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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Polypharmacy
• Intervention / Treatment: Other: systematic and structured review of patient pharmacotherapeutic treatment plans

• Study Type: Interventional
• Enrollment (Estimated): 862
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona, Spain, 43003
    • Recruiting
    • Cecilia Campabadal Prats
    • Contact: Cecília Campabadal Prats; Phone Number: 679716123; Email: cprats.tgn.ics@gencat.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: intervention group	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.

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: nursing home; polypharmacy; pharmaceutical intervention
• Other Study ID Numbers: 22/191-P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No