Communication
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 5,868 |
Baseline characteristics
| Characteristic | Pre-intervention | Total | Post-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 Participants | 49 Participants | 23 Participants |
| Race/Ethnicity, Customized Nurse Black | 5 Participants | 12 Participants | 7 Participants |
| Race/Ethnicity, Customized Nurse Hispanic or Latino | 13 Participants | 18 Participants | 5 Participants |
| Race/Ethnicity, Customized Nurse Other | 11 Participants | 13 Participants | 2 Participants |
| Race/Ethnicity, Customized Nurse White | 129 Participants | 225 Participants | 96 Participants |
| Race/Ethnicity, Customized Parent Asian | 62 Participants | 112 Participants | 50 Participants |
| Race/Ethnicity, Customized Parent Black | 158 Participants | 280 Participants | 122 Participants |
| Race/Ethnicity, Customized Parent Hispanic or Latino | 193 Participants | 374 Participants | 181 Participants |
| Race/Ethnicity, Customized Parent Other | 62 Participants | 140 Participants | 78 Participants |
| Race/Ethnicity, Customized Parent White | 424 Participants | 800 Participants | 376 Participants |
| Race/Ethnicity, Customized Patient Asian | 74 Participants | 132 Participants | 58 Participants |
| Race/Ethnicity, Customized Patient Black | 266 Participants | 487 Participants | 221 Participants |
| Race/Ethnicity, Customized Patient Hispanic or Latino | NA Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized Patient Other | 312 Participants | 712 Participants | 400 Participants |
| Race/Ethnicity, Customized Patient White | 708 Participants | 1308 Participants | 600 Participants |
| Race/Ethnicity, Customized Physician Asian | 60 Participants | 99 Participants | 39 Participants |
| Race/Ethnicity, Customized Physician Black | 11 Participants | 22 Participants | 11 Participants |
| Race/Ethnicity, Customized Physician Hispanic or Latino | 23 Participants | 32 Participants | 9 Participants |
| Race/Ethnicity, Customized Physician Other | 11 Participants | 24 Participants | 13 Participants |
| Race/Ethnicity, Customized Physician White | 226 Participants | 402 Participants | 176 Participants |
| Region of Enrollment Canada | 274 Participants | 680 Participants | 406 Participants |
| Region of Enrollment United States | 2781 Participants | 5188 Participants | 2407 Participants |
| Sex: Female, Male Nurse Female | 171 Participants | 295 Participants | 124 Participants |
| Sex: Female, Male Nurse Male | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Parent Female | 731 Participants | 1379 Participants | 648 Participants |
| Sex: Female, Male Parent Male | 164 Participants | 327 Participants | 163 Participants |
| Sex: Female, Male Patient Female | 767 Participants | 1532 Participants | 765 Participants |
| Sex: Female, Male Patient Male | 775 Participants | 1502 Participants | 727 Participants |
| Sex: Female, Male Physician Female | 236 Participants | 403 Participants | 167 Participants |
| Sex: Female, Male Physician Male | 106 Participants | 188 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,574 | 0 / 1,532 |
| other Total, other adverse events | 0 / 1,574 | 0 / 1,532 |
| serious Total, serious adverse events | 165 / 1,574 | 95 / 1,532 |
Outcome results
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-intervention | Rate of Medical Errors | Overall medical errors | 41.2 Medical errors per 1000 patient-days |
| Pre-intervention | Rate of Medical Errors | Non-harmful errors | 20.0 Medical errors per 1000 patient-days |
| Pre-intervention | Rate of Medical Errors | Harmful errors (i.e., preventable adverse events) | 20.7 Medical errors per 1000 patient-days |
| Post-intervention | Rate of Medical Errors | Overall medical errors | 35.8 Medical errors per 1000 patient-days |
| Post-intervention | Rate of Medical Errors | Non-harmful errors | 22.0 Medical errors per 1000 patient-days |
| Post-intervention | Rate of Medical Errors | Harmful errors (i.e., preventable adverse events) | 12.9 Medical errors per 1000 patient-days |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-intervention | Family Experience With Care | Satisfied with opportunity to ask questions on FCR | 68.59 Top-box percentage |
