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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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First Episode Psychosis Psychosis Psychotic Episode Psychoses, Affective Bipolar Disorder Depressive Psychosis Schizoaffective Disorder Schizophreniform Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Substance Induced Psychoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Immediately after study enrollment, participants will be randomized using an electronic data management system to the active or sham intervention. Randomization will be stratified by sex and referral source (main emergency department vs. Bridging Clinic vs. inpatient unit), using a computer algorithm to perform a blocked randomization assignment within strata.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Participants will not be notified of treatment assignment, but based on the nature of the intervention, they cannot be fully masked. Their care provider may know treatment assignment if disclosed by the participant, or if they get notified that the participant is in distress. Treatment assignment will be known by the research personnel involved in managing the intervention and the database linking participant information to study identification numbers. Treatment assignment may be known by a co-principal investigator providing clinical supervision for adverse or serious events. Research personnel involved in qualitative interviews will also be aware of treatment assignment since only individuals receiving the active treatment participate. The lead principal investigator and research personnel involved in the chart review (where the primary outcome will be extracted) and other analyses will be masked to treatment assignment.

Study Groups

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Active SMS Intervention

Participants assigned to the experimental arm will receive the active SMS intervention. Participants in the active intervention group who consent to participate will be asked to complete a web-based survey. Based on survey findings, purposive sampling will be used to select a subsample of 12 to 20 participants for qualitative interviews.

Group Type EXPERIMENTAL

Active SMS Intervention

Intervention Type 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

Participants assigned to the sham comparator will receive the sham SMS intervention. They will not be re-contacted.

Group Type SHAM_COMPARATOR

Sham SMS

Intervention Type BEHAVIORAL

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

Interventions

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Active SMS Intervention

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.

Intervention Type BEHAVIORAL

Sham SMS

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR