Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme (TIAMO)

Fadoi Foundation, Italy

Status: Completed

Conditions: Hypothyroidism

Treatments: Other: intervening Educational Program

Study type: Observational

Funder types: Other

Identifiers

NCT05314790

FADOI.05.2015

Details and patient eligibility

About

There is still limited knowledge regarding the clinical profile and appropriateness of treatment in patients with hypothyroidism hospitalized in Internal Medicine (IM) Departments in Italy. The aim of this study is to evaluate: 1) the characteristics of patients and possible deviations from national and international clinical practice recommendations (CPRs) in evidence-based guidelines (EBGs); 2) the improvement of patient management by means of a standardized educational programme (EP).

Methods: A nationwide multicentre study, comprising two replications of a retrospective survey (phases 1 and 3) with an intervening EP (phase 2) in half of the centres and no EP in the other half, was conducted. The EP was based on outreach visits. Centres were assigned to the two arms of the study, labelled the training group (TG) and control group (CG) respectively, by cluster randomization.

Full description

Hypothyroidism (HT) is a common disorder that affects more than 4% of the general population. Since this percentage does increase with advancing age, it is reasonable to suppose that hypothyroidism is becoming a widespread disease condition. Furthermore hypothyroidism is correlated with significant cardiovascular morbidity and mortality.

Although the potential clinical impact of hypothyroidism, the clinical profile of patients affected by hypothyroidism and managed in the Internal Medicine setting it is not very well known so far. This study has the aim to take a real-life picture of Internal Medicine patients with diagnosis of hypothyroidism, in order to evaluate possible deviations between the current clinical practice and the evidence-based guidelines, and possibly improving the management by means of an educational program.

The FADOI-TIAMO study is designed as a replicate of two cross-sectional surveys (Phase 1 and 3) interspersed with an educational program (Phase 2) to be conducted in 11 out of the 22 participating Centres. The data collection in Phases 1 and 3 will be based on the review of medical records of the last 30 consecutive patients with known or de novo diagnosis of HT observed in each Centre (globally, 1200 patients).

Enrollment: 1,200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• known diagnosis of hypothyroidism on the basis of medical history or laboratory results, as indicated in the clinical record of inpatients admitted to the IM department for any condition

Exclusion criteria

• none

Trial design

1,200 participants in 2 patient groups

control group (CG)

Description:

Without intervening Educational Program

training group (TG)

Description:

Group who has received an Educational Program (EP). The implementation of an EP based on meetings within the Department, coordinated by an outside tutor (outreach visit model). The EP content was defined beforehand by a Scientific Board, on the basis of evidence-based guidelines (EBGs) and an up-to-date literature review, but also with a specific focus on any departures from standard clinical practice recommendations (CPRs) identified at each IM department in phase 1.

Treatment:

Other: intervening Educational Program