Coaching of Diabetic Patients After Hospital Discharge

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Coaching of Difficult Diabetic Patients by a Care Coordinating Team After Hospital Discharge

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Coaching with coordinate care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coaching with coordinate care<br>After discharge from hospital, patients randomized in the coaching group will be coached by a coordinator nurse. | Behavioral: Coaching with coordinate care<br>* The coordinator nurse will manage ambulatory care with the patient's GP and participate to patient's education.<br>|
| No Intervention: Usual care<br>After discharge from hospital, patients randomized in the no intervention group will be managed as usually. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes-related readmissions | Recording of all readmissions and analysis of files and reports for determining if this readmission was related to diabetes or not. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causes of rehospitalizations | Each admission to hospital (type of department, duration, direct admission or via Emergency room…) will be recorded. All efforts will be made to record the cause of hospitalization. | Up to 1 year | 
| Duration of rehospitalizations |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coaching, therapeutic education, hospital admission, quality improvement strategies, management program, nurse follow up, discharge planning, rehospitalization