- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617614
Evaluation of the Medical Psychiatry Alliance Senior's Outpatient Collaborative Care Project (MPASOP)
March 19, 2021 updated by: Judith Versloot, Trillium Health Centre
This study evaluates the effectiveness of a collaborative care model designed to treat frail seniors with both a mental (anxiety and/or depression) and a physical health condition impacting function with a comparison group that receives a psychiatric mood consult and a letter of recommendation but who are mainly cared for by their PCP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Literature suggests seniors with co-existing mental and physical health concerns encounter challenges with accessing care including limited availability of geriatric specialists, inadequate navigational support, disjointed communication, and limited provider knowledge/ capacity to manage these complex patients.
In conjunction with primary care, a new program was created to assist in addressing these concerns.
A novel collaborative care model was developed integrating Geriatric Medicine and Geriatric Psychiatry anchored in primary care, where primary care remains the most responsible provider.
Care managers (CMs) work with seniors in the community, for up to 16 weeks, who have at least one chronic health condition affecting function and depressed mood and/or anxiety.
The care model focusses on 4 main components: integrated therapeutic care management, systematic case reviews (SCRs), integrated care planning, and education/capacity building.
CMs provide comprehensive assessments, system navigation, monitoring using symptom rating scales, and a problem solving psychotherapy for seniors using reward exposure to form action plans (ENGAGE).
CMs present cases weekly at SCRs, where the team includes a geriatrician, geriatric psychiatrist, primary care, and allied health.
Recommendations are made then sent to the PCP for implementation.
In the current evaluation study we will compare levels of depression, anxiety and functioning of seniors receiving the collaborative care model with those receiving a one time mood consultation.
Study Type
Observational
Enrollment (Actual)
13
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
-
Mississauga, Ontario, Canada, L5B 1B8
- Trillium Health Partners
-
Toronto, Ontario, Canada, M6J 1H4
- Centre for Addiction and Mental Health
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Seniors discharged from the Medical Psychiatry Alliance Senior Outpatient Program or Seniors that received a one time mood consultation at CAMH
Description
Inclusion Criteria:
- Depressive mood PHQ-9 >9 or anxiety GAD-7 >9
- One or more chronic medical condition(s) impacting function
- Had a one time mood consultation at CAMH or has been a patient in the Medical Psychiatry Alliance Senior Outpatient Program
- Able to speak English
Exclusion Criteria:
- Moderate to severe cognitive decline
- Positive psychotic symptoms
- Active suicidal ideation or attempt within the last year
- Psychiatric admission within the last year
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Collaborative Care Model
Participants who received care from the Medical Psychiatry Alliance Seniors Outpatient Collaborative Care Program at Trillium Health Partners.
|
Trained care managers (CM) work collaboratively with patients, caregivers, and primary care providers to provide education, care navigation and behavioral activation.
The latter includes a stepped psychotherapy intervention called ENGAGE, that focuses on "reward exposure" engagement in meaningful, rewarding activities for patients.
Patients (home) visits are delivered over a period of 6 to 16 weeks.
Progress is assessed with standardized measures for depression (PHQ-9), anxiety (GAD-7) and functioning (WHO-DAS).
Furthermore, patients are presented by the CM at Systematic Case Review meetings where an integrated team of medical, psychiatric and allied health professionals work collaboratively to review the patient's goals and treatment to formulate a care plan and recommendations.
Other Names:
|
Mood Consult
Participants who received a one time mood consultation at the Centre for Addiction and Mental Health.
|
A meeting with a psychiatrist to do assessment, provide education and make recommendations regarding the care of the patient for the Primary Care Provider.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Health Questionnaire (PHQ-9) from baseline to 12 months after discharge
Time Frame: Baseline to 12 months after discharge
|
The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that is used for screening, diagnosing, monitoring, and measuring the severity of depression.
Each item can be answered on a 4 point scale running from 0= 'not at all' to 3= 'nearly every day'.
The total score ranges from 0-27 where 0 is no depression and 27 is severe depression.
|
Baseline to 12 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 12 months
Time Frame: Baseline to 12 months after discharge
|
The Generalized Anxiety Disorder 7-item (GAD-7) is a 7-item questionnaire that is used for screening, diagnosing, monitoring, and measuring the severity of anxiety.
Each item can be answered on a 4 point scale running from 0= 'not at all sure' to 3= 'nearly every day'.
The total score ranges from 0-21 where 0 is no anxiety and 27 is severe anxiety.
|
Baseline to 12 months after discharge
|
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS) from baseline to 12 months
Time Frame: Baseline to 12 months after discharge
|
The WHODAS is a practical generic assessment instrument that is used to measure health and disability.
The WHODAS captures level of functioning in six domains: cognition, mobility, self-care, getting along and life activities.
The 12-item questionnaire version asks about difficulties due to patient health conditions.
Patients answer 12 questions within the 6 domains and select the best option of 5 answer categories: 1=none, 2=mild, 3=moderate, 4=severe, 5=extreme or cannot do.
The total sum of the questions range between 12-60.
and is than divided by 12 to determine where the patient falls on "none to extreme or cannot do" (range 1-5) scale .
|
Baseline to 12 months after discharge
|
Patient satisfaction with care
Time Frame: 12 months after discharge
|
The question that will be asked is: 1) I think the services provided at CAMH/THP were of high quality.
The answer category is a 5-point likert rating scale running form 5=strongly agree to 0=strongly disagree.
Score range 0= not at all satisfied to 5= very satisfied.
|
12 months after discharge
|
Healthcare Utilization in the previous 3 months
Time Frame: 12 months after discharge
|
The participants will be asked 6 questions about if the participant has seen a family physician, social worker, psychiatrist, psychologist and/or visited the emergency department and/or has been admitted to the hospital in the past 3 months.
The number of health care providers seen will be summed to a total score that ranges from 0-6 where 0 represents no health care utilization and 6 represent high healthcare utilization.
|
12 months after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Judith Versloot, PhD, Trillium Health Partners
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 (Actual)
July 1, 2018
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
July 19, 2018
First Submitted That Met QC Criteria
July 31, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
March 22, 2021
Last Update Submitted That Met QC Criteria
March 19, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TrilliumHC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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