跳至主要内容
临床试验/NCT06059235
NCT06059235招募中不适用

Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
2
主要终点
presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores)

研究概览

简要总结

The goal of this clinical trial is to assess the impact of pharmaceutical consultations in older patients having a comprehensive geriatric assessment at geriatric day-clinic. The main question it aims to answer is: What is the impact on patient adherence Participants will benefit from medication history taking, medication review, therapeutic education, shared decision-making and follow-up phone call. Researchers will compare with a control group, benefiting from medication history taking and usual care from the geriatric day-clinic.

详细描述

Research question: What is the impact of a clinical pharmacy activity (including a medication history, a medication review, therapeutic education, a shared decision step and a follow-up call) on medication adherence in elderly patients followed up for geriatric assessment at the geriatric day hospital? Design: Intervention study, randomized, controlled, open-label, with evaluation at 2 months. The study will run from January 1, 2023 to September 1, 2024 (20 months), at the CUSL geriatric day hospital.

Participants: patients admitted to the geriatric day hospital for a geriatric assessment will be eligible for the project. A geriatric assessment comprises 2 consultations at the geriatric day hospital: a "assessment" consultation, where the patient meets the members of the multidisciplinary team, and a "results" consultation, where the geriatrician provides the patient with care recommendations.

The general practitioners, pharmacists and nursing home referral nurse (if applicable) of the participants in the intervention group will be invited to take part in a satisfaction survey.

Intervention: The intervention includes several clinical pharmacy activities

  • Medication history (during assessment consultation)
  • Medication review and consultation with the geriatrician
  • Therapeutic education (during results consultation)
  • Shared decision-making (during results consultation)
  • One-week follow-up call Control: usual care. Outcomes: primary: comparison at 1.5 months (telephone FUP) after outcome consultation of ASK-20 total Adherence Survey score (measures medication adherence and identifies barriers to adherence).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
75 Years 至 125 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients admitted to the geriatric day hospital for a geriatric assessment will be eligible for the project. A geriatric assessment comprises 2 consultations at the geriatric day hospital: a "major assessment" consultation, where the patient meets the members of the multidisciplinary team, and a "results" consultation, where the geriatrician provides the patient with care recommendations.

排除标准

  • less than 75
  • not speaking French
  • exlusion based on geriatrician advice

结局指标

主要结局

presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores)

时间窗: 6weeks

ASK-20 (questionnaire) consists of 20 clinically actionable items representing multiple factors that affect medication adherence. Each of the 20 items score from 1 to 5. A score of 20 means low barriers to adherence; A score of 100 means maximum barriers to adherence. Comparizon of ASK-20 score from baseline to 6weeks in both arms. Hahn SR, Park J, Skinner EP, Yu-Isenberg KS, Weaver MB, Crawford B, Flowers PW. Development of the ASK-20 adherence barrier survey. Curr Med Res Opin. 2008 Jul;24(7):2127-38. doi: 10.1185/03007990802174769. Epub 2008 Jun 12. PMID: 18554431.

次要结局

  • count of barriers to adherence measured by TBC ASK-20 (Total Barrier Count)(6weeks)
  • quality of life measured with EQ5D (Visual analogical scale) score(6weeks)
  • number of inappropriate medications per patient according to STOPP/START(6weeks)
  • number of Drug-drug interactions per patient from the Anrys list(6weeks)
  • pain severity (from EQ-D)(6weeks)
  • number of hospital admissions reported by patient(6weeks)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (2)

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