Potentially Inappropriate Prescription Associated to Multimorbidity

Chronic Disease Clinical Trial

— PIMyC  

Official title:

Potentially Inappropriate Prescription Associated to Multimorbidity, Using the Explicit STOPP-START (Screening Tool of Older Persons' Potentially Inappropriate Prescriptions/Screening Tool to Alert Doctors to the Right Treatment) Criteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830425
• Other study ID #: PI15/00552
• Status: Completed
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Spain	Corporacio Parc Taulí	Sabadell

Sponsors (6)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Consorci Hospitalari de Vic, Fondo de Investigacion Sanitaria, Hospital de Galdakao, Hospital del Mar, Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Baré M, Herranz S, Jordana R, Gorgas MQ, Ortonobes S, Sevilla D, De Jaime E, Ibarra O, Martín C; MoPIM study group. Multimorbidity patterns in chronic older patients, potentially inappropriate prescribing and adverse drug reactions: protocol of the multicentre prospective cohort study MoPIM. BMJ Open. 2020 Jan 26;10(1):e033322. doi: 10.1136/bmjopen-2019-033322. — View Citation

Outcome

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