures

Outcome measures
Measure
Pre-intervention
n=1574 Participants
Before implementation of Patient and Family Centered I-PASS.
Post-intervention
n=1532 Participants
After implementation of Patient and Family Centered I-PASS.
Rate of Medical Errors
Overall medical errors
41.2 Medical errors per 1000 patient-days
Interval 31.2 to 54.5
35.8 Medical errors per 1000 patient-days
Interval 26.9 to 47.7
Rate of Medical Errors
Non-harmful errors
20.0 Medical errors per 1000 patient-days
Interval 13.2 to 30.2
22.0 Medical errors per 1000 patient-days
Interval 15.1 to 32.1
Rate of Medical Errors
Harmful errors (i.e., preventable adverse events)
20.7 Medical errors per 1000 patient-days
Interval 15.3 to 28.1
12.9 Medical errors per 1000 patient-days
Interval 8.9 to 18.6

SECONDARY outcome

Timeframe: 6 months (3 months pre, 3 months post) per site (7 sites total)

Population: Patients admitted to study units.

An additional measure of interest was the rate of non-preventable adverse events. Medical errors and adverse events were measured per 1000 patient-days before and after implementation of Patient and Family Centered I-PASS using an established systematic safety surveillance methodology. Trained research clinicians reviewed patient medical charts, hospital incident reports, family safety interviews, and staff reports for potential errors and adverse events. Trained physician-reviewers blinded to pre- vs. post-intervention status then categorized all suspected incidents as either adverse events, non-harmful errors, or exclusions. Adverse events that were clearly caused by a medical error were subsequently deemed preventable and all other cases were categorized as non-preventable.

Outcome measures

Outcome measures
Measure
Pre-intervention
n=1574 Participants
Before implementation of Patient and Family Centered I-PASS.
Post-intervention
n=1532 Participants
After implementation of Patient and Family Centered I-PASS.
Rate of Non-Preventable Adverse Events
12.6 Non-preventable AE per 1000 patient-days
Interval 8.9 to 17.9
5.2 Non-preventable AE per 1000 patient-days
Interval 3.1 to 8.8

SECONDARY outcome

Timeframe: 6 months (3 months pre, 3 months post) per site (7 sites total)

Population: English-, Arabic-, Chinese-, Russian-, and Spanish-speaking parents/caregivers of \<18-year-old patients on the study units were eligible to participate. Of these, 6-8 per week per site were randomly selected and surveyed 24 hours prior to discharge about their experiences with various aspects of communication.

Family experience before and after implementation. Experience was measured using a 10-15 minute survey verbally administered prior to discharge. Parents were asked to rate various aspects of their experience with care. This included experience during and after rounds, experience with written communication, experience with physicians and nurses, and overall hospital experience. The survey was developed, cognitively tested, and piloted at a non-intervention site (Boston Children's Hospital) and translated into Arabic, Chinese, Russian, and Spanish. We compared percent top-box experience ratings pre- vs. post-intervention using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response for the given survey item (e.g., 5=Extremely; 5=Excellent). Missing data was accounted for through use of multiple imputations appropriate for missing data in clustered studies.

