Integrated Care for Mental Health Disorders

(PARTNERs Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Psychotic illness, Bipolar, OCD, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 months

635 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Integrated Care for Mental Health Disorders treatment generally safe for humans?

The research highlights that adverse events (unintended harm from medical care) in mental health settings are common and can be serious, but they are often avoidable with better practices in assessment, communication, and planning. This suggests that while there are safety concerns, improvements in care processes can reduce risks. ^{1 2 3 4 5}

How is the Mental Health Technician treatment unique for mental health disorders?

The Mental Health Technician treatment is unique because it focuses on integrated care, which means it coordinates various healthcare services to improve the management of mental health disorders. This approach emphasizes better resource coordination and cooperation between different healthcare sectors, which can lead to improved patient care compared to traditional, fragmented treatment methods. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Enhanced Usual Care, Duphalac, Kristalose, and Mental Health Technician for mental health disorders?

The integration of mental health care with primary medical care, as seen in various studies, can enhance patient care quality and improve cost-effectiveness. Programs that combine mental health support with primary care, like those involving mental health technicians, have shown benefits in recognizing and treating mental health issues. ^{8 11 12 13 14}

Who Is on the Research Team?

Benoit H Mulsant, MD

Principal Investigator

Centre for Addition and Mental Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are suspected of having depression, anxiety, or alcohol-related issues and are under the care of a primary care provider at participating organizations. They must be able to communicate in English by phone and give informed consent. People with certain mental health conditions, substance abuse (excluding alcohol), cognitive impairment, high suicide risk, physical instability requiring hospitalization, or expected to die within 6 months cannot join.

Inclusion Criteria

Receiving care from a Primary Care Provider at one of the participating health care organizations

Having access to a telephone

Corrected auditory acuity that enables to converse in English by telephone

Exclusion Criteria

Clinically significant cognitive impairment as indicated by a score of 16 or above on the Blessed Orientation Memory Concentration Test

High risk for suicide as indicated by the 5-item Paykel Scale

I am currently hospitalized due to my physical condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment of symptoms, quality of life, and function conducted by telephone

1 week

1 visit (telephone)

Treatment

Participants receive either enhanced usual care or an intervention with telephone-based psychoeducation and monitoring by a Mental Health Technician

12 months

Monthly contacts (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 4, 8, and 12 months

12 months

3 visits (telephone)

Chart Audit

Review of participants' charts to abstract interventions and health services received during the study

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Mental Health Technician

Trial Overview The study tests an integrated care model where Mental Health Technicians use specialized software to help primary care providers manage mental health via telephone. It's compared against enhanced usual care to see if it better starts treatment, reduces symptom severity, and improves life quality/functioning.

How Is the Trial Designed?

Group I: Intervention: Mental Health Technician Experimental Treatment 1 Intervention

The subject's Primary Care Provider will receive results of baseline, four, eight, and twelve month assessments examining the subject's symptoms of depression, anxiety, and other mental health problems, use of alcohol and illicit substances, physical pain, and quality of life and recommendations for treatment. Over a 3-12 months period, the Intervention group will receive a brief, telephone-based intervention by a Mental Health Technician that will focus on monitoring symptoms, treatment adherence, and providing psychoeducation.

Group II: Enhanced Usual Care Experimental Treatment 1 Intervention

This group will receive Enhanced Usual Care. The subject's Primary Care Provider will receive results of baseline, four, eight, and twelve month assessments examining the subject's symptoms of depression, anxiety, and other mental health problems, use of alcohol and illicit substances, physical pain, and quality of life . If the subjects primary care provider chooses, they can use this information to construct the subject's treatment plan.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

CAMH Foundation

Collaborator

Trials

3

Recruited

910+

Capital Solution Design LLC

Collaborator

Trials

1

Recruited

640+

Published Research Related to This Trial

The Health Technology Program (HTP) was well-accepted by patients with schizophrenia spectrum disorders, with 96% rating it as satisfying, indicating a positive response to the integration of digital tools and human support.

Out of 200 patients, 87% utilized at least one digital tool, and they had an average of 28 contacts with a mental health technology coach, suggesting that the program effectively engaged patients in their relapse prevention plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Technology Intervention After Hospitalization for Schizophrenia: Service Utilization and User Satisfaction. Baumel, A., Correll, CU., Hauser, M., et al.[2018]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

A significant 73% of psychiatrists and nurses in six Flemish psychiatric hospitals reported being involved in at least one adverse event during their careers, with suicide-related incidents being the most impactful for nearly 64% of them.

The study highlights the critical need for timely support for healthcare professionals after adverse events, as those affected are at a higher risk of experiencing further incidents within the first 4-24 hours following the event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious reportable events within the inpatient mental health care: Impact on physicians and nurses. Martens, J., Van Gerven, E., Lannoy, K., et al.[2017]

Adverse events in mental health care are common and can lead to significant distress and even death, highlighting the need for improved practices in treatment and discharge processes.

The study identifies critical areas for improvement, including assessment processes, communication, documentation, and training, to reduce the frequency of these adverse events based on coronial recommendations in three Australian States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, risk and mental health: decision-making processes prescribed by Australian mental health legislation. Smith-Merry, J., Caple, A.[2014]

A comprehensive analysis of adverse events in Veterans Health Administration mental health units revealed 87 root cause analysis reports and 9780 safety reports, highlighting a significant risk of various incidents, including 31 suicide attempts and 16 elopements.

Falls were the most frequently reported safety event, followed by medication errors and assaults, indicating that a broad approach to patient safety is essential in mental health settings, similar to medical units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events occurring on mental health units. Mills, PD., Watts, BV., Shiner, B., et al.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Developing a tool for mapping adult mental health care provision in Europe: the REMAST research protocol and its contribution to better integrated care. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of a clinical pharmacist-managed clinic in primary care mental health integration at a Veterans Affairs health system. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An RCT of Effects of Telephone Care Management on Treatment Adherence and Clinical Outcomes Among Veterans With PTSD. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A model for psychiatric services in primary care settings. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Health Technology Intervention After Hospitalization for Schizophrenia: Service Utilization and User Satisfaction. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

Serious reportable events within the inpatient mental health care: Impact on physicians and nurses. [2017]

8. Australia pubmed.ncbi.nlm.nih.gov

Safety, risk and mental health: decision-making processes prescribed by Australian mental health legislation. [2014]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Survey on critical incident reporting in a child and adolescent mental health service. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse events occurring on mental health units. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Integrated mental health: a creative model for community mental health in the 1980s. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Integrated care of mentally ill patients--catchword or a real improvement in care?]. [2010]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Development and Implementation of an Integrated Care Fellowship. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Preparing the workforce for integrated healthcare: A systematic review. [2018]