<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235830</url>
  </required_header>
  <id_info>
    <org_study_id>25160</org_study_id>
    <nct_id>NCT03235830</nct_id>
  </id_info>
  <brief_title>Text Messaging in Healthcare Utilization</brief_title>
  <official_title>Evaluation of Text Messaging as an Educational Method to Improve Healthcare Utilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal is to assess the feasibility and effectiveness of using text messages as an&#xD;
      educational tool in order to improve health care utilization among the parents and caregivers&#xD;
      of newborns; in particular, the investigators seek to understand how educational text&#xD;
      messages counteract the effects of low health literacy as it relates to non-urgent visits to&#xD;
      the emergency department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Health care utilization is a issue germane to health care providers, insurers, and patients&#xD;
      alike. Reducing non-urgent visits to the emergency department (ED) and primary care providers&#xD;
      can improve both the quality and cost of care. There are barriers, however, to educating&#xD;
      patients about more appropriate health care utilization. Low health literacy is one such&#xD;
      barrier, particularly for caregivers of pediatric patients. Research reveals that up to half&#xD;
      of caregivers seeking treatment at the ED have low levels of health literacy; levels that can&#xD;
      make it more difficult to not only make sound decisions, but also provide effective follow-up&#xD;
      care. Moreover, low levels of literacy perpetuate a cycle of seeking care for non-urgent&#xD;
      conditions. Education initiatives designed to counteract the effects of low health literacy&#xD;
      on health care utilization have been shown to reduce non-urgent ED visits by as much as 80%.&#xD;
      These education interventions, while effective, are complex, costly, or time-intensive. For&#xD;
      example, home visits by a nurse, parenting classes, and video tools are all shown to reduce&#xD;
      non-urgent ED use, but each poses a unique problem for implementation in high volume, urban,&#xD;
      pediatric primary care clinic. To date, no study has examined the effectiveness of text&#xD;
      messaging as a possible avenue for educating caregivers about issues related to health care&#xD;
      utilization. Text messaging has been shown to support behavioral change, and represents a&#xD;
      fast and cost-effective alternative to more labor-intensive and expensive alternatives.&#xD;
&#xD;
      Danis Pediatrics, the pediatric practice of Saint Louis University physicians within SSM&#xD;
      Cardinal Glennon Children's Medical Center (CGCMC), serves as a medical home to primarily&#xD;
      urban, low-income patients. In the first half of 2014 alone, there were 5259 visits to the ED&#xD;
      by caregivers of patients &lt; 13 months of age. Of those, 520 Danis Pediatrics patients&#xD;
      accounted for 919 of those visits. In short, just under 1 in 5 visits to the CGCMC ED is a&#xD;
      Danis patient, and Danis patients visit the ED approximately 2 times in the first year.&#xD;
      Previous studies of patients at Danis Pediatrics suggest that this population has access to&#xD;
      text messaging and is interested in receiving healthcare-related information from their&#xD;
      pediatric provider.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2015</start_date>
  <completion_date type="Actual">August 5, 2016</completion_date>
  <primary_completion_date type="Actual">August 5, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Caregivers of newborns (0-10 weeks of age) whose child received primary care at an urban, academic primary care clinic were approached for participation. Inclusion required reliable cellular and text messaging service and the ability to speak English. At intake, caregivers completed a brief demographic survey and were given a researcher-administered health literacy test called the Newest Vital Sign (NVS).&#xD;
Following the initial visit where consent, demographic information, and the NVS were obtained, participants were randomly assigned, by computer, to one of two groups: (1) caregiver receives only enhanced standard of care documents (ESoC), or (2) caregiver receives text messages in addition to enhanced standard of care documents (ESoC + Text). Both research team members and participants were blind to group assignment at the time of consent and enrollment. Clinic staff and providers were not aware of group assignment unless revealed by the participant.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Following the initial visit where consent, demographic information, and the NVS were obtained, participants were randomly assigned, by computer, to one of two groups: (1) caregiver receives only enhanced standard of care documents (ESoC), or (2) caregiver receives text messages in addition to enhanced standard of care documents (ESoC + Text). Both research team members and participants were blind to group assignment at the time of consent and enrollment. Clinic staff and providers were not aware of group assignment unless revealed by the participant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Emergency department use</measure>
    <time_frame>6 months post end of intervention</time_frame>
    <description>Number of emergency department visits</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">231</enrollment>
  <condition>Text Messaging</condition>
  <arm_group>
