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

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.

Study Overview

• Status: Completed
• Conditions: Hypothyroidism
• Intervention / Treatment: Other: intervening Educational Program

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).

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• Italy
  • Belluno, Italy
    • ULSS1 Belluno San Martino
  • Camaiore, Italy
    • Ospedale Versilia
  • Canicattì, Italy
    • Ospedale di Canicattì
  • Castiglione Del Lago, Italy
    • Ospedale di Castiglione del Lago, Medicina del Trasimeno
  • Catania, Italy
    • Garibaldi Nesima
  • Forlì, Italy
    • Ospedale G.B. Morgagni - P.L. Pierantoni
  • Ghilarza, Italy
    • Ospedale G.P. Delogu
  • Gubbio, Italy
    • Ospedale Gubbio-Gualdo Tadino
  • Isernia, Italy
    • Ospedale "F. Veneziale"
  • Latina, Italy
    • ASL Latina
  • Massa Marittima, Italy
    • Ospedale S. Andrea
  • Moncalieri, Italy
    • Ospedale S. Croce di Moncalieri - ASL TO5
  • Napoli, Italy
    • Ospedale del Mare
  • Napoli, Italy
    • Ospedale Fatebenefratelli
  • Novara, Italy
    • Ospedale Maggiore di Novara
  • Palermo, Italy
    • Ospedale Civico di Partinico
  • Reggio Calabria, Italy
    • Ospedale "Bianchi-Melacrino-Morelli"
  • San Giovanni Rotondo, Italy
    • Casa Sollievo della Sofferenza
  • Sassari, Italy
    • AOU di Sassari
  • Savona, Italy
    • Ospedale San Paolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group (CG); Without intervening Educational Program
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.	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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fadoi Foundation, Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: FADOI.05.2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No