- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526026
An Innovative Mental Health Virtual Ward: Evaluation of Patient-Centered Outcomes
The goal of this study is to evaluate if admission to the Mental Health Virtual Ward (MH vWard) for mental health crisis stabilization is having a meaningful positive impact on patient reported outcomes and healthcare utilization. The objectives of this study are:
- Prospectively measure demographic, recovery, service delivery, and systems use outcomes in a cohort of MH vWard admissions.
- establish this cohort for use in future research.
As part of the intervention, participants will receive care in the MH vWard for an average of 5 days following a visit to an emergency department or crisis centre for a mental health crisis. While admitted to the MH vWard, participants will:
- Engage in individual therapy and care planning with a clinician or psychiatry team.
- Have engagement with formal (community providers) and informal supports (family, friends) for collateral and collaboration.
- Receive medication reconciliation and management.
- Participate in group programming.
- Receive referrals for follow-up services.
- Have access to after hours support.
- Have access to the Telus Home Health Monitoring (HHM) App, which is custom designed to complement the services provided by the program.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3G 0N2
- Crisis Stabilization Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals admitted to the Mental Health Virtual Ward.
Exclusion Criteria:
- None.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mental Health Virtual Ward
Admission to the Mental Health Virtual Ward
|
Daily 1:1 sessions with multidisciplinary team via a range of virtual modalities (videoconferencing, phone, text, email), group programming, self-management resources, remote home monitoring app, referrals and linkages to community programs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The World Health Organization-Five (WHO-5) Well-Being Index
Time Frame: 1 week, 5 weeks and 6 months from date of discharge
|
The World Health Organization-Five (WHO-5) Well-Being Index is a questionnaire used for the assessment of subjective psychological well-being. Five questions are answered on a scale of 1-5 (0 meaning the individual agrees with the statement "at no time", 5 meaning they agree with the statement "all of the time"). Minimum value: 0 Maximum value: 25 A higher score represents better quality of life and well-being, a lower score represents lower quality of life and well-being. |
1 week, 5 weeks and 6 months from date of discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-discharge Healthcare Utilization (self-report)
Time Frame: 1 week post discharge, 5 weeks post discharge and 6 months from date of discharge
|
Number of participants who self-report further healthcare utilization following discharge from the virtual ward (all participants) Systems use outcomes will include: emergency department visits, crisis centre visits, and psychiatric hospitalizations collected by self-report. Patients can answer questionnaires electronically, over the phone, or in person with a member of the research team. |
1 week post discharge, 5 weeks post discharge and 6 months from date of discharge
|
|
Post-discharge Healthcare Utilization (administrative data)
Time Frame: 1 week post discharge, 5 weeks post discharge and 6 months from date of discharge
|
Number of participants with administrative data supporting further healthcare utilization following discharge from the virtual ward (urban participants only) Systems use outcomes will include: emergency department visits, crisis centre visits, and psychiatric hospitalizations collected via healthcare administrative data. This data will be used to collect some systems use outcomes data on participants lost to follow-up in the study, as well as allow for the assessment of recall bias when compared to self-reporting of healthcare utilization. |
1 week post discharge, 5 weeks post discharge and 6 months from date of discharge
|
|
Maryland Assessment of Recovery Scale-Twelve (MARS-12)
Time Frame: 1 week post discharge, 5 weeks post discharge, 6 months post-discharge
|
Maryland Assessment of Recovery Scale-Twelve (MARS-12) contains a list of statements about an individuals subjective attitude and beliefs towards their own health an wellness. Twelve questions are answered on a scale from 1-5 (1 meaning the participant "not at all" agrees with the statement, 5 meaning the participant "very much" agrees with the statement). Minimum value: 12 Maximum value: 60 A higher score represents a higher personal recovery post-discharge, a lower score represent a lower personal recovery post-discharge. |
1 week post discharge, 5 weeks post discharge, 6 months post-discharge
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Hensel, MD, University of Manitoba and Shared Health Manitoba/Psychiatry
Publications and helpful links
General Publications
- Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Eisen SV, Normand SL, Belanger AJ, Spiro A 3rd, Esch D. The Revised Behavior and Symptom Identification Scale (BASIS-R): reliability and validity. Med Care. 2004 Dec;42(12):1230-41. doi: 10.1097/00005650-200412000-00010.
