Clinical trial NCT02647814: Salud al Día: Engaging Latino Parents in Pediatric Primary Care
Official title: Salud al Día: Engaging Latino Parents in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Health Care
Keywords: Parent activation
Text-messages
LEP
Latino populations
pediatrics
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Gordon and Betty Moore Foundation
name: emocha Mobile Health, Inc.
name: Maryland Institute College of Art
First posted: 2016-01-06
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: To conduct a pilot randomized controlled trial comparing the effectiveness of a parent support intervention consisting of periodic text messages and educational support (video, collateral materials),and usual care on the healthcare engagement of limited English proficient (LEP) Latino parents during participants' child's first year and to examine its impact on healthcare utilization and primary care quality.

Detailed description: Lessons learned in organizational engagement reveal a critical need to increase healthcare engagement among LEP Latino parents. LEP Latina mothers who were founding members of Latino Family Advisory Board (LFAB) at the Johns Hopkins Bayview Medical Center identified the health system knowledge that enabled participants to more effectively use the healthcare system as one of the key benefits of board membership. The gains in knowledge, skills, and confidence demonstrated in the LFAB evaluation mirror qualitative evaluation findings of other ambulatory care advisory boards, and reflect the concept of patient activation. Patient activation, a component of individual patient engagement, is defined as the patient's willingness to manage their health and healthcare based on understanding one's role in the care process and having the knowledge, skills, and confidence to do so. Interventions focused on increasing activation, using both in-person and mHealth support, have demonstrated efficacy and have led to improvement in health and healthcare quality. mHealth-based interventions have the ability to reach larger populations at lower cost, with the potential for increased tailoring and interactivity, especially as the use of cellular phones becomes nearly universal, even among low-income populations. For example, Text4baby, a perinatal health education program delivered through passive educational text messages, has demonstrated success at reaching low-income Spanish-speaking parents with positive user assessments.

A recent study of parent healthcare activation among low-income parents (conducted by PI: DeCamp) demonstrated that parent activation among parents whose preferred healthcare language was Spanish was significantly lower than that of parents whose preferred healthcare language was English. These findings further support targeting increasing the healthcare engagement of LEP Latino parents.

This novel intervention will integrate mobile health (mHealth) technology and culturally- and linguistically-tailored interpersonal support to increase healthcare engagement of LEP Latino parents and to enable participants to overcome barriers to effective healthcare access and use. Investigators hypothesize that this intervention will measurably increase parent healthcare engagement and that this will positively impact healthcare utilization, quality and the patient/family experience. Increasing healthcare engagement of LEP Latino families and demonstrating positive healthcare impact through a tailored, scalable intervention would create a foundation for larger-scale impact on healthcare disparities for Latino children and a model for increasing engagement of other vulnerable populations.

Eligibility criteria: Inclusion Criteria:

1. Parent or legal guardian of a singleton US-born infant ≤ 2 months of age
2. Parent or legal guardian age 18 or older
3. Parent or legal guardian self-identified as Latino/a
4. Parent or legal guardian foreign-born
5. Parental report of Spanish as their preferred healthcare language
6. Plan to select Medicaid/Priority Partners insurance for their child with the Johns Hopkins Bayview Medical Center Children's Medical Practice as the primary care site
7. Have a working cellular phone with text message capability and parent reports prior use of text messaging

Primary outcomes:
measure: Up to Date Well Child Care
timeFrame: 24 months
measure: Emergency/Urgent Care Utilization
timeFrame: 24 months
measure: Parent experience of care
timeFrame: 12 months
Secondary outcomes:
measure: Parent activation
timeFrame: 12 months
measure: Proportion of visits in the the past 12 months with the primary provider
timeFrame: 12 months
measure: Food stamp enrollment
timeFrame: 12 months
measure: Continuous health insurance for the child each of the last 12 months
timeFrame: 12 months
measure: Use of clinic support programs
timeFrame: 12 months
Other outcomes:
measure: Intervention delivery
timeFrame: 12 months
measure: Intervention satisfaction
timeFrame: 12 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lisa R DeCamp, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roseman D, Osborne-Stafsnes J, Amy CH, Boslaugh S, Slate-Miller K. Early lessons from four 'aligning forces for quality' communities bolster the case for patient-centered care. Health Aff (Millwood). 2013 Feb;32(2):232-41. doi: 10.1377/hlthaff.2012.1085.
citation: Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
citation: Reuland CJ, Godage SK, Wu L, Valenzuela-Araujo D, Cortez JD, Polk S, DeCamp LR. Information and Communication Technology Access and Use Among Low-Income Latino Immigrant Parents. Matern Child Health J. 2021 Dec;25(12):1807-1813. doi: 10.1007/s10995-021-03265-6. Epub 2021 Oct 23.
citation: DeCamp LR, Godage SK, Valenzuela Araujo D, Dominguez Cortez J, Wu L, Psoter KJ, Quintanilla K, Rivera Rodriguez T, Polk S. A Texting Intervention in Latino Families to Reduce ED Use: A Randomized Trial. Pediatrics. 2020 Jan;145(1):e20191405. doi: 10.1542/peds.2019-1405.