Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme
TIAMO
1 other identifier
observational
1,200
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2022
CompletedApril 6, 2022
March 1, 2022
1.6 years
January 20, 2022
March 29, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Clinical profile evaluation of hypothyroidism
4 months for each phase
Study Arms (2)
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.
Interventions
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;
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
Related Publications (1)
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.
PMID: 35769080DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MAURO CAMPANINI
FADOI FOUNDATION
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2022
First Posted
April 6, 2022
Study Start
June 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2019
Last Updated
April 6, 2022
Record last verified: 2022-03