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

NCT ID: NCT05167578

Last Updated: 2022-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Medication Adherence Medication Nonadherence Chronic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with multimorbidity

Patients with multimorbidity who visit the public health centres in Vantaa, Southern Finland

Medication reconciliation

Intervention Type BEHAVIORAL

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.

Interventions

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Medication reconciliation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kirsi Kvarnström

Senior pharmacist in charge

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marja Airaksinen, PhD Pharm

Role: STUDY_DIRECTOR

Locations

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Vantaa healthcare and social services

Vantaa, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Kirsi MK Kvarnström, MScPharm

Role: CONTACT

+358 40 656 9057

Helena Liira, MD

Role: CONTACT

Facility Contacts

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Kirsi MK Kvarnström, McPharm

Role: primary

+358 40 656 9057

Helena Liira, MD

Role: backup

References

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Kvarnstrom K, Westerholm A, Airaksinen MS, Liira H. Why medicines are used differently from prescribed: a protocol for a prospective patient-oriented observational case study to investigate reasons for non-adherence in primary care. BMJ Open. 2022 Dec 22;12(12):e065363. doi: 10.1136/bmjopen-2022-065363.

Reference Type DERIVED
PMID: 36549723 (View on PubMed)

Other Identifiers

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VD/4977/13.00.00/2020

Identifier Type: OTHER

Identifier Source: secondary_id

HUS/1037/2020

Identifier Type: -

Identifier Source: org_study_id

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