A Pharmaceutical Intervention to Reduce Drug-Related Problems in a Home Healthcare Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Polypharmacy, Potentially Inappropriate Medications

Intervention / Treatment
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* Other: Pharmacist-led medication review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication review group<br>Pharmacist-led medication review at patient level, and change proposals at physician level. | Other: Pharmacist-led medication review<br>* 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.<br>|
| No Intervention: Control group<br>Usual pharmacotherapy management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proposals issued | Number of proposals issued by the pharmacist. | Baseline | 
| Proposals implemented | Number of proposals implemented by the physician | 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication reconciliation, Medication review, Pharmacist practice pattern, Primary health care, Domiciliary care, Aged