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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02625142
Other study ID # M-2010-1277
Secondary ID HS018680
Status Completed
Phase N/A
First received
Last updated
Start date February 2010
Est. completion date April 2013

Study information

Verified date January 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 340
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States University of Wisconsin-Madison School of Medicine and Public Health; American Family Children's Hospital Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (24)

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 2 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Oct 2. — View Citation

Cox ED, Smith MA, Brown RL. Evaluating deliberation in pediatric primary care. Pediatrics. 2007 Jul;120(1):e68-77. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sisterhen LL, Blaszak RT, Woods MB, Smith CE. Defining family-centered rounds. Teach Learn Med. 2007 Summer;19(3):319-22. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 Checklist item performance 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
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