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Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience

Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02320175
Enrollment
6478
Registered
2014-12-19
Start date
2014-12-15
Completion date
2017-01-03
Last updated
2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication

Keywords

Family Centered Rounds, Patient Safety, Errors, Adverse Events, Patient Experience, Family Engagement, Interprofessional Communication

Brief summary

Patient and Family-Centered I-PASS is a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. This project tests the hypothesis that rates of medical errors and adverse events (primary outcome), hospital experience, communication, and shared understanding will improve following implementation of Patient and Family Centered I-PASS, as compared with current practice.

Detailed description

We conducted an intervention study on pediatric inpatient units in seven North American hospitals. Each site was assigned to one of 3 staggered waves of implementation and data collection. The Patient and Family Centered I-PASS intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation. We measured errors and adverse events (AEs) via an established systematic surveillance methodology, family experience via pre-discharge surveys, and communication processes via direct observations.

Interventions

BEHAVIORALPatient and Family Centered I-PASS

Patient and Family-Centered I-PASS is a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. The intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* All patients admitted to the pediatric inpatient study units of participating hospitals * Parents/caregivers of patients less than 18 years of age who speak English, Chinese, Arabic, Russian, or Spanish * Nurses working on these units * Residents working on these units * Medical students working on these units

Exclusion criteria

* Parents/caregivers who do not speak a study language (decided based on the 5 most commonly spoken languages across study sites; study languages include: English, Chinese, Arabic, Russian, Spanish) * Parents/caregivers of patients greater than 18 years of age

Design outcomes

Primary

MeasureTime frameDescription
Rate of Medical Errors6 months (3 months pre, 3 months post) per site (7 sites total)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.

Secondary

MeasureTime frameDescription
Rate of Non-Preventable Adverse Events6 months (3 months pre, 3 months post) per site (7 sites total)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.
Family Experience With Care6 months (3 months pre, 3 months post) per site (7 sites total)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.
Quality of Communication on Rounds6 months (3 months pre, 3 months post) per site (7 sites total)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.
Shared Understanding Between Parent, Resident, and Nurse6 months (3 months pre, 3 months post) per site (7 sites total)Shared understanding between parent, resident, and nurse was measured before and after implementation of the Patient and Family Centered I-PASS intervention.

Countries

Canada, United States

Participant flow

Participants by arm

ArmCount
Pre-intervention
Before implementation of Patient and Family Centered I-PASS.
3,055
Post-intervention
After implementation of Patient and Family Centered I-PASS.
2,813
Total5,868

Baseline characteristics

CharacteristicPre-interventionTotalPost-intervention
Age, Continuous
Nurse
34.4 Years
STANDARD_DEVIATION 0.8
34.8 Years
STANDARD_DEVIATION 0.9
35.5 Years
STANDARD_DEVIATION 0.9
Age, Continuous
Parent
36.0 Years
STANDARD_DEVIATION 1.2
36.2 Years
STANDARD_DEVIATION 1.2
36.3 Years
STANDARD_DEVIATION 1.2
Age, Continuous
Patient
6.9 Years
STANDARD_DEVIATION 1.7
7.1 Years
STANDARD_DEVIATION 1.7
7.3 Years
STANDARD_DEVIATION 1.7
Age, Continuous
Physician
28.5 Years
STANDARD_DEVIATION 0.3
28.4 Years
STANDARD_DEVIATION 0.3
28.2 Years
STANDARD_DEVIATION 0.3
Race/Ethnicity, Customized
Nurse
Asian
26 Participants49 Participants23 Participants
Race/Ethnicity, Customized
Nurse
Black
5 Participants12 Participants7 Participants
Race/Ethnicity, Customized
Nurse
Hispanic or Latino
13 Participants18 Participants5 Participants
Race/Ethnicity, Customized
Nurse
Other
11 Participants13 Participants2 Participants
Race/Ethnicity, Customized
Nurse
White
129 Participants225 Participants96 Participants
Race/Ethnicity, Customized
Parent
Asian
62 Participants112 Participants50 Participants
Race/Ethnicity, Customized
Parent
Black
158 Participants280 Participants122 Participants
Race/Ethnicity, Customized
Parent
Hispanic or Latino
193 Participants374 Participants181 Participants
Race/Ethnicity, Customized
Parent
Other
62 Participants140 Participants78 Participants
Race/Ethnicity, Customized
Parent
White
424 Participants800 Participants376 Participants
Race/Ethnicity, Customized
Patient
Asian
74 Participants132 Participants58 Participants
Race/Ethnicity, Customized
Patient
Black
266 Participants487 Participants221 Participants
Race/Ethnicity, Customized
Patient
Hispanic or Latino
NA ParticipantsNA ParticipantsNA Participants
Race/Ethnicity, Customized
Patient
Other
312 Participants712 Participants400 Participants
Race/Ethnicity, Customized
Patient
White
708 Participants1308 Participants600 Participants
Race/Ethnicity, Customized
Physician
Asian
60 Participants99 Participants39 Participants
Race/Ethnicity, Customized
Physician
Black
11 Participants22 Participants11 Participants
Race/Ethnicity, Customized
Physician
Hispanic or Latino
23 Participants32 Participants9 Participants
Race/Ethnicity, Customized
Physician
Other
11 Participants24 Participants13 Participants
Race/Ethnicity, Customized
Physician
White
226 Participants402 Participants176 Participants
Region of Enrollment
Canada
274 Participants680 Participants406 Participants
Region of Enrollment
United States
2781 Participants5188 Participants2407 Participants
Sex: Female, Male
Nurse
Female
171 Participants295 Participants124 Participants
Sex: Female, Male
Nurse
Male
16 Participants31 Participants15 Participants
Sex: Female, Male
Parent
Female
731 Participants1379 Participants648 Participants
Sex: Female, Male
Parent
Male
164 Participants327 Participants163 Participants
Sex: Female, Male
Patient
Female
767 Participants1532 Participants765 Participants
Sex: Female, Male
Patient
Male
775 Participants1502 Participants727 Participants
Sex: Female, Male
Physician
Female
236 Participants403 Participants167 Participants
Sex: Female, Male
Physician
Male
106 Participants188 Participants82 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,5740 / 1,532
other
Total, other adverse events
0 / 1,5740 / 1,532
serious
Total, serious adverse events
165 / 1,57495 / 1,532

