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| Name | Class |
|---|---|
| Institut Català de la Salut | OTHER |
| University Rovira i Virgili | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication review group | Experimental | Pharmacist-led medication review at patient level, and change proposals at physician level. |
|
| Control group | No Intervention | Usual pharmacotherapy management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-led medication review | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication-related problems | Change in number of medication-related problems | Baseline and 6 months follow-up |
| Medication related-problems per patient | Change in number of medication-related problems per patient | Baseline and 6 months follow-up |
| Patients with one or more MRPs | Change in number of patients with one or more MRPs | Baseline and 6 months follow-up |
| Drugs per patient | Change in number of concomitant drugs per patient | 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. | Baseline and 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Proposals issued | Number of proposals issued by the pharmacist. | Baseline |
| Proposals implemented | Number of proposals implemented by the physician |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara Salom Garrigues, Pharm | Contact | +34 665139877 | csalom.tgn.ics@gencat.cat |
| Name | Affiliation | Role |
|---|---|---|
| Clara Salom Garrigues, Pharm | DAP Camp de Tarragona, Institut Català de la Salut. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacy, Camp de Tarragona Health Area, Catalan Health Institute | Recruiting | Tarragona | 43005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41652338 | Derived | Salom-Garrigues C, Aragones E, Giralt M, Campabadal Prats C, Bejarano-Romero F, Martin-Lujan F, Romeu M, Canadell L. Prevalence and associated factors for drug-related problems and polypharmacy identified by a pharmacist-led medication review in patients enrolled in a home healthcare program. BMC Geriatr. 2026 Feb 6;26(1):316. doi: 10.1186/s12877-026-07045-1. | |
| 38373937 |
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All IPD underlying the published results will be shared.
After publication of the results in a medical journal.
The anonymized datasets used and/or analyzed during the current study will be available from the principal investigator on reasonable request.
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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.
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The intervention will be carried out unblinded for the patients/physicians, and the results will be blindly measured by the outcomes assessor.
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| 6 months follow-up |
| 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. |