Coaching of Difficult Diabetic Patients by a Care Coordinating Team After Hospital Discharge
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Diabetes-related readmissions
研究概览
简要总结
One third of the costs of medical care for people with diabetes are related to hospitalization." Difficult" diabetic patient, i.e. those with very high HbA1c, patients > 75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high rate of readmission when discharged at home after an initial hospitalization related to diabetes or its complications. The objective of the study is to test if a coaching with a care coordinating team after hospital discharge would decrease diabetes-related rehospitalization rate compared with usual care.
详细描述
Patients with type 1 (T1D) or type 2 diabetes (T2D) hospitalized (>24h) and presenting at least a risk factor for readmission after discharge at home, will be randomized, at time of discharge, between 2 groups: an "intervention" group and a control group (usual management). Intervention will consist in optimized organization of discharge at home followed by a ambulatory individualized coaching by a nurse including an initial situation assessment, a consultation meeting with the patient's GP in order to propose a Health Personalized Plan, then a follow up program with a face to face session each trimester in order to remind the objectives, to assess compliance to the plan, to evaluate difficulties encountered and to help to find solutions. Final data collection will be done in both groups by questioning the patient's general practitioner (GP) and by collecting data on potential hospitalization. Expected duration : 3 years. Readmission rate, duration and causes of hospitalization will be compared between both groups. Impact of the results : Reduction of costs, improved use of hospital specialized resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •type 1 or type 2 diabetes AND AT LEAST ONE of the following criteria:
- •admission for more than 5 days
- •unplanned admission
- •at least one urgent care/emergency room visit in the 6 previous months, whatever its cause
- •HbA1c > 10% on admission
- •cardiovascular event in the previous year : cardiac failure, myocardial infarction, coronary or peripheral revascularization procedure, stage IV peripheral arteriopathy, stroke.
- •occurence during the previous year of a foot lesion requiring an admission or lasting more than one month (foot lesion risk stage 3)
排除标准
- •patients with one of the following co-morbidity: cancer in active phase of treatment, Parkinson's disease treated, severe chronic respiratory failure,
- •refusal of signing the consent,
- •patients non affiliated to Social Security,
- •pregnant women,
- •people who do not understand French (except if accompanied by somebody able to translate),
- •renal dialysis,
- •patients aged less than 18 years,
- •patients already in a similar type of trial
- •the arisen of a pregnancy or a cancer will cause the stop of the study
结局指标
主要结局
Diabetes-related readmissions
时间窗: Up to 1 year
Recording of all readmissions and analysis of files and reports for determining if this readmission was related to diabetes or not.
次要结局
- Causes of rehospitalizations(Up to 1 year)
- Duration of rehospitalizations(Up to 1 year)