Outcome results

Primary

Rate of Medical Errors

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.

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

Population: Patients admitted to study units.

ArmMeasureGroupValue (NUMBER)
Pre-interventionRate of Medical ErrorsOverall medical errors41.2 Medical errors per 1000 patient-days
Pre-interventionRate of Medical ErrorsNon-harmful errors20.0 Medical errors per 1000 patient-days
Pre-interventionRate of Medical ErrorsHarmful errors (i.e., preventable adverse events)20.7 Medical errors per 1000 patient-days
Post-interventionRate of Medical ErrorsOverall medical errors35.8 Medical errors per 1000 patient-days
Post-interventionRate of Medical ErrorsNon-harmful errors22.0 Medical errors per 1000 patient-days
Post-interventionRate of Medical ErrorsHarmful errors (i.e., preventable adverse events)12.9 Medical errors per 1000 patient-days
Secondary

Family Experience With Care

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
Pre-interventionFamily Experience With CareSatisfied with opportunity to ask questions on FCR68.59 Top-box percentage
Pre-interventionFamily Experience With CareUsefulness of written updates47.32 Top-box percentage
Pre-interventionFamily Experience With CareQuality of communication during morning rounds61.15 Top-box percentage
Pre-interventionFamily Experience With CareShared understanding with doctors of medical plan53.95 Top-box percentage
Pre-interventionFamily Experience With CareFamily was included in decision making56.11 Top-box percentage
Pre-interventionFamily Experience With CareDoctors addressed family concerns61.8 Top-box percentage
Pre-interventionFamily Experience With CareSatisfaction with frequency of updates on child48.87 Top-box percentage
Pre-interventionFamily Experience With CareMDs made family feel important part of care team57.7 Top-box percentage
Pre-interventionFamily Experience With CareExplanation of changes to look out for56.37 Top-box percentage
Pre-interventionFamily Experience With CareShared understanding with nurses of medical plan55.29 Top-box percentage
Pre-interventionFamily Experience With CareQuality of update explanations57.89 Top-box percentage
Pre-interventionFamily Experience With CareNurses addressed family concerns61.21 Top-box percentage
Pre-interventionFamily Experience With CareFamily felt important in their role on rounds49.66 Top-box percentage
Pre-interventionFamily Experience With CareRNs made family feel important part of care team63.19 Top-box percentage
Pre-interventionFamily Experience With CareInclusion in decision making later in day52.55 Top-box percentage
Pre-interventionFamily Experience With CareTeamwork among nurses and doctors58.72 Top-box percentage
Pre-interventionFamily Experience With CareMedical team listened to family concerns66.81 Top-box percentage
Pre-interventionFamily Experience With CareUnderstood reason for child's hospital stay71.27 Top-box percentage
Pre-interventionFamily Experience With CareFrequency of written updates15.6 Top-box percentage
Pre-interventionFamily Experience With CareUnderstood requirements for child's discharge62.09 Top-box percentage
Pre-interventionFamily Experience With CareFamily respectfully spoken to on rounds77.70 Top-box percentage
Pre-interventionFamily Experience With CareOverall quality of child's care69.19 Top-box percentage
Pre-interventionFamily Experience With CareUnderstood written updates provided46.5 Top-box percentage
Pre-interventionFamily Experience With CareQuality of communication during hospital stay54.51 Top-box percentage
Pre-interventionFamily Experience With CareUnderstood what was said on rounds53.92 Top-box percentage
Post-interventionFamily Experience With CareQuality of communication during hospital stay58.7 Top-box percentage
Post-interventionFamily Experience With CareUnderstood what was said on rounds62.84 Top-box percentage
Post-interventionFamily Experience With CareExplanation of changes to look out for58.71 Top-box percentage
Post-interventionFamily Experience With CareSatisfied with opportunity to ask questions on FCR72.11 Top-box percentage
Post-interventionFamily Experience With CareMedical team listened to family concerns71.64 Top-box percentage
Post-interventionFamily Experience With CareFamily was included in decision making58.72 Top-box percentage
Post-interventionFamily Experience With CareFamily felt important in their role on rounds56.57 Top-box percentage
