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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Polypharmacy; Potentially Inappropriate Medications
• Intervention / Treatment: Other: Pharmacist-led medication review

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.

• Study Type: Interventional
• Enrollment (Anticipated): 432
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara Salom Garrigues, Pharm; Phone Number: +34 665139877; Email: csalom.tgn.ics@gencat.cat

Study Locations

• Spain
  • Tarragona, Spain, 43005
    • Recruiting
    • Pharmacy, Camp de Tarragona Health Area, Catalan Health Institute
    • Contact: Clara Salom Garrigues, Pharm; Phone Number: +34 665139877; Email: csalom.tgn.ics@gencat.cat
    • Sub-Investigator: Enric Aragonès Benaiges, MD, PhD
    • Sub-Investigator: Montserrat Giralt Batista, MD, PhD
    • Sub-Investigator: Ferran Bejarano Romero, MD
    • Sub-Investigator: Cecília Campabadal Prats, Pharm
    • Sub-Investigator: Laura Canadell Vilarrasa, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Institut Català de la Salut; University Rovira i Virgili
• Investigators: Principal Investigator: Clara Salom Garrigues, Pharm, DAP Camp de Tarragona, Institut Català de la Salut.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Anticipated): September 22, 2023
• Study Completion (Anticipated): March 22, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Primary health care; Aged; Medication review; Medication reconciliation; Pharmacist practice pattern; Domiciliary care
• Other Study ID Numbers: 19/141-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD underlying the published results will be shared.
• IPD Sharing Time Frame: After publication of the results in a medical journal.
• IPD Sharing Access Criteria: The anonymized datasets used and/or analyzed during the current study will be available from the principal investigator on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No