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Potentially Inappropriate Prescription Associated to Multimorbidity (PIMyC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830425
Recruitment Status : Active, not recruiting
First Posted : July 12, 2016
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Hospital del Mar
Hospital de Galdakao
Consorci Hospitalari de Vic
Hospital Universitario de Canarias
Information provided by (Responsible Party):
Marisa Baré, MD, MPH, PhD, 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.


Condition or disease Intervention/treatment
Chronic Disease Other: No intervention

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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 2016
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria [ Time Frame: At study entry ]

Secondary Outcome Measures :
  1. Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria [ Time Frame: Through study completion, an average of 2 years ]
  2. Percentage of patients with polypharmacy [ Time Frame: At study entry ]
    Polypharmacy=more than 5 chronic medications

  3. Patients with any treatment-related adverse events (ADR), according to the Wills & Brown classification [ Time Frame: Through study completion, an average of 2 years ]
  4. Percentage of different Patterns of multimorbidity in chronic patients, according to clusters or associations of different chronic conditions [ Time Frame: At study entry ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830425


Locations
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Spain
Corporacio Parc Taulí
Sabadell, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Fondo de Investigacion Sanitaria
Hospital del Mar
Hospital de Galdakao
Consorci Hospitalari de Vic
Hospital Universitario de Canarias
Investigators
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Principal Investigator: Marisa Baré, MD, MPH, PhD Corporacio Parc Taulí

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marisa Baré, MD, MPH, PhD, Cancer Screening-Epidemiology Coordinator, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02830425    
Other Study ID Numbers: PI15/00552
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Marisa Baré, MD, MPH, PhD, Corporacion Parc Tauli:
Multimorbidity
Polypharmacy
Appropriateness
STOPP
START
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes