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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03235830
Other study ID # 25160
Secondary ID
Status Completed
Phase N/A
First received July 30, 2017
Last updated July 31, 2017
Start date January 28, 2015
Est. completion date August 5, 2016

Study information

Verified date July 2017
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Health care utilization is a issue germane to health care providers, insurers, and patients alike. Reducing non-urgent visits to the emergency department (ED) and primary care providers can improve both the quality and cost of care. There are barriers, however, to educating patients about more appropriate health care utilization. Low health literacy is one such barrier, particularly for caregivers of pediatric patients. Research reveals that up to half of caregivers seeking treatment at the ED have low levels of health literacy; levels that can make it more difficult to not only make sound decisions, but also provide effective follow-up care. Moreover, low levels of literacy perpetuate a cycle of seeking care for non-urgent conditions. Education initiatives designed to counteract the effects of low health literacy on health care utilization have been shown to reduce non-urgent ED visits by as much as 80%. These education interventions, while effective, are complex, costly, or time-intensive. For example, home visits by a nurse, parenting classes, and video tools are all shown to reduce non-urgent ED use, but each poses a unique problem for implementation in high volume, urban, pediatric primary care clinic. To date, no study has examined the effectiveness of text messaging as a possible avenue for educating caregivers about issues related to health care utilization. Text messaging has been shown to support behavioral change, and represents a fast and cost-effective alternative to more labor-intensive and expensive alternatives.

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.


Recruitment information / eligibility

Status Completed
Enrollment 231
Est. completion date August 5, 2016
Est. primary completion date August 5, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Non-English speaking caregivers

- No reliable text messaging service

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced Standard of Care (ESoC) + Text
See above in arm/group description
Enhanced Standard of Care (ESoC)
See above in arm/group description

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St. Louis University

References & Publications (10)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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). pii: e20151175. doi: 10.1542/peds.2015-1175. Epub 2016 Dec 12. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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 Emergency department use Number of emergency department visits 6 months post end of intervention
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