Trial record 13 of 38 for: "sudden infant death"

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Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance

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ClinicalTrials.gov Identifier: NCT01014169

Recruitment Status : Completed

First Posted : November 16, 2009

Results First Posted : October 19, 2012

Last Update Posted : October 19, 2012

Sponsor:

Collaborator:

The Joel and Barbara Alpert Endowment For The Children of The City

Information provided by (Responsible Party):

Boston Medical Center

Study Description

Brief Summary:

The delivery of anticipatory guidance is an essential component of pediatric practice. Given the large amount of information to be shared during each encounter and the limited time available, there is a need for an effective and efficient means of communication between health care providers and families. The investigators hypothesize that more active parental participation in the form of note taking during the delivery of anticipatory guidance will lead to increased knowledge, higher levels of satisfaction with the encounter, and increased adoption of recommended parenting practices.

In this study, the investigators propose a randomized controlled trial of the impact of note taking during the delivery of newborn anticipatory guidance on maternal practices related to newborn care. The investigators plan to compare a control group of mothers receiving standard of care anticipatory guidance with an intervention group of mothers who are encouraged to take written notes while receiving the anticipatory guidance. The primary outcome of interest is maternal practice related to infant sleep position, and the secondary outcomes of interest are maternal practice related to breastfeeding initiation and car seat use. The investigators also plan to evaluate the impact of note taking on mothers' knowledge of recommended practices related to newborn care and on mothers' satisfaction with the guidance received.

Condition or disease	Intervention/treatment	Phase
Health Education Sudden Infant Death	Behavioral: Note taking	Not Applicable

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	126 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	A Randomized Controlled Trial of The Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance: the Suzuki Music Model Applied to Urban Pediatrics
Study Start Date :	December 2009
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding Sudden Infant Death Syndrome

Genetic and Rare Diseases Information Center resources: Sudden Infant Death Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual care Mothers in the control group will receive the nursing discharge newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
Experimental: Note taking The mothers in the intervention group will be given a pen and encouraged to take written notes in the notes section of the discharge envelope using their language of preference when receiving the standard newborn information.	Behavioral: Note taking The mothers in the intervention group will be given a pen and encouraged to take written notes in the notes section of a discharge envelope using their language of preference when receiving standard newborn discharge information.

Outcome Measures

Primary Outcome Measures :

The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position. [ Time Frame: two days after discharge ]
This measure assesses maternal report of placing the infant on the back to sleep (supine sleep position) as opposed to putting the infant on its side or stomach.

Secondary Outcome Measures :

Maternal Practice Related to Breastfeeding Initiation [ Time Frame: two days after discharge ]
This measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.
Maternal Practice Related to Correct Car Seat Use [ Time Frame: two days after discharge ]
Correct car seat use by all subjects who use cars was defined as placing the car seat in the back seat facing backwards and using the car seat every time the infant travels by car. The number reported is the number who report using the car seat correctly.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	15 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

newborn gestational age greater than 35 weeks
maternal spoken fluency in either English or Spanish
a working telephone in the home.

Exclusion Criteria:

either the newborn or the mother has a medical condition requiring hospitalization for longer than 4 days after a cesarean section or 2 days after a vaginal delivery
mother not expected to retain custody of the infant at the time of discharge

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014169

Locations


United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston Medical Center

The Joel and Barbara Alpert Endowment For The Children of The City

Investigators


Principal Investigator:	C. Jason Wang, MD	Boston Medical Center

More Information

Publications:

Kendall J. Suzuki's Mother Tongue Method. Music Educators Journal. 1986;72:47-50

Creech A and Hallam S. Parent-teacher-pupil interactions in instrumental music tuition: a literature review. B.J. Music Ed. 2003;20:29-44.

Grilli S. An interview with Dr. Shin'ichi Suzuki at the Talent Education Institute. International Review of Education. 1992; 38: 547-551.

Intons-Peterson MJ, Fournier J. External and Internal Memory Aids: When and How Often Do We Use Them? Journal of Experimental Psychology: General. 1986;115:267-280.

Kiewra KA DuBois NF, McShane CD, et al. Note-taking functions and techniques. Journal of Educational Psychology. 1991;83:240-245.

Andrade J. What Does Doodling Do? Appl Cognit Psychol.2009;23:1-7.

Gielen AC, Wilson ME, McDonald EM, Serwint JR, Andrews JS, Hwang WT, Wang MC. Randomized trial of enhanced anticipatory guidance for injury prevention. Arch Pediatr Adolesc Med. 2001 Jan;155(1):42-9.

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.

Kreuter MW, Chheda SG, Bull FC. How does physician advice influence patient behavior? Evidence for a priming effect. Arch Fam Med. 2000 May;9(5):426-33.

Isaacman DJ, Purvis K, Gyuro J, Anderson Y, Smith D. Standardized instructions: do they improve communication of discharge information from the emergency department? Pediatrics. 1992 Jun;89(6 Pt 2):1204-8.

Green M, Kessel SS. Diagnosing and treating health: bright futures. Pediatrics. 1993 May;91(5):998-1000.

2008. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition. Elk Grove Village, IL: American Academy of Pediatrics.

Moon RY, Oden RP, Grady KC. Back to Sleep: an educational intervention with women, infants, and children program clients. Pediatrics. 2004 Mar;113(3 Pt 1):542-7.

United States Preventative Services Task Force: Recommendations of Breastfeeding Counseling. www.ahrq.gov/clinic/uspstf/uspsbrfd.htm. Accessed on 11/25/08.

Zaza S, Sleet DA, Thompson RS, Sosin DM, Bolen JC; Task Force on Community Preventive Services. Reviews of evidence regarding interventions to increase use of child safety seats. Am J Prev Med. 2001 Nov;21(4 Suppl):31-47. Review.

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.

Moon RY, Omron R. Determinants of infant sleep position in an urban population. Clin Pediatr (Phila). 2002 Oct;41(8):569-73.


Responsible Party:	Boston Medical Center
ClinicalTrials.gov Identifier:	NCT01014169 History of Changes
Other Study ID Numbers:	H-28356
First Posted:	November 16, 2009 Key Record Dates
Results First Posted:	October 19, 2012
Last Update Posted:	October 19, 2012
Last Verified:	September 2012

Keywords provided by Boston Medical Center:


Health education Sudden Infant Death Breast Feeding Infant Equipment

Additional relevant MeSH terms:


Infant Death Sudden Infant Death Death Pathologic Processes Death, Sudden

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