Map of Risks in Home Care From Primary Health Care.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Modification of the number of visits to hospital centers, emergency consultations, falls, sores and infections of the study participants.
研究概览
简要总结
Background: Home health care is very complex. The registration of many disassembled information makes it difficult to interpret and does not allow the identification of critical areas for risk management.
Hypothesis / Research question: The availability of a risk map, with visual alerts to identify the critical areas, will facilitate the implementation of safe practices and improve the safety of patients included in the DOMicillary care program (ATDOM).
Objectives: To design and evaluate the effectiveness of the availability of a Visual Risks Map (MRV) in the computerized medical histories of ATDOM patients in the improvement of their safety and quality of life.(QL).
Methods: Once MRV is designed, the investigators will conduct a randomized clinical trial by conglomerates (Primary Care centers) to evaluate whether the fact of having this MRV (intervention) in the medical histories of ATDOM patients reduces avoidable income, falls and wounds and improves QL.
Analysis plan: Baseline description: socio-demographic characteristics, risk's levels in the different areas and other covariates in the control and intervention groups. Chi-square test to compare frequency of outcomes between control and intervention groups. Cox regression model to estimate time until the outcomes appear, adjusting for the different variables.
Expected results: The frequency of avoidable hospital admissions / emergencies' visits, falls and sores / infections will be significantly lower in the group of patients who have MRV in their clinical histories. Their qL wil be better.
Applicability and Relevance: It is a feasible and easy-to-implement project. It provides a practical utility for a lot of information that the investigators record and affects a key aspect of quality of care.
详细描述
Design:1st phase: Visual Risk Map Design (MRV); 2nd Phase: Randomized clinical trial by conglomerates (Primary Care Centers).
Study population (indicate inclusion and exclusion criteria):
Patients included in the Home Care program (ATDOM) assigned to the Primary Care Centers in the territory who agree to participate in the study. The only exclusion criterion will be the patient's refusal to participate in the study
Sample size and sampling procedure:
The study will be conducted in 8 Centers; 4 will be randomly assigned to intervention and 4 to control. If approximately 80% of patients have had an admission in the previous year and the investigators intend that, with our intervention, this percentage drops to 70%, for a confidence of 95% (alpha error of 5%) and a statistical power of 80%, the investigators will need a sample of 231 patients and, if the investigators have a 15% loss, 272 patients per group (control and intervention). Each Center will be able to provide approximately 50 ATDOM patients. All patients will be invited to participate. They will be given a brief explanation of the study and invited to sign informed consent (in case the patient has a significant cognitive impairment, their guardian will sign the consent). All patients who meet inclusion criteria will be included.The basic morbidity and mortality characteristics of the sample will be compared with the MSIQ (health and quality monitoring) record of CatSalut (catalonia health services).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients included in the primary care home care program
排除标准
- •refusal of the patient to participate in the study
结局指标
主要结局
Modification of the number of visits to hospital centers, emergency consultations, falls, sores and infections of the study participants.
时间窗: 1 year
Data will be collected in relation to the number of hospital visits and emergency visits to calculate avoidable visits. Events such as falls, the presence of sores and / or infections of the study participants will be compiled, taking into account their inclusion in the intervention group or control group to which they have been assigned. The data will be extracted from the clinical history (eCAP) according to the corresponding diagnosis.
次要结局
- Infections and sores(1 year)
- Quality of live in ATDOM patients(1 year)
- Rate of admissions and visits to preventable hospital emergencies(1 year)
- Sores, falls, hospital admissions, final institutionalization and death.(1 year)
- Risk management in ATDOM patients(1 year)