Identifying Reasons for Non-adherence in Patients With Multi-morbidity
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ClinicalTrials.gov Identifier: NCT05167578 |
Recruitment Status :
Recruiting
First Posted : December 22, 2021
Last Update Posted : October 17, 2022
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Condition or disease | Intervention/treatment |
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Medication Adherence Medication Nonadherence Chronic Disease | Behavioral: Medication reconciliation |
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 [Patient Registry] |
Estimated Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 4 Weeks |
Official Title: | Identifying Reasons for Non-adherence in Patients With Multi-morbidity: A Protocol for Prospective Observational Study in Primary Care |
Actual Study Start Date : | April 15, 2021 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2024 |
Group/Cohort | Intervention/treatment |
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Patients with multimorbidity
Patients with multimorbidity who visit the public health centres in Vantaa, Southern Finland
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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. |
- Medication discrepancy [ Time Frame: Through study completion, an average of 3 months ]Comparison of actual use of medicines versus prescribed medicines
- The groups of medicines [ Time Frame: Through study completion, an average of 3 months ]The medicines that are used differently as prescribes are classified in anatomical therapeutic chemical groups
- The reason for non-adherence [ Time Frame: Through study completion, an average of 3 months ]Patient reported reasons for not taking medicines as prescribed
- The effectiveness of medication information [ Time Frame: Through study completion, an average of 3 months ]Will the patient consider taking the medication as prescribed after the discussion with the pharmacist

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05167578
Contact: Kirsi MK Kvarnström, MScPharm | +358 40 656 9057 | kirsi.kvarnstrom@hus.fi | |
Contact: Helena Liira, MD | helena.liira@hus.fi |
Finland | |
Vantaa healthcare and social services | Recruiting |
Vantaa, Finland, 01030 | |
Contact: Kirsi MK Kvarnström, McPharm +358 40 656 9057 kirsi.kvarnstrom@hus.fi | |
Contact: Helena Liira, MD helena.liira@hus.fi |
Study Director: | Marja Airaksinen, PhD Pharm |
Responsible Party: | Kirsi Kvarnström, Senior pharmacist in charge, Helsinki University Central Hospital |
ClinicalTrials.gov Identifier: | NCT05167578 |
Other Study ID Numbers: |
HUS/1037/2020 VD/4977/13.00.00/2020 ( Other Identifier: The Institutional Review Board Vantaa ) |
First Posted: | December 22, 2021 Key Record Dates |
Last Update Posted: | October 17, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
medication adherence nonadherence self-management chronic disease multimorbidity |
primary care medication reconciliation pharmacist public health |
Chronic Disease Disease Attributes Pathologic Processes |