Living With Multimorbidity: Care Coordination and Symptom Management Program (COORDINATE)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from Baseline in Health-related Quality of Life as Measured by the EuroQoL at 3 months
研究概览
简要总结
The goal of this clinical trial is to learn if a new care program, called the COORDINATE Program, can help older adults with two or more chronic health conditions. These individuals are being discharged from special hospital units called Intermediate Care Units (IMCUs), which care for people who are very sick but don't need intensive care.
The main questions this study wants to answer are:
- Can the COORDINATE Program improve participants' quality of life?
- Can the program reduce emergency visits, intensive care admissions, and rehospitalizations?
Researchers will compare the COORDINATE Program to the enhanced usual care with extra support to see if it works better. Participants will receive either the COORDINATE Program or enhanced usual care. They will also complete surveys at three different time points: before starting the intervention, at 3 months, and at 12 months.
For those in the COORDINATE Program group, a trained nurse will guide them through:
- A needs assessment to find out what matters most to them
- A list of helpful questions to ask their care team
- Goal-setting to support managing their conditions
- Tracking their symptoms and progress
- Attend a discharge visit and have 5 follow-up phone or video calls over 3 months
Participants in both groups will be compensated for completing the surveys. The study hopes to improve how care is given to older adults with complex health needs and reduce unnecessary hospital visits.
详细描述
This study is a single-blind, two-arm randomized controlled trial (RCT) conducted at Johns Hopkins Health System IMCUs to pilot test the Care Coordination and Symptom Management (COORDINATE) Program, a multicomponent care coordination and symptom management program. The participants will be randomized 1:1 into either the COORDINATE intervention group or the enhanced usual care group. Follow-up assessments will occur at 3 and 12 months post-discharge.
Intervention Participants in the COORDINATE group will receive a structured, nurse-led intervention beginning after randomization and extending through 3 months post-discharge. The program consists of: Needs Assessment, Question Prompt List, Goals of Care Discussion, and Symptom Assessment and Tracking.
Enhanced Usual Care Participants in the enhanced usual care group receive enhanced usual care, which includes standard discharge teaching and follow-up planning by hospital staff. In addition, they are provided with a multimorbidity management toolkit developed during the co-design phase, covering communication strategies, care coordination, and resource access. A nurse also conducts discharge check-ins and follow-up calls, but without the structured components of the COORDINATE program.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 50 years and older
- •living with two or more chronic health conditions as identified by diagnosis in the electronic health record
- •medically complex patients defined as those admitted to intermediate care units
- •have a working telephone or contact method.
排除标准
- •cannot provide informed consent
- •non-English speakers
- •incapacitated or have documented cognitive impairment
- •are in hospice
研究组 & 干预措施
COORDINATE Program Intervention
Participants receive the nurse-led COORDINATE Program, a nurse-led structured intervention focused on transitional care, including a discharge planning visit (pre-discharge and/or within 48 hours of discharge) and follow-ups at 1 week, 4 weeks, 6 weeks, and 3 months.
干预措施: COORDINATE Program (Behavioral)
Enhanced Usual Care
Participants receive enhanced usual care, including standard discharge teaching, a multimorbidity management toolkit, and follow-up check-ins.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Change from Baseline in Health-related Quality of Life as Measured by the EuroQoL at 3 months
时间窗: Baseline and 3 months post-discharge
Health-related quality of life will be assessed using the EuroQoL, a widely used questionnaire that helps measure a person's overall health and quality of life. It asks about five key areas: 1) Mobility, 2) Self-care, 3) Usual daily activities, 4) Pain or discomfort, and 5) Anxiety or depression. It also includes a rating scale (0 to 100) where people mark their overall health, 0 means the worst health you can imagine, and 100 means the best.
Change from Baseline in Quality of Life as Measured by the EuroQoL at 12 Months
时间窗: Baseline and 12 months post-discharge
Health-related quality of life will be assessed using the EuroQoL, a widely used questionnaire that helps measure a person's overall health and quality of life. It asks about five key areas: 1) Mobility, 2) Self-care, 3) Usual daily activities, 4) Pain or discomfort, and 5) Anxiety or depression. It also includes a rating scale (0 to 100) where people mark their overall health, 0 means the worst health you can imagine, and 100 means the best.
次要结局
- Difference in Number of Emergency Department Visits from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care(Immediately hospital discharge to 12 months post-discharge)
- Difference in Number of Critical Care Admissions from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care(Immediately hospital discharge to 12 months post-discharge)
- Difference in Number of All-Cause Rehospitalizations from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care(Immediately hospital discharge to 3 months post-discharge)
- Difference in Number of All-Cause Rehospitalizations from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care(Immediately hospital discharge to 12 months post-discharge)
- Difference in Number of Emergency Department Visits from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care(Immediately hospital discharge to 3 months post-discharge)
- Difference in Number of Critical Care Admissions from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care(Immediately hospital discharge to 3 months post-discharge)