| Pre-intervention | Family Experience With Care | Usefulness of written updates | 47.32 Top-box percentage |
| Pre-intervention | Family Experience With Care | Quality of communication during morning rounds | 61.15 Top-box percentage |
| Pre-intervention | Family Experience With Care | Shared understanding with doctors of medical plan | 53.95 Top-box percentage |
| Pre-intervention | Family Experience With Care | Family was included in decision making | 56.11 Top-box percentage |
| Pre-intervention | Family Experience With Care | Doctors addressed family concerns | 61.8 Top-box percentage |
| Pre-intervention | Family Experience With Care | Satisfaction with frequency of updates on child | 48.87 Top-box percentage |
| Pre-intervention | Family Experience With Care | MDs made family feel important part of care team | 57.7 Top-box percentage |
| Pre-intervention | Family Experience With Care | Explanation of changes to look out for | 56.37 Top-box percentage |
| Pre-intervention | Family Experience With Care | Shared understanding with nurses of medical plan | 55.29 Top-box percentage |
| Pre-intervention | Family Experience With Care | Quality of update explanations | 57.89 Top-box percentage |
| Pre-intervention | Family Experience With Care | Nurses addressed family concerns | 61.21 Top-box percentage |
| Pre-intervention | Family Experience With Care | Family felt important in their role on rounds | 49.66 Top-box percentage |
| Pre-intervention | Family Experience With Care | RNs made family feel important part of care team | 63.19 Top-box percentage |
| Pre-intervention | Family Experience With Care | Inclusion in decision making later in day | 52.55 Top-box percentage |
| Pre-intervention | Family Experience With Care | Teamwork among nurses and doctors | 58.72 Top-box percentage |
| Pre-intervention | Family Experience With Care | Medical team listened to family concerns | 66.81 Top-box percentage |
| Pre-intervention | Family Experience With Care | Understood reason for child's hospital stay | 71.27 Top-box percentage |
| Pre-intervention | Family Experience With Care | Frequency of written updates | 15.6 Top-box percentage |
| Pre-intervention | Family Experience With Care | Understood requirements for child's discharge | 62.09 Top-box percentage |
| Pre-intervention | Family Experience With Care | Family respectfully spoken to on rounds | 77.70 Top-box percentage |
| Pre-intervention | Family Experience With Care | Overall quality of child's care | 69.19 Top-box percentage |
| Pre-intervention | Family Experience With Care | Understood written updates provided | 46.5 Top-box percentage |
| Pre-intervention | Family Experience With Care | Quality of communication during hospital stay | 54.51 Top-box percentage |
| Pre-intervention | Family Experience With Care | Understood what was said on rounds | 53.92 Top-box percentage |
| Post-intervention | Family Experience With Care | Quality of communication during hospital stay | 58.7 Top-box percentage |
| Post-intervention | Family Experience With Care | Understood what was said on rounds | 62.84 Top-box percentage |
| Post-intervention | Family Experience With Care | Explanation of changes to look out for | 58.71 Top-box percentage |
| Post-intervention | Family Experience With Care | Satisfied with opportunity to ask questions on FCR | 72.11 Top-box percentage |
| Post-intervention | Family Experience With Care | Medical team listened to family concerns | 71.64 Top-box percentage |
| Post-intervention | Family Experience With Care | Family was included in decision making | 58.72 Top-box percentage |
| Post-intervention | Family Experience With Care | Family felt important in their role on rounds | 56.57 Top-box percentage |
| Post-intervention | Family Experience With Care | Family respectfully spoken to on rounds | 78.97 Top-box percentage |
| Post-intervention | Family Experience With Care | Quality of communication during morning rounds | 66.19 Top-box percentage |
| Post-intervention | Family Experience With Care | Satisfaction with frequency of updates on child | 53.83 Top-box percentage |
