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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01836601
Other study ID # IRB-P00006501
Secondary ID
Status Completed
Phase N/A
First received April 10, 2013
Last updated July 28, 2015
Start date April 2013
Est. completion date November 2014

Study information

Verified date July 2015
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study seeks to determine whether a family-centered nighttime communication intervention improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of nighttime medical care.


Recruitment information / eligibility

Status Completed
Enrollment 1334
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Parents of patients admitted to the general pediatrics inpatient units

- Overnight nurses working on the general pediatrics inpatient units

- Overnight residents working on the general pediatrics inpatient units

Exclusion Criteria:

- Non-English speaking parents

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Family-centered nighttime communication bundle


Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital Boston Program for Patient Safety and Quality

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Provider and parent experience of nighttime care This will be assessed through surveys administered to parents and providers for a subset of patients. Answers will be compared pre and post-intervention. 18 months No
Primary Concordance between parent, resident, and nurse reported elements of the patient action plan and overall plan This will be assessed through surveys administered to parents, residents, and nurses for a subset of patients every evening. Parent, resident, and nurse responses will be compared pre and post-intervention. 18 months No
Secondary Parent-reported medical errors This will be assessed through surveys administered to parents for a subset of patients every evening. Parent error reporting will be compared pre and post-intervention. 18 months Yes
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