    <arm_group_label>Enhanced Standard of Care (ESoC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects received a condensed version of the American Academy of Pediatrics Bright Futures content at their scheduled well-child visits though 6 months of age. The enhanced standard of care (ESoC) materials were added, by members of the research team, to registration packets and were given to caregivers by clinic staff, who were all trained to give the ESoC. For any patients who did not receive ESoC materials at their visit, an age-appropriate ESoC was mailed to the caregiver.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Standard of Care (ESoC) + Text</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects assigned to the text messaging intervention group received four educational messages per week until their child was 6 months of age in addition to the ESoC documents. The text messages directly reflected Bright Futures and ESoC content, addressing infant development, safety, care, and the most common causes of nonurgent visits in the first year. Bright Futures content was adapted both for language and length to accommodate character limits and the patient population.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Standard of Care (ESoC) + Text</intervention_name>
    <description>See above in arm/group description</description>
    <arm_group_label>Enhanced Standard of Care (ESoC) + Text</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Standard of Care (ESoC)</intervention_name>
    <description>See above in arm/group description</description>
    <arm_group_label>Enhanced Standard of Care (ESoC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking parents and/or guardians of newborns (aged 0 to 2 months)&#xD;
&#xD;
          -  Receive primary care at Danis Pediatrics&#xD;
&#xD;
          -  Must have reliable mobile phone service and be able to receive text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking caregivers&#xD;
&#xD;
          -  No reliable text messaging service&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matt Broom, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <reference>
    <citation>Hodgkinson S, Godoy L, Beers LS, Lewin A. Improving Mental Health Access for Low-Income Children and Families in the Primary Care Setting. Pediatrics. 2017 Jan;139(1):e20151175. doi: 10.1542/peds.2015-1175. Epub 2016 Dec 12.</citation>
    <PMID>27965378</PMID>
  </reference>
  <reference>
    <citation>Yin HS, Johnson M, Mendelsohn AL, Abrams MA, Sanders LM, Dreyer BP. The health literacy of parents in the United States: a nationally representative study. Pediatrics. 2009 Nov;124 Suppl 3:S289-98. doi: 10.1542/peds.2009-1162E.</citation>
    <PMID>19861483</PMID>
  </reference>
  <reference>
    <citation>DeWalt DA, Hink A. Health literacy and child health outcomes: a systematic review of the literature. Pediatrics. 2009 Nov;124 Suppl 3:S265-74. doi: 10.1542/peds.2009-1162B.</citation>
    <PMID>19861480</PMID>
  </reference>
  <reference>
    <citation>Morrison AK, Schapira MM, Gorelick MH, Hoffmann RG, Brousseau DC. Low caregiver health literacy is associated with higher pediatric emergency department use and nonurgent visits. Acad Pediatr. 2014 May-Jun;14(3):309-14. doi: 10.1016/j.acap.2014.01.004.</citation>
    <PMID>24767784</PMID>
  </reference>
  <reference>
    <citation>DeAngelis C, Fosarelli P, Duggan AK. Use of the emergency department by children enrolled in a primary care clinic. Pediatr Emerg Care. 1985 Jun;1(2):61-5.</citation>
    <PMID>3843434</PMID>
  </reference>
  <reference>
    <citation>Salami O, Salvador J, Vega R. Reasons for nonurgent pediatric emergency department visits: perceptions of health care providers and caregivers. Pediatr Emerg Care. 2012 Jan;28(1):43-6. doi: 10.1097/PEC.0b013e31823f2412.</citation>
    <PMID>22193700</PMID>
  </reference>
  <reference>
    <citation>Morgan SR, Chang AM, Alqatari M, Pines JM. Non-emergency department interventions to reduce ED utilization: a systematic review. Acad Emerg Med. 2013 Oct;20(10):969-85. doi: 10.1111/acem.12219.</citation>
    <PMID>24127700</PMID>
  </reference>
  <reference>
    <citation>Yoffe SJ, Moore RW, Gibson JO, Dadfar NM, McKay RL, McClellan DA, Huang TY. A reduction in emergency department use by children from a parent educational intervention. Fam Med. 2011 Feb;43(2):106-11.</citation>
    <PMID>21305425</PMID>
  </reference>
  <reference>
    <citation>Fieldston ES, Nadel FM, Alpern ER, Fiks AG, Shea JA, Alessandrini EA. Effects of an education and training intervention on caregiver knowledge of nonurgent pediatric complaints and on child health services utilization. Pediatr Emerg Care. 2013 Mar;29(3):331-6. doi: 10.1097/PEC.0b013e31828512c7.</citation>
    <PMID>23426249</PMID>
  </reference>
  <reference>
    <citation>Zandieh SO, Gershel JC, Briggs WM, Mancuso CA, Kuder JM. Revisiting predictors of parental health care-seeking behaviors for nonurgent conditions at one inner-city hospital. Pediatr Emerg Care. 2009 Apr;25(4):238-243. doi: 10.1097/pec.0b013e31819e350e.</citation>
    <PMID>19382324</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Matthew A. Broom, MD, FAAP</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Healthcare utilization</keyword>
  <keyword>Health literacy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03235830/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03235830/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03235830/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235830
org study id: 25160
nct id: NCT03235830
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal is to assess the feasibility and effectiveness of using text messages as an
      educational tool in order to improve health care utilization among the parents and caregivers
      of newborns; in particular, the investigators seek to understand how educational text
      messages counteract the effects of low health literacy as it relates to non-urgent visits to
      the emergency department.
