AnxietyMPASOPNCT03617614
Evaluation of the Medical Psychiatry Alliance Senior's Outpatient Collaborative Care Project
An observational study of Anxiety and Depression, run by Trillium Health Centre at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Collaborative Care Model and Mood Consultation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jul 2018to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Seniors discharged from the Medical Psychiatry Alliance Senior Outpatient Program or Seniors that received a one time mood consultation at CAMH
Who may be able to join
- 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
Who cannot join
- Moderate to severe cognitive decline
- Positive psychotic symptoms
- Active suicidal ideation or attempt within the last year
- Psychiatric admission within the last year
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Trillium Health Partners
Mississauga, Ontario, L5B 1B8
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
About this study
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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Collaborative Care Model, Mood Consultation
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care ModelBehavioural
Also called ENGAGE
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.
Mood ConsultationBehavioural
A meeting with a psychiatrist to do assessment, provide education and make recommendations regarding the care of the patient for the Primary Care Provider.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care Model | Participants who received care from the Medical Psychiatry Alliance Seniors Outpatient Collaborative Care Program at Trillium Health Partners. Receives: Behavioral: Collaborative Care Model | |
| Mood Consult | Participants who received a one time mood consultation at the Centre for Addiction and Mental Health. Receives: Behavioral: Mood Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire (PHQ-9) from 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.
Measured: Baseline to 12 months after discharge
Secondary outcomes (4)
Change in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 12 months
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.
Measured: Baseline to 12 months after discharge
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS) from baseline to 12 months
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 .
Measured: Baseline to 12 months after discharge
Patient satisfaction with care
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.
Measured: 12 months after discharge
Healthcare Utilization in the previous 3 months
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.
Measured: 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Jan 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trillium Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Medical Psychiatry Alliance
- Responsible party
- Principal investigator, Judith Versloot, Trillium Health Centre
- Investigators
- Judith Versloot, PhD, Principal investigator, Trillium Health Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617614
- Sponsor's protocol ID
- TrilliumHC
- Acronym
- MPASOP
- Status last verified
- Mar 2021
- First submitted
- 19 Jul 2018
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Medical Psychiatry Alliance Senior's Outpatient Collaborative Care Project
- ClinicalTrials.gov ID
- NCT03617614
- Acronym / sponsor ID
- MPASOP / TrilliumHC
- Conditions
- Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Trillium Health CentreUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Medical Psychiatry Alliance
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care Model | – | Behavioral: Collaborative Care ModelParticipants who received care from the Medical Psychiatry Alliance Seniors Outpatient Collaborative Care Program at Trillium Health Partners. |
| Mood Consult | – | Behavioral: Mood ConsultationParticipants who received a one time mood consultation at the Centre for Addiction and Mental Health. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Seniors discharged from the Medical Psychiatry Alliance Senior Outpatient Program or Seniors that received a one time mood consultation at CAMH
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Moderate to severe cognitive decline
- Positive psychotic symptoms
- Active suicidal ideation or attempt within the last year
- Psychiatric admission within the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Care ModelAlso: ENGAGETrained 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. | Behavioural | Collaborative Care Model |
| Mood ConsultationA meeting with a psychiatrist to do assessment, provide education and make recommendations regarding the care of the patient for the Primary Care Provider. | Behavioural | Mood Consult |
Primary outcome
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.
4 secondary outcomes
Change in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 12 months
Time frame: 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
Patient satisfaction with care
Time frame: 12 months after discharge
Healthcare Utilization in the previous 3 months
Time frame: 12 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Versloot, PhD principal investigator
Trillium Health Partners
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Trillium Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire (PHQ-9) from baseline to 12 months after discharge (time frame: Baseline to 12 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.