Outcome measures

Outcome measures
Measure
Pre-intervention
n=651 Participants
Before implementation of Patient and Family Centered I-PASS.
Post-intervention
n=573 Participants
After implementation of Patient and Family Centered I-PASS.
Family Experience With Care
Understood what was said on rounds
53.92 Top-box percentage
Interval 44.6 to 62.98
62.84 Top-box percentage
Interval 53.71 to 71.13
Family Experience With Care
Explanation of changes to look out for
56.37 Top-box percentage
Interval 47.5 to 64.85
58.71 Top-box percentage
Interval 50.08 to 66.83
Family Experience With Care
Satisfied with opportunity to ask questions on FCR
68.59 Top-box percentage
Interval 57.73 to 77.73
72.11 Top-box percentage
Interval 61.61 to 80.64
Family Experience With Care
Medical team listened to family concerns
66.81 Top-box percentage
Interval 56.98 to 75.36
71.64 Top-box percentage
Interval 62.22 to 79.48
Family Experience With Care
Family was included in decision making
56.11 Top-box percentage
Interval 46.24 to 65.52
58.72 Top-box percentage
Interval 49.05 to 67.77
Family Experience With Care
Family felt important in their role on rounds
49.66 Top-box percentage
Interval 41.76 to 57.57
56.57 Top-box percentage
Interval 48.83 to 63.99
Family Experience With Care
Family respectfully spoken to on rounds
77.70 Top-box percentage
Interval 70.57 to 83.51
78.97 Top-box percentage
Interval 72.22 to 84.44
Family Experience With Care
Quality of communication during morning rounds
61.15 Top-box percentage
Interval 51.93 to 69.62
66.19 Top-box percentage
Interval 57.32 to 74.06
Family Experience With Care
Satisfaction with frequency of updates on child
48.87 Top-box percentage
Interval 41.17 to 56.63
53.83 Top-box percentage
Interval 46.27 to 61.21
Family Experience With Care
Quality of update explanations
57.89 Top-box percentage
Interval 47.53 to 67.6
59.64 Top-box percentage
Interval 49.46 to 69.06
Family Experience With Care
Inclusion in decision making later in day
52.55 Top-box percentage
Interval 44.49 to 60.48
55.05 Top-box percentage
Interval 47.22 to 62.65
Family Experience With Care
Frequency of written updates
15.6 Top-box percentage
Interval 8.9 to 25.93
33.7 Top-box percentage
Interval 23.88 to 45.17
Family Experience With Care
Understood written updates provided
46.5 Top-box percentage
Interval 34.17 to 59.27
57.86 Top-box percentage
Interval 46.38 to 68.55
Family Experience With Care
Usefulness of written updates
47.32 Top-box percentage
Interval 36.58 to 58.3
49.7 Top-box percentage
Interval 40.54 to 58.59
Family Experience With Care
Shared understanding with doctors of medical plan
53.95 Top-box percentage
Interval 44.56 to 63.07
59.16 Top-box percentage
Interval 49.91 to 67.81
Family Experience With Care
Doctors addressed family concerns
61.8 Top-box percentage
Interval 52.51 to 70.3
65.85 Top-box percentage
Interval 56.83 to 73.85
Family Experience With Care
MDs made family feel important part of care team
57.7 Top-box percentage
Interval 45.91 to 68.67
60.88 Top-box percentage
Interval 49.2 to 71.42
Family Experience With Care
Shared understanding with nurses of medical plan
55.29 Top-box percentage
Interval 47.98 to 62.38
65.41 Top-box percentage
Interval 58.45 to 71.76
Family Experience With Care
Nurses addressed family concerns
61.21 Top-box percentage
Interval 53.42 to 68.46
70.22 Top-box percentage
Interval 62.91 to 76.63
Family Experience With Care
RNs made family feel important part of care team
63.19 Top-box percentage
Interval 53.49 to 71.93
70.74 Top-box percentage
Interval 61.45 to 78.56
Family Experience With Care
Teamwork among nurses and doctors
58.72 Top-box percentage
Interval 51.9 to 65.22
61.43 Top-box percentage
Interval 54.92 to 67.56
Family Experience With Care
Understood reason for child's hospital stay
71.27 Top-box percentage
Interval 60.88 to 79.82
71.44 Top-box percentage
Interval 61.26 to 79.83
Family Experience With Care
Understood requirements for child's discharge
62.09 Top-box percentage
Interval 53.34 to 70.13
65.69 Top-box percentage
Interval 57.23 to 73.26
Family Experience With Care
Overall quality of child's care
69.19 Top-box percentage
Interval 60.27 to 76.87
72.79 Top-box percentage
Interval 64.27 to 79.92
Family Experience With Care
Quality of communication during hospital stay
54.51 Top-box percentage
Interval 45.85 to 62.9
58.7 Top-box percentage
Interval 50.25 to 66.66

SECONDARY outcome

Timeframe: 6 months (3 months pre, 3 months post) per site (7 sites total)

Population: Observations and audio-recordings of rounds were conducted at each site for one hour at a time on a randomly selected day each week. A median of 3 (IQR 2,5) patients were observed and recorded per session. Of these, 2 patients per week per site were randomly selected for post-hoc analysis.

Changes in quality of communication during rounds processes were assessed before and after implementation based on: (a) real-time structured direct observations of rounds (n=653) and (b) post-hoc analyses of audio-recordings of a subset of rounds observations (n=164). Research assistants conducted 1-hour weekly in-person rounds observation sessions per site, simultaneously completing a real-time assessment tool for each patient and audio-recording rounds. Site research clinicians blinded to pre- vs. post-intervention status conducted post-hoc analyses of a subset of rounds audio recordings using a structured assessment tool to measure rounding team adherence. Percent top-box ratings pre- vs. post-intervention were compared using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response (e.g., 5=Excellent). Missing data were accounted for through use of multiple imputations.

