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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Communication

Intervention / Treatment
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* Behavioral: Patient and Family Centered I-PASS


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-intervention<br>Before implementation of Patient and Family Centered I-PASS. | |
| Experimental: Post-intervention<br>After implementation of Patient and Family Centered I-PASS. | Behavioral: Patient and Family Centered I-PASS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months (3 months pre, 3 months post) per site (7 sites total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months (3 months pre, 3 months post) per site (7 sites total) | 
| 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. | 6 months (3 months pre, 3 months post) per site (7 sites total) | 
| 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. | 6 months (3 months pre, 3 months post) per site (7 sites total) | 
| 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. | 6 months (3 months pre, 3 months post) per site (7 sites total) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Centered Rounds, Patient Safety, Errors, Adverse Events, Patient Experience, Family Engagement, Interprofessional Communication