跳至主要内容
临床试验/NCT05820945
NCT05820945招募中不适用

Evaluation of a Pharmacist-Led Intervention to Reduce Drug-Related Problems in Patients Included in a Home Healthcare Program: A Pragmatic Randomized Clinical Trial

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2020年3月2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
432
试验地点
2
主要终点
Medication-related problems

研究概览

简要总结

The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of patients in a home healthcare program will be effective in improving the quality and safety of treatments. This study aims to evaluate the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients (catalan home healthcare program at primary care level), compared to the usual management.

详细描述

ATDOM is the catalan home healthcare program at primary care level. Patients in home care program are frequently polymedicated, which entails a high risk of drug-related problems (DRPs). The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of ATDOM patients will be effective in improving the quality and safety of treatments, reducing DRPs in terms of indication, adequacy, effectiveness, and safety.

The main objective of this study is therefore to evaluate the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients, compared to the usual management.

Specifically, the investigators want to determine, through a six-month intervention, the effectiveness in reducing DRPs per patient and polypharmacy. Additionally, the investigators will evaluate in the intervention group the implementation of the proposals for change or improvement by the responsible physician.

This is a pragmatic randomized clinical trial with a comparable control group, with prospective follow-up of an intervention for the adequacy of the pharmacological treatment of patients in the ATDOM program assigned to primary care teams of the Camp de Tarragona Primary Care Directorate. PRMs, proposals and implementation will be determined.

A descriptive statistical analysis will be carried out using multivariate adjustments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

The intervention will be carried out unblinded for the patients/physicians, and the results will be blindly measured by the outcomes assessor.

入排标准

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

入选标准

  • Patient in the home care program
  • Sixty-five years of age or older
  • Active pharmacological treatment plan with at least one drug

排除标准

  • The responsible physician considers that participation may harm the patient

结局指标

主要结局

Medication-related problems

时间窗: Baseline and 6 months follow-up

Change in number of medication-related problems

Medication related-problems per patient

时间窗: Baseline and 6 months follow-up

Change in number of medication-related problems per patient

Patients with one or more MRPs

时间窗: Baseline and 6 months follow-up

Change in number of patients with one or more MRPs

Drugs per patient

时间窗: Baseline and 6 months follow-up

Change in number of concomitant drugs per patient

Polymedicated patients

时间窗: Baseline and 6 months follow-up

Change in number of polymedicated patients. We define polypharmacy as the simultaneous use of 8 or more different drugs.

次要结局

  • Proposals issued(Baseline)
  • Proposals implemented(6 months follow-up)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara Salom

Clinical Pharmacist

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

研究点 (2)

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