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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease; Medication Adherence; Medication Nonadherence
• Intervention / Treatment: Behavioral: Medication reconciliation

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Kirsi MK Kvarnström, MScPharm; Phone Number: +358 40 656 9057; Email: kirsi.kvarnstrom@hus.fi
• Study Contact Backup: Name: Helena Liira, MD; Email: helena.liira@hus.fi

Study Locations

• Finland
  • Vantaa, Finland, 01030
    • Recruiting
    • Vantaa healthcare and social services
    • Contact: Helena Liira, MD; Email: helena.liira@hus.fi
    • Contact: Kirsi MK Kvarnström, McPharm; Phone Number: +358 40 656 9057; Email: kirsi.kvarnstrom@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication discrepancy	Comparison of actual use of medicines versus prescribed medicines	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The groups of medicines	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	Patient reported reasons for not taking medicines as prescribed	Through study completion, an average of 3 months
The effectiveness of medication information	Will the patient consider taking the medication as prescribed after the discussion with the pharmacist	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Marja Airaksinen, PhD Pharm

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: self-management; primary care; pharmacist; medication adherence; chronic disease; multimorbidity; public health; medication reconciliation; nonadherence
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: HUS/1037/2020; VD/4977/13.00.00/2020 (Other Identifier: The Institutional Review Board Vantaa)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No