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OpenTrials
Completed

NCT Number: NCT02830425

Potentially Inappropriate Prescription Associated to Multimorbidity

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.

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Key information

Conditions

Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Corporacio Parc Taulí

Sabadell, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria

    Time frame: At study entry

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

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

Registry information

Official study 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

Acronym: PIMyC

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2016
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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