Clinical trial NCT05314790: Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme
Official title: Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with known diagnosis of hypothyroidism on the basis of medical history or laboratory results,as hospitalized and as outpatients, in Internal Medicine Units

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).

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

Primary outcomes:
measure: To evaluate any possible offset between treatment standards for hypothyroidism and the real-life management of patient
timeFrame: 4 months for each phase
measure: Effects of an educational programme
timeFrame: 4 months for each phase
Secondary outcomes:
measure: Clinical profile evaluation of hypothyroidism
timeFrame: 4 months for each phase
Other outcomes:
Locations:
city: Belluno
country: Italy
facility: ULSS1 Belluno San Martino
city: Camaiore
country: Italy
facility: Ospedale Versilia
city: Canicattì
country: Italy
facility: Ospedale di Canicattì
city: Castiglione Del Lago
country: Italy
facility: Ospedale di Castiglione del Lago, Medicina del Trasimeno
city: Catania
country: Italy
facility: Garibaldi Nesima
city: Forlì
country: Italy
facility: Ospedale G.B. Morgagni - P.L. Pierantoni
city: Ghilarza
country: Italy
facility: Ospedale G.P. Delogu
city: Gubbio
country: Italy
facility: Ospedale Gubbio-Gualdo Tadino
city: Isernia
country: Italy
facility: Ospedale "F. Veneziale"
city: Latina
country: Italy
facility: ASL Latina
city: Massa Marittima
country: Italy
facility: Ospedale S. Andrea
city: Moncalieri
country: Italy
facility: Ospedale S. Croce di Moncalieri - ASL TO5
city: Napoli
country: Italy
facility: Ospedale Del Mare
city: Napoli
country: Italy
facility: Ospedale Fatebenefratelli
city: Novara
country: Italy
facility: Ospedale Maggiore di Novara
city: Palermo
country: Italy
facility: Ospedale Civico di Partinico
city: Reggio Calabria
country: Italy
facility: Ospedale "Bianchi-Melacrino-Morelli"
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Sassari
country: Italy
facility: AOU di Sassari
city: Savona
country: Italy
facility: Ospedale San Paolo
Study officials:
affiliation: FADOI FOUNDATION
name: MAURO CAMPANINI
role: STUDY_DIRECTOR
References:
citation: 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.