| Post-intervention | Family Experience With Care | Quality of update explanations | 59.64 Top-box percentage |
| Post-intervention | Family Experience With Care | Inclusion in decision making later in day | 55.05 Top-box percentage |
| Post-intervention | Family Experience With Care | Frequency of written updates | 33.7 Top-box percentage |
| Post-intervention | Family Experience With Care | Understood written updates provided | 57.86 Top-box percentage |
| Post-intervention | Family Experience With Care | Usefulness of written updates | 49.7 Top-box percentage |
| Post-intervention | Family Experience With Care | Shared understanding with doctors of medical plan | 59.16 Top-box percentage |
| Post-intervention | Family Experience With Care | Doctors addressed family concerns | 65.85 Top-box percentage |
| Post-intervention | Family Experience With Care | MDs made family feel important part of care team | 60.88 Top-box percentage |
| Post-intervention | Family Experience With Care | Shared understanding with nurses of medical plan | 65.41 Top-box percentage |
| Post-intervention | Family Experience With Care | Nurses addressed family concerns | 70.22 Top-box percentage |
| Post-intervention | Family Experience With Care | RNs made family feel important part of care team | 70.74 Top-box percentage |
| Post-intervention | Family Experience With Care | Teamwork among nurses and doctors | 61.43 Top-box percentage |
| Post-intervention | Family Experience With Care | Understood reason for child's hospital stay | 71.44 Top-box percentage |
| Post-intervention | Family Experience With Care | Understood requirements for child's discharge | 65.69 Top-box percentage |
| Post-intervention | Family Experience With Care | Overall quality of child's care | 72.79 Top-box percentage |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-intervention | Quality of Communication on Rounds | Family-centered rounds occurred for this patient | 72.2 Top-box percentage |
| Pre-intervention | Quality of Communication on Rounds | Nurse engagement | 20.4 Top-box percentage |
| Pre-intervention | Quality of Communication on Rounds | Family engagement | 55.6 Top-box percentage |
| Pre-intervention | Quality of Communication on Rounds | Written summary provided to family | 17.8 Top-box percentage |
| Pre-intervention | Quality of Communication on Rounds | Family expressed concerns at start of rounds | 18.2 Top-box percentage |
| Pre-intervention | Quality of Communication on Rounds | Family reporting of illness severity | 28.8 Top-box percentage |
| Pre-intervention | Quality of Communication on Rounds | Family synthesis (i.e., reading back) of key items | 4.7 Top-box percentage |
| Pre-intervention | Quality of Communication on Rounds | Effective use of plain language by providers | 28.8 Top-box percentage |
| Post-intervention | Quality of Communication on Rounds | Family reporting of illness severity | 43.5 Top-box percentage |
| Post-intervention | Quality of Communication on Rounds | Family-centered rounds occurred for this patient | 82.8 Top-box percentage |
| Post-intervention | Quality of Communication on Rounds | Family expressed concerns at start of rounds | 37.7 Top-box percentage |
| Post-intervention | Quality of Communication on Rounds | Nurse engagement | 35.5 Top-box percentage |
| Post-intervention | Quality of Communication on Rounds | Family synthesis (i.e., reading back) of key items | 26.5 Top-box percentage |
| Post-intervention | Quality of Communication on Rounds | Family engagement | 66.7 Top-box percentage |
| Post-intervention | Quality of Communication on Rounds | Effective use of plain language by providers | 34.7 Top-box percentage |
| Post-intervention | Quality of Communication on Rounds | Written summary provided to family | 53.6 Top-box percentage |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-intervention | Rate of Non-Preventable Adverse Events | 12.6 Non-preventable AE per 1000 patient-days |
| Post-intervention | Rate of Non-Preventable Adverse Events | 5.2 Non-preventable AE per 1000 patient-days |
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.