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

NCT ID: NCT05820945

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2024-03-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Medication review group

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

Group Type: EXPERIMENTAL

Pharmacist-led medication review

Intervention Type: OTHER

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.

Control group

Usual pharmacotherapy management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català de la Salut

OTHER

Sponsor Role: collaborator

University Rovira i Virgili

OTHER

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Clara Salom

Clinical Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clara Salom Garrigues, Pharm

Role: PRINCIPAL_INVESTIGATOR

DAP Camp de Tarragona, Institut Català de la Salut.

Locations

Pharmacy, Camp de Tarragona Health Area, Catalan Health Institute

Tarragona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Clara Salom Garrigues, Pharm

Role: CONTACT

csalom.tgn.ics@gencat.cat

+34 665139877

Facility Contacts

Clara Salom Garrigues, Pharm

Role: primary

csalom.tgn.ics@gencat.cat

+34 665139877

References

Salom-Garrigues C, Aragones E, Giralt M, Campabadal Prats C, Bejarano-Romero F, Canadell L. Evaluation of a pharmacist-led intervention to reduce drug-related problems in patients included in a home healthcare program: study protocol for a pragmatic randomized clinical trial. BMC Geriatr. 2024 Feb 19;24(1):170. doi: 10.1186/s12877-024-04763-2.

Reference Type: DERIVED

PMID: 38373937 (View on PubMed)

Other Identifiers

19/141-P

Identifier Type: -

Identifier Source: org_study_id