Nighttime Communication Study

July 28, 2015 updated by: Alisa Khan, Boston Children's Hospital

The Effect of a Family-Centered Nighttime Communication Bundle on Shared Mental-Model Building, Safety, and Patient Experience

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-nighttime communication intervention arm
This arm is the pre-intervention arm of parents, nurses, and residents before the nighttime communication bundle has been enacted.
Experimental: Post-nighttime communication intervention arm
This arm is the post-intervention arm of parents, nurses, and residents after the nighttime communication bundle has been enacted.
Behavioral: Family-centered nighttime communication bundle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between parent, resident, and nurse reported elements of the patient action plan and overall plan
Time Frame: 18 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-reported medical errors
Time Frame: 18 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider and parent experience of nighttime care
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Program for Patient Safety and Quality

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-P00006501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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