"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
Primary Purpose
Health Knowledge, Attitudes, Practice, Sneezing, Constipation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensified anticipatory guidance
Routine
Sponsored by
About this trial
This is an interventional prevention trial for Health Knowledge, Attitudes, Practice focused on measuring Non-urgent ED visits, Neonates, Newborn care
Eligibility Criteria
Inclusion Criteria:
- Mother of a newborn in the WBN of Bronx-Lebanon Hospital Center during the 4-month recruitment period of the study
Exclusion Criteria:
- Mothers selected for video-based anticipatory guidance that have a hearing/vision impairment.
- Mothers selected for handout-based anticipatory guidance who speak a language other than Spanish or English.
Sites / Locations
- Bronx Lebanon Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
Mothers receive routine anticipatory guidance
Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance
Outcomes
Primary Outcome Measures
Non-urgent ED visits by neonates
Reduction in non-urgent ED visits in mothers who received the intervention (video-based and handout-based anticipatory guidance regarding non-urgent problems), compared to the control group (received CAU anticipatory guidance)
Secondary Outcome Measures
Changes in caregivers' knowledge and attitude
Improvement in parental knowledge, attitude and behaviors related to non-urgent problems as a result of receiving anticipatory guidance (video and handouts) regarding non-urgent problems
Full Information
NCT ID
NCT01859065
First Posted
May 17, 2013
Last Updated
May 17, 2013
Sponsor
Bronx-Lebanon Hospital Center Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT01859065
Brief Title
"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
Official Title
"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx-Lebanon Hospital Center Health Care System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Kennedy et al, in a study of pediatric Emergency Department (ED) use by newborns less than 14 days of age, revealed that half of all visits in this population were non-acute problems. Other pediatric ED utilization studies have shown similar findings in that 32% to 72% of all visits were for non-urgent problems.
Many studies have found that primiparity and young maternal age are associated with non-acute ED presentations. A recent factor that has been investigated is the effect of early neonatal discharge. Some other factors are nonwhite mothers and mothers on Medicaid. Zandieh et al, found additional predisposing determinants for non-urgent ED visits, such as single parenthood, Hispanic ethnicity, and having perceptions that their child's overall physical health was poor.
Paradis et al found that parents receiving a video intervention rated higher confidence with specific infant care skills and reported feeling better prepared to care for their baby, compared to parents receiving only handouts. However, there isn't any reported study that evaluates the benefits of receiving both, a video intervention along with handouts.
Aim: to demonstrate whether conducting anticipatory guidance related to non-urgent problems will reduce non-urgent ED visits, compared to care as usual (CAU) anticipatory guidance (Sudden Infant Death Syndrome and Shaken Baby Syndrome videos; and unstructured talk about jaundice, vaccinations, appointments, care of umbilical stump, normal urination and bowel movement, fever).
Detailed Description
Inclusion Criteria: Mother of a newborn in the Well Baby Nursery (WBN) of Bronx-Lebanon Hospital Center during the 4-month recruitment period of the study.
Exclusion Criteria:
Mothers selected for video-based anticipatory guidance that have a hearing/vision impairment.
Mothers selected for handout-based anticipatory guidance who speak a language other than Spanish or English.
Primary outcome measure: reduction in non-urgent ED visits in mothers who received the intervention (video-based and handout-based anticipatory guidance regarding non-urgent problems), compared to the control group (received CAU anticipatory guidance)
Secondary outcome measure: improvement in parental knowledge, attitude and behaviors related to non-urgent problems as a result of receiving anticipatory guidance (video and handouts) regarding non-urgent problems;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Knowledge, Attitudes, Practice, Sneezing, Constipation, Nasal Congestion and Inflammations
Keywords
Non-urgent ED visits, Neonates, Newborn care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Mothers receive routine anticipatory guidance
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance
Intervention Type
Behavioral
Intervention Name(s)
Intensified anticipatory guidance
Intervention Description
Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance
Intervention Type
Behavioral
Intervention Name(s)
Routine
Intervention Description
Routine anticipatory guidance (control)
Primary Outcome Measure Information:
Title
Non-urgent ED visits by neonates
Description
Reduction in non-urgent ED visits in mothers who received the intervention (video-based and handout-based anticipatory guidance regarding non-urgent problems), compared to the control group (received CAU anticipatory guidance)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Changes in caregivers' knowledge and attitude
Description
Improvement in parental knowledge, attitude and behaviors related to non-urgent problems as a result of receiving anticipatory guidance (video and handouts) regarding non-urgent problems
Time Frame
1 month
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mother of a newborn in the WBN of Bronx-Lebanon Hospital Center during the 4-month recruitment period of the study
Exclusion Criteria:
Mothers selected for video-based anticipatory guidance that have a hearing/vision impairment.