Post-interventionFamily Experience With CareFamily respectfully spoken to on rounds78.97 Top-box percentage
Post-interventionFamily Experience With CareQuality of communication during morning rounds66.19 Top-box percentage
Post-interventionFamily Experience With CareSatisfaction with frequency of updates on child53.83 Top-box percentage
Post-interventionFamily Experience With CareQuality of update explanations59.64 Top-box percentage
Post-interventionFamily Experience With CareInclusion in decision making later in day55.05 Top-box percentage
Post-interventionFamily Experience With CareFrequency of written updates33.7 Top-box percentage
Post-interventionFamily Experience With CareUnderstood written updates provided57.86 Top-box percentage
Post-interventionFamily Experience With CareUsefulness of written updates49.7 Top-box percentage
Post-interventionFamily Experience With CareShared understanding with doctors of medical plan59.16 Top-box percentage
Post-interventionFamily Experience With CareDoctors addressed family concerns65.85 Top-box percentage
Post-interventionFamily Experience With CareMDs made family feel important part of care team60.88 Top-box percentage
Post-interventionFamily Experience With CareShared understanding with nurses of medical plan65.41 Top-box percentage
Post-interventionFamily Experience With CareNurses addressed family concerns70.22 Top-box percentage
Post-interventionFamily Experience With CareRNs made family feel important part of care team70.74 Top-box percentage
Post-interventionFamily Experience With CareTeamwork among nurses and doctors61.43 Top-box percentage
Post-interventionFamily Experience With CareUnderstood reason for child's hospital stay71.44 Top-box percentage
Post-interventionFamily Experience With CareUnderstood requirements for child's discharge65.69 Top-box percentage
Post-interventionFamily Experience With CareOverall quality of child's care72.79 Top-box percentage
p-value: <0.05GEE chi-squared test for binary outcomes
Secondary

Quality of Communication on Rounds

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
Pre-interventionQuality of Communication on RoundsFamily-centered rounds occurred for this patient72.2 Top-box percentage
Pre-interventionQuality of Communication on RoundsNurse engagement20.4 Top-box percentage
Pre-interventionQuality of Communication on RoundsFamily engagement55.6 Top-box percentage
Pre-interventionQuality of Communication on RoundsWritten summary provided to family17.8 Top-box percentage
Pre-interventionQuality of Communication on RoundsFamily expressed concerns at start of rounds18.2 Top-box percentage
Pre-interventionQuality of Communication on RoundsFamily reporting of illness severity28.8 Top-box percentage
Pre-interventionQuality of Communication on RoundsFamily synthesis (i.e., reading back) of key items4.7 Top-box percentage
Pre-interventionQuality of Communication on RoundsEffective use of plain language by providers28.8 Top-box percentage
Post-interventionQuality of Communication on RoundsFamily reporting of illness severity43.5 Top-box percentage
Post-interventionQuality of Communication on RoundsFamily-centered rounds occurred for this patient82.8 Top-box percentage
Post-interventionQuality of Communication on RoundsFamily expressed concerns at start of rounds37.7 Top-box percentage
Post-interventionQuality of Communication on RoundsNurse engagement35.5 Top-box percentage
Post-interventionQuality of Communication on RoundsFamily synthesis (i.e., reading back) of key items26.5 Top-box percentage
Post-interventionQuality of Communication on RoundsFamily engagement66.7 Top-box percentage
Post-interventionQuality of Communication on RoundsEffective use of plain language by providers34.7 Top-box percentage
Post-interventionQuality of Communication on RoundsWritten summary provided to family53.6 Top-box percentage
Secondary

Rate of Non-Preventable Adverse Events

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.

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

Population: Patients admitted to study units.

ArmMeasureValue (NUMBER)
Pre-interventionRate of Non-Preventable Adverse Events12.6 Non-preventable AE per 1000 patient-days
Post-interventionRate of Non-Preventable Adverse Events5.2 Non-preventable AE per 1000 patient-days
Secondary

Shared Understanding Between Parent, Resident, and Nurse

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

Time frame: 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.

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026