Effectiveness of an Intervention of Pharmacotherapeutic Plans to Reduce Medication-related Problems in Geriatric Residences

NCT ID: NCT05944328

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2024-06-01

Brief Summary

Background: Patients living in Geriatric Residences (RG) have increased aging, comorbidity, spending on health resources and mortality. High drug use is associated with an increased risk of falls, disability, and death. It is estimated that 20-50% of inappropriate medications are consumed in the elderly.

Hypothesis: A pharmaceutical intervention based on a clinical review of the pharmacotherapeutic plan of patients in RG will be useful in optimizing the prescription in terms of safety, reducing by 10% or more the inappropriate prescriptions.

Objectives: Evaluate the effectiveness of a structured pharmaceutical intervention based on the clinical review of the pharmacotherapeutic plan to improve its adequacy.

Decrease inadequate prescriptions in patients admitted to RG by 10%

Methodology: Pre-post, quasi-experimental intervention study with control group with prospective follow-up of a cohort of patients in RG. The intervention consists of the clinical review of the pharmacotherapeutic plan carried out by the pharmacist and subsequently agreed in the Pharmacotherapeutic Advisory Committee.

Determinations: The study variables will be evaluated at baseline and 3 months post-intervention. The primary variable is number of inappropriate prescriptions.

Statistical analysis: Percentage change will be measured before and after the intervention. Descriptive statistics will be performed for quantitative variables such as qualitative and comparison of means and proportions.

Expected results: Achieve a 10% decrease in inappropriate prescriptions

Applicability and Relevance: This study will expand the collaboration between the Pharmacy and Primary Care physicians, promoting the continuum of care, strengthening the safety culture, and improving prescribing habits.

Conditions

Polypharmacy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

intervention group

Group Type: EXPERIMENTAL

systematic and structured review of patient pharmacotherapeutic treatment plans

Intervention Type: OTHER

The intervention consisted of a systematic and structured review of patient pharmacotherapeutic treatment plans to identify problems or situations of risk related to pharmacological treatments and to propose changes or improvements to optimise them. phases:

Individualised review of pharmacological treatment plans to detect drug-related problems:

Indication, Appropriateness, Effectiveness, Safety When a drug-related problem was detected according to the above criteria, the pharmacist proposed an adjustment to the pharmacotherapeutic plan. The proposals could include: discontinuation of the drug, change of drug, change to a therapeutic equivalent, initiation of treatment, change of dosage, change of frequency or intensified monitoring.

The proposals made by the pharmacist were assessed and agreed upon by a committee comprising the doctors responsible and the pharmacist. Thereafter, the consensual proposals for change were discussed with the patient.

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

systematic and structured review of patient pharmacotherapeutic treatment plans

The intervention consisted of a systematic and structured review of patient pharmacotherapeutic treatment plans to identify problems or situations of risk related to pharmacological treatments and to propose changes or improvements to optimise them. phases:

Individualised review of pharmacological treatment plans to detect drug-related problems:

Indication, Appropriateness, Effectiveness, Safety When a drug-related problem was detected according to the above criteria, the pharmacist proposed an adjustment to the pharmacotherapeutic plan. The proposals could include: discontinuation of the drug, change of drug, change to a therapeutic equivalent, initiation of treatment, change of dosage, change of frequency or intensified monitoring.

The proposals made by the pharmacist were assessed and agreed upon by a committee comprising the doctors responsible and the pharmacist. Thereafter, the consensual proposals for change were discussed with the patient.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 65 years or older
• Pharmacological treatment with at least one drug and for a period of more than three months

Exclusion Criteria

• Individuals who at the time of the pharmaceutical review were in hospital
• Patients nearing the end of life
• Patients whose participation was considered by the doctor responsible to be potentially detrimental
• Patients not covered by the public healthcare or pharmacy system were excluded.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cecilia Campabadal Prats

Tarragona, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Cecília Campabadal Prats

Role: primary

cprats.tgn.ics@gencat.cat

679716123

References

Campabadal-Prats C, Aragones E, Romeu M, Salom-Garrigues C, Bejarano F, Martin Lujan F, Canadell L. Effectiveness of a structured pharmaceutical review of pharmacotherapeutic plans to reduce drug-related problems in nursing homes: a study protocol of a pragmatic quasi-experimental trial. Front Pharmacol. 2025 Jul 11;16:1522650. doi: 10.3389/fphar.2025.1522650. eCollection 2025.

Reference Type: DERIVED

PMID: 40717969 (View on PubMed)

Other Identifiers

22/191-P

Identifier Type: -

Identifier Source: org_study_id