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Trial record 11 of 201 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Outcomes in Youth Visiting the ED With Mental Health Issues: a Pilot Text Based Intervention

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ClinicalTrials.gov Identifier: NCT02744326
Recruitment Status : Not yet recruiting
First Posted : April 20, 2016
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The investigators will conduct a prospective study and a randomized controlled trial (RCT) involving children and adolescents presenting with a primary mental health (MH) concern to the emergency departments (EDs) of Children's Hospitals and Clinics of Minnesota (CH). The investigators will characterize the primary MH concerns of 800 patients and assess their baseline access to and utilization of external resources. All enrolled patients will be followed 3-months after their initial visit to determine ED revisits and identify factors associated with connection to outpatient care. The RCT portion of the study will involve 200 patients discharged from the ED with a referral to an outpatient MH provider, and will test a novel text-message communication method by which parents/caregivers can be encouraged to complete follow-up care for their child. The experimental group will receive tailored text message reminders regarding follow-up appointments.

Relevance: Pediatric ED visits for MH issues are increasing, but the current system of managing these patients is not optimal. More information is needed to accelerate change and to efficiently invest in improving services available to MH patients. Specifically, information is needed on which MH populations need to be targeted, and on simple, reproducible interventions which improve connection with community resources. The proposed study will collect vital information needed to develop programs that improve outcomes and reduce ED revisits in pediatric patients visiting the EDs at CH with primary MH concerns, and will set the stage for future work focused on improving core and outcomes for MH youth.


Condition or disease Intervention/treatment
Mental Health Disorder Mental and Behavioral Disorder Self-inflicted Injury Behavioral: Text message reminders

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Detailed Description:

Background/Significance The number of youth visiting the ED with MH issues has risen dramatically in the last decade.1 EDs have become a safety net for a strained mental health system that is under resourced and lacks adequate services to meet demands at the impatient and outpatient level.2 EDs bear a high burden of caring for children and adolescents with acute psychiatric illness, and pediatric patients with MH-related visits require substantial ED resources.2,3 Visits to the ED for MH are longer, more likely to be triaged to urgent evaluation and result in more admissions or transfers compared to visits for other reasons.4,5 ED revisits are also are also common in pediatric MH patients, with a recent study finding return rates of 6-9% within 72 hours, and return rates around 30% over a 4-year study period.6 ED visits for children and adolescents with MH concerns are resource intensive, and further research will be crucial for improving the management of these patients.2,3

Information lacking on resources needed by MH diagnostic subgroup:

MH issues encountered by ED physicians cover a broad range of diagnoses. Bardach et al. examined MH hospitalizations and identified the following as the most common diagnostic subgroups: depression, bipolar disorder, psychosis, externalizing disorder, anxiety disorder, ADHD, eating disorder, substance abuse, reaction disorder and autism.7 ED visits for MH concerns are often thought to mainly involve suicide attempts, self-harm behavior or psychosis, but a recent study of a large urban pediatric ED found that almost half of the visits were for behavioral problems.8 Preliminary data has described that almost half of the behavioral assessments done at CH in 2013 were on individuals with developmental disorders (i.e. autism spectrum disorders). The number of MH ED visits for behavioral issues is growing, but there is limited information regarding this population.8 Overall, the ED experience has not been well documented based upon diagnostic subgroup, but there are critical differences in MH patients depending on their primary concern, specifically connection to outpatient resources and risk of ED revisit.8,9 In order to more efficiently help MH youth it is crucial to obtain information regarding services, and how this differs by diagnostic subgroup.8

Text-messaging to improve MH referral follow-up:

The ED represents a suboptimal care setting for MH youth but does provide an important opportunity to identify children and adolescents in crisis and connect them with external resources.8 Unfortunately, successful follow-up with MH resources by ED patients has been shown to be low, with some studies finding follow-up rates below 30%.10,11 A recent study found that 66% of patients visiting the ED with suicidal behaviors successfully followed up with a mental health provider, a more positive number, but one that still shows a large need for improvement.12 Strategies are needed to improve successful follow-up with MH outpatient referrals as failure to comply with ED discharge guidelines could result in worsening of symptoms and return visits to the ED. While ED providers have a unique opportunity to identify MH youth and provide referrals, they also have limited time and resources. If an intervention is to be incorporated into usual care in the ED, it must be simple, efficient, and easy to replicate. Automated text messaging reminders have been shown to increase attendance to healthcare appointments.13 Over 90% of Americans reported owning a cell phone in 2013, and 81% report using their cell phone to send or receive text messages.14 In addition, the cost and personnel requirements needed to implement an automated text message based system are low, making this a unique intervention technique that could be easily incorporated into usual care in any ED.15 A recent study found that automated text message appointment reminders improved follow-up attendance to primary or specialty care in adult ED patients.15 Additional research is needed to examine the potential of a text message strategy to increase attendance to follow-up appointments in a diverse population of youth visiting the ED the MH concerns.

