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
A prospective multicenter cohort study in 5 hospitals in Spain will be initiated in 2016.
- To estimate and describe patterns of multimorbidity and polypharmacy in patients over 64 admitted for a chronic disease exacerbation.
- To analyze the potentially inappropriate prescribing (PPI) drugs according to STOPP / START (SS) criteria.
- 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|
|Study Type :||Observational|
|Actual Enrollment :||800 participants|
|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|
- Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria [ Time Frame: At study entry ]
- Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria [ Time Frame: Through study completion, an average of 2 years ]
- Percentage of patients with polypharmacy [ Time Frame: At study entry ]Polypharmacy=more than 5 chronic medications
- Patients with any treatment-related adverse events (ADR), according to the Wills & Brown classification [ Time Frame: 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 ]
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
|Corporacio Parc Taulí|
|Sabadell, Spain, 08208|
|Principal Investigator:||Marisa Baré, MD, MPH, PhD||Corporacio Parc Taulí|