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Clinical Trials/NCT05167578
NCT05167578
Recruiting
Not Applicable

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

Helsinki University Central Hospital1 site in 1 country250 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Helsinki University Central Hospital
Enrollment
250
Locations
1
Primary Endpoint
Medication discrepancy
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kirsi Kvarnström

Senior pharmacist in charge

Helsinki University Central Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Medication discrepancy

Time Frame: Through study completion, an average of 3 months

Comparison of actual use of medicines versus prescribed medicines

Secondary Outcomes

  • The groups of medicines(Through study completion, an average of 3 months)
  • The reason for non-adherence(Through study completion, an average of 3 months)
  • The effectiveness of medication information(Through study completion, an average of 3 months)

Study Sites (1)

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