- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298450
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Kozloff, MD, SM
- Phone Number: 30769 4165358501
- Email: n.kozloff@mail.utoronto.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6J1H1
- Recruiting
- Centre for Addiction and Mental Health
-
Contact:
- Nicole Kozloff, MD, SM
- Phone Number: 30769 4165358501
- Email: nicole.kozloff@camh.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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 Comparator: Sham SMS
Participants assigned to the sham comparator will receive the sham SMS intervention.
They will not be re-contacted.
|
Single welcome message letting participant know they will be contacted to book an appointment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Service engagement - absolute drop-out
Time Frame: 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.
|
6 months
|
Service engagement - Service Engagement Scale (SES)
Time Frame: 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.
|
6 months
|
Change in psychotic illness as measured by the Clinical Global Impression (CGI)
Time Frame: 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.
|
6 months
|
System-level outcomes: emergency department visits
Time Frame: 6 months and 2 years
|
Number of emergency department visits, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
|
6 months and 2 years
|
System-level outcomes: mental health hospitalizations
Time Frame: 6 months and 2 years
|
Number of mental health hospitalizations, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
|
6 months and 2 years
|
System-level outcomes: days in mental health hospitalizations
Time Frame: 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)
|
6 months and 2 years
|
System-level outcomes: outpatient mental health visits with primary care provider
Time Frame: 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)
|
6 months and 2 years
|
System-level outcomes: outpatient mental health visits with psychiatrist
Time Frame: 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)
|
6 months and 2 years
|
System-level outcomes: continuous prescriptions
Time Frame: 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)
|
6 months and 2 years
|
System-level outcomes: mortality
Time Frame: 6 months and 2 years
|
Mortality, extracted from provincial administrative data held at the Institute for Clinical Evaluative Sciences (ICES)
|
6 months and 2 years
|
Health care costs
Time Frame: 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
|
6 months and 2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: George Foussias, MD, PhD, Centre for Addiction and Mental Health
- Principal Investigator: Aristotle N Voineskos, MD, PhD, Centre for Addiction and Mental Health
- Principal Investigator: Vicky Stergiopoulos, MD, MHSc, Centre for Addiction and Mental Health
- Principal Investigator: Albert HC Wong, MD, PhD, Centre for Addiction and Mental Health
- Principal Investigator: Nicole Kozloff, MD, SM, Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Mood Disorders
- Disease Attributes
- Bipolar and Related Disorders
- Poisoning
- Emergencies
- Schizophrenia
- Psychotic Disorders
- Mental Disorders
- Bipolar Disorder
- Shared Paranoid Disorder
- Schizophrenia Spectrum and Other Psychotic Disorders
- Psychoses, Substance-Induced
- Affective Disorders, Psychotic
Other Study ID Numbers
- 088/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Active SMS Intervention
-
Fundación Cardiovascular de ColombiaLondon School of Hygiene and Tropical Medicine; University College, London; Universidad...Completed
-
Stanford UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedSedentary LifestyleUnited States
-
Central South UniversityCompletedNon-suicidal Self-injuryChina
-
University of RochesterNational Cancer Institute (NCI)RecruitingCervical CancerUnited States
-
Harvard Medical School (HMS and HSDM)Partners in HealthActive, not recruitingCOVID-19 | Mental Health | MisinformationHaiti, Malawi, Rwanda
-
University of Missouri, St. LouisRecruiting
-
Washington University School of MedicineThe Foundation for Barnes-Jewish HospitalCompletedStroke | Multiple Sclerosis | Spinal Cord InjuriesUnited States
-
Addis Ababa UniversityFogarty International Center of the National Institute of HealthUnknownTuberculosis | UndernutritionEthiopia
-
NYU Langone HealthCompletedType2 DiabetesUnited States
-
Mayo ClinicCompletedTobacco Smoking | Tobacco Use Cessation | Perioperative/Postoperative ComplicationsUnited States