Text MessagingNCT03235830
Text Messaging in Healthcare Utilization
A study of Text Messaging, run by St. Louis University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2015to 5 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English-speaking parents and/or guardians of newborns (aged 0 to 2 months)
- Receive primary care at Danis Pediatrics
- Must have reliable mobile phone service and be able to receive text messages
Who cannot join
- Non-English speaking caregivers
- No reliable text messaging service
About this study
Official title: Evaluation of Text Messaging as an Educational Method to Improve Healthcare Utilization
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.
Read the detailed description
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.
- Conditions
- Text Messaging
- Being tested
- Enhanced Standard of Care (ESoC) + Text, Enhanced Standard of Care (ESoC)
- Keywords
- Healthcare utilization, Health literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Standard of Care (ESoC) + TextBehavioural
See above in arm/group description
Enhanced Standard of Care (ESoC)Behavioural
See above in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard of Care (ESoC) | Active comparator | 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. Receives: Behavioral: Enhanced Standard of Care (ESoC) |
| Enhanced Standard of Care (ESoC) + Text | Experimental | 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. Receives: Behavioral: Enhanced Standard of Care (ESoC) + Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency department use
Number of emergency department visits
Measured: 6 months post end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start28 Jan 2015
- Primary completion5 Aug 2016
- Study completion5 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Text MessagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew A. Broom, MD, FAAP, St. Louis University
- Investigators
- Matt Broom, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235830
- Sponsor's protocol ID
- 25160
- Status last verified
- Jul 2017
- First submitted
- 30 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27965378Yin 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.
PubMed 19861483DeWalt 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.
PubMed 19861480Morrison 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.
PubMed 24767784DeAngelis 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.
PubMed 3843434Salami 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.
PubMed 22193700Morgan 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.
PubMed 24127700Yoffe 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.
PubMed 21305425Fieldston 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.
PubMed 23426249Zandieh 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.
PubMed 19382324
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Text Messaging as an Educational Method to Improve Healthcare Utilization
- ClinicalTrials.gov ID
- NCT03235830
- Acronym / sponsor ID
- 25160
- Conditions
- Text Messaging
- Keywords
- Healthcare utilization, Health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 28 Jan 2015 (actual)
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard of Care (ESoC) | Active comparator | Behavioral: Enhanced Standard of Care (ESoC)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. |
| Enhanced Standard of Care (ESoC) + Text | Experimental | Behavioral: Enhanced Standard of Care (ESoC) + TextSubjects 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. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking parents and/or guardians of newborns (aged 0 to 2 months)
- Receive primary care at Danis Pediatrics
- Must have reliable mobile phone service and be able to receive text messages
Key exclusion criteria (2 listed)
- Non-English speaking caregivers
- No reliable text messaging service
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Standard of Care (ESoC) + TextSee above in arm/group description | Behavioural | Enhanced Standard of Care (ESoC) + Text |
| Enhanced Standard of Care (ESoC)See above in arm/group description | Behavioural | Enhanced Standard of Care (ESoC) |
Primary outcome
Emergency department use
Time frame: 6 months post end of intervention
Number of emergency department visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Background: PubMed 27965378Hodgkinson 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.
- Background: PubMed 19861483Yin 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.
- Background: PubMed 19861480DeWalt 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.
- Background: PubMed 24767784Morrison 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.
- Background: PubMed 3843434DeAngelis 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.
- Background: PubMed 22193700Salami 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.
- Background: PubMed 24127700Morgan 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.
- Background: PubMed 21305425Yoffe 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.
- Background: PubMed 23426249Fieldston 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.
- Background: PubMed 19382324Zandieh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Broom, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
A study of Text Messaging, run by St. Louis University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency department use (time frame: 6 months post end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235830, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017; AzTrials last refreshed its copy on 28 Oct 2026.