Application of Personalized Palliative Care in Patients With Newly Diagnosed Idiopathic Pulmonary Fibrosis - An Exploratory-Descriptive Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of concordance between the levels of palliative care obtained using a triage questionnaire and those derived from the clinical judgments of the dedicated pulmonologist and the dedicated palliative care physician
研究概览
简要总结
This study aims to develop a tool that helps the medical-nursing team in the identification of the real palliative care needs of each individual patient. Patients with newly diagnosed Idiopathic Pulmonary Fibrosis will be asked just a few simple questions in order to place them at the most appropriate level of palliative care (PC) even before the first medical contact. This would not only optimize resource allocation (e.g., allowing patients with low palliative needs to be assessed solely by the PC nurse), but also benefit patients who have difficulty leaving their homes by enabling them to receive evaluation and palliative care directly at home rather than after a hospital assessment.
详细描述
The population of this study consists of patients with newly diagnosed Idiopathic Pulmonary Fibrosis (IPF) who are being followed at the specialized outpatient clinics of APPI Fibrosi, within the Unit of Pulmonology and Respiratory Intensive Care, at the IRCCS Azienda Ospedaliero-Universitaria, Policlinico di S. Orsola.
During the initial interview prior to the pulmonology visit, Pulmonologist A will inform the patient about the study, provide the information sheet, and obtain informed consent for participation in the study and data processing. Subsequently, the questionnaire will be used to interview the patients, collect their responses, and assign them to the corresponding level of palliative care (PC) according to the score obtained. The assignment to the level of PC intensity made by Pulmonologist A will not in any way modify the patient's allocation to the level of PC.
During the pulmonology visit, which takes place immediately after the questionnaire administration, Pulmonologist B will conduct the visit according to the standard procedures (collection of past medical history, recent history, occupational history, family history, evaluation of laboratory and instrumental tests, medical examination, measurement of viral parameters, potential prescription of antifibrotic medication, and oxygen therapy if respiratory failure is detected, etc.). At the end of the visit, Pulmonologist B will give their clinical judgment on the appropriate level of PC required for the patient, based on the visit and collected data.
On the same day, the patient will also have an appointment with the PC team (doctor and nurse), as per current protocols at APPI Fibrosi IRCCS AOUBO, during which information on the patient's symptoms, the impact of symptoms on daily life activities, quality of life (QoL), and the patient's support network will be gathered. At the end of the visit, the PC team will express their judgment on the referral of a patient to a specific level of PC, based on the visit and collected data.
As per clinical practice, Pulmonologist B can give their own opinion, but the final decision regarding the assignment is made by the PC team.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •New diagnosis of Idiopathic Pulmonary Fibrosis (IPF) established through a Multidisciplinary Interstitial Disease Meeting.
- •Obtaining written informed consent.
排除标准
- •Patient's inability to understand and/or respond to the questions in the questionnaire as judged by the healthcare provider.
- •Patient already receiving care from the Palliative Care Service.
结局指标
主要结局
Evaluation of concordance between the levels of palliative care obtained using a triage questionnaire and those derived from the clinical judgments of the dedicated pulmonologist and the dedicated palliative care physician
时间窗: 18 months
The primary objective will be measured by calculating Krippendorff's alpha coefficient of reliability among the classifications obtained with the questionnaire, the clinical judgment of the pulmonologist, and the clinical judgment of the palliative care physician
次要结局
- Description of the degree of palliative care needs that patients with IPF present when referred to the reference pulmonology center(18 months)