Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT02744326
Study type Interventional
Source Children's Hospitals and Clinics of Minnesota
Contact Gretchen Cutler, PhD
Email Gretchen.cutler@childrensmn.org
Status Not yet recruiting
Phase N/A
Start date April 2016
Completion date April 2017

See also
  Status Clinical Trial Phase
Recruiting NCT05639855 - Study on Mental Health-related Stigma N/A
Completed NCT03042832 - Testing the Leadership and Organizational Change for Implementation (LOCI) Intervention N/A
Completed NCT03007940 - Using NIATx Strategies to Implement Integrated Services in Routine Care N/A
Active, not recruiting NCT05726617 - Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders N/A
Active, not recruiting NCT04090723 - Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum N/A
Enrolling by invitation NCT05523843 - Pilot Study on the Clinical Utility of the Tulsa Life Chart
Recruiting NCT04299789 - Military Service Identification Tool
Recruiting NCT05258578 - Tele-BARICARE to Manage COVID-19-Related Distress N/A
Recruiting NCT06190184 - Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions N/A
Completed NCT04649736 - Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients N/A
Not yet recruiting NCT05097807 - The Impact of Shallow Reading in Social Media N/A
Active, not recruiting NCT03013595 - The MILESTONE Study: Improving Transition From Child to Adult Mental Health Care N/A
Active, not recruiting NCT05092542 - Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers N/A
Completed NCT05274958 - Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures N/A
Completed NCT05303870 - Impact of Psychological Therapies on Emergency Medical Patients N/A
Recruiting NCT04841655 - Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment
Completed NCT05213182 - Peer Support Intervention to Mitigate Social Isolation and Stigma of Adolescent Motherhood in Zimbabwe Phase 2
Completed NCT05638516 - Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product N/A
Completed NCT06311084 - IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People N/A
Active, not recruiting NCT04600414 - Collaborating to Heal Addiction and Mental Health in Primary Care N/A