Family-Centered Rounds Checklist Implementation

January 11, 2019 updated by: University of Wisconsin, Madison

Engaging Families in Bedside Rounds to Promote Pediatric Patient Safety

The goal of this study is to develop, implement, and evaluate the effectiveness of an intervention designed to facilitate family engagement during bedside rounds at a children's hospital. The intervention consists of a "checklist" of key behaviors associated with the delivery of quality family-centered rounds, as well as training in the use of the checklist tool. In a pre-post controlled design, two hospital services will be randomized to use the checklist while two others will be randomized to usual care. The intervention is expected to increase to the performance of key checklist behaviors, family engagement, and family perceptions of patient safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Family engagement in children's healthcare encounters has been suggested as a means to improve safety. To engage families in care, the recommended practice is to conduct rounds at the child's bedside with the family present (family-centered rounds). Family-centered rounds strive to engage families in (1) a relationship with care providers, (2) exchange of information for decision making, and (3) deliberation about decisions. Bedside rounds represent a consistent venue to engage families in the care of hospitalized children, yet no studies have systematically identified and examined the barriers and facilitators of family engagement during rounds as a means to improve safety.

Study Type

Interventional

Enrollment (Actual)

340

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin-Madison School of Medicine and Public Health; American Family 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

No older than 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted as an inpatient on the pediatric hospitalist service, pulmonary service, or hematology/oncology service, during the study period.

Exclusion Criteria:

  • Stigmatizing/sensitive reason for hospitalization (e.g., suspected non-accidental trauma or mental health concerns)
  • New cancer diagnosis
  • Parent(s) unable to speak or read English
  • Parent(s) unavailable to consent (absent or sleeping during recruitment visits)
  • Already participated in the study during a prior inpatient admission

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family-centered rounds checklist
During the "post-intervention" period, health care team members on two pediatric inpatient services received the Family-centered Rounds Checklist tool, as well as training in how to use the checklist in the delivery of effective family-centered rounds
Other: Family-centered rounds checklist tool
A printed checklist containing 9 key tasks associated with effective delivery of family-centered rounds. A previously-identified member of each rounding team was responsible for holding the printed checklist during morning rounds. Team members were trained the in the use of this checklist prior to the post-intervention period, and a brief refresher training was conducted mid-way through the period.
No Intervention: Usual care
Two pediatric inpatient services were not provided the Family-centered rounds checklist tool, and delivered morning rounds in their usual manner. These services served as a control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent perceptions of hospital safety climate
Time Frame: Change between baseline (inpatient admission) and study completion (discharge from hospital, an average of 6 days)
Children's Hospital Safety Climate survey
Change between baseline (inpatient admission) and study completion (discharge from hospital, an average of 6 days)
Family engagement in rounds
Time Frame: Every family-centered morning round that occurred during the patient's hospital stay through study completion, an average of 6 days
Video data was collected for every morning round over the course of the patient's hospital stay. These videos were coded for measures of family engagement in rounds using established and validated coding systems (e.g. RIAS).
Every family-centered morning round that occurred during the patient's hospital stay through study completion, an average of 6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Checklist item performance
Time Frame: Every family-centered morning round that occurred during the patient's hospital stay through study completion, an average of 6 days
Assessment of how many key checklist elements were performed during each family-centered round (coded from video recordings of each round).
Every family-centered morning round that occurred during the patient's hospital stay through study completion, an average of 6 days

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Madison

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Elizabeth D Cox, MD PhD, Dept. of Pediatrics, School of Medicine and Public Health, UW-Madison

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

February 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M-2010-1277
  • HS018680 (Other Grant/Funding Number: AHRQ)

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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