Clinical trial NCT05820945: A Pharmaceutical Intervention to Reduce Drug-Related Problems in a Home Healthcare Program
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polypharmacy
Potentially Inappropriate Medications
Keywords: Medication reconciliation
Medication review
Pharmacist practice pattern
Primary health care
Domiciliary care
Aged
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: University Rovira i Virgili
First posted: 2023-04-20
Enrollment: 432
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups in parallel for the duration of the study: (a) intervention group (medication review), in which the patients will receive pharmacist-led medication review, and change proposals through their physician, and (b) control group, in which the patients will be subjected to usual pharmacotherapy management.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Medication-related problems
timeFrame: Baseline and 6 months follow-up
measure: Medication related-problems per patient
timeFrame: Baseline and 6 months follow-up
measure: Patients with one or more MRPs
timeFrame: Baseline and 6 months follow-up
measure: Drugs per patient
timeFrame: Baseline and 6 months follow-up
measure: Polymedicated patients
timeFrame: Baseline and 6 months follow-up
Secondary outcomes:
measure: Proposals issued
timeFrame: Baseline
measure: Proposals implemented
timeFrame: 6 months follow-up
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Pharmacy, Camp de Tarragona Health Area, Catalan Health Institute
Study officials:
affiliation: DAP Camp de Tarragona, Institut Català de la Salut.
name: Clara Salom Garrigues, Pharm
role: PRINCIPAL_INVESTIGATOR
References: