NCT02625142

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.2 years

First QC Date

November 2, 2015

Last Update Submit

January 11, 2019

Conditions

Keywords

Morning RoundsPatient-centered CareHospital MedicinePediatricsHospitals, Pediatric

Outcome Measures

Primary Outcomes (2)

  • Parent perceptions of hospital safety climate

    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

    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 Outcomes (1)

  • Checklist item performance

    Every family-centered morning round that occurred during the patient's hospital stay through study completion, an average of 6 days

Study Arms (2)

Family-centered rounds checklist

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

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.

Family-centered rounds checklist

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison School of Medicine and Public Health; American Family Children's Hospital

Madison, Wisconsin, 53705, United States

Location

Related Publications (24)

  • Mittal V. Family-centered rounds. Pediatr Clin North Am. 2014 Aug;61(4):663-70. doi: 10.1016/j.pcl.2014.04.003.

    PMID: 25084715BACKGROUND
  • Seltz LB, Zimmer L, Ochoa-Nunez L, Rustici M, Bryant L, Fox D. Latino families' experiences with family-centered rounds at an academic children's hospital. Acad Pediatr. 2011 Sep-Oct;11(5):432-8. doi: 10.1016/j.acap.2011.06.002. Epub 2011 Jul 23.

    PMID: 21783452BACKGROUND
  • COMMITTEE ON HOSPITAL CARE and INSTITUTE FOR PATIENT- AND FAMILY-CENTERED CARE. Patient- and family-centered care and the pediatrician's role. Pediatrics. 2012 Feb;129(2):394-404. doi: 10.1542/peds.2011-3084. Epub 2012 Jan 30.

    PMID: 22291118BACKGROUND
  • Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/

    PMID: 25057539BACKGROUND
  • Webster PD, Johnson BH. Developing Patient- and Family-Centered Vision, Mission, and Philosophy of Care Statements. Bethesda, MD: Institute of Family-Centered Care; 1999:55.

    BACKGROUND
  • Johnson B, Abraham M, Conway J, Simmons L, Edgman-Levitan S, Sodomka P, Schlucter J, Ford D. Partnering With Patients and Families to Design a Patient- and Family-Centered Health Care System: Recommendations and Promising Practices. Bethesda, MD: Institute for Patient- and Family-Centered Care; 2008.

    BACKGROUND
  • Davidson JE, Powers K, Hedayat KM, Tieszen M, Kon AA, Shepard E, Spuhler V, Todres ID, Levy M, Barr J, Ghandi R, Hirsch G, Armstrong D; American College of Critical Care Medicine Task Force 2004-2005, Society of Critical Care Medicine. Clinical practice guidelines for support of the family in the patient-centered intensive care unit: American College of Critical Care Medicine Task Force 2004-2005. Crit Care Med. 2007 Feb;35(2):605-22. doi: 10.1097/01.CCM.0000254067.14607.EB.

    PMID: 17205007BACKGROUND
  • Mittal VS, Sigrest T, Ottolini MC, Rauch D, Lin H, Kit B, Landrigan CP, Flores G. Family-centered rounds on pediatric wards: a PRIS network survey of US and Canadian hospitalists. Pediatrics. 2010 Jul;126(1):37-43. doi: 10.1542/peds.2009-2364. Epub 2010 Jun 29.

    PMID: 20587682BACKGROUND
  • Sisterhen LL, Blaszak RT, Woods MB, Smith CE. Defining family-centered rounds. Teach Learn Med. 2007 Summer;19(3):319-22. doi: 10.1080/10401330701366812.

    PMID: 17594229BACKGROUND
  • Roter D, Larson S. The Roter interaction analysis system (RIAS): utility and flexibility for analysis of medical interactions. Patient Educ Couns. 2002 Apr;46(4):243-51. doi: 10.1016/s0738-3991(02)00012-5.

    PMID: 11932123BACKGROUND
  • Roter DL, Larson S. The relationship between residents' and attending physicians' communication during primary care visits: an illustrative use of the Roter Interaction Analysis System. Health Commun. 2001;13(1):33-48. doi: 10.1207/S15327027HC1301_04. No abstract available.

