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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05167578
Recruitment Status : Recruiting
First Posted : December 22, 2021
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Kirsi Kvarnström, Helsinki University Central Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Medication Adherence Medication Nonadherence Chronic Disease 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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Medication discrepancy [ Time Frame: Through study completion, an average of 3 months ]
    Comparison of actual use of medicines versus prescribed medicines


Secondary Outcome Measures :
  1. 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

  2. The reason for non-adherence [ Time Frame: Through study completion, an average of 3 months ]
    Patient reported reasons for not taking medicines as prescribed

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Patients with chronic conditions and multiple medication who visit the public health centres in Vantaa, Southern Finland
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Kirsi MK Kvarnström, MScPharm +358 40 656 9057 kirsi.kvarnstrom@hus.fi
Contact: Helena Liira, MD helena.liira@hus.fi

Locations
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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   
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Marja Airaksinen, PhD Pharm
More Information
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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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirsi Kvarnström, Helsinki University Central Hospital:
medication adherence
nonadherence
self-management
chronic disease
multimorbidity
 primary care
medication reconciliation
pharmacist
public health
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes