Potentially Inappropriate Prescription Associated to Multimorbidity

Completed

• Conditions: Chronic Disease

• Registration Number: NCT02830425
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

A prospective multicenter cohort study in 5 hospitals in Spain will be initiated in 2016.

Objectives:

1. To estimate and describe patterns of multimorbidity and polypharmacy in patients over 64 admitted for a chronic disease exacerbation.

2. To analyze the potentially inappropriate prescribing (PPI) drugs according to STOPP / START (SS) criteria.

3. To evaluate the relationship between multimorbidity and PPI and adverse medication (RAM) preventable reaction.

The cohort will include 800 patients \>64 years admitted in internal medicine and / or geriatric department of 5 hospitals of the National Health Service. Application of the SS criteria (released in 2015) on admission and at discharge, and collection of demographic and clinical variables including comorbidities, baseline chronic medication, geriatric syndromes, functional capacity and RAM. Descriptive analysis and bivariate parametric or nonparametric tests will be applied to analyze relationship between morbidity, polypharmacy, SS criteria and RAM. Intraobserver agreement will be assessed for SS criteria. Multiple regression techniques will be applied, where the dependent variable will be the PPI or the RAM.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Primary Completion: 2019-07
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

• Patient admitted to the Internal Medicine or Geriatrics department
• Admitted to hospital because of an exacerbation of any previous chronic condition

Exclusion Criteria

• Terminal ill patients at admission
• Patients with lower forecast life than 1 year
• Patient admitted to the hospital only because an acute problem
• In patient home care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria	At study entry

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria	Through study completion, an average of 2 years
Percentage of patients with polypharmacy	At study entry	Polypharmacy=more than 5 chronic medications
Patients with any treatment-related adverse events (ADR), according to the Wills & Brown classification	Through study completion, an average of 2 years
Percentage of different Patterns of multimorbidity in chronic patients, according to clusters or associations of different chronic conditions	At study entry

Trial Locations

Locations (1)

Corporacio Parc Taulí; 🇪🇸 Sabadell, Spain