Health care utilization is a issue germane to health care providers, insurers, and patients
      alike. Reducing non-urgent visits to the emergency department (ED) and primary care providers
      can improve both the quality and cost of care. There are barriers, however, to educating
      patients about more appropriate health care utilization. Low health literacy is one such
      barrier, particularly for caregivers of pediatric patients. Research reveals that up to half
      of caregivers seeking treatment at the ED have low levels of health literacy; levels that can
      make it more difficult to not only make sound decisions, but also provide effective follow-up
      care. Moreover, low levels of literacy perpetuate a cycle of seeking care for non-urgent
      conditions. Education initiatives designed to counteract the effects of low health literacy
      on health care utilization have been shown to reduce non-urgent ED visits by as much as 80%.
      These education interventions, while effective, are complex, costly, or time-intensive. For
      example, home visits by a nurse, parenting classes, and video tools are all shown to reduce
      non-urgent ED use, but each poses a unique problem for implementation in high volume, urban,
      pediatric primary care clinic. To date, no study has examined the effectiveness of text
      messaging as a possible avenue for educating caregivers about issues related to health care
      utilization. Text messaging has been shown to support behavioral change, and represents a
      fast and cost-effective alternative to more labor-intensive and expensive alternatives.

      Danis Pediatrics, the pediatric practice of Saint Louis University physicians within SSM
      Cardinal Glennon Children's Medical Center (CGCMC), serves as a medical home to primarily
      urban, low-income patients. In the first half of 2014 alone, there were 5259 visits to the ED
      by caregivers of patients < 13 months of age. Of those, 520 Danis Pediatrics patients
      accounted for 919 of those visits. In short, just under 1 in 5 visits to the CGCMC ED is a
      Danis patient, and Danis patients visit the ED approximately 2 times in the first year.
      Previous studies of patients at Danis Pediatrics suggest that this population has access to
      text messaging and is interested in receiving healthcare-related information from their
      pediatric provider.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Caregivers of newborns (0-10 weeks of age) whose child received primary care at an urban, academic primary care clinic were approached for participation. Inclusion required reliable cellular and text messaging service and the ability to speak English. At intake, caregivers completed a brief demographic survey and were given a researcher-administered health literacy test called the Newest Vital Sign (NVS).
Following the initial visit where consent, demographic information, and the NVS were obtained, participants were randomly assigned, by computer, to one of two groups: (1) caregiver receives only enhanced standard of care documents (ESoC), or (2) caregiver receives text messages in addition to enhanced standard of care documents (ESoC + Text). Both research team members and participants were blind to group assignment at the time of consent and enrollment. Clinic staff and providers were not aware of group assignment unless revealed by the participant.
primary purpose: Health Services Research
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: Following the initial visit where consent, demographic information, and the NVS were obtained, participants were randomly assigned, by computer, to one of two groups: (1) caregiver receives only enhanced standard of care documents (ESoC), or (2) caregiver receives text messages in addition to enhanced standard of care documents (ESoC + Text). Both research team members and participants were blind to group assignment at the time of consent and enrollment. Clinic staff and providers were not aware of group assignment unless revealed by the participant.
