Clinical trial NCT02345122: CAMH PARTNERs Integrated Care Study
Official title: CAMH PARTNERs: Integrated Care for Better Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Alcohol Drinking
Keywords: At-risk Drinking
Depression
Anxiety
Alcohol Drinking
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: CAMH Foundation
name: Capital Solution Design LLC
First posted: 2015-01-26
Enrollment: 635
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study will evaluate an integrated care model of telephone-based, computer-aided care management using a new role of Mental Health Technician and specialized software to support primary care providers in providing mental health care. The study will compare the effectiveness of this model vs. enhanced usual care in improving initiation of specific treatment by the primary care provider, reduction in severity of symptoms, and improvement in quality of life or functioning.

Detailed description: This is a randomized clinical trial of an intervention to improve the outcomes of depressive disorders, generalized anxiety, panic disorder, and at-risk drinking or alcohol use disorders in primary care. Two groups will be included: (1) Adult patients who self-refer or are referred to the study by their Primary Care Provider; or (2) patients who are referred by their Primary Care Provider to the tele-mental health consultation service at the Centre for Addiction and Mental Health (Toronto, Ontario). Patients who consent and meet the eligibility criteria will be randomized to either: (1) usual care provided by their Primary Care Provider enhanced by a baseline assessment and follow-up assessments 4, 8, and 12 months later; or (2) an intervention consisting of care provided by their Primary Care Provider enhanced by a baseline assessment, follow-up assessments 4, 8, and 12 months later plus psychoeducation, monitoring, and support offered by telephone by a Mental Health Technician receiving supervision from a project psychiatrist.

At baseline and 4, 8, and 12 months later, symptoms, quality of life, and function of all participants will be assessed by telephone by Research Analysts (RAs) blind to the randomization. In addition, at 12 months, patient satisfaction will be assessed. Results of these assessments will be shared with the participant's Primary Care Provider, regardless of randomization. The Primary Care Provider will receive a document summarizing the results of the baseline assessment and the three follow-up assessments for the participants of both the usual care and intervention groups. For participants in the intervention group the Primary Care Provider will also receive treatment recommendations and updates as needed.

In the enhanced usual care group, the Primary Care Provider will treat the participant as they deem appropriate. In the intervention group, participants will be assigned to a team constituted by a Mental Health Technician and a psychiatrist. The team will communicate evidence-based treatment recommendations to the Primary Care Provider, for example initiating the use of an antidepressant or referring the participant for therapy or counselling. The Mental Health Technician will offer participants telephone-based psychoeducation about their diagnoses made by their Primary Care Provider or other consulting physicians, their symptoms, and the treatment selected by the Primary Care Provider. The Mental Health Technician will also monitor by phone the progress of treatment and communicate updates to the Primary Care Provider with additional recommendations as required. Thus, the Mental Health Technician will contact the Primary Care Provider on an as needed basis. In addition, for participants who are doing well and for whom no new recommendations are needed, the Mental Health Technician will provide a brief "progress report" to the Primary Care Provider on a monthly basis.

In addition, at the completion of the one-year period, the RA will review all the participants' charts to abstract the intervention (e.g., medications, doses, refills) and other health services (e.g., diagnostic tests, referrals, mental health evaluations) they have received during their participation in the study. The chart audit will be conducted using REDCap, a secure application supported by the CAMH Information Management Group (IMG). IMG has all the necessary physical and operational securities in place to meet security and privacy regulations for data transmission and storage using REDCap. Investigators will follow the best practices outlined by IMG to ensure that all data and information is kept private and confidential.

Eligibility criteria: Inclusion Criteria:

1. Age 18 and older
2. Receiving care from a Primary Care Provider at one of the participating health care organizations
3. Self-referred or referred by a participating primary care provider because of suspected depression, anxiety, alcohol disorder or at risk drinking
4. Having access to a telephone
5. Willingness and ability to converse in English by telephone
6. Corrected auditory acuity that enables to converse in English by telephone
7. Willingness and ability to provide informed consent

Exclusion Criteria:

1. Not meeting all inclusion criteria
2. Lifetime primary psychotic illness, bipolar disorder, obsessive-compulsive disorder, or post-traumatic disorder
3. Current substance abuse or dependence (not including alcohol use disorders)
4. Clinically significant cognitive impairment as indicated by a score of 16 or above on the Blessed Orientation Memory Concentration Test
5. High risk for suicide as indicated by the 5-item Paykel Scale
6. Being physically unstable as evidenced by needing to be hospitalized
7. Being expected by one's Primary Care Provider to die during the next 6 months

Primary outcomes:
measure: Severity of depressive symptoms, as measured with PHQ-9 during phone interviews at 4, 8, and 12 months
timeFrame: One year
Secondary outcomes:
measure: Initiation or change in antidepressant medication documented in the health record at the 4-, 8-, and 12-month follow up
timeFrame: One year
measure: Severity of anxiety symptoms during the past 2 weeks and number of drinks during the past week
timeFrame: One year
measure: Time to initiation of first specific treatment for depression by the primary care provider
timeFrame: One year
Other outcomes:
measure: Proportion of subjects receiving treatment for depression, anxiety, an alcohol use disorder or at-risk drinking
timeFrame: One year
measure: Rates of depression remission, depression response, anxiety remission, anxiety response, and decrease in alcohol use to the point where it meets the guidelines for safe drinking, remaining stable, or worsening.
timeFrame: One year
measure: Changes on the Veterans Rand-12 (VR-12) Health Survey
timeFrame: One year
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addition and Mental Health
name: Benoit H Mulsant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodie DJ, Fitzgibbon K, Perivolaris A, Crawford A, Geist R, Levinson A, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. The primary care assessment and research of a telephone intervention for neuropsychiatric conditions with education and resources study: Design, rationale, and sample of the PARTNERs randomized controlled trial. Contemp Clin Trials. 2021 Apr;103:106284. doi: 10.1016/j.cct.2021.106284. Epub 2021 Jan 19.
citation: Zaheer S, Garofalo V, Rodie D, Perivolaris A, Chum J, Crawford A, Geist R, Levinson A, Mitchell B, Oslin D, Sunderji N, Mulsant BH; PARTNERs Study Group. Computer-Aided Telephone Support for Primary Care Patients with Common Mental Health Conditions: Randomized Controlled Trial. JMIR Ment Health. 2018 Dec 10;5(4):e10224. doi: 10.2196/10224.