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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Enrolling

Conditions: Potentially Inappropriate Medications; Polypharmacy

Treatments: Other: Pharmacist-led medication review

Study type: Interventional

Funder types: Other

Identifiers

NCT05820945

19/141-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 432 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• The responsible physician considers that participation may harm the patient

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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432 participants in 2 patient groups

Medication review group

Experimental group

Description:

Pharmacist-led medication review at patient level, and change proposals at physician level.

Treatment:

Other: Pharmacist-led medication review

Control group

No Intervention group

Description:

Usual pharmacotherapy management.