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Identifying Reasons for Non-adherence in Patients With Multi-morbidity

13. oktober 2022 opdateret af: Kirsi Kvarnström, Helsinki University Central Hospital

Identifying Reasons for Non-adherence in Patients With Multi-morbidity: A Protocol for Prospective Observational Study in Primary Care

The study will be carried out during pharmacist-conducted medication reconciliation. The pharmacist will ask how the patient has been taking the prescribed medicines and whether any over-the-counter medicines and food supplements have been used for self-medication. The data will be analyzed for descriptive statistics to identify 1) the number of discrepancies between the physician's prescription orders and the patient's self-reported use of the medicines, 2) what kind of discrepancies there are, and 3) which of them negatively influence patients' medicine taking.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with chronic conditions and multiple medication who visit the public health centres in Vantaa, Southern Finland

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Marja Airaksinen, PhD Pharm

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. april 2021

Primær færdiggørelse (Forventet)

31. december 2023

Studieafslutning (Forventet)

31. december 2024

Datoer for studieregistrering

Først indsendt

19. november 2021

Først indsendt, der opfyldte QC-kriterier

9. december 2021

Først opslået (Faktiske)

22. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUS/1037/2020
  • VD/4977/13.00.00/2020 (Anden identifikator: The Institutional Review Board Vantaa)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

All data relevant to the study will be included in the article or uploaded as supplementary information. The data does not include patient identifiable data.

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