Tailoring Post Discharge (TPD) - Bridging the Gap Through Education and Community Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Repeat MI - Composite outcome measure
研究概览
简要总结
This randomized control trial seeks to better understand the educational needs of Acute Coronary Symptom (ACS) patients including the optimal timing and method of delivery as well as linkages with appropriate community resources and supports are important for cardiac patients to self-manage post hospital discharge to improve outcomes. While there is some literature of the learning needs of ACS patients, there is a paucity of research related to the timing and preferred methods of delivery. This study aims to better understand how best to tailor care for ACS patients from hospital to community. Specifically, the investigators propose a 2 phased approach to understand the needs of patients, and then to develop and deliver a tailored approach to assess, educate and support patients both in-hospital and within the community. The intervention compares 1) a virtual remote home monitoring (RHM) platform and 2) Rapid Response Nursing (RRN) staff to follow, educate and support ACS patients post hospital discharge for a period of no more than 30 days.
The Primary Objective of this study is to safely transition low risk ACS patients, from hospital to home, with appropriate supports to safely self-manage in the community and to provide educational and community supports to improve post discharge outcomes of low risk ACS patients
详细描述
Study design: 2 phase single center randomized, prospective pilot study
Phase 1) Evaluation of quality indicator results from discharge questionnaires from patients post ACS and a further investigation through patient engagement techniques about education, community support and quality of care. This process, comprising of patient collaborators/partners, will contribute to the study design, tool and resource development.
Phase 2) Randomized trial - Intervention (low risk 24-hour discharge support using Rapid Response nursing (RRN) vs low risk 24-hour discharge support using Remote Home Monitoring (RHM). Patients will be assessed using a trialed multipoint tool developed for this research study utilizing the cardiac, medical, community and patient risks. After assessment, low-risk patients will be randomized into the study. The study interventions will utilize either the RRN or the RHM to deliver education and support to patients post discharge.
Phase 1 - Patient Engagement Panel:
Patient engagement in research involves meaningful and active collaboration between patients and researchers throughout the different phases of a research project, including planning, data collection, data analysis, and knowledge translation. These collaborative meetings inform and guide study development. The central tenet of patient engagement in research is that, while clinicians and investigators have disease and research specific expertise, patients have expertise that stems from lived experience of their health issues. By sharing their experiences of the daily impact of disease and their perspectives regarding unmet needs, therapeutic burdens, balance of benefits and risks, and types of research questions most important to them, patients can transform the research process from one directed by investigators to one driven and informed by the needs of patients and their caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients who presented with ACS to St. Boniface Hospital
- •Considered low risk based on cardiac risk, comorbidities, community and patient resources
排除标准
- •Age less than 18 years.
- •Unable or unwilling to provide consent
- •Considered high risk for early discharge
- •Lives outside of Winnipeg (for Phase 2 of the study, we will only be focusing on patients that live within Winnipeg)
- •No internet or mobile data access
结局指标
主要结局
Repeat MI - Composite outcome measure
时间窗: 30-days post hospital discharge
repeat myocardial infarction - measured as yes/no (repeat MI at 30 days = yes)
Mortality - Composite outcome measure
时间窗: 30-days post hospital discharge
mortality - measured as yes/no (Alive at 30 days = no)
Re-Admission - Composite outcome measure
时间窗: 30-days post hospital discharge
re-hospitalization and emergency room/urgent care visits measured as yes/no (rehospitalization at 30 days = yes)
Congestive Heart Failure - Composite outcome measure
时间窗: 30-days post hospital discharge
congestive heart failure - measured as yes/no (Ejection fraction \< 40% is CHF)
次要结局
- EQ-VAS - Health related Quality of Life(baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge)
- EQ-5D-5L - Health related Quality of Life(baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge)
- General Anxiety Disorder (GAD) - 7(baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge)
- Patient Health Questionnaire (PHQ) - 9(baseline (before discharge from hospital), 2-weeks post hospital discharge, and 30 Days post hospital Discharge)
研究者
Shuangbo Liu
Principal Investigator
St. Boniface Hospital
