Operationalizing PCplanner, a Needs-focused Palliative Care for Older Adults in Intensive Care Units: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
研究概览
简要总结
The quality of intensive care unit (ICU)-based palliative care is highly variable, particularly for the 2 million older adults admitted annually to ICUs. To address these care delivery barriers among older ICU patients, a mobile app platform called PCplanner (Palliative Care planner) was developed. PCplanner automates the identification of high-risk patients (e.g., dementia, declining health status, poor functioning) by directly capturing data from electronic health record (EHR) systems, cultivates family engagement with supportive information and a digital system for self-report of actual needs, and facilitates the delivery of care to those with a high burden of need by coordinating collaboration between ICU teams and palliative care specialists.
150 patients, 150 family caregivers, and 75 physicians from academic and community settings will be enrolled in a RCT designed to test the efficacy of PCplanner-augmented collaborative palliative care vs usual care. Family caregiver and clinician experiences will be explored using mixed methods to understand intervention mechanisms as well as implementation barriers within diverse case contexts. The key hypothesis is that compared to usual care, PCplanner will reduce family caregivers' unmet needs and psychological distress, increase the frequency of goal concordant treatment among older adult patients, and reduce hospital length of stay.
详细描述
The quality of intensive care unit (ICU)-based palliative care is highly variable, particularly for the 2 million older adults admitted annually to ICUs. However, improving care quality on a broad scale with the efficient delivery of patient-centered, need-targeted palliative care is challenging because of logistical and technological barriers. To address these care delivery barriers among older ICU patients, a mobile app platform called PCplanner (Palliative Care planner) was developed. PCplanner automates the identification of high-risk patients (e.g., dementia, declining health status, poor functioning) by directly capturing data from electronic health record (EHR) systems, cultivates family engagement with supportive information and a digital system for self-report of actual needs, and facilitates the delivery of care to those with a high burden of need by coordinating collaboration between ICU teams and palliative care specialists. In pilot comparison to a standard palliative care control, the intervention reduced unmet needs, psychological distress, and length of stay and increased goal concordant care, communication, and hospice utilization.
While these data are compelling, an efficacy evaluation of PCplanner is needed. Therefore, we plan to enroll approximately 150 patients, 150 family caregivers, and 75 physicians will be enrolled from academic and community settings in a project with 2 key aims: (1) Test the efficacy of PCplanner-augmented collaborative palliative care vs usual care in a randomized clinical trial (RCT) with 3-month follow up, and (2) Explore family caregiver and clinician experiences using mixed methods to understand intervention mechanisms as well as implementation barriers within diverse case contexts. The key hypothesis is that compared to usual care, PCplanner will reduce family caregivers' unmet needs and psychological distress, increase the frequency of goal concordant treatment among older adult patients, and reduce hospital length of stay.
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 (Participant, Outcomes Assessor)
盲法说明
All masking done via differential user accesses allowed by a mobile app platform.
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
- •Inclusion Criteria:
- •≥50 years of age
- •Receive care in a study ICU for ≥24 hours
- •Meets ≥1 of 9 high risk phenotypes a. Dementia (e.g., Alzheimer's, multi-infarct, other dementia etiology) b. Declining health status defined by EITHER: i. ≥2 hospital admissions in 3 months preceding current admission OR ii. >1 ICU admission in 3 months preceding current admission c. Poor functional status defined by EITHER: i. admit from Skilled Nursing Facility (SNF) or Long-Term Acute Care (LTAC) facility OR ii. ≥3 activities of daily living (ADL) limitations at admission d. Severe acute illness defined by EITHER: i. cardiac arrest OR ii. multisystem organ failure (≥3 of: lung, kidney, hematological, brain, cardiac, liver) that has worsened over 48 hours (i.e., Sequential Organ Failure Assessment [SOFA] score increase) e. Severe acute stroke (e.g., acute intracranial hemorrhage, ischemic stroke, or traumatic brain injury) f. Acute respiratory failure (ventilation or high oxygen support for ≥24 hours) g. Acute renal failure (new hemodialysis or continuous venovenous hemodiafiltration for ≥1 hour) h. Advanced cancer (Advanced / metastatic cancer diagnosis) i. Shock (use of vasopressor or inotrope for ≥4 hours)
排除标准
- •(pre-consent):
- •Palliative care consultation performed during the hospitalization before eligibility determination
- •Current admission to ICU at the index hospital ≥8 days
- •Imprisoned
- •No known family or surrogate decision maker
- •Death expected within 24 hours
- •Exclusion Criteria (post-consent):
- •- Patient dies before T2
- •FAMILY MEMBER
- •Inclusion Criteria:
- •≥18 years of age
- •Self-described as the individual (related or unrelated) who provides the most support and with whom the patient has a significant relationship (per definition of 'family' described in the Society of Critical Care Medicine 2016 Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU)
- •Exclusion Criteria (pre-consent):
- •Lack a knowledge of English such that the potential participant is not confident that they could complete study tasks (app viewing, surveys)
- •Imprisoned
- •Unable to complete surveys for any reason
- •Exclusion Criteria (post-consent):
- •- Low need burden (NEST score <10) at baseline
- •ICU PHYSICIANS
- •Inclusion Criteria:
- •≥18 years of age
- •Attending or fellow physician in a study ICU
- •Exclusion Criteria:
研究组 & 干预措施
Usual care control
Usual care
Intervention
PCplanner intervention during hospitalization
干预措施: PCplanner (Behavioral)
结局指标
主要结局
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
时间窗: Time 1 (baseline), Time 2 (~3 days post-randomization), and Time 3 (~1 week post-randomization)
The NEST is a palliative care needs instrument capturing all 8 domains of palliative care quality from patients' family members. Scores range from 0 (no needs) to 130 (higher needs). Reported here is scores at Time 3 (\~1 week post-randomization).
次要结局
- Post-randomization Hospital Length of Stay(from randomization until hospital discharge)
- Patient Health Questionnaire 9-Item Scale (PHQ-9)(Time 1 (baseline), Time 3 (~1 week post-randomization), and Time 4 (3 months post-randomization))
- Generalized Anxiety Disorder 7-Item Scale (GAD-7)(Time 1 (baseline), Time 3 (target ~1 week post-randomization), and Time 4 (3 months post-randomization))
- Post-Traumatic Stress Symptom (PTSS) Inventory(Time 1 (baseline) and Time 4 (3 months post-randomization))
- Post-randomization Intensive Care Unit Length of Stay(from randomization until intensive care unit discharge)
- Number of Participants With Goal Concordant Care(Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization))
- Patient-Perceived Patient-Centeredness (PPPC) Scale(Time 3 (target ~1 week post-randomization))