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

2022年10月13日 更新者:Kirsi Kvarnström、Helsinki University Central Hospital

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (预期的)

250

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Vantaa、芬兰、01030
        • 招聘中
        • Vantaa healthcare and social services
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Patients with multimorbidity
Patients with multimorbidity who visit the public health centres in Vantaa, Southern Finland
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Medication discrepancy
大体时间:Through study completion, an average of 3 months
Comparison of actual use of medicines versus prescribed medicines
Through study completion, an average of 3 months

次要结果测量

结果测量
措施说明
大体时间
The groups of medicines
大体时间:Through study completion, an average of 3 months
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
大体时间:Through study completion, an average of 3 months
Patient reported reasons for not taking medicines as prescribed
Through study completion, an average of 3 months
The effectiveness of medication information
大体时间:Through study completion, an average of 3 months
Will the patient consider taking the medication as prescribed after the discussion with the pharmacist
Through study completion, an average of 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Marja Airaksinen, PhD Pharm

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月15日

初级完成 (预期的)

2023年12月31日

研究完成 (预期的)

2024年12月31日

研究注册日期

首次提交

2021年11月19日

首先提交符合 QC 标准的

2021年12月9日

首次发布 (实际的)

2021年12月22日

研究记录更新

最后更新发布 (实际的)

2022年10月17日

上次提交的符合 QC 标准的更新

2022年10月13日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HUS/1037/2020
  • VD/4977/13.00.00/2020 (其他标识符:The Institutional Review Board Vantaa)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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