Implementation of a Structured Post-pulmonary Embolism Follow-up Model in a Danish Hospital Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
研究概览
简要总结
Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis or pulmonary embolism (PE) is the third most frequent cardiovascular disease and is associated with substantial short- and long-term morbidity and mortality and high costs of care. In addition negative physical and mental complications following VTE are common. However in terms of PE, there are no structured follow-up programs in Denmark and there is considerable variation in practice patterns of post-PE management both within and between countries.
This project aims to develop, test and implement a structured follow-up care model for patients with PE (The Attend-PE model). This project is a pre-post intervention study and will estimate the effectiveness of implementing the structured follow-up care model on a national level.
详细描述
The pre-post intervention study aims to measure differences in self-reported and clinical outcomes in patients with PE before and after the developed Attend-PE model has been implemented.
For the pre-intervention period, patient-reported questionnaires and registry data will be collected on all persons having received a CT-verified diagnosis of PE in the period March 2022 - May 2023. At 6 and 12 months following the PE event, the patients will receive an online letter with an invitation to complete an online questionnaire. The questionnaire includes validated patient-reported outcome measures and questions about sociodemographic factors. Furthermore, for all patients who have been invited to participate, register data will be retrieved on use of health care services, sick leave, prescription medication, as well as information on hospital of admission. Thus, the last PROM and register data for the 12-month follow-up will be retrieved in May 2024.
From October 2023 - Juni 2024 implementation of the Attend-PE model takes place on a national level, with a project team managing training of personnel and supporting the reorganization of care at the participating hospitals. 16 Danish hospitals have agreed to participate.
Following the implementation of the Attend-PE model, the post-intervention period is initiated. From October 2023 - Juni 2025 a data collection period similar to the pre-intervention period will take place, with patient-reported questionnaires forwarded to patients following a diagnosis of PE at 6 and 12 months, and data from registries being collected in the same time period. Thus, the last 12-month follow-up is expected to be completed in Juni 2026.
Detailed description of Attend-PE model:
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
- •adult patients (≥18 years)
- •CT-verified diagnosis of PE
排除标准
- •patients who are not living in Denmark on the extraction date
- •patients with a active cancer
研究组 & 干预措施
Attend-PE
干预措施: Attend-PE model (Other)
结局指标
主要结局
The Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
时间窗: 6 and 12 month follow-up
42 item covering health-related quality of life after pulmonary embolism. Transformed scale show score from 0-100, where 0 is the worst outcome and 100 is the best outcome.
Adherence to the anticoagulant treatment
时间窗: within the first 6 and 12 months
Patients having redeemed ≥80% of the prescribed anticoagulant medication. Using The Danish National Prescription Registry.
次要结局
- EuroQol 5 Dimensions (EQ-5D)(6 and 12 month follow-up)
- Post-VTE Functional Status Scale (PFVS)(6 and 12 month follow-up)
- Anti-Clot Treatment Scale (ACTS)(6 and 12 month follow-up)
- General Anxiety Disorder-7 (GAD7)(6 and 12 month follow-up)
- Patient Health Questionnaire (PHQ-9)(6 and 12 month follow-up)
- Patient Activation Measure (PAM)(6 and 12 month follow-up)
- Work Productivity and Activity Impairment questionnaire (WPAI:GH, v2.0.)(6 and 12 month follow-up)
- Recurrent VTE(within the first 6 and 12 months)
- Major and clinically relevant nonmajor bleeding(within the first 6 and 12 months)
- VTE-related death(within the first 6 and 12 months)
研究者
Stine Foged Lindegaard
PhD student
Aalborg University Hospital