Clinical Trial of Home Palliative Care for Seriously Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 4
- 主要终点
- Integrated Palliative Outcomes Scale
研究概览
简要总结
The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with serious illness and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for a minimum of 6 months.
After 6 months, patients can remain in the program if there is ongoing clinical need; data collection beyond 6 months will be done on all patients through chart abstraction/ administrative claims only.
Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.
详细描述
The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.
Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.
Patients in the intervention arm will receive ongoing monitoring and input (telephone-based and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single Blind Control - Outcomes assessor is blind to randomization arms
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a "serious medical illness" - according to pre-specified diagnostic code-based criteria
- •Subject has a Mount Sinai physician who authorizes their participation in the study and receipt of the program
- •Subject is resident in Manhattan outside of a long term care facility and is not receiving hospice
- •Subject has evidence of capacity to benefit from enrollment in palliative care program
- •Subject is conversant in English or Spanish
- •Subject has capacity to consent
排除标准
- •Subject has no usual physician within Mount Sinai
- •Subject's usual physician doesn't provide authorization to patient participation
- •Subject resident outside of Manhattan or in long term care facility or receiving hospice
- •Subject is not conversant in English or Spanish
- •Subject cannot provide informed consent to participation
- •Dementia (where the subject does not have the capacity to consent)
结局指标
主要结局
Integrated Palliative Outcomes Scale
时间窗: 6 months
Patient symptoms determined by the Integrated Palliative Outcomes Scale, a validated structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. The Integrated Palliative Outcomes Scale is scored on a likert scale from 0-4, with higher score indicating worse symptoms.
次要结局
- McGill quality of life-revised(6 months)
- Family Satisfaction with End-of-Life Care (FAMCARE-10)(6 months)
- Number of Completion of Advance Directives(6 months)
- Zarit Burden Inventory(6 months)
- The Patient Health Questionnaire (PHQ-9)(6 months)
- Number of inpatient admissions(6 months)
- Number of outpatient appointments(6 months)
- Number of Preference Consistent Care(6 months)
- FAMCARE-10(6 months)
- Number of emergency department visits(6 months)
研究者
Nathan Goldstein
Professor
Icahn School of Medicine at Mount Sinai