Clinical trial NCT04298450: ED to EPI: Using SMS to Improve the Transition from the Emergency Department to Early Psychosis Intervention
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Keywords: Early Psychosis Intervention
Mobile Health Intervention
Patient and Family Engagement
Pragmatic Clinical Trials
Transitions in Care
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Institute for Clinical Evaluative Sciences
First posted: 2020-03-06
Enrollment: 186
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance at the first early psychosis intervention (EPI) consultation appointment
timeFrame: 30 days
Secondary outcomes:
measure: Service engagement - absolute drop-out
timeFrame: 6 months
measure: Service engagement - Service Engagement Scale (SES)
timeFrame: 6 months
measure: Change in psychotic illness as measured by the Clinical Global Impression (CGI)
timeFrame: 6 months
measure: System-level outcomes: emergency department visits
timeFrame: 6 months and 2 years
measure: System-level outcomes: mental health hospitalizations
timeFrame: 6 months and 2 years
measure: System-level outcomes: days in mental health hospitalizations
timeFrame: 6 months and 2 years
measure: System-level outcomes: outpatient mental health visits with primary care provider
timeFrame: 6 months and 2 years
measure: System-level outcomes: outpatient mental health visits with psychiatrist
timeFrame: 6 months and 2 years
measure: System-level outcomes: continuous prescriptions
timeFrame: 6 months and 2 years
measure: System-level outcomes: mortality
timeFrame: 6 months and 2 years
measure: Health care costs
timeFrame: 6 months and 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Nicole Kozloff, MD, SM
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: George Foussias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Aristotle N Voineskos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Vicky Stergiopoulos, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Albert HC Wong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polillo A, Foussias G, Wong AHC, Ampofo A, Stergiopoulos V, Anderson KK, Bromley S, D'Arcey J, de Oliveira C, Duda L, Henderson J, Kidd S, Kurdyak P, Wang W, Zaheer J, Voineskos AN, Kozloff N. ED to EPI: protocol for a pragmatic randomised controlled trial of an SMS (text) messaging intervention to improve the transition from the emergency department to early psychosis intervention for young people with psychosis. BMJ Open. 2020 Dec 17;10(12):e042751. doi: 10.1136/bmjopen-2020-042751.