Using Technology to Optimize Collaborative Care Management of Depression in Urban and Rural Cancer Centers (AKA: SUPPORTING COLLABORATIVE CARE TO OPTIMIZE PSYCHOSOCIAL ENGAGEMENT IN THE CANCER SETTING [SCOPE])
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 297
- 试验地点
- 4
- 主要终点
- Level of treatment engagement (collaboration & coordination of care)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (t-CoCM)
Patients use the t-CoCM digital app platform and clinic care managers use the t-CoCM web-based registry platform to support delivery of collaborative care. Patient's 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 regarding their experience with CoCM and the newly developed web-based platform.
干预措施: Interview or Focus Group (Other)
Arm I (t-CoCM)
Patients use the t-CoCM digital app platform and clinic care managers use the t-CoCM web-based registry platform to support delivery of collaborative care. Patient's 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 regarding their experience with CoCM and the newly developed web-based platform.
干预措施: Media/technology Intervention with collaborative care (Other)
Arm I (t-CoCM)
Patients use the t-CoCM digital app platform and clinic care managers use the t-CoCM web-based registry platform to support delivery of collaborative care. Patient's 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 regarding their experience with CoCM and the newly developed web-based platform.
干预措施: Survey Administration (Other)
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.
干预措施: Collaborative care (Other)
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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Level of treatment engagement (collaboration & coordination of care)
时间窗: Baseline to 12 months
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.
Use of depression patient-reported outcomes for measurement-based care
时间窗: Baseline to 12 months
Patient-reported depression measure (PHQ-9) score collected (in person or remotely) and entered into patient registry.
Adherence to guideline-level depression treatment
时间窗: Baseline to 12 months
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.
Change in depression severity
时间窗: Baseline, 3, 6, and 9 months
The Symptom Checklist (SCL)-20 depression scale contains the 20 items from the SCL-90 that relate specifically to depressive symptoms.
次要结局
- Change in anxiety severity(Baseline, 3, 6, and 9 months)
- Change in patient-centered shared decision-making score(3, 6, and 9 months)
- Change in patient-reported depression severity(Baseline to 12 months)
- Change in patient-reported anxiety severity(Baseline to 12 months)
- Change in health-related quality of life global scales and subscales(Baseline, 3, 6, and 9 months)
- Change in functional status(Baseline, 3, 6, and 9 months)
- Change in patient impression of change and satisfaction with care(3, 6, and 9 months)
- Change in health services utilization(Baseline, 3, 6, and 9 months)
- Change in environmental reward score(Baseline and 6 months)
- Change in Instrumental Support: patient's perception of available support(Baseline and 6 months)
- Change in Alcohol, Smoking, and Substance Use(Baseline and 6 months)
- Change in Daily Alcohol Use(Baseline and 6 months)
- Change in Cannabis Use(Baseline, 3, 6, and 9 months)
- Change in Use of Complementary and Alternative Therapy Use(Baseline and 6 months)
- Patient's experience using the new technology(Survey: 6 Months; Interview/focus group: between 6-12 months)
- Care Managers experience using the new technology(Up to 5 years)
- Care manager (CM) satisfaction with Collaborative Care Management (CoCM) of depression(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(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))