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

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of a Structured Pharmaceutical Review Intervention of Pharmacotherapeutic Plans to Reduce Medication-related Problems in Geriatric Residences: a Quasi-experimental Pragmatic Assay

Conditions
-----------------
Polypharmacy

Intervention / Treatment
-----------------
* Other: systematic and structured review of patient pharmacotherapeutic treatment plans


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br> | Other: systematic and structured review of patient pharmacotherapeutic treatment plans<br>* 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.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic variables | genre: female/male | Basal | 
| Sociodemographic variables | median age | Basal | 
| Sociodemographic variables | average months in the geriatric residence | Basal | 
| Description and classification of the DRPs detected Description and classification of the DRPs detected | number of prm classified as indication | Basal | 
| Description and classification of the DRPs detected Description and classification of the DRPs detected | number of prm classified as adequate | Basal | 
| Description and classification of the DRPs detected Description and classification of the DRPs detected | number of prm classified as effectiveness | Basal | 
| Description and classification of the DRPs detected Description and classification of the DRPs detected | number of prm classified as security | Basal | 
| Description and classification of the DRPs detected Description and classification of the DRPs detected | number of prm classified as indication | Three months | 
| Description and classification of the DRPs detected Description and classification of the DRPs detected | number of prm classified as adequate | Three months | 
| Description and classification of the DRPs detected Description and classification of the DRPs detected | number of prm classified as effectiveness | Three months | 
| Description and classification of the DRPs detected Description and classification of the DRPs detected | number of prm classified as security | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmaceutical intervention, polypharmacy, nursing home