Using Technology to Optimize Collaborative Care Management of Depression in Urban and Rural Cancer Centers, SCOPE

University of Washington297 enrolled

Overview

This study compares the effectiveness of technology-enhanced collaborative care management (t-CoCM) to usual collaborative care management (u-CoCM) in achieving fidelity to processes of care and reducing depression symptoms in patients currently receiving cancer treatment. CoCM is a population-based, integrated care approach, where care managers, who are clinicians (typically clinical social workers), deliver behavioral treatments, coordinate psychosocial care, monitor outcomes, and adjust treatment with the input of a psychiatric consultant. The use of t-CoCM may improve the treatment of depression and improve patient outcomes and quality of life.

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (t-CoCM): Patients use the t-CoCM digital app platform and clinic care managers use the t-CoCM web-based patient registry platform to support delivery of collaborative care. Patients complete surveys at baseline, 3, 6 and 9 months. Some patients also participate in an interview or focus group about their user experience with the t-CoCM digital platform. Care managers also participate in interviews or focus groups regarding their experience with CoCM and the newly developed web-based platform. ARM II (u-CoCM): Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

297

Conditions

Depression

Interventions

Collaborative careOTHER

Receive u-CoCM

Interview or Focus GroupOTHER

Participate in an interview or focus group

Media/technology Intervention with collaborative careOTHER

Use t-CoCM digital platform with collaborative care

Survey AdministrationOTHER

Complete surveys

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients receiving active treatment (surgery, chemotherapy, immunotherapy, targeted therapy, stem cell transplant, hormone therapy, radiation therapy) for a malignancy * \>= 18 years old * Participants must be ambulatory for clinical care visits * Clinically significant depression (Patient Health Questionnaire-9 (PHQ-9) \>= 10 with at least one cardinal symptom \> 1) * Access to smartphone, tablet, or computer with internet access; or landline * Patients who do not have a smartphone will be offered assistance in obtaining a free smartphone through the government-sponsored Lifeline Phone Program for low-resourced individuals Exclusion Criteria: * Advanced cancer or other condition that limits remaining life expectancy to less than 9 months * Already engaged in or needing immediate specialty mental health care e.g., for bipolar disorder or schizophrenia * Inability to speak and read English

Locations (4)

MultiCare Regional Cancer Center - Auburn

Auburn, Washington, United States

MultiCare Regional Cancer Center - Gig Harbor

Gig Harbor, Washington, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, United States

Outcomes

Primary Outcomes

Level of treatment engagement (collaboration & coordination of care)

Follow-up contacts (in person, phone or video) documented in patient registry and electronic health record (EHR). Case reviews with consulting study psychiatrist. Total time spent interacting with patients documented by the care manager in the patient registry.

Time frame: Baseline to 12 months

Use of depression patient-reported outcomes for measurement-based care

Patient-reported depression measure (PHQ-9) score collected (in person or remotely) and entered into patient registry.

Time frame: Baseline to 12 months

Adherence to guideline-level depression treatment

Antidepressant treatment: Achieving therapeutic dose for at least 6 weeks. Dosage and adherence recorded in the patient registry and EHR, and self-reported medication data requested at 3, 6, and 9 month outcome assessments.

Time frame: Baseline to 12 months

Change in depression severity

The Symptom Checklist (SCL)-20 depression scale contains the 20 items from the SCL-90 that relate specifically to depressive symptoms.

Time frame: Baseline, 3, 6, and 9 months

Secondary Outcomes

Change in patient-centered shared decision-making score

The 9-item Shared Decision-Making Questionnaire (SDM-Q-9) will be adapted and administered.

Time frame: 3, 6, and 9 months

Change in anxiety severity

The SCL-10 contains the 10 items from the SCL-90 that relate specifically to anxiety symptoms.

Time frame: Baseline, 3, 6, and 9 months

Change in patient-reported depression severity

Self-report Patient Health Questionnaire (PHQ-9) collected from patient registry and patient medical records.

Time frame: Baseline to 12 months

Change in patient-reported anxiety severity

Self-report Generalized Anxiety Disorder questionnaire (GAD-7) collected from patient registry and patient medical records.

Time frame: Baseline to 12 months

Change in health-related quality of life global scales and subscales

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 - Functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures.

Time frame: Baseline, 3, 6, and 9 months

Change in functional status

The Sheehan Disability Scale (SDS) was developed to assess functional impairment in three inter-related domains; work/school, social, and family life.

Time frame: Baseline, 3, 6, and 9 months

Change in patient impression of change and satisfaction with care

The Patient's Global Impression of Change (PGIC) and satisfaction with care (7- point Likert) scales.

Time frame: 3, 6, and 9 months

Change in health services utilization

Cornell Services Index (CSI), measures the quantity and characteristics of health services used in the past 3 months.

Time frame: Baseline, 3, 6, and 9 months

Change in environmental reward score

Environmental Reward Observation Scale (EROS) measures self-rated environmental reward and response-contingent positive reinforcement.

Time frame: Baseline and 6 months

Change in Instrumental Support: patient's perception of available support

NIH Toolbox Instrumental Support Survey measures patient's perceived availability of people who can provide functional aid to help them complete daily tasks.

Time frame: Baseline and 6 months

Change in Alcohol, Smoking, and Substance Use

Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) documents psychoactive substance use and related problems in patients.

Time frame: Baseline and 6 months

Change in Daily Alcohol Use

Daily Drinking Questionnaire (DDQ) measures the quantity and frequency of participant's alcohol use.

Time frame: Baseline and 6 months

Change in Cannabis Use

Self-report survey about patient's reasons, routes of administration, and frequency of cannabis use.

Time frame: Baseline, 3, 6, and 9 months

Change in Use of Complementary and Alternative Therapy Use

Self-report survey about patient's recent use of complementary and alternative therapies.

Time frame: Baseline and 6 months

Patient's experience using the new technology

Self reported survey; and for a subset of participants, an interview or focus group

Time frame: Survey: 6 Months; Interview/focus group: between 6-12 months

Care Managers experience using the new technology

Interview or focus group of care managers

Time frame: Up to 5 years

Care manager (CM) satisfaction with Collaborative Care Management (CoCM) of depression

Measures CM satisfaction with implementation of CoCM.

Time frame: At the end of the study or when a Care Manager leaves their role (Up to 5 years)

Oncology provider's perception of patient's adherence to cancer treatment

The patient's primary oncology provider will complete a standardized questionnaire to report delays or disruptions encountered in their planned cancer treatment.

Time frame: After the patient is sent their 9 Month survey. Oncologists may participate on behalf of multiple patients for a period of up to 3 years)