Trial · NCT02320175
Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience
NCT02320175, Not applicable, Completed, Boston Children's Hospital; results first posted 2020-09-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience. Trials, record NCT02320175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02320175
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience
- NCT number
- NCT02320175
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 6,478 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Communication
- Interventions
- Patient and Family Centered I-PASS
- First posted
- 2014-12-19
- Last updated
- 2020-09-01
- Results first posted
- 2020-09-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Medical Errors | 6 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 | Rate of Non-Preventable Adverse Events | 6 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. |
| Secondary | Family Experience With Care | 6 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. |
| Secondary | Quality of Communication on Rounds | 6 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. |
| Secondary | Shared Understanding Between Parent, Resident, and Nurse | 6 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Medical Errors | 6 months (3 months pre, 3 months post) per site (7 sites total) | Patients admitted to study units. | Medical errors per 1000 patient-days | NUMBER |
| SECONDARY | Rate of Non-Preventable Adverse Events | 6 months (3 months pre, 3 months post) per site (7 sites total) | Patients admitted to study units. | Non-preventable AE per 1000 patient-days | NUMBER |
| SECONDARY | Family Experience With Care | 6 months (3 months pre, 3 months post) per site (7 sites total) | 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. | Top-box percentage | NUMBER |
| SECONDARY | Quality of Communication on Rounds | 6 months (3 months pre, 3 months post) per site (7 sites total) | 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. | Top-box percentage | NUMBER |
| SECONDARY | Shared Understanding Between Parent, Resident, and Nurse | 6 months (3 months pre, 3 months post) per site (7 sites total) | 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
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Medical Errors | Pre-intervention | Overall medical errors | 41.2 | 95% Confidence Interval 31.2 to 54.5 | Medical errors per 1000 patient-days |
| Rate of Medical Errors | Post-intervention | Overall medical errors | 35.8 | 95% Confidence Interval 26.9 to 47.7 | Medical errors per 1000 patient-days |
| Rate of Medical Errors | Pre-intervention | Non-harmful errors | 20.0 | 95% Confidence Interval 13.2 to 30.2 | Medical errors per 1000 patient-days |
| Rate of Medical Errors | Post-intervention | Non-harmful errors | 22.0 | 95% Confidence Interval 15.1 to 32.1 | Medical errors per 1000 patient-days |
| Rate of Medical Errors | Pre-intervention | Harmful errors (i.e., preventable adverse events) | 20.7 | 95% Confidence Interval 15.3 to 28.1 | Medical errors per 1000 patient-days |
| Rate of Medical Errors | Post-intervention | Harmful errors (i.e., preventable adverse events) | 12.9 | 95% Confidence Interval 8.9 to 18.6 | Medical errors per 1000 patient-days |
| Rate of Non-Preventable Adverse Events | Pre-intervention | 12.6 | 95% Confidence Interval 8.9 to 17.9 | Non-preventable AE per 1000 patient-days | |
| Rate of Non-Preventable Adverse Events | Post-intervention | 5.2 | 95% Confidence Interval 3.1 to 8.8 | Non-preventable AE per 1000 patient-days | |
| Family Experience With Care | Pre-intervention | Understood what was said on rounds | 53.92 | 95% Confidence Interval 44.60 to 62.98 | Top-box percentage |
| Family Experience With Care | Post-intervention | Understood what was said on rounds | 62.84 | 95% Confidence Interval 53.71 to 71.13 | Top-box percentage |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pre-intervention | 3,538 | |
| Overall Study | STARTED | Post-intervention | 2,940 | |
| Overall Study | COMPLETED | Pre-intervention | 3,538 | |
| Overall Study | COMPLETED | Post-intervention | 2,940 | |
| Overall Study | NOT COMPLETED | Pre-intervention | 0 | |
| Overall Study | NOT COMPLETED | Post-intervention | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Other Adverse Events | General disorders | Pre-intervention | 0 | 1,574 | 0 |
| other | Other Adverse Events | General disorders | Post-intervention | 0 | 1,532 | 0 |
| serious | Serious Adverse Events | General disorders | Pre-intervention | 165 | 1,574 | 192 |
| serious | Serious Adverse Events | General disorders | Post-intervention | 95 | 1,532 | 112 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-intervention | 0 | 1,574 |
| Total, all-cause mortality | Post-intervention | 0 | 1,532 |
| Total, other adverse events | Pre-intervention | 0 | 1,574 |
| Total, other adverse events | Post-intervention | 0 | 1,532 |
| Total, serious adverse events | Pre-intervention | 165 | 1,574 |
| Total, serious adverse events | Post-intervention | 95 | 1,532 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pre-intervention vs Post-intervention: deaths from any cause | Trial comparisons |
| Pre-intervention vs Post-intervention: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02320175
GET https://conductscience.org/api/trials/v1/NCT02320175/results?page=2