Governance of Diabetes Management in Non-specialistic Hospital Settings
NCT ID: NCT02640768
Last Updated: 2015-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1449 participants
INTERVENTIONAL
2012-01-31
2015-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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educational training
educational training
educational training
implementation of a structured educational program for physicians and nurses
no educational training
no educational training wards
No interventions assigned to this group
Interventions
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educational training
implementation of a structured educational program for physicians and nurses
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients hospitalized for diabetic complications: ketoacidosis, hyperosmolar syndrome, hypoglycemic coma, pregnant diabetics or gestational diabetes
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria di Parma
OTHER
Responsible Party
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Ivana Zavaroni
Associate Professor
Principal Investigators
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Ivana Zavaroni, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria Parma
Locations
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AUSL Ospedale Maggiore
Bologna, , Italy
Azienda Ospedaliero-Universitaria
Ferrara, , Italy
AUSL Carpi
Modena, , Italy
Azienda Ospedaliero-Universitaria Parma
Parma, , Italy
AUSL Piacenza
Piacenza, , Italy
AUSL Montecchio
Reggio Emilia, , Italy
Countries
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References
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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.
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.
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.
Other Identifiers
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AOParma
Identifier Type: -
Identifier Source: org_study_id