Governance of Diabetes Management in Non-specialistic Hospital Settings
Governance of Diabetes Management in Non-specialistic Hospital Settings
The prevalence of diabetes among inpatients in medical wards, surgery and intensive care
 units in Italy is approximatively 12-25%. The management of in hospital diabetes and
 hyperglycemia is complex and requires a specific training for physicians and nurses in
 non-specialist settings. The overall project aims at the implementation of a "best practice"
 model of care for hospitalized diabetic patients in non-specialist settings.
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.
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