跳至主要内容
临床试验/NCT05629936
NCT05629936Enrolling By Invitation不适用

Improving Medication Therapy and Patient Involvement Through a Digital Interdisciplinary Model Among Old People in Primary Care Living in Sparsely Populated Regions in Sweden

Umeå University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
2
主要终点
Identification and classfication of medication-related problems

研究概览

简要总结

In this study, a telepharmacy service in primary care for home-living older adults in Northern Sweden's rural areas will be developed and evaluated. The primary objective is to evaluate the effect of the service regarding the identification, classification, and resolution of medication-related problems (MRPs). Secondary objectives are to evaluate participants' medication adherence, health-related quality of life, and beliefs about medicines through self-report questionnaires. The telepharmacy service include medication interviews, structured medication reviews, interdisciplinary patient-centred discussions, and follow-ups.

详细描述

Participants that meet the inclusion criteria will be invited to participate in the study via mail. The participants will also receive three validated questionnaires; Medication Adherence Report Scale-5 (MARS-5), EuroQol-5 Dimension-5 Level questionnaire (EQ-5D-5L) and The Beliefs about Medicines Questionnaire (BMQ) to fill in prior to initiation of the study, to collect baseline data. The intervention consists of several steps, and all meetings will be conducted through video conferencing via a secure virtual care platform. Initially, the participant will have a medication interview with a clinical pharmacist, Next, the clinical pharmacist conducts a structured medication review based on information from the interview and the participant's medical records and laboratory values. The clinical pharmacist and the participant's primary care physician will then have a video-based interdisciplinary meeting. During this meeting, the clinical pharmacist presents recommendations to resolve potential MRPs, and the physician may accept or reject the pharmacist's recommendations. The primary-care physician informs the participant about any changes in their medication therapy and follows-up and monitors these changes. Video-based follow-up meetings between the participant and the clinical pharmacist will take place 1-2, 4 and 12 weeks after the first video-based meeting. Additional meetings can be scheduled, if requested by the participant, or if considered necessary by the clinical pharmacist. The clinical pharmacist will also conduct medical record reviews once every two weeks during the 12-week intervention period. At 12 weeks, after the last follow-up, the participant will be asked to fill in the three questionnaires one more time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Using five or more prescribed medications and/or considered as a potential candidate by the primary care physician.
  • •Living at home (i.e not in a nursing home)
  • •Registered at primary healthcare centres in rural municipalities within Västerbotten County (and neighbouring counties if necessary)

排除标准

  • •Do not speak Swedish
  • •Unable to communicate
  • •Has a confirmed major neurocognitive disorder
  • •Receives palliative care

研究组 & 干预措施

Digital intervention

Other

Video-based telepharmacy service

干预措施: Telepharmacy service (Other)

结局指标

主要结局

Identification and classfication of medication-related problems

时间窗: The 12-week intervention period

Classification of mediation-related problems according to a modified version of the classification system by Cipolle et al (1998).

Resolution of medication-related problems

时间窗: 12-week intervention period

The clinical pharmacists' recommendations to resolve medication-related problems will be classified according to a modified version of a system developed by the French Society of Clinical pharmacy. Physicians' acceptance rate of pharmacists' recommendations will be classified. The acceptance rate will be classified as accepted recommendation, rejected recommendation, or unknown.

Intra-individual change in self-reported medication adherence: Medication Adherence Report Scale-5 (MARS-5)

时间窗: Baseline and 12 weeks

Assessing self-reported medication adherence through the MARS-5 questionnaire. Total score ranging between 5 and 25, with higher scores indicating a higher level of medication adherence.

Intra-individual change in self-reported health-related quality of life: EuroQol-5 Dimension-5 Level questionnaire (EQ-5D-5L)

时间窗: Baseline and 12 weeks

Assessing health-related quality of life through the EQ-5D-5L-questionnaire. The questionnaire consists of five questions regarding self-perceived quality of life, and a visual analogue scale on which the respondents evaluate their own health status on a scale of 0-100.

Intra-individual change in self-reported beliefs about medicines: The Beliefs about Medicines Questionnaire (BMQ)

时间窗: Baseline and 12 weeks

Assessing beliefs about medicines through the BMQ. The questionnaire consists of two different scales; BMQ-General assesses the respondent's beliefs about medicines in general and BMQ-Specific evaluates the individual's beliefs about medicines prescribed for their own use.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Gustafsson

Principal investigator

Umeå University

研究点 (2)

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