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

Primary Purpose

First Episode Psychosis, Psychosis, Psychotic Episode

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active SMS Intervention
Sham SMS
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for First Episode Psychosis focused on measuring Early Psychosis Intervention, Mobile Health Intervention, Patient and Family Engagement, Pragmatic Clinical Trials, Transitions in Care

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active SMS Intervention

Sham SMS

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Service engagement - absolute drop-out
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.
Service engagement - Service Engagement Scale (SES)
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.
Change in psychotic illness as measured by the Clinical Global Impression (CGI)
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.
System-level outcomes: emergency department visits
Number of emergency department visits, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
System-level outcomes: mental health hospitalizations
Number of mental health hospitalizations, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
System-level outcomes: days in mental health hospitalizations
Number of days in mental health hospitalizations, 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
Number of outpatient mental health visits with primary care provider, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
System-level outcomes: outpatient mental health visits with psychiatrist
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: continuous prescriptions
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: mortality
Mortality, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Health care costs
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

Full Information

First Posted
March 3, 2020
Last Updated
September 13, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04298450
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active SMS Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham SMS
Arm Type
Sham Comparator
Arm Description
Participants assigned to the sham comparator will receive the sham SMS intervention. They will not be re-contacted.
Intervention Type
Behavioral
Intervention Name(s)
Active SMS Intervention
Intervention Description
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
Intervention Name(s)
Sham SMS
Intervention Description
Single welcome message letting participant know they will be contacted to book an appointment.
Primary Outcome Measure Information:
Title
Attendance at the first early psychosis intervention (EPI) consultation appointment
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Service engagement - absolute drop-out
Description
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.
Time Frame
6 months
Title
Service engagement - Service Engagement Scale (SES)
Description
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.
Time Frame
6 months
Title
Change in psychotic illness as measured by the Clinical Global Impression (CGI)
Description
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.
Time Frame
6 months
Title
System-level outcomes: emergency department visits
Description
Number of emergency department visits, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Time Frame
6 months and 2 years
Title
System-level outcomes: mental health hospitalizations
Description
Number of mental health hospitalizations, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Time Frame
6 months and 2 years
Title
System-level outcomes: days in mental health hospitalizations
Description
Number of days in mental health hospitalizations, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Time Frame
6 months and 2 years
Title
System-level outcomes: outpatient mental health visits with primary care provider
Description
Number of outpatient mental health visits with primary care provider, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Time Frame
6 months and 2 years
Title
System-level outcomes: outpatient mental health visits with psychiatrist
Description
Number of outpatient mental health visits with psychiatrist, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Time Frame
6 months and 2 years
Title
System-level outcomes: continuous prescriptions
Description
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)
Time Frame
6 months and 2 years
Title
System-level outcomes: mortality
Description
Mortality, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
Time Frame
6 months and 2 years
Title
Health care costs
Description
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
Time Frame
6 months and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Kozloff, MD, SM
Phone
4165358501
Ext
30769
Email
n.kozloff@mail.utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Kozloff, MD, SM
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Foussias, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aristotle N Voineskos, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vicky Stergiopoulos, MD, MHSc
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albert HC Wong, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J1H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Kozloff, MD, SM
Phone
4165358501
Ext
30769
Email
nicole.kozloff@camh.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data (IPD) other than system-level data held at ICES will be available upon reasonable request.
IPD Sharing Time Frame
Within 12 months of posting the study results on this website
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the study's Steering Committee and after Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Citations:
PubMed Identifier
33334839
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.
Results Reference
derived

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

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