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Clinical Trials/NCT05820945
NCT05820945
Recruiting
Not Applicable

Evaluation of a Pharmacist-Led Intervention to Reduce Drug-Related Problems in Patients Included in a Home Healthcare Program: A Pragmatic Randomized Clinical Trial

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country432 target enrollmentMarch 2, 2020

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2020
End Date
March 22, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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