An interventional study of Clinical Pharmacist Intervention Group in Hypothyroidism, Hyperthyroidism and Thyroid Diseases, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Health services research
Hypothyroidism (HoT) treatment involves lifelong thyroxine replacement therapy and regular monitoring. The objective of this study was to assess the impact of clinical pharmacist (CP) intervention in managing drug-related problems (DRPs) on outcomes among hypothyroid patients receiving levothyroxine (LT4) therapy.
The first choice in the treatment of hypothyroidism (HoT) is replacement therapy with levothyroxine (LT4). Factors other than the use of the drug are as crucial as the use of LT4 at the right time and in the right way. Drugs used by patients other than LT4, comorbidities, diet, age, and weight of the patient also affect the benefit seen from LT4 treatment.
LT4, which has a narrow therapeutic index, may cause drug-related problems (DRP) such as non-adherence to treatment, the timing of drug use, inappropriate use of the drug, inadequate therapeutic dose, duration of treatment, inadequate monitoring of treatment and potential drug-drug interactions (pDDI). In a study conducted in a hospital in India, DRP encountered during treatment with narrow therapeutic index drugs were compared with DRP encountered with other drugs. It was reported that DRPs were associated with pDDIs, adverse effects, dose overdose, dose underdose, untreated indications, inappropriate drug use, unnecessary drug use, and patient-related factors. In the study in which LT4 was also included, the rate of DRPs to narrow therapeutic index was 22%, and the rate of DRPs to other drugs was reported to be 8%. In a study documenting the interventions of pharmacists in hospitals in Germany, the interventions made between 2009 and 2012 were analyzed; LT4 was one of the ten drugs with the highest number of problems, and half of these problems were drug interactions and the inadequate therapeutic dose in patients with organ failure.
Aluminum hydroxide, bile acid secretagogues, calcium polystyrene sulphonate, sodium polystyrene sulphonate, calcium salts, iron preparations, multivitamin supplements containing iron, lanthanum carbonate, sevelamer, magnesium salts, orlistat, and raloxifene cause D-level drug interactions with LT4. In the concomitant use of calcium salts with LT4, it is observed that LT4 absorption and, consequently, therapeutic effect decreases [8,9]. In a systematic review of the concomitant use of LT4 and proton pump inhibitors (PPI) in hypothyroid patients with dyspepsia, gastroesophageal reflux, or peptic ulcer, a statistically significant increase in thyroid-stimulating hormone (TSH) levels was observed.
Since the therapeutic index of the LT4 drug is narrow, it emphasizes the importance of adherence to the drug in reaching ideal TSH levels. Medication adherence is a dynamic process closely linked to treatment outcomes in patients with chronic diseases. Very few studies exist on LT4 treatment and patient adherence to treatment. In their study, Yavuz et al. emphasized that almost half of HoT patients had serum TSH values outside the reference range despite receiving LT4 treatment and that adherence with LT4 treatment was one of the most critical determinants in reaching target TSH levels.
217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.
This study's enrollment of 44 is below the median of 70 across 109 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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Exclusion Criteria:
Group in which only observation is made by the clinical pharmacist For patients in this group, no intervention (i.e. recommendation) will be made to physicians by the clinical pharmacist. Within the intervention group, patient characteristics such as the underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received levothyroxine treatment for thyroid diseases and met the inclusion criteria. The participant will take standard treatment. Evaluations will be recorded.
Group to which the clinical pharmacist makes recommendations For patients in this group, intervention (i.e. recommendation) will be made to physician in charge by the clinical pharmacist. Within the intervention group, patient characteristics such as the underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received treatment for thyroid diseases and met the inclusion criteria. Through medication reviews, evaluations were made to identify drug-related problems and provide solutions to these problems. The clinical pharmacist provided recommendations to the physicians regarding significant clinically important problems.
Behavioral: Clinical Pharmacist Intervention Group
Group to which the clinical pharmacist makes recommendations The drugs administered to patients during scheduled hospital visits will be recorded. A detailed medication review will be conducted by the clinical pharmacist. As a result of a comprehensive evaluation, recommendations were made to doctors regarding drug-related problems and were recorded.
Also known as: Intervention Group
Acceptance rate of suggested intervention (number)
Acceptance rate of suggested intervention. Drug-related problems and recommendations are classified according to PCNE (Pharmaceutical Care Network Europe) version 9.1. It was recorded how many suggestions were made in the intervention group and how many of these suggestions were accepted.
Time frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Serum Thyroid Stimulating Hormone Levels
Serum Thyroid Stimulating Hormone Levels
Time frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Having serum T4 Levels within the normal range
Having serum T4 Levels within the normal range
Time frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Change in medication adherence rate for patients with thyroid disorders
Change in medication adherence rate for patients with thyroid disorders
Time frame: From the date of randomization until there are 18 patient participants in each group. Average 6 months.
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Sep 2022, 6 months.
Of 27 interventional studies with no phase under Hypothyroidism, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11. This study's 6 months is below that.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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