- Frank L, Basch E, Selby JV; Patient-Centered Outcomes Research Institute. The PCORI perspective on patient-centered outcomes research. JAMA. 2014 Oct 15;312(15):1513-4. doi: 10.1001/jama.2014.11100. No abstract available.
- Ramsay C, Pickard R, Robertson C, Close A, Vale L, Armstrong N, Barocas DA, Eden CG, Fraser C, Gurung T, Jenkinson D, Jia X, Lam TB, Mowatt G, Neal DE, Robinson MC, Royle J, Rushton SP, Sharma P, Shirley MD, Soomro N. Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer. Health Technol Assess. 2012;16(41):1-313. doi: 10.3310/hta16410.
- Arsenault-Lapierre G, Henein M, Gaid D, Le Berre M, Gore G, Vedel I. Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Jun 1;4(6):e2111568. doi: 10.1001/jamanetworkopen.2021.11568.
- Castillo BA, Shterenberg R, Bolton JM, Dewa CS, Pullia K, Hensel JM. Virtual Acute Psychiatric Ward: Evaluation of Outcomes and Cost Savings. Psychiatr Serv. 2023 Oct 1;74(10):1045-1051. doi: 10.1176/appi.ps.20220332. Epub 2023 Apr 5.
- Pullia K, Clavio A, Bolton JM, Hunzinger E, Svenne S, Hensel JM. Providing crisis care in a pandemic: a virtual based crisis stabilization unit. Front Health Serv. 2023 May 16;3:1030396. doi: 10.3389/frhs.2023.1030396. eCollection 2023.
- Palay J, Taillieu TL, Afifi TO, Turner S, Bolton JM, Enns MW, Smith M, Lesage A, Bakal JA, Rush B, Adair CE, Vigod SN, Clelland S, Rittenbach K, Kurdyak P, Sareen J. Prevalence of Mental Disorders and Suicidality in Canadian Provinces. Can J Psychiatry. 2019 Nov;64(11):761-769. doi: 10.1177/0706743719878987. Epub 2019 Oct 16.
- Butler A, Adair C, Jones W, et al. Towards quality mental health services in Canada: a comparison of performance indicators across 5 provinces. Vancouver, BC: Centre for Applied
- Shared Health (2018). Shared Health Mental Health Program STATs 2018.
- Crisis Response Services (2022). Crisis Response Services Annual Performance Report April 1, 2021-Mrach 31, 2022
- Canadian Institute for Health Information, 2016.
- Hensel JM, Bolton JM, Svenne DC, Ulrich L. Innovation through virtualization: Crisis mental health care during Covid-19. Canadian Journal of Community Mental Health. 2020 Nov 2;39(2):71-5.
- Lee K, Bolton SL, Shterenberg R, Bolton JM, Hensel JM. Early Learning From a Low-Resource COVID-Response Virtual Mental Health Crisis Ward: Mixed Methods Study. JMIR Form Res. 2022 Nov 4;6(11):e39861. doi: 10.2196/39861.
- Bhattacharyya O, Hayden L, Hensel J. Health Services and Designing for Uncertainty: How a "lean startup" approach can help create an effective community-based program. Stanford Social Innovation Review. 2015;doi:10.48558/kw2z-6a08
- Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2016 Jan 12;352:i195. doi: 10.1136/bmj.i195. No abstract available.
- Newnham EA, Hooke GR, Page AC. Monitoring treatment response and outcomes using the World Health Organization's Wellbeing Index in psychiatric care. J Affect Disord. 2010 Apr;122(1-2):133-8. doi: 10.1016/j.jad.2009.06.005. Epub 2009 Jul 9.
- Idiculla T, Eisen S. Integrating science and practice. The BASIS-24 Behavior and symptom identification scale. ResearchGate. 2012; 2(2):16-19.
- Drapalski AL, Medoff D, Unick GJ, Velligan DI, Dixon LB, Bellack AS. Assessing recovery of people with serious mental illness: development of a new scale. Psychiatr Serv. 2012 Jan;63(1):48-53. doi: 10.1176/appi.ps.201100109.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS26297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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