Developing a Customized Care Intervention to Improve Mental Health Outcomes in Multimorbidity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patient-PCP communication
研究概览
简要总结
The goal of this study is to develop and test Customized Care, an intervention to help patients dealing with depression and/or anxiety in the context of multiple chronic conditions. Customized Care is designed to help patients communicate about important issues, such as financial and safety concerns, with their primary care providers (PCPs). The intervention will be delivered in patient waiting rooms prior to a routine follow-up visit with the PCP. Phase 1 of the project will ensure that the main components of Customized Care are acceptable to patients and PCPs. Phase 2 will include a pilot study to test the effects of Customized Care on patient-PCP communication.
Participants aged 40 years or older who have a diagnosis of two or more common chronic medical conditions will be recruited from primary care clinics. Patients screening positive for either depression or anxiety will be randomized to Customized Care vs. an active control.
The investigators hypothesize that the Customized Care will improve patient-Primary Care-Provider communication.
详细描述
Patients with depression or anxiety in the context of multimorbidity (2 or more chronic conditions such as Diabetes, Heart Disease, Arthritis, COPD, Asthma) are often preoccupied with day-to-day concerns related to issues such as finances, safety and functional ability. Determining which issues to discuss, and when to discuss it, is always difficult in the 15-minute primary care visit, but it is especially challenging when patients have multiple diagnoses, symptoms and concerns.
In this application the investigators will develop and test the feasibility of Customized Care, an intervention that capitalizes on decision technology and will be deployed in primary care waiting rooms. The investigators will assess whether customized care will improve outcomes among patients with depression and/or anxiety in the context of multimorbidity. Customized Care consists of two different components designed to improve health outcomes by improving patient-provider communication. The first component is a computer-based discussion prioritization tool (DPT). The DPT forces patients to make trade-offs between competing concerns to help them determine which are the most important to discuss. The second component is a customized question prompt list (QPL) to help patients communicate their priorities to the PCP. The QPL will be generated after patients use the DPT, and consists of question prompts tailored to the patients' priorities.
When patients express their day-to-day concerns, and PCPs become aware of these concerns, the patient-provider alliance can deepen. In addition, patient motivation (perceived autonomy, competence) to manage those everyday concerns and engage in care for chronic disease and associated mental health conditions will increase. This project will lay the ground work for a larger randomized trial to assess whether customized care can improve mental health outcomes among patients with multimorbidity.
The specific aims are:
- To assess usability of the Customized Care components (the DPT and QPL)
- To assess feasibility of Customized Care in primary care settings
- To conduct a pilot study of the effects of Customized Care on patient-PCP communication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants in both arms use iPad to complete assessments, Customized Care (intervention arm) receives intervention on iPad, care as usual completes assessments only
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients attending a primary care clinic for routine follow-up care
- •age 40 or older
- •diagnosed with 2 or more chronic medical conditions including: diabetes, heart disease, arthritis, asthma, COPD
- •positive screen for symptoms of depression and/or anxiety
排除标准
- •non-English speakers
- •patients with a diagnosis of dementia or cognitive deficit
- •patients with acute medical needs requiring urgent treatment
研究组 & 干预措施
Customized Care
Before the office visit with the PCP, patient participants in the intervention group will interact with the computer based components of the customized care intervention while in the waiting room. The research staff will help the participant use an iPad in the waiting room and direct them to the Discussion Prioritization tool (DPT). After participants use the DPT, the program automatically generates a customized questions prompt list (QPL) which will be printed out in the office. Study staff will hand the QPL to intervention patients to bring to their office visit with the PCP. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
干预措施: Customized Care (Other)
Care As Usual
Before the office visit with the PCP, patient participants in the Care As Usual arm will interact with the research staff who will help the participant use an iPad in the waiting room to complete baseline health assessments. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
干预措施: Care As Usual (Other)
结局指标
主要结局
Patient-PCP communication
时间窗: from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes
After the patient completes the experimental or active comparator intervention on the iPad, the patient will proceed with their office visit. The subsequent conversations between the patient and PCP will be audio-recorded and transcribed. We will use a coding scheme to measure communication during the patient-PCP office visit.
次要结局
未报告次要终点
研究者
Marsha Wittink
Assistant Professor
University of Rochester