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

NCT05944328 | Unknown

• 1 other identifier: 22/191-P
• Study Type: interventional
• Target: 862
• Locations: 1 country
• Sites: 1

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

Keywords

pharmaceutical intervention; polypharmacy; nursing home

Outcome Measures

Primary Outcomes (10)

• Drug-related problems

  Total count

  Basal

• Drug-related problems

  Total count

  Three months

• Drug-related problems

  average prm per patient

  Basal

• Drug-related problems

  average prm per patient

  Three months

• Drug-related problems

  % patients with prm

  Basal

• Drug-related problems

  % patients with prm

  Three months

• Polymedication:

  Average number of drugs

  Basal

• Polymedication:

  Average number of drugs

  Three months

• Polymedication:

  number of polymedicated patients (\> 10 drugs)

  Basal

• Polymedication:

  number of polymedicated patients (\>10 drugs)

  Three months

Secondary Outcomes (11)

• Sociodemographic variables

  Basal

• Sociodemographic variables

  Basal

• Sociodemographic variables

  Basal

• Description and classification of the DRPs detected Description and classification of the DRPs detected

  Basal

• Description and classification of the DRPs detected Description and classification of the DRPs detected

  Basal

Study Arms (2)

intervention group

EXPERIMENTAL

Other: systematic and structured review of patient pharmacotherapeutic treatment plans

control group

NO INTERVENTION

Interventions

systematic and structured review of patient pharmacotherapeutic treatment plans 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.

intervention group

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Cecilia Campabadal Prats

Tarragona, 43003, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 40717969 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 13, 2023
• Study Start: February 22, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-03

Locations

ES (1)