NCT02023957

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

December 12, 2013

Last Update Submit

June 1, 2016

Conditions

Mental Health Disorders

Keywords

Interactive Health-risk assessmentPrimary CareRandomizedOpen LabelEfficacy Study

Outcome Measures

Primary Outcomes (2)

  • Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence

    Chart review for the index visit

    Day 1

  • Patient discussion on mental health

    Exit Survey of patients after the index visit

    Day 1

Secondary Outcomes (4)

  • Patient intention to see a mental health counselor

    Day 1

  • Patient satisfaction with health services

    Day 1

  • Patient enablement to cope with these conditions

    Day 1

  • Patient adherence to follow-up advice and referrals to mental health support

    3 month

Other Outcomes (1)

  • Symptom reduction

    6 month

Study Arms (2)

Interactive computer-assisted screening

EXPERIMENTAL

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.

Behavioral: Interactive computer-assisted screening (iCAS)

Usual Care

NO INTERVENTION

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.

Interventions

Interactive computer-assisted screening (iCAS)BEHAVIORAL
Interactive computer-assisted screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Speak/read Spanish
  • Speak/read English
  • Visiting the consenting clinician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related Publications (2)

  • 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.

    PMID: 28401134DERIVED

  • 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.

    PMID: 27663508DERIVED

Study Officials

  • Farah Ahmad, PhD

    York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 30, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

CA(1)