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- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Kirsi MK Kvarnström, MScPharm
- Telefoonnummer: +358 40 656 9057
- E-mail: kirsi.kvarnstrom@hus.fi
Studie Contact Back-up
- Naam: Helena Liira, MD
- E-mail: helena.liira@hus.fi
Studie Locaties
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Vantaa, Finland, 01030
- Werving
- Vantaa healthcare and social services
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Contact:
- Helena Liira, MD
- E-mail: helena.liira@hus.fi
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Contact:
- Kirsi MK Kvarnström, McPharm
- Telefoonnummer: +358 40 656 9057
- E-mail: kirsi.kvarnstrom@hus.fi
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Medication discrepancy
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The groups of medicines
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Marja Airaksinen, PhD Pharm
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUS/1037/2020
- VD/4977/13.00.00/2020 (Andere identificatie: The Institutional Review Board Vantaa)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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