MANAGEMENT OF PATIENTS WITH TYPE 2 DIABETES MELLITUS HOSPITALIZED IN INTERNAL MEDICINE UNITS (MINDER Study)

NCT ID: NCT04589533

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2022-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

EDUCATIONAL PROGRAM GROUP

This group will receive an educational program based . This group, as the other group, during phase 1 and phase 3, will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause.

educational program

Intervention Type: OTHER

The educational program will be based on: a outreach visit (a 3-h face-to-face meeting between a trained diabetes specialist from outside the Center and the staff of the Center itself) and a distance learning (FAD).The educational programme will be focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1

CONTROL GROUP

Control group will not receive educational program. This group, as the other group, during phase 1 and phase 3, will review the medical records of the last 40 patients (for each phase) with known T2DM and hospitalized for any cause.

No interventions assigned to this group

Interventions

educational program

The educational program will be based on: a outreach visit (a 3-h face-to-face meeting between a trained diabetes specialist from outside the Center and the staff of the Center itself) and a distance learning (FAD).The educational programme will be focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fadoi Foundation, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ANDREA FONTANELLA

Role: STUDY_DIRECTOR

FADOI FOUNDATION

Locations

Azienda Toscana Nord Ovest, Cecina

Cecina, , Italy

Site Status: RECRUITING

Po Nord "S. Maria Goretti"

Latina, , Italy

Site Status: RECRUITING

ASST Sette Laghi, Ospedale Confalonieri di Luino

Luino, , Italy

Site Status: RECRUITING

Ospedale Fatebenefratelli

Napoli, , Italy

Site Status: RECRUITING

Usl Toscana Sud Est, Petruccioli

Pitigliano, , Italy

Site Status: RECRUITING

Presidio di Passirana ASST RHODENSE

Rho, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

ELISA ZAGARRI'

Role: CONTACT

elisa.zagarri@fadoi.org

+393387063726

Facility Contacts

MARTINA LOMBARDI

Role: primary

GIUSEPPE CAMPAGNA

Role: primary

TIZIANA ATTARDO

Role: primary

ANDREA FONTANELLA

Role: primary

ANDREA MONTAGNANI

Role: primary

PAOLA NOVATI

Role: primary

Other Identifiers

FADOI.01.2020

Identifier Type: -

Identifier Source: org_study_id