    PMID: 11370921BACKGROUND
  • Cooper LA, Roter DL, Johnson RL, Ford DE, Steinwachs DM, Powe NR. Patient-centered communication, ratings of care, and concordance of patient and physician race. Ann Intern Med. 2003 Dec 2;139(11):907-15. doi: 10.7326/0003-4819-139-11-200312020-00009.

    PMID: 14644893BACKGROUND
  • Cox ED, Raaum SE. Discussion of alternatives, risks and benefits in pediatric acute care. Patient Educ Couns. 2008 Jul;72(1):122-9. doi: 10.1016/j.pec.2008.01.025. Epub 2008 Mar 17.

    PMID: 18343624BACKGROUND
  • Cox ED, Smith MA, Brown RL. Evaluating deliberation in pediatric primary care. Pediatrics. 2007 Jul;120(1):e68-77. doi: 10.1542/peds.2006-2602.

    PMID: 17606551BACKGROUND
  • Sorra JS, Dyer N. Multilevel psychometric properties of the AHRQ hospital survey on patient safety culture. BMC Health Serv Res. 2010 Jul 8;10:199. doi: 10.1186/1472-6963-10-199.

    PMID: 20615247BACKGROUND
  • Cox ED, Smith MA, Brown RL, Fitzpatrick MA. Effect of gender and visit length on participation in pediatric visits. Patient Educ Couns. 2007 Mar;65(3):320-8. doi: 10.1016/j.pec.2006.08.013. Epub 2006 Oct 2.

    PMID: 17011738BACKGROUND
  • Cypress BS. Family presence on rounds: a systematic review of literature. Dimens Crit Care Nurs. 2012 Jan-Feb;31(1):53-64. doi: 10.1097/DCC.0b013e31824246dd.

    PMID: 22156815BACKGROUND
  • Tarini BA, Lozano P, Christakis DA. Afraid in the hospital: parental concern for errors during a child's hospitalization. J Hosp Med. 2009 Nov;4(9):521-7. doi: 10.1002/jhm.508.

    PMID: 19653281BACKGROUND
  • 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.

  • Xie A, Carayon P, Cox ED, Cartmill R, Li Y, Wetterneck TB, Kelly MM. Application of participatory ergonomics to the redesign of the family-centred rounds process. Ergonomics. 2015;58(10):1726-44. doi: 10.1080/00140139.2015.1029534. Epub 2015 Apr 22.

  • Kelly MM, Xie A, Carayon P, DuBenske LL, Ehlenbach ML, Cox ED. Strategies for improving family engagement during family-centered rounds. J Hosp Med. 2013 Apr;8(4):201-7. doi: 10.1002/jhm.2022. Epub 2013 Mar 6.

  • Carayon P, Li Y, Kelly MM, DuBenske LL, Xie A, McCabe B, Orne J, Cox ED. Stimulated recall methodology for assessing work system barriers and facilitators in family-centered rounds in a pediatric hospital. Appl Ergon. 2014 Nov;45(6):1540-6. doi: 10.1016/j.apergo.2014.05.001. Epub 2014 Jun 2.

  • Cox ED, Carayon P, Hansen KW, Rajamanickam VP, Brown RL, Rathouz PJ, DuBenske LL, Kelly MM, Buel LA. Parent perceptions of children's hospital safety climate. BMJ Qual Saf. 2013 Aug;22(8):664-71. doi: 10.1136/bmjqs-2012-001727. Epub 2013 Mar 29.

  • Benjamin JM, Cox ED, Trapskin PJ, Rajamanickam VP, Jorgenson RC, Weber HL, Pearson RE, Carayon P, Lubcke NL. Family-initiated dialogue about medications during family-centered rounds. Pediatrics. 2015 Jan;135(1):94-101. doi: 10.1542/peds.2013-3885. Epub 2014 Dec 15.

Study Officials

  • Elizabeth D Cox, MD PhD

    Dept. of Pediatrics, School of Medicine and Public Health, UW-Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

December 9, 2015

Study Start

February 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations