Reforça't: A Randomized Community Clinical Trial With a Social and Healthcare Approach to Improve Functional Outcomes in Patients With Chronic Cardiac, Respiratory, or Mixed Conditions After Hospital Discharge
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Reduction of mortality, readmission and nursing home admission
研究概览
简要总结
The goal of this randomized clinical trial is to determine whether an interdisciplinary, community-based intervention can reduce 30-day hospital readmissions and improve functional outcomes in patients aged 65 or older with chronic cardiac, respiratory, or mixed conditions following hospital discharge.
The main questions it aims to answer are:
Can the Reforça't program reduce 30-day hospital readmission rates to 25% compared to standard care? Does participation in Reforça't improve functional outcomes, medication adherence, quality of life, and mortality rates in this patient population?
Researchers will compare patients enrolled in Reforça't (intervention group) with those receiving standard care (control group) to determine whether the program leads to lower readmission rates, improved health outcomes, and higher cost-effectiveness.
Participants will:
Undergo a pre- and post-intervention assessment (30 days post-discharge). Receive comprehensive, interdisciplinary care integrating medical, social, and rehabilitation services.
Be monitored for 12 months to assess readmissions, survival, nursing home admissions, and overall well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Users admitted to the Polivalent Observation Units, Internal Medicine, or Hospital at home.
- •Individuals aged 65 years or older.
- •Hospital admission due to decompensation of a cardiac, respiratory, or mixed condition.
- •Place of residence within the health coverage area of Sant Jaume de Calella Hospital - Corporació de Salut del Maresme i la Selva.
- •Willingness to participate in the study as gathered by the signing of an informed consent document
排除标准
- •Users institutionalized in a nursing home
- •Users already enrolled in home care programs
- •Users in the Advanced Chronic Care Model program with a limited life prognosis
- •Users on the waiting list for organ transplantation
- •Users with language barriers
- •Users with a GDS (Global Deterioration Scale) score of 5 or higher
- •Users who have already been included in the Reforça't program
结局指标
主要结局
Reduction of mortality, readmission and nursing home admission
时间窗: 3, 6, 9, and 12 months after hospital discharge
Reduction of the Readmission Rate in the Intervention Group
时间窗: 30 days after hospital discharge
The investigators aim for the intervention to result in a 20% reduction of the readmission rate among users included in the experimental group
次要结局
- Reduction in Frailty Index Score(30 days after hospital discharge)
- Reduction in the number of inappropriate prescriptions(30 days after hospital discharge)
- Reduction of the mortality rate(30 days after hospital discharge)
- Increase in pharmacotherapeutic adherence(30 days after hospital discharge)
- Reduction in functional deterioration(30 days after hospital discharge)
- Reduction in the risk of falls(30 days after hospital discharge)
- Increase in physical function(30 days after hospital discharge)
- Increase in the number of beneficiaries of social prescribing or community referrals(30 days after hospital discharge)
- Obtain positive patient satisfaction(30 days after hospital discharge)
- Reduction or delay in institutionalization in nursing homes among users(30 days after hospital discharge)
- Reduction in Zarit Score for caregiver burden(30 days after hospital discharge)
- Reduction in the risk of social isolation(30 days after hospital discharge)
- Increase in emotional well-being(30 days after hospital discharge)
- Increase in the smoking cessation rate(30 days after hospital discharge)
研究者
Griselda Manzano Monfort
Head of Hospital At Home Unit at Corporació de Salut del Maresme i la Selva (CSMS). Postdoctoral researcher at Digital Health Research Group (IDIBGI-CSMS)
Corporació de Salut del Maresme i la Selva