Clinical trial NCT05167578: Identifying Reasons for Non-adherence in Patients With Multi-morbidity
Official title: Identifying Reasons for Non-adherence in Patients With Multi-morbidity: A Protocol for Prospective Observational Study in Primary Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Adherence
Medication Nonadherence
Chronic Disease
Keywords: medication adherence
nonadherence
self-management
chronic disease
multimorbidity
primary care
medication reconciliation
pharmacist
public health
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 250
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic conditions and multiple medication who visit the public health centres in Vantaa, Southern Finland

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.

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

Primary outcomes:
measure: Medication discrepancy
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: The groups of medicines
timeFrame: Through study completion, an average of 3 months
measure: The reason for non-adherence
timeFrame: Through study completion, an average of 3 months
measure: The effectiveness of medication information
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Vantaa
country: Finland
facility: Vantaa healthcare and social services
Study officials:
name: Marja Airaksinen, PhD Pharm
role: STUDY_DIRECTOR
References: