Salud al Día: Engaging Latino Parents in Pediatric Primary Care

August 14, 2018 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
Emergency/Urgent Care Utilization
Time Frame: 24 months
# of ED/Urgent care visits
24 months
Parent experience of care
Time Frame: 12 months
Use of standard measure of healthcare experiences (Child-CAHPS)
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Parent activation
Time Frame: 12 months
12 months
Proportion of visits in the the past 12 months with the primary provider
Time Frame: 12 months
12 months
Food stamp enrollment
Time Frame: 12 months
12 months
Continuous health insurance for the child each of the last 12 months
Time Frame: 12 months
12 months
Use of clinic support programs
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention delivery
Time Frame: 12 months
Measurement of intervention activities delivered per participant in the intervention arm
12 months
Intervention satisfaction
Time Frame: 12 months
Quantitative and qualitative measurement of intervention experience for participants in the intervention arm
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lisa R DeCamp, MD, MSPH, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

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)?

UNDECIDED

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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