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Clinical Trials/NCT04298450
NCT04298450
Completed
Not Applicable

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

Centre for Addiction and Mental Health1 site in 1 country186 target enrollmentSeptember 21, 2020

Overview

Phase
Not Applicable
Intervention
Active SMS Intervention
Conditions
First Episode Psychosis
Sponsor
Centre for Addiction and Mental Health
Enrollment
186
Locations
1
Primary Endpoint
Attendance at the first early psychosis intervention (EPI) consultation appointment
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2020
End Date
December 20, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: Active SMS Intervention

Sham SMS

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

Intervention: Sham SMS

Outcomes

Primary Outcomes

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

  • System-level outcomes: days in mental health hospitalizations(6 months and 2 years)
  • System-level outcomes: continuous prescriptions(6 months and 2 years)
  • Service engagement - absolute drop-out(6 months)
  • Change in psychotic illness as measured by the Clinical Global Impression (CGI)(6 months)
  • System-level outcomes: outpatient mental health visits with primary care provider(6 months and 2 years)
  • Service engagement - Service Engagement Scale (SES)(6 months)
  • System-level outcomes: emergency department visits(6 months and 2 years)
  • System-level outcomes: outpatient mental health visits with psychiatrist(6 months and 2 years)
  • System-level outcomes: mental health hospitalizations(6 months and 2 years)
  • Health care costs(6 months and 2 years)
  • System-level outcomes: mortality(6 months and 2 years)

Study Sites (1)

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