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Nighttime Communication Study

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ClinicalTrials.gov Identifier: NCT01836601
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : July 29, 2015
Sponsor:
Collaborator:
Program for Patient Safety and Quality
Information provided by (Responsible Party):
Alisa Khan, Boston Children’s Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Communication Behavioral: Family-centered nighttime communication bundle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1334 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effect of a Family-Centered Nighttime Communication Bundle on Shared Mental-Model Building, Safety, and Patient Experience
Study Start Date : April 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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): NCT01836601


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Program for Patient Safety and Quality

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alisa Khan, Instructor, Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01836601    
Other Study ID Numbers: IRB-P00006501
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Keywords provided by Alisa Khan, Boston Children’s Hospital:
safety
patient experience
family-centered rounds