Evaluation of a Pharmacist-Led Intervention to Reduce Drug-Related Problems in Patients Included in a Home Healthcare Program: A Pragmatic Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Polypharmacy
- Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Enrollment
- 432
- Locations
- 1
- Primary Endpoint
- Medication-related problems
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Clara Salom
Clinical Pharmacist
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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
Outcomes
Primary Outcomes
Medication-related problems
Time Frame: Baseline and 6 months follow-up
Change in number of medication-related problems
Medication related-problems per patient
Time Frame: Baseline and 6 months follow-up
Change in number of medication-related problems per patient
Patients with one or more MRPs
Time Frame: Baseline and 6 months follow-up
Change in number of patients with one or more MRPs
Drugs per patient
Time Frame: Baseline and 6 months follow-up
Change in number of concomitant drugs per patient
Polymedicated patients
Time Frame: 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 Outcomes
- Proposals issued(Baseline)
- Proposals implemented(6 months follow-up)