Conclusion:

The overall goal of the proposed study is to collect vital information needed to develop programs that improve outcomes and reduce revisits in children and adolescents who present to the ED with primary MH concerns. Pediatric ED visits for MH issues are increasing.1 The current system is in need of improvement, yet more information is needed to accelerate change, including information on which MH populations need to be targeted, and on simple, reproducible interventions which improve connection with community resources. The proposed project will collect data on a cohort of MH patients from two large urban EDs to characterize diagnostic subgroups and current access to care, will follow all patients 3-months post visit to identify risk factors for ED revisits and barriers to outpatient care, and will test a novel text message reminder system focused on improving the linkage of MH patients with follow-up referrals. The EDs of CH provide the vast majority of emergent pediatric care within the Twin City Metro area, and a substantial proportion of these visits are mental health related. The proposed project provides a unique opportunity to meet the study goals, and sets the stage for future work focused on improving care and outcomes for MH youth.

Research Question

  1. Which pediatric MH patients visiting the ED at CH are in the most need of additional support (lowest baseline access to and utilization of outpatient care, highest risk of ED revisit, lowest follow-up with outpatient referrals)?
  2. Does a targeted text-message communication method improve compliance with ED discharge in pediatric MH patients?

Specific Aims and Hypotheses

  1. Characterize the primary MH concerns of children and adolescent visiting the EDs of CH and assesses their baseline access to and utilization of external MH resources.

    Hypothesis: MH patients will represent several subgroups of primary concerns and these subgroups will differ in their baseline connection to and utilization of community resources.

  2. Follow all enrolled MH patients post visit to determine factors associated with ED revisits and barriers to outpatient care.

    Hypothesis: Patients who have public or no insurance, who visit the ED with self-inflicted injuries, or who identify multiple barriers to connecting with outpatient MH care will have higher rates of ED revisits.

  3. Develop and test a novel text-message communication method focused on increasing rates of discharge referral follow-up in ED patients with MH concerns.

Hypothesis: Patients randomized to a text-message communication system will have higher rates of follow-up care and lower rates of ED revisit compared to patients who receive usual care


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Outcomes for Youth Visiting the Emergency Department With Mental Health Issues
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Text message reminder group
A subset of patients discharged from the ED with an outpatient referral will be randomized to receive text message reminders to attend or schedule a follow-up outpatient referral.
Behavioral: Text message reminders
Patients assigned to the intervention group will receive a series of 7 to 10 text message reminders to schedule or attend their follow-up appointment.
No Intervention: Usual Care group
A subset of patients discharged from the ED with an outpatient referral will be randomized to receive the usual standard of care.


Outcome Measures

Primary Outcome Measures :
  1. Outpatient care post Emergency Department Visit [ Time Frame: 3 months ]
    Did the patient attend follow-up outpatient care visit(s) after visiting the ED


Secondary Outcome Measures :
  1. Emergency Department return visit [ Time Frame: 3 months ]
    Did the patient return to the Emergency Department for a mental health related reason, in the 3 months following the initial visit.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 0-17.999 years
  • Assessed by social work in the ED for mental health concern
  • Parent present and able to consent
  • Phone able to receive text messages (for RCT portion only)

Exclusion Criteria:

  • Non-English Speaking parents
  • Medical condition preventing enrollment, such as a condition which requires immediated hospital procedures or admission
  • Suspected abuse
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744326


Contacts
Contact: Gretchen Cutler, PhD Gretchen.cutler@childrensmn.org
Contact: Kristin Frenn, MPH kristin.frenn@childrensmn.org

Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Gretchen Cutler, PhD Children's Hospitals and Clinics of Minnesota
More Information

Publications:

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT02744326     History of Changes
Other Study ID Numbers: 1603-026
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Problem Behavior
Mental Disorders
Self Mutilation
Pathologic Processes
Behavioral Symptoms
Wounds and Injuries
Self-Injurious Behavior