Child, HospitalizedNCT02625142
Family-Centered Rounds Checklist Implementation
A study testing Family-centered rounds checklist tool in people with Child, Hospitalized and Delivery of Health Care, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Hospitalized, Delivery of Health Care, Morning Rounds
- What is being tested?
- Family-centered rounds checklist tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Admitted as an inpatient on the pediatric hospitalist service, pulmonary service, or hematology/oncology service, during the study period.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison School of Medicine and Public Health; American Family Children's Hospital
Madison, Wisconsin, 53705
About this study
Official title: 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.
Read the 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.
- Conditions
- Child, Hospitalized, Delivery of Health Care, Morning Rounds
- Being tested
- Family-centered rounds checklist tool
- Keywords
- Morning Rounds, Patient-centered Care, Hospital Medicine, Pediatrics, Hospitals, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-centered rounds checklist toolOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent perceptions of hospital safety climate
Children's Hospital Safety Climate survey
Measured: 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).
Measured: 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
Assessment of how many key checklist elements were performed during each family-centered round (coded from video recordings of each round).
Measured: Every family-centered morning round that occurred during the patient's hospital stay through study completion, an average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startFeb 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Child, HospitalizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Elizabeth D Cox, MD PhD, Principal investigator, Dept. of Pediatrics, School of Medicine and Public Health, UW-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625142
- Sponsor's protocol ID
- M-2010-1277
- Other IDs
- HS018680
- Status last verified
- Jan 2019
- First submitted
- 2 Nov 2015
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mittal V. Family-centered rounds. Pediatr Clin North Am. 2014 Aug;61(4):663-70. doi: 10.1016/j.pcl.2014.04.003.
PubMed 25084715Seltz 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.
PubMed 21783452COMMITTEE 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.
PubMed 22291118Institute 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/
PubMed 25057539Webster PD, Johnson BH. Developing Patient- and Family-Centered Vision, Mission, and Philosophy of Care Statements. Bethesda, MD: Institute of Family-Centered Care; 1999:55.
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.
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.
PubMed 17205007Mittal 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.
PubMed 20587682Sisterhen LL, Blaszak RT, Woods MB, Smith CE. Defining family-centered rounds. Teach Learn Med. 2007 Summer;19(3):319-22. doi: 10.1080/10401330701366812.
PubMed 17594229Roter 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.
PubMed 11932123Roter 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.
PubMed 11370921Cooper 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.
PubMed 14644893Cox 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.
PubMed 18343624Cox ED, Smith MA, Brown RL. Evaluating deliberation in pediatric primary care. Pediatrics. 2007 Jul;120(1):e68-77. doi: 10.1542/peds.2006-2602.
PubMed 17606551Sorra 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.
PubMed 20615247
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Families in Bedside Rounds to Promote Pediatric Patient Safety
- ClinicalTrials.gov ID
- NCT02625142
- Acronym / sponsor ID
- M-2010-1277
- Conditions
- Child, Hospitalized, Delivery of Health Care, Morning Rounds
- Keywords
- Morning Rounds, Patient-centered Care, Hospital Medicine, Pediatrics, Hospitals, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Feb 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-centered rounds checklist | Experimental | Other: Family-centered rounds checklist toolDuring 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 |
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Admitted as an inpatient on the pediatric hospitalist service, pulmonary service, or hematology/oncology service, during the study period.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-centered rounds checklist toolA 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. | Other | Family-centered rounds checklist |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Background: PubMed 25084715Mittal V. Family-centered rounds. Pediatr Clin North Am. 2014 Aug;61(4):663-70. doi: 10.1016/j.pcl.2014.04.003.
- Background: PubMed 21783452Seltz 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.
- Background: PubMed 22291118COMMITTEE 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.
- Background: PubMed 25057539Institute 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/
- BackgroundWebster PD, Johnson BH. Developing Patient- and Family-Centered Vision, Mission, and Philosophy of Care Statements. Bethesda, MD: Institute of Family-Centered Care; 1999:55.
- BackgroundJohnson 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: PubMed 17205007Davidson 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.
- Background: PubMed 20587682Mittal 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.
- Background: PubMed 17594229Sisterhen LL, Blaszak RT, Woods MB, Smith CE. Defining family-centered rounds. Teach Learn Med. 2007 Summer;19(3):319-22. doi: 10.1080/10401330701366812.
- Background: PubMed 11932123Roter 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.
- Background: PubMed 11370921Roter 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.
- Background: PubMed 14644893Cooper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth D Cox, MD PhD principal investigator
Dept. of Pediatrics, School of Medicine and Public Health, UW-Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-centered rounds checklist tool in people with Child, Hospitalized and Delivery of Health Care, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent perceptions of hospital safety climate (time frame: Change between baseline (inpatient admission) and study completion (discharge from hospital, an average of 6 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625142, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.