Coaching of Diabetic Patients After Hospital Discharge (SORTIDIAB)

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Coaching with coordinate care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin-bicetre, France, 94 275
    • Recruiting
    • Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
    • Contact: Philippe CHANSON, MD, PhD; Phone Number: + 33 1 45 21 37 08; Email: philippe.chanson@bct.aphp.fr
    • Principal Investigator: Philippe CHANSON, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Philippe CHANSON, MD, PhD, Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (Estimate): June 13, 2013

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: hospital admission; therapeutic education; coaching; discharge planning; rehospitalization; quality improvement strategies; management program; nurse follow up
• Other Study ID Numbers: P110602; 2012-A00938-35 (Other Identifier: IRB number)