- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Kirsi MK Kvarnström, MScPharm
- Telefonnummer: +358 40 656 9057
- E-post: kirsi.kvarnstrom@hus.fi
Studer Kontakt Backup
- Navn: Helena Liira, MD
- E-post: helena.liira@hus.fi
Studiesteder
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Vantaa, Finland, 01030
- Rekruttering
- Vantaa healthcare and social services
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Ta kontakt med:
- Helena Liira, MD
- E-post: helena.liira@hus.fi
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Ta kontakt med:
- Kirsi MK Kvarnström, McPharm
- Telefonnummer: +358 40 656 9057
- E-post: kirsi.kvarnstrom@hus.fi
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Medication discrepancy
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The groups of medicines
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Marja Airaksinen, PhD Pharm
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HUS/1037/2020
- VD/4977/13.00.00/2020 (Annen identifikator: The Institutional Review Board Vantaa)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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