Emergency Medicine Palliative Care Access (EMPallA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,606
- 试验地点
- 34
- 主要终点
- Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
研究概览
简要总结
This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure (New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) < 15 ml/min/m2 or dialysis ; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher, or oxygen-dependent chronic obstructive pulmonary disease (COPD) who present to the Emergency Department (ED), along with 675 of their informal caregivers. Investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.
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 (Participant)
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
- •English or Spanish-speaking patients ages 50 years and older
- •Qualifying serious, life-limiting conditions and who are scheduled for ED discharge, observation status, or admission for two midnights or less.
- •Qualifying conditions include: advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) < 15 ml/min/m2 or dialysis; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or stage III or IV, or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- •Patients must have health insurance, reside within the geographical area, and have a working telephone.
- •Informal Caregivers:
- •English or Spanish-speaking primary caregivers (relative or friend who has contact with the patient at least two times per week) ages 18 years and older.
排除标准
- •Patients with dementia identified in the EHR, who received hospice services in the last six months, who have received 2 or more palliative care visits in the last 6 months, and those who reside in a skilled nursing or assisted living facility, or chronic care hospital.
结局指标
主要结局
Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
时间窗: Baseline, Month 6
* Measured by change from enrollment to 6 months * Used to measure a person's quality of life * 27 questions total * 5-point Likert scale * Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.
次要结局
- Proportion of Participants Who Used Hospice(Up to Month 12)
- Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)(Baseline, Month 12)
- Number of Emergency Department (ED) Revisits(Up to Month 12)
- Change in Quality of Life for Patients, as Measured by the FACT-G(Baseline, Month 12)
- Number of Inpatient Days(Up to Month 12)
- Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)(Baseline, Month 12)
- Change in Loneliness, as Measured by the Three-Item Loneliness Scale(Baseline, Month 12)
- Caregiver Bereavement, as Measured by the Texas Inventory of Grief(3 Months Post-Patient Death)
- Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)(Baseline, Month 3)
- Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)(Baseline, Month 12)