The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Acceptability of intervention
研究概览
简要总结
The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.
详细描述
Interstitial lung disease (ILD) affects roughly 6.3 to 76 per 100,000 people of predominantly older adult patients worldwide and is associated with high morbidity and mortality. Patients with such idiopathic pulmonary fibrosis suffer symptom burdens similar to patients with cancer and commonly experience long, costly hospitalizations that often include care in an intensive care unit (ICU). Despite the presence of numerous unmet needs, ILD patients uncommonly receive palliative care because of lack of symptom recognition, supports to provide advanced care planning (ACP) and symptom control, and processes to promote collaboration between primary teams and palliative care specialists to deliver the appropriate level of care. To address this important clinical gap, we propose adapting our existing needs-targeted PCplanner (Palliative Care planner) mobile app platform to the outpatient setting. PCplanner Outpatient will allow patients to report their needs, provide video content to stimulate knowledge of and discussion about more advanced care planning, and assist primary physicians in recognizing the optimal timing of specialist palliative care referral.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has diagnosis of idiopathic pulmonary fibrosis
- •Patient has GAP (gender, age, physiology) index score ≥ 4
- •Patient is established in interstitial lung disease clinic (i.e., has had at least 1 previous clinic visit)
排除标准
- •Patient lacks fluency in English sufficient to complete study surveys
- •Patient is already seeing palliative care or enrolled in hospice
- •NEST score <10 at baseline T1
结局指标
主要结局
Acceptability of intervention
时间窗: Up to 16 weeks
Number of participants who stated they were satisfied with the intervention as measured by patient survey.
Documentation of advance care planning in electronic health record
时间窗: Up to 16 weeks
Includes all or any of the following: code status, healthcare power of attorney, advance directive
Feasibility of intervention
时间窗: Up to 16 weeks
Number of participants who stated intervention was easy to use as measured by patient survey.
Completion of intervention
时间窗: Up to 16 weeks
Number of participants who completed all three surveys and intervention telephone visits.
Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
时间窗: Baseline to week 8
Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.
次要结局
- Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale(Baseline to week 16)
- Change in General Anxiety Disorder-7 (GAD-7) score(Baseline to week 16)
- Change in Patient Health Questionnaire-9 (PHQ-9) score(Baseline to week 16)
- Change in Quality of Life Visual Analogue Scale (QOL VAS)(Baseline to week 16)
- Change in Patient Health Questionnaire-10 (PHQ-10) score(Baseline to week 16)
- Change in Therapeutic Alliance score(Baseline to week 16)
- Change in EuroQol - 5 Dimension (EQ-5D) score(Baseline to week 16)