Chronic DiseasePIMyCNCT02830425
Potentially Inappropriate Prescription Associated to Multimorbidity
An observational study of Chronic Disease, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Disease
- How many people
- 740 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly with any chronic condition admitted in Internal Medicine or Geriatrics department because of an exacerbation of any chronic condition
Who may be able to join
- Patient admitted to the Internal Medicine or Geriatrics department
- Admitted to hospital because of an exacerbation of any previous chronic condition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
A prospective multicenter cohort study in 5 hospitals in Spain will be initiated in 2016.
Objectives:
Read more
- 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.
- Conditions
- Chronic Disease
- Being tested
- No intervention
- Keywords
- Multimorbidity, Polypharmacy, Appropriateness, STOPP, START
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria
Measured: At study entry
Secondary outcomes (4)
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria
Measured: Through study completion, an average of 2 years
Percentage of patients with polypharmacy
Polypharmacy=more than 5 chronic medications
Measured: At study entry
Patients with any treatment-related adverse events (ADR), according to the Wills & Brown classification
Measured: 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
Measured: At study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Hospital del Mar, Hospital de Galdakao, Consorci Hospitalari de Vic, Hospital Universitario de Canarias
- Responsible party
- Principal investigator, Marisa Baré, MD, MPH, PhD, Corporacion Parc Tauli
- Investigators
- Marisa Baré, MD, MPH, PhD, Principal investigator, Corporacio Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830425
- Sponsor's protocol ID
- PI15/00552
- Acronym
- PIMyC
- Status last verified
- Apr 2020
- First submitted
- 1 Jul 2016
- Last updated
- 9 Apr 2020
- Results posted
- No
Publications
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.
PubMed 31988230Ortonobes S, Herranz S, Lleal M, Sevilla-Sanchez D, Jordana R, Mascaro O, Ferrandez O, de Jaime E, Estrada R, Nazco GJ, Bare M; MoPIM Study Group. Multidisciplinary medication review during older patient hospitalization according to STOPP/START criteria reduces potentially inappropriate prescriptions: MoPIM cohort study. BMC Geriatr. 2024 Jul 8;24(1):584. doi: 10.1186/s12877-024-05185-w.
PubMed 38978009Lleal M, Bare M, Ortonobes S, Sevilla-Sanchez D, Jordana R, Herranz S, Gorgas MQ, Espaulella-Ferrer M, Arellano M, de Antonio M, Nazco GJ, Hernandez-Luis R, On Behalf Of The MoPIM Study Group. Comprehensive Multimorbidity Patterns in Older Patients Are Associated with Quality Indicators of Medication-MoPIM Cohort Study. Int J Environ Res Public Health. 2022 Nov 29;19(23):15902. doi: 10.3390/ijerph192315902.
PubMed 36497976Bare 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.
PubMed 35016636Bare 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.
PubMed 34782339
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02830425
- Acronym / sponsor ID
- PIMyC / PI15/00552
- Conditions
- Chronic Disease
- Keywords
- Multimorbidity, Polypharmacy, Appropriateness, STOPP, START
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Hospital del Mar, Hospital de Galdakao, Consorci Hospitalari de Vic, Hospital Universitario de Canarias
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly with any chronic condition admitted in Internal Medicine or Geriatrics department because of an exacerbation of any chronic condition
Key inclusion criteria (2 listed)
- Patient admitted to the Internal Medicine or Geriatrics department
- Admitted to hospital because of an exacerbation of any previous chronic condition
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria
Time frame: At study entry
4 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Background: PubMed 31988230Bare 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.
- Derived from this study: PubMed 38978009Ortonobes S, Herranz S, Lleal M, Sevilla-Sanchez D, Jordana R, Mascaro O, Ferrandez O, de Jaime E, Estrada R, Nazco GJ, Bare M; MoPIM Study Group. Multidisciplinary medication review during older patient hospitalization according to STOPP/START criteria reduces potentially inappropriate prescriptions: MoPIM cohort study. BMC Geriatr. 2024 Jul 8;24(1):584. doi: 10.1186/s12877-024-05185-w.
- Derived from this study: PubMed 36497976Lleal M, Bare M, Ortonobes S, Sevilla-Sanchez D, Jordana R, Herranz S, Gorgas MQ, Espaulella-Ferrer M, Arellano M, de Antonio M, Nazco GJ, Hernandez-Luis R, On Behalf Of The MoPIM Study Group. Comprehensive Multimorbidity Patterns in Older Patients Are Associated with Quality Indicators of Medication-MoPIM Cohort Study. Int J Environ Res Public Health. 2022 Nov 29;19(23):15902. doi: 10.3390/ijerph192315902.
- Derived from this study: PubMed 35016636Bare 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.
- Derived from this study: PubMed 34782339Bare 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisa Baré, MD, MPH, PhD principal investigator
Corporacio Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with Potentially inappropriate medication, according to STOPP-START explicit criteria (time frame: At study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830425, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.