measure: Emergency department use
time frame: 6 months post end of intervention
description: Number of emergency department visits
arm group label: Enhanced Standard of Care (ESoC)
arm group type: Active Comparator
description: Subjects received a condensed version of the American Academy of Pediatrics Bright Futures content at their scheduled well-child visits though 6 months of age. The enhanced standard of care (ESoC) materials were added, by members of the research team, to registration packets and were given to caregivers by clinic staff, who were all trained to give the ESoC. For any patients who did not receive ESoC materials at their visit, an age-appropriate ESoC was mailed to the caregiver.
arm group label: Enhanced Standard of Care (ESoC) + Text
arm group type: Experimental
description: Subjects assigned to the text messaging intervention group received four educational messages per week until their child was 6 months of age in addition to the ESoC documents. The text messages directly reflected Bright Futures and ESoC content, addressing infant development, safety, care, and the most common causes of nonurgent visits in the first year. Bright Futures content was adapted both for language and length to accommodate character limits and the patient population.
intervention type: Behavioral
intervention name: Enhanced Standard of Care (ESoC) + Text
description: See above in arm/group description
arm group label: Enhanced Standard of Care (ESoC) + Text
intervention type: Behavioral
intervention name: Enhanced Standard of Care (ESoC)
description: See above in arm/group description
arm group label: Enhanced Standard of Care (ESoC)
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matt Broom, MD
role: Principal Investigator
affiliation: St. Louis University
citation: Hodgkinson S, Godoy L, Beers LS, Lewin A. Improving Mental Health Access for Low-Income Children and Families in the Primary Care Setting. Pediatrics. 2017 Jan;139(1):e20151175. doi: 10.1542/peds.2015-1175. Epub 2016 Dec 12.
PMID: 27965378
citation: Yin HS, Johnson M, Mendelsohn AL, Abrams MA, Sanders LM, Dreyer BP. The health literacy of parents in the United States: a nationally representative study. Pediatrics. 2009 Nov;124 Suppl 3:S289-98. doi: 10.1542/peds.2009-1162E.
PMID: 19861483
citation: DeWalt DA, Hink A. Health literacy and child health outcomes: a systematic review of the literature. Pediatrics. 2009 Nov;124 Suppl 3:S265-74. doi: 10.1542/peds.2009-1162B.
PMID: 19861480
citation: Morrison AK, Schapira MM, Gorelick MH, Hoffmann RG, Brousseau DC. Low caregiver health literacy is associated with higher pediatric emergency department use and nonurgent visits. Acad Pediatr. 2014 May-Jun;14(3):309-14. doi: 10.1016/j.acap.2014.01.004.
PMID: 24767784
citation: DeAngelis C, Fosarelli P, Duggan AK. Use of the emergency department by children enrolled in a primary care clinic. Pediatr Emerg Care. 1985 Jun;1(2):61-5.
PMID: 3843434
citation: Salami O, Salvador J, Vega R. Reasons for nonurgent pediatric emergency department visits: perceptions of health care providers and caregivers. Pediatr Emerg Care. 2012 Jan;28(1):43-6. doi: 10.1097/PEC.0b013e31823f2412.
PMID: 22193700
citation: Morgan SR, Chang AM, Alqatari M, Pines JM. Non-emergency department interventions to reduce ED utilization: a systematic review. Acad Emerg Med. 2013 Oct;20(10):969-85. doi: 10.1111/acem.12219.
PMID: 24127700
citation: Yoffe SJ, Moore RW, Gibson JO, Dadfar NM, McKay RL, McClellan DA, Huang TY. A reduction in emergency department use by children from a parent educational intervention. Fam Med. 2011 Feb;43(2):106-11.
PMID: 21305425
citation: Fieldston ES, Nadel FM, Alpern ER, Fiks AG, Shea JA, Alessandrini EA. Effects of an education and training intervention on caregiver knowledge of nonurgent pediatric complaints and on child health services utilization. Pediatr Emerg Care. 2013 Mar;29(3):331-6. doi: 10.1097/PEC.0b013e31828512c7.
PMID: 23426249
citation: Zandieh SO, Gershel JC, Briggs WM, Mancuso CA, Kuder JM. Revisiting predictors of parental health care-seeking behaviors for nonurgent conditions at one inner-city hospital. Pediatr Emerg Care. 2009 Apr;25(4):238-243. doi: 10.1097/pec.0b013e31819e350e.
PMID: 19382324
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Matthew A. Broom, MD, FAAP
investigator title: Associate Professor of Pediatrics
sharing ipd: No
provided document: 
provided document: 
provided document: 