NCT01014169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 19, 2012

Completed
Last Updated

October 19, 2012

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

November 13, 2009

Results QC Date

August 20, 2012

Last Update Submit

September 20, 2012

Conditions

Keywords

Health educationSudden Infant DeathBreast FeedingInfant Equipment

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.

    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.

    two days after discharge

Secondary Outcomes (2)

  • Maternal Practice Related to Breastfeeding Initiation

    two days after discharge

  • Maternal Practice Related to Correct Car Seat Use

    two days after discharge

Study Arms (2)

Usual care

NO INTERVENTION

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.

Note taking

EXPERIMENTAL

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

Interventions

Note takingBEHAVIORAL

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.

Note taking

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (17)

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

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

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

    BACKGROUND
  • 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.

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

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

    BACKGROUND
  • 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. doi: 10.1001/archpedi.155.1.42.

    PMID: 11177061BACKGROUND
  • 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.

    PMID: 15867120BACKGROUND
  • 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. doi: 10.1001/archfami.9.5.426.

    PMID: 10810947BACKGROUND
  • 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.

    PMID: 1594378BACKGROUND
  • Green M, Kessel SS. Diagnosing and treating health: bright futures. Pediatrics. 1993 May;91(5):998-1000. No abstract available.

    PMID: 8474827BACKGROUND
  • 2008. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition. Elk Grove Village, IL: American Academy of Pediatrics.

    BACKGROUND
  • 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. doi: 10.1542/peds.113.3.542.

    PMID: 14993547BACKGROUND
  • United States Preventative Services Task Force: Recommendations of Breastfeeding Counseling. www.ahrq.gov/clinic/uspstf/uspsbrfd.htm. Accessed on 11/25/08.

    BACKGROUND
  • 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. doi: 10.1016/s0749-3797(01)00377-4.

    PMID: 11691560BACKGROUND
  • 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.

    PMID: 11115301BACKGROUND
  • Moon RY, Omron R. Determinants of infant sleep position in an urban population. Clin Pediatr (Phila). 2002 Oct;41(8):569-73. doi: 10.1177/000992280204100803.

    PMID: 12403373BACKGROUND

MeSH Terms

Conditions

Health EducationSudden Infant DeathBreast Feeding

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsInfant DeathFeeding Behavior

Limitations and Caveats

Conducted as a pilot study and not powered to demonstrate a significant difference between the two groups; subjects and NPs were aware of the group assignment; outcomes were determined using maternal self report.

Results Point of Contact

Title
Dr Caroline Kistin
Organization
Boston University School of Medicine/Boston Medical Center

Study Officials

  • C. Jason Wang, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 16, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 19, 2012

Results First Posted

October 19, 2012

Record last verified: 2012-09

Locations