NCT02647814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

December 18, 2015

Last Update Submit

August 14, 2018

Conditions

Keywords

Parent activationText-messagesLEPLatino populationspediatrics

Outcome Measures

Primary Outcomes (3)

  • 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

  • Emergency/Urgent Care Utilization

    \# of ED/Urgent care visits

    24 months

  • Parent experience of care

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

    12 months

Secondary Outcomes (5)

  • Parent activation

    12 months

  • Proportion of visits in the the past 12 months with the primary provider

    12 months

  • Food stamp enrollment

    12 months

  • Continuous health insurance for the child each of the last 12 months

    12 months

  • Use of clinic support programs

    12 months

Other Outcomes (2)

  • Intervention delivery

    12 months

  • Intervention satisfaction

    12 months

Study Arms (2)

Salud al Día

EXPERIMENTAL

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.

Behavioral: Salud al Día

Usual Care

NO INTERVENTION

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.

Interventions

Salud al DíaBEHAVIORAL

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.

Salud al Día

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (4)

  • 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.

    PMID: 23381515BACKGROUND
  • 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.

    PMID: 23381511BACKGROUND
  • 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 Officials

  • Lisa R DeCamp, MD, MSPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2015

First Posted

January 6, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations