NCT01836601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

April 10, 2013

Last Update Submit

July 28, 2015

Conditions

Keywords

safetypatient experiencefamily-centered rounds

Outcome Measures

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.

    18 months

Secondary Outcomes (1)

  • Parent-reported medical errors

    18 months

Other Outcomes (1)

  • Provider and parent experience of nighttime care

    18 months

Study Arms (2)

Pre-nighttime communication intervention arm

NO INTERVENTION

This arm is the pre-intervention arm of parents, nurses, and residents before the nighttime communication bundle has been enacted.

Post-nighttime communication intervention arm

EXPERIMENTAL

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

Post-nighttime communication intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor, Pediatrics

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 22, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations