- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02640768
Governance of Diabetes Management in Non-specialistic Hospital Settings
Study Overview
Detailed Description
The project aims at defining a model of care for hospitalized diabetic patients in non-specialist settings based on the national and international recommendations. This is a cluster randomized study to evaluate the efficacy of a structured education training program for physicians and nurses in improving an ad hoc composite performance score of diabetes management and some clinical outcomes. The study will be carried out in 6 hospitals of the Emilia-Romagna region in Italy and it will involve 3 different wards (internal medicine, intensive care unit, surgery). For each hospital one intervention and two controls wards will be randomly identified.
At baseline the clinical management of patients with stress hyperglycemia/diabetes will be assessed in all participating wards over a 3-month period. Then, a structured educational program regarding the management of stress hyperglycemia/diabetes in the inpatient setting will be carried out only in the intervention wards. This program will last 2 months. Health care professionals also will be trained in the regular use of appropriate management tools (hyperglycemia dedicated standard operation procedures, audits, etc.).
Three months after the end of the educational program, the 3-month assessment of clinical management of patients with stress hyperglycemia/diabetes will be repeated in all participating wards.
The assessment of clinical management of stress hyperglycemia/diabetes will be based on a set of clinical performance indicators concerning 5 major domains (admission assessment, glucose monitoring, medical therapy, management of consults, management of discharge). These indicators will be used to define a composite performance score of appropriateness and efficacy. The highest score (1) will be assigned when the indicator is monitored, the lowest (0) when the indicator will be not detected, according to the scoring method previously reported by Rossi et al. Therefore, the score of each domain will range between 0 and the number of indicators used to assess appropriateness and efficacy of that domain.
Domain 1 - Initial assessment: score 0-5
- records of admission glycemia
- records of fasting plasma glucose
- records of HbA1c
- appropriate diagnosis of stress hyperglycemia/diabetes mellitus according to ADA
- records of history of presence/absence of pharmacological diabetes therapy
Domain 2 - Glucose monitoring: score 0-4
- appropriate glucose monitoring: at least 80% of three daily preprandial glycemia or, in critically ill patients, monitoring according to the specific algorithm used in the ward
- presence and use of specific forms for glucose records
- presence of ward standing orders to recognize and correct hypoglycemia
- presence of ward standing orders to monitor and manage glucose in critically ill patients (Critically ill patients are defined as patients who require intensive care for acute critical illnesses, such as myocardial infarction, stroke, septic shock or severe respiratory failure, requiring intensive or semi-intensive therapy and, as a rule, not taking food orally during the first 24-72 hours)
Domain 3 - Medical therapy: score 0-2
- records of time and dose of insulin therapy
- interruption of Metformin therapy when indicated (correct indications to discontinuation of Metformin therapy were: any critical illness, acute renal, cardiac and/or respiratory failure, surgery or iodinated contrast agents administration.)
Domain 4 - Consults: score 0-2
- request and records of diabetes specialist consult
- request and records of nursing consult
Domain 5 - Management of discharge: score 0-3
- planning of diabetes follow-up visit after hospitalization
- patient education for home blood glucose self-monitoring
- patient education for all other aspects of diabetes management
The sum of the scores of each domain from 1 to 5 is the composite performance score.
