- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05167578
Identifying Reasons for Non-adherence in Patients With Multi-morbidity
Identifying Reasons for Non-adherence in Patients With Multi-morbidity: A Protocol for Prospective Observational Study in Primary Care
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This study aims to identify patient-reported reasons for medication non-adherence during pharmacist-led medication reconciliation in primary care. The investigators will examine medication discrepancies between physicians' prescription orders and patients' self-reported medication use, which medicines patients most often use against physician's order, and the reasons for the variant use of medicines. Additionally, the investigators will study the correlation between medication discrepancies and the number of medicines the patient uses. The investigators also aim to investigate which medicines can be classified as high-risk medicines for non-adherence.
The research method will contain a pharmacist-conducted medication reconciliation including a patient interview in a 30-minute appointment. Physicians, nurses, and pharmacists identify patients who are eligible for this study. The study will include 250 patients who visit the public health centres in Vantaa, Southern Finland.
Medication reconciliation will take place at the admission to the health centre, usually before physicians' appointments. A pharmacist will go through all medicines physicians have prescribed, over-the-counter medicines (OTC) and food supplements one by one to assess the actual medicine used by the patient. If a pharmacist identifies medication discrepancies between physician's prescriptions and patient's self-reported use of medicine during the medication reconciliation, she/he will find out the patients' reasons for adjusting the medication. Based on this process pharmacist formulates the updated medication list, including clinically appropriate over-the-counter medicines (OTC medicines) in the patient record system Apotti, where the physician will once more make sure that everything is in order. The pharmacist will advise the patient to clarify the possible misunderstandings or concerns toward medications and motivate the patient to use the medication as prescribed. The outcome of the discussion is documented.
The data will be analyzed by descriptive statistical analysis. The patients' reported reasons for medication discrepancies will be analyzed quantitatively, and central themes and subthemes will be classified. The risk ratio will be identified, i.e., the relative risk among the number of medicines and medication discrepancies. The investigators will compare the total number of patients' medicine, including non-prescription medicine, to medicine the patient is using differently as prescribed and calculate the possible comparative risk adjusting the medicine with the number of prescribed medicines. The investigators will also identify the high-risk medications for non-adherence. The investigators will analyze patients' need for information on medicines as the patient receives guidance and encouragement when the pharmacist identifies discrepancies. The data will be analyzed using IBM SPSS Statistics 26 software.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Kirsi MK Kvarnström, MScPharm
- Telefonní číslo: +358 40 656 9057
- E-mail: kirsi.kvarnstrom@hus.fi
Studijní záloha kontaktů
- Jméno: Helena Liira, MD
- E-mail: helena.liira@hus.fi
Studijní místa
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-
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Vantaa, Finsko, 01030
- Nábor
- Vantaa healthcare and social services
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Kontakt:
- Helena Liira, MD
- E-mail: helena.liira@hus.fi
-
Kontakt:
- Kirsi MK Kvarnström, McPharm
- Telefonní číslo: +358 40 656 9057
- E-mail: kirsi.kvarnstrom@hus.fi
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patients with multimorbidity
- Patients with ≥5 prescription medicines
- Finnish speaking
- Living at home and managing daily life independently
- Willingness to take part and sign the informed consent
Exclusion Criteria:
- Patients not understand Finnish
- Diagnosed Alzheimer or another memory disorder
- Need help to manage daily life
- End of life care
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Patients with multimorbidity
Patients with multimorbidity who visit the public health centres in Vantaa, Southern Finland
|
A pharmacist will go through all medicines physicians have prescribed, over-the-counter medicines (OTC) and food supplements one by one to assess the actual medicine used by the patient.
If a pharmacist identifies medication discrepancies between physician's prescriptions and patient's self-reported use of medicine during the medication reconciliation, she/he will find out the patients' reasons for adjusting the medication.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Medication discrepancy
Časové okno: Through study completion, an average of 3 months
|
Comparison of actual use of medicines versus prescribed medicines
|
Through study completion, an average of 3 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The groups of medicines
Časové okno: Through study completion, an average of 3 months
|
The medicines that are used differently as prescribes are classified in anatomical therapeutic chemical groups
|
Through study completion, an average of 3 months
|
|
The reason for non-adherence
Časové okno: Through study completion, an average of 3 months
|
Patient reported reasons for not taking medicines as prescribed
|
Through study completion, an average of 3 months
|
|
The effectiveness of medication information
Časové okno: Through study completion, an average of 3 months
|
Will the patient consider taking the medication as prescribed after the discussion with the pharmacist
|
Through study completion, an average of 3 months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Marja Airaksinen, PhD Pharm
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HUS/1037/2020
- VD/4977/13.00.00/2020 (Jiný identifikátor: The Institutional Review Board Vantaa)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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