An interventional study of Pharmacist-led medication review in Polypharmacy and Potentially Inappropriate Medications, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Other
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.
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.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pharmacist-led medication review at patient level, and change proposals at physician level.
Other: Pharmacist-led medication review
Usual pharmacotherapy management.
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.
Medication-related problems
Change in number of medication-related problems
Time frame: Baseline and 6 months follow-up
Medication related-problems per patient
Change in number of medication-related problems per patient
Time frame: Baseline and 6 months follow-up
Patients with one or more MRPs
Change in number of patients with one or more MRPs
Time frame: Baseline and 6 months follow-up
Drugs per patient
Change in number of concomitant drugs per patient
Time frame: Baseline and 6 months follow-up
Polymedicated patients
Change in number of polymedicated patients. We define polypharmacy as the simultaneous use of 8 or more different drugs.
Time frame: Baseline and 6 months follow-up
Proposals issued
Number of proposals issued by the pharmacist.
Time frame: Baseline
Proposals implemented
Number of proposals implemented by the physician
Time frame: 6 months follow-up
Plan to share: Yes — All IPD underlying the published results will be shared.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina