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Completed

NCT Number: NCT02647814

Salud al Día: Engaging Latino Parents in Pediatric Primary Care

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salud al Día

Behavioral

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.

Primary outcomes

  1. Up to Date Well Child Care

    Time frame: 24 months

    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

  2. Emergency/Urgent Care Utilization

    Time frame: 24 months

    # of ED/Urgent care visits

  3. Parent experience of care

    Time frame: 12 months

    Use of standard measure of healthcare experiences (Child-CAHPS)

Secondary outcomes

  1. Parent activation

    Time frame: 12 months

  2. Proportion of visits in the the past 12 months with the primary provider

    Time frame: 12 months

  3. Food stamp enrollment

    Time frame: 12 months

  4. Continuous health insurance for the child each of the last 12 months

    Time frame: 12 months

  5. Use of clinic support programs

    Time frame: 12 months

Other outcomes

  1. Intervention delivery

    Time frame: 12 months

    Measurement of intervention activities delivered per participant in the intervention arm

  2. Intervention satisfaction

    Time frame: 12 months

    Quantitative and qualitative measurement of intervention experience for participants in the intervention arm

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Gordon and Betty Moore Foundation
  • Maryland Institute College of Art
  • emocha Mobile Health, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2016
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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