- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023957
A Pilot With Interactive Computer-assisted Screening for Mental Health in Primary Care (iCAS)
June 1, 2016 updated by: Farah Ahmad, York University
Interactive Computer-assisted Screening for Mental Health in Primary Care
The current protocol pertains to the evaluation of the interactive computer-assisted screening (iCAS) tool through a pilot randomized control trial.
The purpose of this evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection of common mental health conditions (i.e.
major depression/generalized anxiety/post-traumatic stress disorder/alcohol dependence), and patients' discussion on mental health.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The iCAS tool is a health-risk assessment survey that is completed by adult patients using touch-screen iPad device in their waiting time before seeing their clinician (family physician or nurse practitioner).
The computer program generates tailored risk-report for the clinician and a simple recommendation sheet for the patient, with community resources and health information, at the point of care.
The iCAS tool currently includes validated screening scales for depression, generalized anxiety, posttraumatic stress disorder and alcohol abuse.
There are some questions on the social determinants of mental health as well.
The current versions of the tool are in English and Spanish; a Chinese language version will also be developed.
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M3J 1P3
- York University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years of age
- Speak/read Spanish
- Speak/read English
- Visiting the consenting clinician
Exclusion Criteria:
- Patient accompanied by a family member for interpretation
- New patients coming for first visit
- Patients feeling unwell (self-report)
- Inability of the research staff to offer study details in privacy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interactive computer-assisted screening
Eligible patients completed the interactive computer-assisted screening (iCAS) tool in English or Spanish before seeing the consenting clinician.
Participating patients then received the iCAS generated tailored recommendation sheet.
Participating clinicians received the iCAS generated risk report.
|
|
No Intervention: Usual Care
Eligible patients randomized to the control group completed their standard visit to the participating clinician.
There was no pre-visit health risk screening.
There were no tailored reports for the patients or clinicians.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence
Time Frame: Day 1
|
Chart review for the index visit
|
Day 1
|
Patient discussion on mental health
Time Frame: Day 1
|
Exit Survey of patients after the index visit
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient intention to see a mental health counselor
Time Frame: Day 1
|
Exit Survey of patients after the index visit
|
Day 1
|
Patient satisfaction with health services
Time Frame: Day 1
|
Exit Survey of patients after the index visit
|
Day 1
|
Patient enablement to cope with these conditions
Time Frame: Day 1
|
Exit Survey of patients after the index visit
|
Day 1
|
Patient adherence to follow-up advice and referrals to mental health support
Time Frame: 3 month
|
Chart review
|
3 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom reduction
Time Frame: 6 month
|
Measurement of this outcome depends on availability of funds for follow-up phone interviews
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Farah Ahmad, PhD, York University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ahmad F, Lou W, Shakya Y, Ginsburg L, Ng PT, Rashid M, Dinca-Panaitescu S, Ledwos C, McKenzie K. Preconsult interactive computer-assisted client assessment survey for common mental disorders in a community health centre: a randomized controlled trial. CMAJ Open. 2017 Mar 1;5(1):E190-E197. doi: 10.9778/cmajo.20160118. eCollection 2017 Jan-Mar.
- Ferrari M, Ahmad F, Shakya Y, Ledwos C, McKenzie K. Computer-assisted client assessment survey for mental health: patient and health provider perspectives. BMC Health Serv Res. 2016 Sep 23;16(1):516. doi: 10.1186/s12913-016-1756-0.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
December 12, 2013
First Submitted That Met QC Criteria
December 24, 2013
First Posted (Estimate)
December 30, 2013
Study Record Updates
Last Update Posted (Estimate)
June 3, 2016
Last Update Submitted That Met QC Criteria
June 1, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- e2013 - 291
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.
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