Clinical trial NCT04589533: MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study)
Official title: MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS: A Multicenter Study Before & After Educational Program, With Cluster Randomization (MINDER Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 4320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in Internal Medicine and with known diagnosis of diabetes.

Brief summary: This is a national multicenter study that involves 54 Internal Medicine Units throughout Italy. It is designed as a replicate of two cross-sectional surveys interspersed with an educational program. The study is composed by three steps. Phase 1 concerns a retrospective data collection pertaining to patients with known diagnosis of T2DM. In phase 2 an educational training (focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1) will be conducted in 36 randomized centres out of the 54 ones enrolled (cluster randomization). The ratio 2:1 has been selected in order to offer to the majority of Centres the opportunity to undergo a program of training and maximize the potential positive effect of the educational program on patient management. Randomization will be performed at the beginning of the study. Centres will be selected according to their ability to prescribe all classes of antidiabetic drugs. Phase 3 will occur around 6 months after the training and concerns a new data collection mirroring the previous one. In the phase 1, as well as in the phase 3, the data collection will be based on the review of the medical records of the last 40 consecutive patients with T2DM hospitalized in each Centre of Internal Medicine (in total, 80 patients for each Centre). After a period of 6 months from the hospitalization, a phone call follow up will be performed to know the clinical status of the patient enrolled, if he/she has been re-hospitalized after the index admission and current diabetes treatment.

Detailed description: During phase 1 and phase 3, each Center will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause. Therefore, being the data collection retrospective, patients will be managed according to routine clinical practice. During phase 2, 36 randomized centers, out of the 54 ones enrolled, will receive an educational intervention based on outreach visit (EOV), a 3-h face-to-face meeting between a trained diabetes specialist from outside the Center and the staff of the Center itself. This method was selected being considered as one of the most effective to modify professional practice and improve health care outcomes. In addition, at least 50% of the physicians who are part of the staff of the Center will receive distance learning (FAD). The contents of the educational program will be defined by the study Steering Committee, on the basis of guidelines, and possible deviations from the best medical practice detected during phase 1. In order to minimize the "awareness bias" (i.e. the possibility that participation to the project significantly influence clinical attitudes in phase 3), only one physician of the Centers of the "Control" group (not receiving EOV) will be made aware of the study design and procedures, and he/she will be eventually supported in the study data collection by nurses, or physicians who do not have the possibility of prescribing, in particular regarding the new categories of antidiabetic drugs.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Known diagnosis of type-2 diabetes
3. Informed Consent

Exclusion Criteria:

1. Current treatment with insulin
2. Patients treated with rapid acting insulin during the hospitalization
3. Patients hospitalized for less than 5 days.

Primary outcomes:
measure: Variation in fasting glycemia between the two groups of Centres during phase 3 of the study
timeFrame: 18 months
Secondary outcomes:
measure: Variation in fasting glycemia during hospitalization between the phase 1 and phase 3
timeFrame: 18 months
measure: Description of characteristics of patients with T2DM hospitalized in Internal Medicine
timeFrame: 18 months
Other outcomes:
Locations:
city: Cecina
country: Italy
facility: Azienda Toscana Nord Ovest, Cecina
city: Latina
country: Italy
facility: Po Nord "S. Maria Goretti"
city: Luino
country: Italy
facility: ASST Sette Laghi, Ospedale Confalonieri di Luino
city: Napoli
country: Italy
facility: Ospedale Fatebenefratelli
city: Pitigliano
country: Italy
facility: Usl Toscana Sud Est, Petruccioli
city: Rho
country: Italy
facility: Presidio di Passirana ASST RHODENSE
Study officials:
affiliation: FADOI FOUNDATION
name: ANDREA FONTANELLA
role: STUDY_DIRECTOR
References: