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

NCT05820945 | Unknown

• 1 other identifier: 19/141-P
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy; Potentially Inappropriate Medications

Keywords

Medication reconciliation; Medication review; Pharmacist practice pattern; Primary health care; Domiciliary care; Aged

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Proposals issued

  Baseline

• Proposals implemented

  6 months follow-up

Study Arms (2)

Medication review group

EXPERIMENTAL

Pharmacist-led medication review at patient level, and change proposals at physician level.

Other: Pharmacist-led medication review

Control group

NO INTERVENTION

Usual pharmacotherapy management.

Interventions

Pharmacist-led medication review OTHER

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.

Medication review group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient in the home care program
• Sixty-five years of age or older
• Active pharmacological treatment plan with at least one drug

You may not qualify if:

• The responsible physician considers that participation may harm the patient

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Català de la Salut: collaborator
• University Rovira i Virgili: collaborator

Study Sites (1)

Pharmacy, Camp de Tarragona Health Area, Catalan Health Institute

Tarragona, 43005, Spain

RECRUITING

Related Publications (1)

• Salom-Garrigues C, Aragones E, Giralt M, Campabadal Prats C, Bejarano-Romero F, Canadell L. Evaluation of a pharmacist-led intervention to reduce drug-related problems in patients included in a home healthcare program: study protocol for a pragmatic randomized clinical trial. BMC Geriatr. 2024 Feb 19;24(1):170. doi: 10.1186/s12877-024-04763-2.

  PMID: 38373937 DERIVED

Study Officials

• Clara Salom Garrigues, Pharm

  DAP Camp de Tarragona, Institut Català de la Salut.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Salom Garrigues, Pharm

CONTACT

+34 665139877; csalom.tgn.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The intervention will be carried out unblinded for the patients/physicians, and the results will be blindly measured by the outcomes assessor.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 20, 2023
• Study Start: March 2, 2020
• Primary Completion: September 22, 2023
• Study Completion: March 22, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of the results in a medical journal.
• Access Criteria: The anonymized datasets used and/or analyzed during the current study will be available from the principal investigator on reasonable request.

Locations

ES (1)