The following clinical outcomes will be recorded both at baseline and 3 months after the end of the educational program in all participating wards.:
- all hypoglycemic events (blood glucose ≤ 70 mg/dl)
- severe hypoglycemic events (blood glucose ≤ 40 mg/dl with or without clouding of consciousness)
- difference between plasma glycemia at admission and mean plasma glucose during the last-48-hours before discharge
- achievement of glycemic goals: 4 consecutive blood glucose levels ≤ 130 mg/dl (preprandial) or ≤ 180 mg/dl (postprandial), or 4 consecutive blood glucose levels between 140 and 180 mg/dl in critically ill patients
- survival
- discharge condition: a score of 0 will be assigned in case of death or transfer to a higher intensity ward and score 1 in all other cases, i.e. home discharge or transferral to a lower intensity ward.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy
- AUSL Ospedale Maggiore
-
Ferrara, Italy, 44121
- Azienda Ospedaliero-Universitaria
-
Modena, Italy
- AUSL Carpi
-
Parma, Italy, 43126
- Azienda Ospedaliero-Universitaria Parma
-
Piacenza, Italy, 29121
- AUSL Piacenza
-
Reggio Emilia, Italy, 42027
- AUSL Montecchio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with type 2 or type 1 diabetes or stress hyperglycemia
Exclusion Criteria:
- age <18,
- patients hospitalized for diabetic complications: ketoacidosis, hyperosmolar syndrome, hypoglycemic coma, pregnant diabetics or gestational diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: educational training
|
implementation of a structured educational program for physicians and nurses
|
No Intervention: no educational training
no educational training wards
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite performance score computed as the sum of the performance scores of all 5 domains of appropriateness and efficacy in both the intervention and the control wards
Time Frame: 11 months
|
Efficacy of educational training will be evaluated as absolute change of the performance scores after the intervention compared to baseline in the two groups
|
11 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hypoglycemic events in the intervention and control wards
Time Frame: 11 months
|
rate difference of hypoglycemia events (blood glucose ≤ 70 mg/dl) in the intervention and control wards
|
11 months
|
severe hypoglycemic events in the intervention and control wards
Time Frame: 11 months
|
rate difference of severe hypoglycemia events (blood glucose ≤ 40 mg/dL with or without clouding of consciousness) in the intervention and control wards
|
11 months
|
difference between plasma glycemia at admission and mean plasma glucose during the last-48-hours before discharge
Time Frame: 11 months
|
difference between plasma glycemia at admission and mean plasma glucose during the last-48-hours before discharge
|
11 months
|
achievement of glycemic goals in the intervention and control wards
Time Frame: 11 months
|
number of patients that achieve glycemic goals: 4 consecutive blood glucose levels ≤ 130 mg/dl (preprandial) or ≤ 180 mg/dl (postprandial), or 4 consecutive blood glucose levels between 140 and 180 mg/dl in critically ill patients
|
11 months
|
survival rate during hospitalization in the intervention and control wards
Time Frame: 11 months
|
survival rate during hospitalization (score 1 for survival, score 0 for death)
|
11 months
|
discharge condition in the intervention and control wards
Time Frame: 11 months
|
a score of 0 will be assigned in case of death or transfer to a higher intensity ward and score 1 in all other cases, i.e. home discharge or transferral to a lower intensity ward.
|
11 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ivana Zavaroni, MD, Azienda Ospedaliero-Universitaria Parma
Publications and helpful links
General Publications
- Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006 Feb 2;354(5):449-61. doi: 10.1056/NEJMoa052521.
- Cook CB, Castro JC, Schmidt RE, Gauthier SM, Whitaker MD, Roust LR, Argueta R, Hull BP, Zimmerman RS. Diabetes care in hospitalized noncritically ill patients: More evidence for clinical inertia and negative therapeutic momentum. J Hosp Med. 2007 Jul;2(4):203-11. doi: 10.1002/jhm.188.
- American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.
- Rossi MC, Lucisano G, Comaschi M, Coscelli C, Cucinotta D, Di Blasi P, Bader G, Pellegrini F, Valentini U, Vespasiani G, Nicolucci A; AMD-QUASAR Study Group. Quality of diabetes care predicts the development of cardiovascular events: results of the AMD-QUASAR study. Diabetes Care. 2011 Feb;34(2):347-52. doi: 10.2337/dc10-1709.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOParma
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
Clinical Trials on educational training
-
Barcelonabeta Brain Research Center, Pasqual Maragall...Fundacion SARquavitaeCompletedDementia | Alzheimer's DiseaseSpain
-
University Hospital of FerraraUniversity of PadovaRecruitingMedication Adherence | Aging | Fall | Multidisciplinary Communication | Hospital DischargeItaly
-
University of IbadanRecruitingUrinary Tract Infections | Urinary Tract Infection Lower AcuteNigeria
-
University of Texas Southwestern Medical CenterThe Hospital for Sick ChildrenCompletedColonoscopy | Education, MedicalUnited States
-
Michigan State UniversityCompleted
-
Mersin UniversityCompleted
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedGestational Diabetes | Gestational Diabetes Mellitus in PregnancyUnited States
-
Taipei Medical UniversityNot yet recruiting
-
Northwestern UniversityCompletedMelanoma | Nevi | Skin MolesUnited States
-
The Cleveland ClinicNational Institutes of Health (NIH)CompletedAging | Alzheimer's DiseaseUnited States