Identifying Reasons for Non-adherence in Patients With Multi-morbidity

• ClinicalTrials.gov Identifier: NCT05167578
• Recruitment Status: Recruiting
• First Posted: December 22, 2021
• Last Update Posted: October 17, 2022
• Sponsor: Helsinki University Central Hospital
• Information provided by (Responsible Party): Kirsi Kvarnström, Helsinki University Central Hospital

Tracking Information

• First Submitted Date: November 19, 2021
• First Posted Date: December 22, 2021
• Last Update Posted Date: October 17, 2022
• Actual Study Start Date: April 15, 2021
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 9, 2021)

Medication discrepancy [ Time Frame: Through study completion, an average of 3 months ]

Comparison of actual use of medicines versus prescribed medicines

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 9, 2021)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 4 Weeks
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients with chronic conditions and multiple medication who visit the public health centres in Vantaa, Southern Finland

Condition

• Medication Adherence
• Medication Nonadherence
• Chronic Disease

Intervention

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.

Study Groups/Cohorts

Patients with multimorbidity

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

Intervention: Behavioral: Medication reconciliation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 9, 2021): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kirsi MK Kvarnström, MScPharm; +358 40 656 9057; kirsi.kvarnstrom@hus.fi

Contact: Helena Liira, MD; helena.liira@hus.fi

• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT05167578
• Other Study ID Numbers: HUS/1037/2020; VD/4977/13.00.00/2020 ( Other Identifier: The Institutional Review Board Vantaa )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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.

• Current Responsible Party: Kirsi Kvarnström, Helsinki University Central Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Helsinki University Central Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Marja Airaksinen, PhD Pharm

• PRS Account: Helsinki University Central Hospital
• Verification Date: October 2022