Developing a Novel Precision Medicine Clinic to Drive Integration of Research Into Routine Healthcare: Precision Care Initiative
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Clinical Outcomes
研究概览
简要总结
The purpose of this study is to drive integration of precision medicine into routine oncology healthcare. It is hoped that this research will not only optimise the newly established Precision Care Clinic within the Prince of Wales Hospital, but also prime it for use within other health care sites. The multidisciplinary team will work to achieve the following three objectives:
- Co-design a Precision Care Clinic, its implementation platform and suite of outcome measures (Phase 1)
- Test the implementation-, service-, clinical, and cost-effectiveness of a Precision Care Clinic (Phase 2)
- Develop and pilot test a Precision Care scale-up model and toolkit (Phase 3)
A mixed-methods approach will be used to develop and evaluate an implementation platform to support the integration of precision medicine into the routine oncology setting at a single hospital site. In the first study phase, interviews and focus-groups will be used to develop the implementation platform, which involves a co-designed model of care supported by a Learning Health System. A Type II Hybrid effectiveness-implementation trial design will then be used to test the implementation, clinical, and cost-effectiveness of this novel model of care (phase 2). A combination of patient surveys and interviews will be used to measure patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs); stakeholder and patient interviews, surveys and focus-groups will be used to measure implementation outcomes; and cost data will be collected to inform an economic evaluation. These data will be collected at various stages of implementation to evaluate the effectiveness of the model of care over time. In the final study phase (phase 3), a scale-up model will be developed to support implementation of the new model of care across a wider range of clinical contexts. (Phase 3 will be detailed in a separate ethics amendment)
It is hoped that this research will not only optimise the newly established model of care within The Prince of Wales Hospital, but also prime it for use within other health care sites.
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
- •have been referred to the Precision Care Clinic at POWH
- •speak English
- •are aged 18 years or over
- •are able to provide informed consent
排除标准
- •aged under 18 years
- •non-English speaking
- •are unable to provide informed consent
结局指标
主要结局
Clinical Outcomes
时间窗: 3 months post-referral
Patient reported experience of coordinated care; collected via questionnaires adapted for the precision medicine context; measured as ratings; a higher rating indicates a preferred outcome.
Implementation Outcomes
时间窗: 3 months post-referral
appropriateness (e.g., perceived fit); qualitative measurement collected via interviews/focus groups/questionnaires
Service Outcomes
时间窗: 3 months post-referral
Upstream indicators of clinical effectiveness: intervals between time from referral to treatment; captured via audit data; measured in days; a smaller value indicates a preferred outcome.
次要结局
- Clinical Outcome: Quality of life improvement (EQ-5D-5L, EuroQol-5 Dimension-5 Level)(3, 6, 9 months post-referral)
- Clinical Outcome: Views and attitudes (patient-perceived benefits and drawbacks of process and care model), result return preferences, knowledge, perceived importance of genomic profiling(3, 6, 9 months post-referral)
- Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty)(3, 6, 9 months post-referral)
- Clinical Outcome: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction)(3, 6, 9 months post-referral)
研究者
Natalie Taylor
Associate Professor
The University of New South Wales