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Clinical Trials/NCT02320175
NCT02320175
Completed
Not Applicable

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

Boston Children's Hospital7 sites in 2 countries6,478 target enrollmentDecember 15, 2014
ConditionsCommunication

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Communication
Sponsor
Boston Children's Hospital
Enrollment
6478
Locations
7
Primary Endpoint
Rate of Medical Errors
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2014
End Date
January 3, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher Landrigan

Professor of Pediatrics, Harvard Medical School; Research and Fellowship Director, Boston Children's Hospital Inpatient Pediatrics Service

Boston Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Rate of Non-Preventable Adverse Events(6 months (3 months pre, 3 months post) per site (7 sites total))
  • Family Experience With Care(6 months (3 months pre, 3 months post) per site (7 sites total))
  • Quality of Communication on Rounds(6 months (3 months pre, 3 months post) per site (7 sites total))
  • Shared Understanding Between Parent, Resident, and Nurse(6 months (3 months pre, 3 months post) per site (7 sites total))

Study Sites (7)

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