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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05167578
Enrollment
250
Registered
2021-12-22
Start date
2021-04-15
Completion date
2024-12-31
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Medication Adherence, Medication Nonadherence

Keywords

medication adherence, nonadherence, self-management, chronic disease, multimorbidity, primary care, medication reconciliation, pharmacist, public health

Brief summary

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

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.

Interventions

BEHAVIORALMedication 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.

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medication discrepancyThrough study completion, an average of 3 monthsComparison of actual use of medicines versus prescribed medicines

Secondary

MeasureTime frameDescription
The groups of medicinesThrough study completion, an average of 3 monthsThe medicines that are used differently as prescribes are classified in anatomical therapeutic chemical groups
The reason for non-adherenceThrough study completion, an average of 3 monthsPatient reported reasons for not taking medicines as prescribed
The effectiveness of medication informationThrough study completion, an average of 3 monthsWill the patient consider taking the medication as prescribed after the discussion with the pharmacist

Countries

Finland

Contacts

Primary ContactKirsi MK Kvarnström, MScPharm
kirsi.kvarnstrom@hus.fi+358 40 656 9057
Backup ContactHelena Liira, MD
helena.liira@hus.fi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026