Management of Patients With Diagnosis of Hypothyroidism, as Hospitalized and as Outpatients, in Internal Medicine Units: Observational Study Before & After Educational Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 20
- 主要终点
- Effects of an educational programme
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Effects of an educational programme
时间窗: 4 months for each phase
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)
To evaluate any possible offset between treatment standards for hypothyroidism and the real-life management of patient
时间窗: 4 months for each phase
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)
次要结局
- Clinical profile evaluation of hypothyroidism(4 months for each phase)