Clinical trial NCT02955719: CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia
Official title: CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Mild Cognitive Impairment
Keywords: Collaborative Care
Depression
Anxiety
Mild Cognitive Impairment
Integrated Care Pathway
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2016-11-04
Enrollment: 145
Sex: ALL
Minimum age (years): 60
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Age remains the single most significant risk factor for developing dementia, particularly Alzheimer's dementia (AD). Given the rate at which Canada's population is aging, the quest to determine modifiable risk factors, whether by prevention, earlier detection, or an ability to slow the rate of decline, is a key priority in health care. Primary care is likely to play a pivotal role in this initiative. Collaborative mental health care between primary care providers and mental health clinicians has been demonstrated to be effective at the patient and system levels. Thus, the overall goal of this project is to assess impact and feasibility of implementing a collaborative care evidence-based Integrated Care Pathway (ICP) in addressing three potentially reversible risk factors at high risk for developing AD: anxiety, depression, or mild cognitive impairment (MCI).

Detailed description: The investigators will enroll 150 participants overall (CAMH and McMaster). Seventy-five will be cases who will be enrolled into the ICP arm of the study and these will be patients born in the calendar year 1951, 1953 or 1955. The investigators will enroll an additional 75 controls that were born in the calendar year 1950, 1952 or 1956.

Patients of general practitioners being seen at primary healthcare clinics in the Greater Toronto Area and in Hamilton, who were born in the calendar year 1950, 1951, 1952, 1953, 1955, or 1956 will be consented and screened for anxiety, depression, and Mild Cognitive Impairment (MCI).

If patients born in 1951, 1953 and 1955 reach a threshold level of anxiety, depression, or MCI symptom burden and have a confirmed diagnosis, rather than receive treatment as usual, the participants will be enrolled into an Integrated Care Pathway (ICP), which offers evidence-informed treatment for the management of these syndromes in a routine, algorithmic fashion. All enrolled cases entered in the study will be provided with general interventions that address lifestyle and medical factors that both contribute to these syndromes and are thought to predispose patients to develop dementia. If the symptom burden is severe enough, based on standardized assessments, evidence-based psychopharmacology (a trial of sertraline and/or venlafaxine) will also be offered, with a standardized titration schedule. Collaboration will be built into the ICP - a psychiatrist will be present at the clinic and in contact with primary care providers to provide patient- and physician-level support, consultation, and episodes of care as necessary. Rates of anxiety, depression, and MCI diagnosis/detection, time to treatment initiation, and improvement in symptom burden will be assessed.

If patients born in 1950, 1952 and 1956 reach a threshold level of anxiety, depression, or MCI symptom burden, these individuals will form our comparison group and will receive treatment as usual (TAU).

Eligibility criteria: Inclusion Criteria

1. Female or male primary practice patients of participating physicians born in 1951, 1953 or 1955 (ICP) and 1950, 1952 or 1956 (TAU).
2. Can read and understand English.
3. Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.
4. Willing and able to provide informed consent

Exclusion Criteria:

1. Diagnosis of dementia.
2. Substance abuse identified as an acute problem in the four weeks before being enrolled in the study (i.e. the day the patient signs the informed consent form).
3. Those with delirium, or where we are unable to make a diagnosis of MCI, due to unstable comorbidities.
4. Palliative-care patients.

Primary outcomes:
measure: Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups
timeFrame: From Baseline Screening to 24 month follow-up
Secondary outcomes:
measure: Acceptability and perceived utility of the ICP
timeFrame: Baseline to 24 month follow-up
measure: Feasibility of the ICP
timeFrame: Baseline to 24 month follow-up
measure: Adjustments made for the adoption of the ICP in primary care teams
timeFrame: Baseline to 24 month follow-up
measure: Barriers to implementation of the ICP and the key elements to initiate, sustain and spread the ICP
timeFrame: Baseline to 24 month follow-up
measure: Changes in the primary care providers' knowledge of, and ability to recognize and manage, depression, anxiety, and MCI in older adults.
timeFrame: Baseline to 24 month follow-up
measure: Time-to-treatment initiation among those in the ICP arm versus those in the comparison arm.
timeFrame: Baseline to 24 month followup
measure: Specific Aim 3a: To assess the impact of the ICP on the rates of diagnoses/detection among older patients with anxiety, depression, or MCI compared to before ICP implementation.
timeFrame: Calculate one year prior to the time of Site Initiation Visit for all recruiting sites.
measure: Specific Aim 3b: To assess the impact of ICP on rates of diagnoses/detection among patients of the same age cohort as our target ICP population, but not in our study sample.
timeFrame: Calculate the 6 month period prior to the last study assessment for a given recruitment site.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Center for Addiction and Mental Health
name: Tarek Rajji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kates N, Craven M; Collaborative Working Group of the College of Family Physicians of Canada, Canadian Psychiatric Association. Shared mental health care. Update from the Collaborative Working Group of the College of Family Physicians of Canada and the Canadian Psychiatric Association. Can Fam Physician. 2002 May;48:936. No abstract available.