ED to EPI: Using SMS to Improve the Transition from the Emergency Department to Early Psychosis Intervention
- Conditions
- First Episode PsychosisPsychosisBipolar DisorderSchizophreniform DisordersSchizoaffective DisorderSchizophreniaSubstance Induced PsychosesPsychotic EpisodePsychoses, AffectiveDepressive Psychosis
- Interventions
- Behavioral: Active SMS InterventionBehavioral: Sham SMS
- Registration Number
- NCT04298450
- Lead Sponsor
- Centre for Addiction and Mental Health
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 186
- 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
- Inability to communicate in basic written English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active SMS Intervention 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. Sham SMS Sham SMS Participants assigned to the sham comparator will receive the sham SMS intervention. They will not be re-contacted.
- Primary Outcome Measures
Name Time Method Attendance at the first early psychosis intervention (EPI) consultation appointment 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 Outcome Measures
Name Time Method System-level outcomes: days in mental health hospitalizations 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)
System-level outcomes: mental health hospitalizations 6 months and 2 years Number of mental health hospitalizations, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Health care costs 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
System-level outcomes: continuous prescriptions 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)
System-level outcomes: outpatient mental health visits with primary care provider 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)
Service engagement - absolute drop-out 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.
Change in psychotic illness as measured by the Clinical Global Impression (CGI) 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.
Service engagement - Service Engagement Scale (SES) 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.
System-level outcomes: emergency department visits 6 months and 2 years Number of emergency department visits, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
System-level outcomes: outpatient mental health visits with psychiatrist 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)
System-level outcomes: mortality 6 months and 2 years Mortality, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Trial Locations
- Locations (1)
Centre for Addiction and Mental Health
🇨🇦Toronto, Ontario, Canada