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

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ClinicalTrials.gov Identifier: NCT02320175
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Christopher Landrigan, Boston Children’s Hospital

Brief Summary:

The investigators propose implementing a bundle of communication interventions - Patient and Family-Centered I-PASS - 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 investigators believe that doing so has the potential to substantially improve both patient safety and patient and family experience.

The specific aims of the project are - To test the hypothesis that a) rates of serious medical errors (including both preventable adverse events and near misses), determined both by an established, systematic daily hospital surveillance methodology (primary outcome) and family reports (secondary outcome); as well as b) poor verbal handoffs during family centered rounds (FCRs - assessed through direct observation - secondary outcome); rates of discordant understanding of the care plan between healthcare providers and families (assessed through survey instruments - secondary outcome); and rates of family (primary outcome) and nurse and physician dissatisfaction (secondary outcomes) will decrease following implementation of Family-Centered I-PASS, as compared with current practice.


Condition or disease Intervention/treatment Phase
Communication Behavioral: Communication Bundle Not Applicable

Detailed Description:

The bundle includes changes to family centered rounds, written communications with families and further communications throughout the day.

Data will be gathered pre vs. post intervention using a well established surveillance process for measuring rates of medical errors and adverse events, as well as survey instruments and direct observational methods.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3372 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bringing I-PASS to the Bedside: A Communication Bundle to Improve Patient Safety and Experience
Actual Study Start Date : December 15, 2014
Actual Primary Completion Date : January 3, 2017
Actual Study Completion Date : January 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

Arm Intervention/treatment
No Intervention: Pre-intervention Arm
This group is the pre-intervention group of physicians, residents, nurses and patients and families that will be interviewed and surveyed before applying the intervention (standard practices). Data on patient safety will be gathered as well
Experimental: Post-intervention Arm
This arm is the post-intervention group of physicians, residents, nurses and patients and families that will be interviewed and surveyed after applying the intervention - the Communication Bundle to Improve Patient Safety and Experience. Data on patient safety will be gathered as well
Behavioral: Communication Bundle
Communication bundle to improve patient and family experience and patient safety




Primary Outcome Measures :
  1. Rates of medical errors and adverse events [ Time Frame: 6 months (3 months pre, 3 months post) ]
    Rates will be collected through comprehensive error surveillance and incident reports by medical staff

  2. Parent experience with care [ Time Frame: 6 months (3 months pre, 3 months post) ]
    Assessed through discharge surveys of parents of hospitalized children


Secondary Outcome Measures :
  1. percent concordance between parent, resident, and nurse reported understanding of the reason for hospitalization and the key elements of the medical plan [ Time Frame: 6 months (3 months pre, 3 months post) ]
    Assessed through verbally administered surveys with patient families and care providers. Concordance about the care plan will be compared pre and post intervention

  2. Nurse and resident experience [ Time Frame: 6 months (3 months pre, 3 months post) ]
    Assessed through surveys of hospital providers

  3. Quality of communication on rounds [ Time Frame: 6 months (3 months pre, 3 months post) ]
    Process measures of the rounding process, including team behavior, family involvement in rounds, nurse involvement in rounds, and aspects of the intervention will be assessed before and after the intervention

  4. Rates of parent reported errors [ Time Frame: 6 months (3 months pre, 3 months post) ]
    The overall rates of errors and adverse events reported by parents during child's hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients and parents of patients admitted to the general pediatrics inpatient units
  • Nurses working on the general pediatrics inpatient units
  • Residents working on the general pediatrics inpatient units

Exclusion Criteria:

  • No potential subjects will be excluded on the basis of age, gender, ethnicity, race, or other demographic features

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320175


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Sponsors and Collaborators
Boston Children’s Hospital
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Christopher Landrigan, MD, MPH Boston Children’s Hospital

Responsible Party: Christopher Landrigan, Research and Fellowship Director, Boston Children's Hospital Inpatient Pediatrics Service, Associate Professor of Medicine and Pediatrics, Harvard Medical School, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02320175     History of Changes
Other Study ID Numbers: CDR-1306-03556
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Christopher Landrigan, Boston Children’s Hospital:
family centered rounds
patient safety
errors
adverse events
concordance
patient experience