Potentially Inappropriate Prescription Associated to Mult... | NCT02830425

Studies
Potentially Inappropriate Prescription Associated to Multimorbidity

NCT02830425

Sponsor

Corporacion Parc Tauli

Status

Completed

Last Update Posted

Apr 9, 2020Actual

Enrollment

740Actual

Phase

Not provided

Conditions

Chronic Disease

Interventions

No intervention

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Jul 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Jul 1, 2016

First Submission Date that Met QC Criteria

Jul 8, 2016

First Posted Date

Jul 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2020

Last Update Posted Date

Apr 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marisa Baré, MD, MPH, PhD, Cancer Screening-Epidemiology Coordinator, Corporacion Parc TauliPrincipal Investigator

Lead Sponsor

Corporacion Parc TauliOTHER

Collaborators

Name	Class
Fondo de Investigacion Sanitaria	OTHER
Hospital del Mar	OTHER
Hospital de Galdakao	OTHER
Consorci Hospitalari de Vic

Description Module

Brief Summary

A prospective multicenter cohort study in 5 hospitals in Spain will be initiated in 2016.

Objectives:

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

740Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria		Through study completion, an average of 2 years
Percentage of patients with polypharmacy	Polypharmacy=more than 5 chronic medications

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marisa Baré, MD, MPH, PhD	Corporacio Parc Taulí	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Corporacio Parc Taulí		Sabadell		08208	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31988230	Background	Bare M, Herranz S, Jordana R, Gorgas MQ, Ortonobes S, Sevilla D, De Jaime E, Ibarra O, Martin 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.
38978009

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms