NCT05820945

A Pharmaceutical Intervention to Reduce Drug-Related Problems in a Home Healthcare Program

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. If the evaluation results are favorable, widespread implementation of the program would be possible. It could be extended to all ATDOM patients or outpatients in general. Thus, interdisciplinary teamwork would be strengthened to favor the health care continuum.

Conditions

• Polypharmacy
• Potentially Inappropriate Medications

Interventions

Type	Name	Description
OTHER	Pharmacist-led medication review	Clinical review by a primary care pharmacist of the primary care clinical history and the pharmacological treatment plan. After the review process, a meeting will be held between the pharmacist and the responsible physician in order to present proposals for pharmacotherapeutic optimization.

Timeline

• Start date: 2020-03-02
• Primary completion: 2023-09-22
• Completion: 2024-03-22
• First posted: 2023-04-20
• Last updated: 2023-04-20

Locations

1 site across 1 country: Spain