NCT03235830

Brief Summary

The overall goal is to assess the feasibility and effectiveness of using text messages as an educational tool in order to improve health care utilization among the parents and caregivers of newborns; in particular, the investigators seek to understand how educational text messages counteract the effects of low health literacy as it relates to non-urgent visits to the emergency department.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

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

Study Start

First participant enrolled

January 28, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

July 30, 2017

Last Update Submit

July 31, 2017

Conditions

Keywords

Healthcare utilizationHealth literacy

Outcome Measures

Primary Outcomes (1)

  • Emergency department use

    Number of emergency department visits

    6 months post end of intervention

Study Arms (2)

Enhanced Standard of Care (ESoC)

ACTIVE COMPARATOR

Subjects received a condensed version of the American Academy of Pediatrics Bright Futures content at their scheduled well-child visits though 6 months of age. The enhanced standard of care (ESoC) materials were added, by members of the research team, to registration packets and were given to caregivers by clinic staff, who were all trained to give the ESoC. For any patients who did not receive ESoC materials at their visit, an age-appropriate ESoC was mailed to the caregiver.

Behavioral: Enhanced Standard of Care (ESoC)

Enhanced Standard of Care (ESoC) + Text

EXPERIMENTAL

Subjects assigned to the text messaging intervention group received four educational messages per week until their child was 6 months of age in addition to the ESoC documents. The text messages directly reflected Bright Futures and ESoC content, addressing infant development, safety, care, and the most common causes of nonurgent visits in the first year. Bright Futures content was adapted both for language and length to accommodate character limits and the patient population.

Behavioral: Enhanced Standard of Care (ESoC) + Text

Interventions

See above in arm/group description

Enhanced Standard of Care (ESoC) + Text

See above in arm/group description

Enhanced Standard of Care (ESoC)

Eligibility Criteria

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

You may qualify if:

  • English-speaking parents and/or guardians of newborns (aged 0 to 2 months)
  • Receive primary care at Danis Pediatrics
  • Must have reliable mobile phone service and be able to receive text messages

You may not qualify if:

  • Non-English speaking caregivers
  • No reliable text messaging service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Hodgkinson S, Godoy L, Beers LS, Lewin A. Improving Mental Health Access for Low-Income Children and Families in the Primary Care Setting. Pediatrics. 2017 Jan;139(1):e20151175. doi: 10.1542/peds.2015-1175. Epub 2016 Dec 12.

    PMID: 27965378BACKGROUND
  • Yin HS, Johnson M, Mendelsohn AL, Abrams MA, Sanders LM, Dreyer BP. The health literacy of parents in the United States: a nationally representative study. Pediatrics. 2009 Nov;124 Suppl 3:S289-98. doi: 10.1542/peds.2009-1162E.

    PMID: 19861483BACKGROUND
  • DeWalt DA, Hink A. Health literacy and child health outcomes: a systematic review of the literature. Pediatrics. 2009 Nov;124 Suppl 3:S265-74. doi: 10.1542/peds.2009-1162B.

    PMID: 19861480BACKGROUND
  • Morrison AK, Schapira MM, Gorelick MH, Hoffmann RG, Brousseau DC. Low caregiver health literacy is associated with higher pediatric emergency department use and nonurgent visits. Acad Pediatr. 2014 May-Jun;14(3):309-14. doi: 10.1016/j.acap.2014.01.004.

    PMID: 24767784BACKGROUND
  • DeAngelis C, Fosarelli P, Duggan AK. Use of the emergency department by children enrolled in a primary care clinic. Pediatr Emerg Care. 1985 Jun;1(2):61-5.

    PMID: 3843434BACKGROUND
  • Salami O, Salvador J, Vega R. Reasons for nonurgent pediatric emergency department visits: perceptions of health care providers and caregivers. Pediatr Emerg Care. 2012 Jan;28(1):43-6. doi: 10.1097/PEC.0b013e31823f2412.

    PMID: 22193700BACKGROUND
  • Morgan SR, Chang AM, Alqatari M, Pines JM. Non-emergency department interventions to reduce ED utilization: a systematic review. Acad Emerg Med. 2013 Oct;20(10):969-85. doi: 10.1111/acem.12219.

    PMID: 24127700BACKGROUND
  • Yoffe SJ, Moore RW, Gibson JO, Dadfar NM, McKay RL, McClellan DA, Huang TY. A reduction in emergency department use by children from a parent educational intervention. Fam Med. 2011 Feb;43(2):106-11.

    PMID: 21305425BACKGROUND
  • Fieldston ES, Nadel FM, Alpern ER, Fiks AG, Shea JA, Alessandrini EA. Effects of an education and training intervention on caregiver knowledge of nonurgent pediatric complaints and on child health services utilization. Pediatr Emerg Care. 2013 Mar;29(3):331-6. doi: 10.1097/PEC.0b013e31828512c7.

    PMID: 23426249BACKGROUND
  • 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.

    PMID: 19382324BACKGROUND

Study Officials

  • Matt Broom, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Following the initial visit where consent, demographic information, and the NVS were obtained, participants were randomly assigned, by computer, to one of two groups: (1) caregiver receives only enhanced standard of care documents (ESoC), or (2) caregiver receives text messages in addition to enhanced standard of care documents (ESoC + Text). Both research team members and participants were blind to group assignment at the time of consent and enrollment. Clinic staff and providers were not aware of group assignment unless revealed by the participant.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Caregivers of newborns (0-10 weeks of age) whose child received primary care at an urban, academic primary care clinic were approached for participation. Inclusion required reliable cellular and text messaging service and the ability to speak English. At intake, caregivers completed a brief demographic survey and were given a researcher-administered health literacy test called the Newest Vital Sign (NVS). Following the initial visit where consent, demographic information, and the NVS were obtained, participants were randomly assigned, by computer, to one of two groups: (1) caregiver receives only enhanced standard of care documents (ESoC), or (2) caregiver receives text messages in addition to enhanced standard of care documents (ESoC + Text). Both research team members and participants were blind to group assignment at the time of consent and enrollment. Clinic staff and providers were not aware of group assignment unless revealed by the participant.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

July 30, 2017

First Posted

August 1, 2017

Study Start

January 28, 2015

Primary Completion

August 5, 2016

Study Completion

August 5, 2016

Last Updated

August 2, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share