"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"

Constipation Clinical Trial

Official title:

"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859065
• Other study ID #: 09 15 11 10
• Status: Completed
• Phase: N/A
• First received: May 17, 2013
• Last updated: May 17, 2013
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: Bronx-Lebanon Hospital Center Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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:

1. Mothers selected for video-based anticipatory guidance that have a hearing/vision impairment.

2. 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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Constipation
• Health Knowledge, Attitudes, Practice
• Inflammation
• Nasal Congestion and Inflammations
• Sneezing

Intervention

Behavioral:
• Intensified anticipatory guidance
Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance
• Routine
Routine anticipatory guidance (control)

Locations

Country	Name	City	State
United States	Bronx Lebanon Hospital Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bronx-Lebanon Hospital Center Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Rudominer A. Reducing Newborn Office Visits and Improving Satisfaction through Parent Education and Learning Communities. Perm J. 2009 Summer;13(3):25-30. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 month	No
Secondary	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	1 month	No