Polypharmacy, Potentially Inappropriate Medications
Conditions
Keywords
Medication reconciliation, Medication review, Pharmacist practice pattern, Primary health care, Domiciliary care, Aged
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.
Interventions
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.
Sponsors
Institut Català de la Salut
University Rovira i Virgili
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The intervention will be carried out unblinded for the patients/physicians, and the results will be blindly measured by the outcomes assessor.
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication related-problems per patient | Baseline and 6 months follow-up | Change in number of medication-related problems per patient |
| Drugs per patient | Baseline and 6 months follow-up | Change in number of concomitant drugs per patient |
| Polymedicated patients | Baseline and 6 months follow-up | Change in number of polymedicated patients. We define polypharmacy as the simultaneous use of 8 or more different drugs. |
| Medication-related problems | Baseline and 6 months follow-up | Change in number of medication-related problems |
| Patients with one or more MRPs | Baseline and 6 months follow-up | Change in number of patients with one or more MRPs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proposals implemented | 6 months follow-up | Number of proposals implemented by the physician |
| Proposals issued | Baseline | Number of proposals issued by the pharmacist. |
Countries
Spain
Contacts
Primary ContactClara Salom Garrigues, Pharm
Outcome results
None listed