PATIENT VOICES - A Project for the Integration of Systematic Assessment of Patient Reported Outcomes Within an E-Health Program in an Italian Comprehensive Cancer Center
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Proportion of patient compliant with ePROM assessment
研究概览
简要总结
Listening to "patient voices" in terms of symptoms, emotional status, satisfaction with care and information received, represents a major shift in medicine. It is in fact crucial in medical decision making and patient empowerment, especially in cancer care.
Patient Reported Outcomes Measures (PROMs) and in particular electronically assessed PROMS (ePROMS), have been identified as potentially effective tools to systematically gather patient voices. Despite international extensive and growing interest, systematic PROM collection is not widely implemented in routine cancer care, due to barriers at various levels.
The PATIENT VOICES is a project aimed at achieving a stepwise inclusion and integration of PROMs within routine clinical practice at the FONDAZIONE IRCCS ISTITUTO NAZIONALE TUMORI-MILANO. Phase I of the Patient Voices project (pilot and feasibility testing), will be the focus of the present study and its results will be the base for subsequent phases (implementation and impact assessment).
详细描述
Study aims of this phase are:
- Assessing the use and attitudes toward PROMs by clinicians in a comprehensive cancer centre.
- Reviewing and compare pre-existing ePROMS assessment systems.
- Developing and pilot testing a flexible system for electronic collection of PROMs.
- Assessing feasibility of ePROM assessment of physical symptoms, psychological distress and patient satisfaction.
- Identifying barriers to and developing strategies for the final implementation and integration of routine ePROMs into the clinical practice.
The project will last 2 years. Longitudinal and cross-sectional studies will be carried out with the aim to evaluate compliance, acceptability, and usability of a routine ePROM assessment system by both patients and clinicians. Participants will be enrolled among patients attending 3 out-patient clinics (physical symptom), 3 inpatient wards (psychological distress) and 5 multidisciplinary teams (patient satisfaction). The Edmonton symptom assessment scale, the Distress Thermometer, and a questionnaire adapted from the Bench-Can and EURACAN projects plus the institutional customer satisfaction survey, will be used in the three studies. Qualitative methods will be used identify patient and clinician related barriers to ePROM assessment and to pinpoint engagement strategies to promote its use in routine cancer care. Semi-structured interviews and focus groups will be carried out.
Quantitative and qualitative studies will respectively enroll 600 and 40 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •age 18 years or above
- •a verified cancer diagnosis
排除标准
- •inability to fill in PROMs due to cognitive impairment, psychological disturbance or language problems as judged by the study personnel.
结局指标
主要结局
Proportion of patient compliant with ePROM assessment
时间窗: Baseline (one-time point only)
Compliant patients are defined as patients successfully completing ePROM assessment.
Proportion of clinical encounters using ePROM assessment
时间窗: Baseline (one-time point only)
Clinical encounters using ePROM assessment are encounters in which the clinician gets access to symptom or psychological distress data collected by the patients through ePROM assessment
次要结局
- Proportion of patient compliant with ePROM repeated assessments(6 months)
- Proportion of refusals(Baseline (one-time point only))
研究者
Cinzia Brunelli
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano