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NCT Number: NCT04298450

ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention

Psychosis is a disabling condition that typically has its onset in adolescence and early adulthood. Many young people with psychosis have difficulty navigating services or are reluctant to engage in treatment until their illness becomes an emergency. Consequently, nearly half of all new psychotic disorders are diagnosed in the emergency department (ED). Despite the rationale and evidence for early psychosis intervention (EPI), around half of youth do not access these services. The investigators will use short message service (SMS)/text messaging, a low-cost, low-complexity, youth-friendly approach, to improve transitions in care from the ED and related acute services to EPI services, investigating the intervention's effect on attendance at the first consultation appointment, longer term service engagement, and system-level outcomes. The investigators will also evaluate cost-effectiveness and user perspectives of the intervention.

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Key information

Conditions

First Episode Psychosis Affective Disorders, Psychotic Bipolar Disorder Bipolar and Related Disorders Chemically-Induced Disorders Depressive Psychosis Mental Disorders Mood Disorders Poisoning Psychoses, Affective Psychoses, Substance-Induced Psychosis Psychotic Disorders Psychotic Episode Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorders Substance Induced Psychoses Substance-Related Disorders

Age range

16 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H1, Canada

About this study

At the Centre for Addiction and Mental Health (CAMH), the investigators will recruit a consecutive series of 186 participants aged 16 to 29 referred by the CAMH ED and related acute services to CAMH's EPI program for a pragmatic randomized controlled trial of a 2-way SMS intervention involving reminders, psychoeducation, and check-ins. The primary outcome will be rate of attendance at the first consultation appointment assessed through chart reviews. Secondary outcomes will include indicators of long-term service engagement as well as symptoms and functioning 6 months following study enrollment and health service utilization for up to 2 years using administrative data from the Institute for Clinical Evaluative Sciences (ICES). Administrative data will be used for an economic analysis. Participants who receive the active intervention will be asked to complete a web-based survey evaluating their experience and a subgroup will be asked to participate in in-depth in-person qualitative interviews. Patients and family members with lived experience will be engaged in all aspects of the project, including shaping the intervention and study design.

The investigators hypothesize that the intervention will result in increased rate of attendance at the first EPI consultation appointment, as well as improved longer-term engagement in outpatient EPI services compared to the sham comparator. Demonstrating evidence that this low-cost, low-complexity, youth-friendly intervention improves engagement in outpatient EPI services has the potential to improve long-term outcomes for young people with psychosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have been referred by the Centre for Addiction and Mental Health (CAMH) emergency department or related acute services to the CAMH early psychosis intervention (EPI) program for suspected psychosis

Exclusion criteria

  • Inability to communicate in basic written English

Treatment and study plan

Active SMS Intervention

Behavioral

Welcome message letting participant know they will be contacted to book an appointment, followed by appointment reminders and other clinic information, psychoeducational materials, and a distress check-in with two-way feedback to their care team, all sent by SMS/text message at the participant's preferred time of day. If they indicate that they are in high distress, or they request, their care provider will be notified and asked to reach out to them. They will also receive crisis resources.The intervention will continue until the patient attends the first consultation appointment, or for up to 30 days if the patient does not attend, which reflects the program's practice of closing referrals for non-attending patients.

Sham SMS

Behavioral

Single welcome message letting participant know they will be contacted to book an appointment.

Primary outcomes

  1. Attendance at the first early psychosis intervention (EPI) consultation appointment

    Time frame: 30 days

    Attendance at the outpatient EPI consultation appointment will be assessed through chart reviews and categorized as: Yes - attended at original appointment time, Yes - attended at later date within 30 days, No - did not attend appointment within 30 days.

Secondary outcomes

  1. Service engagement - absolute drop-out

    Time frame: 6 months

    Absolute dropouts will be assessed through chart reviews and categorized as: Still in EPI treatment, Not accepted for EPI treatment, Accepted for EPI treatment but transitioned to local services, Accepted for EPI treatment but disengaged, or Other.

  2. Service engagement - Service Engagement Scale (SES)

    Time frame: 6 months

    The Service Engagement Scale is a brief, validated, clinician-rated tool designed to measure engagement with community mental health services. In 14 items, it assesses patients' availability for treatment, collaboration, help seeking behaviors and treatment adherence on a four-point Likert scale with total scores ranging from 0-42, and higher scores indicating difficulties in service engagement. The Service Engagement Scale total score and treatment adherence score will be extracted through chart reviews.

  3. Change in psychotic illness as measured by the Clinical Global Impression (CGI)

    Time frame: 6 months

    The Clinical Global Impression (CGI) is a clinician-rated measure of the patient's symptom severity and treatment response prior to and after initiating an intervention. It includes subscales for Severity and Improvement. The Clinical Global Impression - Severity scale ranges from 1-7 with higher scores indicating higher severity of illness, relative to other patients with the same diagnosis. The Clinical Global Impression - Improvement scale ranges from 1-7 with 4 indicating no change, 1 indicating very much improved, and 7 indicating very much worse relative to the patient's illness at the beginning of the intervention. Scores will be extracted through chart reviews.

  4. System-level outcomes: emergency department visits

    Time frame: 6 months and 2 years

    Number of emergency department visits, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)

  5. System-level outcomes: mental health hospitalizations

    Time frame: 6 months and 2 years

    Number of mental health hospitalizations, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)

  6. System-level outcomes: days in mental health hospitalizations

    Time frame: 6 months and 2 years

    Number of days in mental health hospitalizations, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)

  7. System-level outcomes: outpatient mental health visits with primary care provider

    Time frame: 6 months and 2 years

    Number of outpatient mental health visits with primary care provider, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)

  8. System-level outcomes: outpatient mental health visits with psychiatrist

    Time frame: 6 months and 2 years

    Number of outpatient mental health visits with psychiatrist, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)

  9. System-level outcomes: continuous prescriptions

    Time frame: 6 months and 2 years

    For participants with provincial drug coverage, continuous vs. non-continuous prescriptions for antipsychotic or mood stabilizer medications, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)

  10. System-level outcomes: mortality

    Time frame: 6 months and 2 years

    Mortality, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)

  11. Health care costs

    Time frame: 6 months and 2 years

    Total direct patient-level health care costs incurred by the public third-party payer based on administrative data held at the Institute for Clinical Evaluative Sciences (ICES) using an established costing algorithm

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Institute for Clinical Evaluative Sciences

Registry information

Official study title

ED to EPI: Using SMS (Text) Messaging to Improve the Transition From the Emergency Department to Early Psychosis Intervention for Young People With Psychosis

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2020
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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