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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05944328
Other study ID # 22/191-P
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2023
Est. completion date June 1, 2024

Study information

Verified date March 2023
Source Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 862
Est. completion date June 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years to 110 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Spain Cecilia Campabadal Prats Tarragona

Sponsors (1)

Lead Sponsor Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug-related problems Total count Basal
Primary Drug-related problems Total count Three months
Primary Drug-related problems average prm per patient Basal
Primary Drug-related problems average prm per patient Three months
Primary Drug-related problems % patients with prm Basal
Primary Drug-related problems % patients with prm Three months
Primary Polymedication: Average number of drugs Basal
Primary Polymedication: Average number of drugs Three months
Primary Polymedication: number of polymedicated patients (> 10 drugs) Basal
Primary Polymedication: number of polymedicated patients (>10 drugs) Three months
Secondary Sociodemographic variables genre: female/male Basal
Secondary Sociodemographic variables median age Basal
Secondary Sociodemographic variables average months in the geriatric residence Basal
Secondary Description and classification of the DRPs detected Description and classification of the DRPs detected number of prm classified as indication Basal
Secondary Description and classification of the DRPs detected Description and classification of the DRPs detected number of prm classified as adequate Basal
Secondary Description and classification of the DRPs detected Description and classification of the DRPs detected number of prm classified as effectiveness Basal
Secondary Description and classification of the DRPs detected Description and classification of the DRPs detected number of prm classified as security Basal
Secondary Description and classification of the DRPs detected Description and classification of the DRPs detected number of prm classified as indication Three months
Secondary Description and classification of the DRPs detected Description and classification of the DRPs detected number of prm classified as adequate Three months
Secondary Description and classification of the DRPs detected Description and classification of the DRPs detected number of prm classified as effectiveness Three months
Secondary Description and classification of the DRPs detected Description and classification of the DRPs detected number of prm classified as security Three months
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