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CompletedNCT01836601Updated Jul 29, 2015

Nighttime Communication Study

An interventional study of Family-centered nighttime communication bundle in Communication, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-07-29.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,334
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Communication

Keywords

  • safety
  • patient experience
  • family-centered rounds
03

In context

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Non-English speaking parents
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,334 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralFamily-centered nighttime communication bundle
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

Secondary outcomes

  1. 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.

    Time frame: 18 months

Other outcomes

  1. 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.

    Time frame: 18 months

07

Study locations

1 site
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • Khan A, Rogers JE, Forster CS, Furtak SL, Schuster MA, Landrigan CP. Communication and Shared Understanding Between Parents and Resident-Physicians at Night. Hosp Pediatr. 2016 Jun;6(6):319-29. doi: 10.1542/hpeds.2015-0224. PubMed 27188189 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01836601
Lead sponsor
Boston Children's Hospital
Collaborators
Program for Patient Safety and Quality
Responsible party
Alisa Khan (Instructor, Pediatrics, Boston Children's Hospital) — Principal investigator
First posted
Apr 22, 2013
Start date
Apr 2013
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Jul 29, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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