A Pharmaceutical Intervention to Reduce Drug-Related Problems in a Home Healthcare Program
- Conditions
- Potentially Inappropriate MedicationsPolypharmacy
- Interventions
- Other: Pharmacist-led medication review
- Registration Number
- NCT05820945
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 432
- Patient in the home care program
- Sixty-five years of age or older
- Active pharmacological treatment plan with at least one drug
- The responsible physician considers that participation may harm the patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medication review group Pharmacist-led medication review Pharmacist-led medication review at patient level, and change proposals at physician level.
- Primary Outcome Measures
Name Time Method Medication-related problems Baseline and 6 months follow-up Change in number of medication-related problems
Medication related-problems per patient Baseline and 6 months follow-up Change in number of medication-related problems per patient
Patients with one or more MRPs Baseline and 6 months follow-up Change in number of patients with one or more MRPs
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.
- Secondary Outcome Measures
Name Time Method Proposals issued Baseline Number of proposals issued by the pharmacist.
Proposals implemented 6 months follow-up Number of proposals implemented by the physician
Trial Locations
- Locations (1)
Pharmacy, Camp de Tarragona Health Area, Catalan Health Institute
🇪🇸Tarragona, Spain