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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02647814
Other study ID # IRB00075868
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date February 2018

Study information

Verified date August 2018
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 158
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Salud al Día
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.

Locations

Country Name City State
United States Johns Hopkins Bayview Medical Center Baltimore Maryland

Sponsors (4)

Lead Sponsor Collaborator
Johns Hopkins University emocha, Gordon and Betty Moore Foundation, Maryland Institute College of Art

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Intervention delivery Measurement of intervention activities delivered per participant in the intervention arm 12 months
Other Intervention satisfaction Quantitative and qualitative measurement of intervention experience for participants in the intervention arm 12 months
Primary Up to Date Well Child Care 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
Primary Emergency/Urgent Care Utilization # of ED/Urgent care visits 24 months
Primary Parent experience of care Use of standard measure of healthcare experiences (Child-CAHPS) 12 months
Secondary Parent activation 12 months
Secondary Proportion of visits in the the past 12 months with the primary provider 12 months
Secondary Food stamp enrollment 12 months
Secondary Continuous health insurance for the child each of the last 12 months 12 months
Secondary Use of clinic support programs 12 months
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