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

NCT ID: NCT05314790

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2019-01-01

Brief Summary

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.

Detailed 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).

Conditions

Hypothyroidism

Study Design

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

Study Groups

control group (CG)

Without intervening Educational Program

No interventions assigned to this group

training group (TG)

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.

intervening Educational Program

Intervention Type: OTHER

The implementation of an EP is 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;

Interventions

intervening Educational Program

The implementation of an EP is 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;

Intervention Type: OTHER

Eligibility Criteria

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

• 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

MAURO CAMPANINI

Role: STUDY_DIRECTOR

FADOI FOUNDATION

Locations

ULSS1 Belluno San Martino

Belluno, , Italy

Ospedale Versilia

Camaiore, , Italy

Ospedale di Canicattì

Canicattì, , Italy

Ospedale di Castiglione del Lago, Medicina del Trasimeno

Castiglione del Lago, , Italy

Garibaldi Nesima

Catania, , Italy

Ospedale G.B. Morgagni - P.L. Pierantoni

Forlì, , Italy

Ospedale G.P. Delogu

Ghilarza, , Italy

Ospedale Gubbio-Gualdo Tadino

Gubbio, , Italy

Ospedale "F. Veneziale"

Isernia, , Italy

ASL Latina

Latina, , Italy

Ospedale S. Andrea

Massa Marittima, , Italy

Ospedale S. Croce di Moncalieri - ASL TO5

Moncalieri, , Italy

Ospedale Del Mare

Napoli, , Italy

Ospedale Fatebenefratelli

Napoli, , Italy

Ospedale Maggiore di Novara

Novara, , Italy

Ospedale Civico di Partinico

Palermo, , Italy

Ospedale "Bianchi-Melacrino-Morelli"

Reggio Calabria, , Italy

Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

AOU di Sassari

Sassari, , Italy

Ospedale San Paolo

Savona, , Italy

Countries

Italy

References

Brancato D, Biondi B, Attardo TM, Fierro A, Nizzoli M, Vettor R, Monaco E, Romano R, Ariete V, Usai C, Zagarri E, Campanini M. Management of Hypothyroidism in Internal Medicine: Patient Profile and Effects of an Educational Programme in the Cluster-Randomized FADOI TIAMO Study. Front Endocrinol (Lausanne). 2022 Jun 13;13:839300. doi: 10.3389/fendo.2022.839300. eCollection 2022.

Reference Type: DERIVED

PMID: 35769080 (View on PubMed)

Other Identifiers

FADOI.05.2015

Identifier Type: -

Identifier Source: org_study_id