Clinical trial NCT02625142: Family-Centered Rounds Checklist Implementation
Official title: Engaging Families in Bedside Rounds to Promote Pediatric Patient Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Hospitalized
Delivery of Health Care
Morning Rounds
Keywords: Morning Rounds
Patient-centered Care
Hospital Medicine
Pediatrics
Hospitals, Pediatric
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-12-09
Enrollment: 340
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent perceptions of hospital safety climate
timeFrame: Change between baseline (inpatient admission) and study completion (discharge from hospital, an average of 6 days)
measure: Family engagement in rounds
timeFrame: Every family-centered morning round that occurred during the patient's hospital stay through study completion, an average of 6 days
Secondary outcomes:
measure: Checklist item performance
timeFrame: Every family-centered morning round that occurred during the patient's hospital stay through study completion, an average of 6 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison School of Medicine and Public Health; American Family Children's Hospital
state: Wisconsin
Study officials:
affiliation: Dept. of Pediatrics, School of Medicine and Public Health, UW-Madison
name: Elizabeth D Cox, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Xie A, Carayon P, Cartmill R, Li Y, Cox ED, Plotkin JA, Kelly MM. Multi-stakeholder collaboration in the redesign of family-centered rounds process. Appl Ergon. 2015 Jan;46 Pt A:115-23. doi: 10.1016/j.apergo.2014.07.011. Epub 2014 Aug 12.
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