Clinical trial NCT02830425: Potentially Inappropriate Prescription Associated to Multimorbidity
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Keywords: Multimorbidity
Polypharmacy
Appropriateness
STOPP
START
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
name: Hospital del Mar
name: Hospital de Galdakao
name: Consorci Hospitalari de Vic
name: Hospital Universitario de Canarias
First posted: 2016-07-12
Enrollment: 740
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria
timeFrame: At study entry
Secondary outcomes:
measure: Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria
timeFrame: Through study completion, an average of 2 years
measure: Percentage of patients with polypharmacy
timeFrame: At study entry
measure: Patients with any treatment-related adverse events (ADR), according to the Wills & Brown classification
timeFrame: Through study completion, an average of 2 years
measure: Percentage of different Patterns of multimorbidity in chronic patients, according to clusters or associations of different chronic conditions
timeFrame: At study entry
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacio Parc Taulí
Study officials:
affiliation: Corporacio Parc Taulí
name: Marisa Baré, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bare M, Lleal M, Ortonobes S, Gorgas MQ, Sevilla-Sanchez D, Carballo N, De Jaime E, Herranz S; MoPIM study group. Factors associated to potentially inappropriate prescribing in older patients according to STOPP/START criteria: MoPIM multicentre cohort study. BMC Geriatr. 2022 Jan 11;22(1):44. doi: 10.1186/s12877-021-02715-8.
citation: Bare M, Herranz S, Roso-Llorach A, Jordana R, Violan C, Lleal M, Roura-Poch P, Arellano M, Estrada R, Nazco GJ; MoPIM study group. Multimorbidity patterns of chronic conditions and geriatric syndromes in older patients from the MoPIM multicentre cohort study. BMJ Open. 2021 Nov 15;11(11):e049334. doi: 10.1136/bmjopen-2021-049334.