- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02647814
Salud al Día: Engaging Latino Parents in Pediatric Primary Care
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parent or legal guardian of a singleton US-born infant ≤ 2 months of age
- Parent or legal guardian age 18 or older
- Parent or legal guardian self-identified as Latino/a
- Parent or legal guardian foreign-born
- Parental report of Spanish as their preferred healthcare language
- 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
- Have a working cellular phone with text message capability and parent reports prior use of text messaging
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Salud al Día
The participants in the intervention group will receive interactive text-messages with a link to support if needed for: clinic appointment reminders, follow-up on medicine and referral adherence, and illness care needs and use.
Participants will additionally receive reminders for insurance renewal, food stamp applications, and health-promoting community events.
Participants in this arm will complete a baseline survey when their infant is ≤ 2 months of age, a mid-point survey at 7-9 months, and a follow-up survey at by age 15 months.
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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 LEP Latino parents during their child's first year and to examine its impact on healthcare utilization and primary care quality.
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No Intervention: Usual Care
The participants in the usual care group will receive the clinic's usual care in terms of receiving no text messages.
Participants in this arm will complete a baseline survey when their infant is ≤ 2 months of age, a mid-point survey at 7-9 months, and a follow-up survey at by age 15 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Up to Date Well Child Care
Time Frame: 24 months
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Composite variable of % of AAP recommended well visits completed at intervals 12 and 24 months of age, up to date immunizations and screening at 12 and 24 months
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24 months
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Emergency/Urgent Care Utilization
Time Frame: 24 months
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# of ED/Urgent care visits
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24 months
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Parent experience of care
Time Frame: 12 months
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Use of standard measure of healthcare experiences (Child-CAHPS)
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parent activation
Time Frame: 12 months
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12 months
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Proportion of visits in the the past 12 months with the primary provider
Time Frame: 12 months
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12 months
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Food stamp enrollment
Time Frame: 12 months
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12 months
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Continuous health insurance for the child each of the last 12 months
Time Frame: 12 months
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12 months
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Use of clinic support programs
Time Frame: 12 months
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12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention delivery
Time Frame: 12 months
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Measurement of intervention activities delivered per participant in the intervention arm
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12 months
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Intervention satisfaction
Time Frame: 12 months
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Quantitative and qualitative measurement of intervention experience for participants in the intervention arm
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa R DeCamp, MD, MSPH, Johns Hopkins University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00075868
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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