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Family-Centered Rounds Checklist Implementation

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ClinicalTrials.gov Identifier: NCT02625142
Recruitment Status : Completed
First Posted : December 9, 2015
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE November 2, 2015
First Posted Date  ICMJE December 9, 2015
Last Update Posted Date January 15, 2019
Study Start Date  ICMJE February 2010
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • 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
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
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 History Complete list of historical versions of study NCT02625142 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
  • 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).
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family-Centered Rounds Checklist Implementation
Official Title  ICMJE Engaging Families in Bedside Rounds to Promote Pediatric Patient Safety
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Child, Hospitalized
  • Delivery of Health Care
  • Morning Rounds
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Other: Family-centered rounds checklist tool
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2015)
340
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02625142
Other Study ID Numbers  ICMJE M-2010-1277
HS018680 ( Other Grant/Funding Number: AHRQ )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Elizabeth D Cox, MD PhD Dept. of Pediatrics, School of Medicine and Public Health, UW-Madison
PRS Account University of Wisconsin, Madison
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP