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

Hypothyroidism Clinical Trial

— TIAMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314790
• Other study ID #: FADOI.05.2015
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2022
• Source: Fadoi Foundation, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Other:
• 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;

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Fadoi Foundation, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate any possible offset between treatment standards for hypothyroidism and the real-life management of patient	To evaluate, in the real-life management of the hypothyroidism therapy, possible deviations from national and international clinical practice recommendations (CPR) in evidence-based guidelines (EBGs). Four EBGs and 39 CPRs have provided the basis on which 22 treatment management indicators have been identified (e.g. Number of Patients on LT4 replacement therapy who are not taking oral solution or softgel formulations are on absorption-hindering medication and/or do not comply with timing in relation to meals / Number of patients on LT4 replacement therapy who do not comply with the prescribed timing before meals and/or are taking absorption-hindering medication; Number of patients on replacement therapy with TSH in the ATA target range/ Number of patients on replacement therapy with known TSH; Number of patients on replacement therapy, taking LT4 tablets at least 60' before breakfast or at least 3 h after dinner / Number of patients on replacement therapy with LT4 tablets)	4 months for each phase
Primary	Effects of an educational programme	To evaluate the improvement of some indicators (the same of outcome 1) in the management of patients with hypothyroidism by means of a standardized educational programme (e.g. Number of Patients on LT4 replacement therapy who are not taking oral solution or softgel formulations are on absorption-hindering medication and/or do not comply with timing in relation to meals / Number of patients on LT4 replacement therapy who do not comply with the prescribed timing before meals and/or are taking absorption-hindering medication; Number of patients on replacement therapy with TSH in the ATA target range/ Number of patients on replacement therapy with known TSH; Number of patients on replacement therapy, taking LT4 tablets at least 60' before breakfast or at least 3 h after dinner / Number of patients on replacement therapy with LT4 tablets)	4 months for each phase
Secondary	Clinical profile evaluation of hypothyroidism	Assessment of age, gender, weight, hormonal hypothyroidism status (TSH, FT3, FT4), comorbidity, treatment of hypothyroidism and other pharmacological therapies of patients with hypothyroidism	4 months for each phase