Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
231 participants
INTERVENTIONAL
2015-01-28
2016-08-05
Brief Summary
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Detailed Description
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Danis Pediatrics, the pediatric practice of Saint Louis University physicians within SSM Cardinal Glennon Children's Medical Center (CGCMC), serves as a medical home to primarily urban, low-income patients. In the first half of 2014 alone, there were 5259 visits to the ED by caregivers of patients \< 13 months of age. Of those, 520 Danis Pediatrics patients accounted for 919 of those visits. In short, just under 1 in 5 visits to the CGCMC ED is a Danis patient, and Danis patients visit the ED approximately 2 times in the first year. Previous studies of patients at Danis Pediatrics suggest that this population has access to text messaging and is interested in receiving healthcare-related information from their pediatric provider.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Enhanced Standard of Care (ESoC)
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.
Enhanced Standard of Care (ESoC)
See above in arm/group description
Enhanced Standard of Care (ESoC) + Text
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.
Enhanced Standard of Care (ESoC) + Text
See above in arm/group description
Interventions
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Enhanced Standard of Care (ESoC) + Text
See above in arm/group description
Enhanced Standard of Care (ESoC)
See above in arm/group description
Eligibility Criteria
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Inclusion Criteria
* Receive primary care at Danis Pediatrics
* Must have reliable mobile phone service and be able to receive text messages
Exclusion Criteria
* No reliable text messaging service
15 Years
65 Years
ALL
Yes
Sponsors
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St. Louis University
OTHER
Responsible Party
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Matthew A. Broom, MD, FAAP
Associate Professor of Pediatrics
Principal Investigators
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Matt Broom, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis University
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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25160
Identifier Type: -
Identifier Source: org_study_id
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