Potentially Inappropriate Prescription Associated to Multimorbidity (PIMyC)

April 7, 2020 updated by: Marisa Baré, MD, MPH, PhD, Corporacion Parc Tauli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

740

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sabadell, Spain, 08208
        • Corporació Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly with any chronic condition admitted in Internal Medicine or Geriatrics department because of an exacerbation of any chronic condition

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria
Time Frame: At study entry
At study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Percentage of patients with polypharmacy
Time Frame: At study entry
Polypharmacy=more than 5 chronic medications
At study entry
Patients with any treatment-related adverse events (ADR), according to the Wills & Brown classification
Time Frame: Through study completion, an average of 2 years
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
Time Frame: At study entry
At study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Collaborators

Fondo de Investigacion Sanitaria
Hospital del Mar
Hospital Universitario de Canarias
Consorci Hospitalari de Vic
Hospital de Galdakao

Investigators

  • Principal Investigator: Marisa Baré, MD, MPH, PhD, Corporació Parc Tauli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 1, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI15/00552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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