Mothers selected for handout-based anticipatory guidance who speak a language other than Spanish or English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayoade Adeniyi, MD
Organizational Affiliation
Bronx-Lebanon Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx Lebanon Hospital Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21272821
Citation
Paradis HA, Conn KM, Gewirtz JR, Halterman JS. Innovative delivery of newborn anticipatory guidance: a randomized, controlled trial incorporating media-based learning into primary care. Acad Pediatr. 2011 Jan-Feb;11(1):27-33. doi: 10.1016/j.acap.2010.12.005.
Results Reference
background
PubMed Identifier
15867120
Citation
Rosenthal MS, Lannon CM, Stuart JM, Brown L, Miller WC, Margolis PA. A randomized trial of practice-based education to improve delivery systems for anticipatory guidance. Arch Pediatr Adolesc Med. 2005 May;159(5):456-63. doi: 10.1001/archpedi.159.5.456.
Results Reference
background
PubMed Identifier
11115301
Citation
Schuster MA, Duan N, Regalado M, Klein DJ. Anticipatory guidance: what information do parents receive? What information do they want? Arch Pediatr Adolesc Med. 2000 Dec;154(12):1191-8. doi: 10.1001/archpedi.154.12.1191.
Results Reference
background
PubMed Identifier
16302840
Citation
Barkin SL, Scheindlin B, Brown C, Ip E, Finch S, Wasserman RC. Anticipatory guidance topics: are more better? Ambul Pediatr. 2005 Nov-Dec;5(6):372-6. doi: 10.1367/A04-2131R1.1.
Results Reference
background
PubMed Identifier
15232243
Citation
Kennedy TJ, Purcell LK, LeBlanc JC, Jangaard KA. Emergency department use by infants less than 14 days of age. Pediatr Emerg Care. 2004 Jul;20(7):437-42. doi: 10.1097/01.pec.0000132216.65600.1b.
Results Reference
background
PubMed Identifier
12488831
Citation
Pomerantz WJ, Schubert CJ, Atherton HD, Kotagal UR. Characteristics of nonurgent emergency department use in the first 3 months of life. Pediatr Emerg Care. 2002 Dec;18(6):403-8. doi: 10.1097/00006565-200212000-00001.
Results Reference
background
PubMed Identifier
19382324
Citation
Zandieh SO, Gershel JC, Briggs WM, Mancuso CA, Kuder JM. Revisiting predictors of parental health care-seeking behaviors for nonurgent conditions at one inner-city hospital. Pediatr Emerg Care. 2009 Apr;25(4):238-243. doi: 10.1097/pec.0b013e31819e350e.
Results Reference
background
PubMed Identifier
20740085
Citation
Rudominer A. Reducing Newborn Office Visits and Improving Satisfaction through Parent Education and Learning Communities. Perm J. 2009 Summer;13(3):25-30. doi: 10.7812/TPP/08-096. No abstract available.
Results Reference
background
PubMed Identifier
27212955
Citation
Kamimura-Nishimura K, Chaudhary V, Olaosebikan F, Azizi M, Galiveeti S, Adeniyi A, Neugebauer R, Hagmann SH. Does Nursery-Based Intensified Anticipatory Guidance Reduce Emergency Department Use for Nonurgent Conditions in the First Month of Life? A Randomized Controlled Trial. Int J Pediatr. 2016;2016:8356582. doi: 10.1155/2016/8356582. Epub 2016 Apr 24.
Results Reference
derived
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"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
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