- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Kirsi MK Kvarnström, MScPharm
- Numero di telefono: +358 40 656 9057
- Email: kirsi.kvarnstrom@hus.fi
Backup dei contatti dello studio
- Nome: Helena Liira, MD
- Email: helena.liira@hus.fi
Luoghi di studio
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Vantaa, Finlandia, 01030
- Reclutamento
- Vantaa healthcare and social services
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Contatto:
- Helena Liira, MD
- Email: helena.liira@hus.fi
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Contatto:
- Kirsi MK Kvarnström, McPharm
- Numero di telefono: +358 40 656 9057
- Email: kirsi.kvarnstrom@hus.fi
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Patients with multimorbidity
Patients with multimorbidity who visit the public health centres in Vantaa, Southern Finland
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Medication discrepancy
Lasso di tempo: Through study completion, an average of 3 months
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Comparison of actual use of medicines versus prescribed medicines
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Through study completion, an average of 3 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The groups of medicines
Lasso di tempo: Through study completion, an average of 3 months
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The medicines that are used differently as prescribes are classified in anatomical therapeutic chemical groups
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Through study completion, an average of 3 months
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The reason for non-adherence
Lasso di tempo: Through study completion, an average of 3 months
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Patient reported reasons for not taking medicines as prescribed
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Through study completion, an average of 3 months
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The effectiveness of medication information
Lasso di tempo: Through study completion, an average of 3 months
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Will the patient consider taking the medication as prescribed after the discussion with the pharmacist
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Through study completion, an average of 3 months
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Marja Airaksinen, PhD Pharm
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUS/1037/2020
- VD/4977/13.00.00/2020 (Altro identificatore: The Institutional Review Board Vantaa)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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