Outcome measures

Outcome measures
Measure
Pre-intervention
n=305 Participants
Before implementation of Patient and Family Centered I-PASS.
Post-intervention
n=348 Participants
After implementation of Patient and Family Centered I-PASS.
Quality of Communication on Rounds
Family-centered rounds occurred for this patient
72.2 Top-box percentage
Interval 53.5 to 85.4
82.8 Top-box percentage
Interval 64.9 to 92.6
Quality of Communication on Rounds
Nurse engagement
20.4 Top-box percentage
Interval 7.04 to 46.6
35.5 Top-box percentage
Interval 17.0 to 59.6
Quality of Communication on Rounds
Family engagement
55.6 Top-box percentage
Interval 32.9 to 76.2
66.7 Top-box percentage
Interval 43.0 to 84.1
Quality of Communication on Rounds
Written summary provided to family
17.8 Top-box percentage
Interval 4.7 to 48.6
53.6 Top-box percentage
Interval 27.4 to 78.0
Quality of Communication on Rounds
Family expressed concerns at start of rounds
18.2 Top-box percentage
Interval 5.7 to 45.3
37.7 Top-box percentage
Interval 17.6 to 63.3
Quality of Communication on Rounds
Family reporting of illness severity
28.8 Top-box percentage
Interval 13.1 to 52.1
43.5 Top-box percentage
Interval 23.8 to 65.4
Quality of Communication on Rounds
Family synthesis (i.e., reading back) of key items
4.7 Top-box percentage
Interval 0.7 to 25.2
26.5 Top-box percentage
Interval 26.5 to 12.7
Quality of Communication on Rounds
Effective use of plain language by providers
28.8 Top-box percentage
Interval 9.2 to 61.5
34.7 Top-box percentage
Interval 12.6 to 66.3

SECONDARY outcome

Timeframe: 6 months (3 months pre, 3 months post) per site (7 sites total)

Population: These data were collected but final analyses are still pending. The shared understanding measure was a novel secondary measure in this study, and the analysis was more complex than initially anticipated. Therefore, the number of participants analyzed is currently 0.

Shared understanding between parent, resident, and nurse was measured before and after implementation of the Patient and Family Centered I-PASS intervention.

Outcome measures

Outcome data not reported

Adverse Events

Pre-intervention

Serious events: 165 serious events
Other events: 0 other events
Deaths: 0 deaths

Post-intervention

Serious events: 95 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Pre-intervention
n=1574 participants at risk
Before implementation of Patient and Family Centered I-PASS.
Post-intervention
n=1532 participants at risk
After implementation of Patient and Family Centered I-PASS.
General disorders
Serious Adverse Events
10.5%
165/1574 • Number of events 192 • Time on study unit, from admission to discharge, on average approximately 5 days.
Please see 'Rate of Medical Errors' and 'Rate of Non-Preventable Adverse Events' for detailed results on rates of adverse events pre- and post-intervention.
6.2%
95/1532 • Number of events 112 • Time on study unit, from admission to discharge, on average approximately 5 days.
Please see 'Rate of Medical Errors' and 'Rate of Non-Preventable Adverse Events' for detailed results on rates of adverse events pre- and post-intervention.

Other adverse events

Other adverse events
Measure
Pre-intervention
n=1574 participants at risk
Before implementation of Patient and Family Centered I-PASS.
Post-intervention
n=1532 participants at risk
After implementation of Patient and Family Centered I-PASS.
General disorders
Other Adverse Events
0.00%
0/1574 • Time on study unit, from admission to discharge, on average approximately 5 days.
Please see 'Rate of Medical Errors' and 'Rate of Non-Preventable Adverse Events' for detailed results on rates of adverse events pre- and post-intervention.
0.00%
0/1532 • Time on study unit, from admission to discharge, on average approximately 5 days.
Please see 'Rate of Medical Errors' and 'Rate of Non-Preventable Adverse Events' for detailed results on rates of adverse events pre- and post-intervention.

Additional Information

Isabella Liss, Patient and Family Centered I-PASS SCORE Study Coordinator

Boston Children's Hospital

Phone: 857-218-3229

Results disclosure agreements

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