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

Polypharmacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820945
• Other study ID #: 19/141-P
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: March 22, 2024

Study information

• Verified date: April 2023
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: Clara Salom Garrigues, Pharm
• Phone: +34 665139877
• Email: csalom.tgn.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: March 22, 2024
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Polypharmacy
• Potentially Inappropriate Medications

Intervention

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.

Locations

Country	Name	City	State
Spain	Pharmacy, Camp de Tarragona Health Area, Catalan Health Institute	Tarragona

Sponsors (3)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Institut Català de la Salut, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication-related problems	Change in number of medication-related problems	Baseline and 6 months follow-up
Primary	Medication related-problems per patient	Change in number of medication-related problems per patient	Baseline and 6 months follow-up
Primary	Patients with one or more MRPs	Change in number of patients with one or more MRPs	Baseline and 6 months follow-up
Primary	Drugs per patient	Change in number of concomitant drugs per patient	Baseline and 6 months follow-up
Primary	Polymedicated patients	Change in number of polymedicated patients. We define polypharmacy as the simultaneous use of 8 or more different drugs.	Baseline and 6 months follow-up
Secondary	Proposals issued	Number of proposals issued by the pharmacist.	Baseline
Secondary	Proposals implemented	Number of proposals implemented by the physician	6 months follow-up