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Completed

NCT Number: NCT03617614

Evaluation of the Medical Psychiatry Alliance Senior's Outpatient Collaborative Care Project

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Trillium Health Partners, Mississauga, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collaborative Care Model

Behavioral

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: ENGAGE

Mood Consultation

Behavioral

A meeting with a psychiatrist to do assessment, provide education and make recommendations regarding the care of the patient for the Primary Care Provider.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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 .

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Trillium Health Centre

Other

Collaborators

  • Centre for Addiction and Mental Health
  • Medical Psychiatry Alliance

Registry information

Acronym: MPASOP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2018
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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