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Completed

NCT Number: NCT02320175

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient and Family Centered I-PASS

Behavioral

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.

Primary outcomes

  1. Rate of Medical Errors

    Time frame: 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 outcomes

  1. Rate of Non-Preventable Adverse Events

    Time frame: 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.

  2. Family Experience With Care

    Time frame: 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.

  3. Quality of Communication on Rounds

    Time frame: 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.

  4. Shared Understanding Between Parent, Resident, and Nurse

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2014
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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