Internal MedicineNCT05756400
Polypharmacy Among Internal Medicine Patients
An observational study of Internal Medicine, run by University of Iceland at 1 site in Iceland.
Trial summary
The World Health Organisation Patient Safety Challenge: Medication Without Harm has brought our attention to the importance of medication-related harm as a global public health issue. One of the major contributing factors is polypharmacy, the usage of multiple medicines at the same time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Medicine
- How many people
- 85,942 participants
- Where
- 1 siteIceland
- Study dates
- 1 Jan 2023to 1 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is Internal medicine patients in hospital settings. The cohort will include 100% of tertiary care internal medicine admissions in Iceland and 70-80% of secondary care in Iceland. The study population includes 85942 number of participants.
Who may be able to join
- Population-based cohort study that included all patients ≥18 years hospitalized in internal medicine ward at Landspitali - The National University Hospital of Iceland during the study period 1st January 2010 and 31st December 2020
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polypharmacy and Associated Risk Factors and Clinical Outcomes for Internal Medicine Patients Discharged From Hospital
The World Health Organisation Patient Safety Challenge: Medication Without Harm has brought our attention to the importance of medication-related harm as a global public health issue. One of the major contributing factors is polypharmacy, the usage of multiple medicines at the same time. People are getting older and living longer with chronic diseases; they need more medications, which frequently leads to polypharmacy. Subsequently, they are at more risk of medication-related harm. The planned project is an epidemiological study on polypharmacy, medication appropriateness, risk factors, and clinical outcomes post-discharge from a hospital for internal medicine patients.
The study group hypothesise that pre- and post-admission polypharmacy and potentially inappropriate prescribing is common, especially among older patients, patients with a high comorbidity and frailty burden. Our hypothesis is additionally that preadmission polypharmacy and potentially inappropriate prescribing is associated with higher short- and long-term mortality, a longer primary hospitalization length of stay, and a higher risk of readmission.
Read the detailed description
This is an observational, retrospective, single-centered study using clinical data from the patient's medical record from the hospital, the national prescription database of the Directorate of Health, and the ICD-10 codes from primary care records. For this analysis, medicines will be classified into drug classes based on the first five characters of their WHO Anatomical Therapeutic Chemical (ATC) code. The prevalence (pre) and incidence (post) of polypharmacy (≥5 or more regular medicines) and hyper-polypharmacy (≥10 regular medicines) will be calculated. Potentially inappropriate prescribing will be assessed in individuals ≥65 years, applying Beers 2019, Start and Stopp 2014, explicit prescribing criteria. The analysis will be restricted to older individuals, as Beers criteria have not been validated in younger age groups. The anticholinergic burden will be assessed for all individuals ≥18 years will be assessed by applying the anticholinergic burden scale, and the PRIME tool will be applied to predict the likelihood of medication-related harm post-discharge. The PRIME tool consists of eight variables drawn from clinical, medication, and psychosocial domains. Applied at the point of discharge, it provides the absolute risk of an individual older adult experiencing medication-related harm during the eight weeks after discharge from acute hospital admission. This stratification is important in order to deliver targeted interventions in resource-limited healthcare settings.
- Conditions
- Internal Medicine
- Keywords
- Polypharmacy, Potentially Inappropriate Medication List, Risk Factors, Cinical Outcomes, Predication on Medication Related Harm, Discharge, Inappropriate Prescribing, Drug-related side effects and adverse reaction,, Readmisson, Patient discharge, Prediction tool, Start and stop, Beers
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of polypharmacy
Polypharmacy measured by by the number of different ATC classes of medications filled in the year preceding and year following surgery. Polypharmacy further quantified into categories of non-polypharmacy (<5), polypharmacy (5-9) and hyper-polypharmacy (≥10).
Measured: Two years, one year pre-admission and one year post-admisson, 2010-2020
Secondary outcomes (7)
Incidence of polypharmacy
Polypharmacy measured by by the number of different ATC classes of medications filled in the year preceding and year following surgery. Polypharmacy further quantified into categories of non-polypharmacy (<5), polypharmacy (5-9) and hyper-polypharmacy (≥10).
Measured: Two years, one year pre-admission and one year post-admisson, 2010-2020
Potentially inappropriate prescribing by Beers criteria 2019
The association of potentially inappropriate prescribing by applying Beers criteria 2019 with polypharmacy (summary score, yes/no)
Measured: 2010-2020
Anticholinergic burden by applying the Anticholinergic burden scale
The association of anticholinergic burden by applying the Anticholinergic burden scale with polypharmacy ((summary score, yes/no)
Measured: 2010-2020
Demographics
Gender (male, female),age (years), comorbidity based on the International Statistical Classification of Diseases, and Related Health Problems, ninth or tenth revision, ICD9/10 classification system
Measured: 2010-2020
Comorbidity burden
The association of comorbidity burden will be described by calculating the Charlson Comorbidity Index and Elixhauser comorbidity index (summary score) with polypharmacy ((summary score, yes/no)
Measured: 2010-2020
Drug classes
Drug classes based on ATC-codes on filled medications from the Prescription Medicines Registry and association with polypharmacy
Measured: 2010-2020
Clinical outcomes
Mortality (short-and long-term mortality) Length of hospital stay (number of days, ≥ ten days) Readmission (number of days until readmission, readmission <30 days)
Measured: 2010-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Jan 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Internal MedicineStudies 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
- Retrospective
- Enrolment
- 85,942 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756400
- Sponsor's protocol ID
- UI-2022-Polypharmacy-medicine
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Jonsdottir F, Blondal AB, Gudmundsson A, Bates I, Stevenson JM, Sigurdsson MI. The association of degree of polypharmacy before and after among hospitalised internal medicine patients and clinical outcomes: a retrospective, population-based cohort study. BMJ Open. 2024 Mar 28;14(3):e078890. doi: 10.1136/bmjopen-2023-078890.
PubMed 38548367
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypharmacy and Associated Risk Factors and Clinical Outcomes for Internal Medicine Patients Discharged From Hospital
- ClinicalTrials.gov ID
- NCT05756400
- Acronym / sponsor ID
- UI-2022-Polypharmacy-medicine
- Conditions
- Internal Medicine
- Keywords
- Polypharmacy, Potentially Inappropriate Medication List, Risk Factors, Cinical Outcomes, Predication on Medication Related Harm, Discharge, Inappropriate Prescribing, Drug-related side effects and adverse reaction,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85,942 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 6 Mar 2023 (actual)
- 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.
The World Health Organisation Patient Safety Challenge: Medication Without Harm has brought our attention to the importance of medication-related harm as a global public health issue. One of the major contributing factors is polypharmacy, the usage of multiple medicines at the same time. People are getting older and living longer with chronic diseases; they need more medications, which frequently leads to polypharmacy. Subsequently, they are at more risk of medication-related harm. The planned project is an epidemiological study on polypharmacy, medication appropriateness, risk factors, and clinical outcomes post-discharge from a hospital for internal medicine patients.
The study group hypothesise that pre- and post-admission polypharmacy and potentially inappropriate prescribing is common, especially among older patients, patients with a high comorbidity and frailty burden. Our hypothesis is additionally that preadmission polypharmacy and potentially inappropriate prescribing is associated with higher short- and long-term mortality, a longer primary hospitalization length of stay, and a higher risk of readmission.
Detailed description
This is an observational, retrospective, single-centered study using clinical data from the patient's medical record from the hospital, the national prescription database of the Directorate of Health, and the ICD-10 codes from primary care records. For this analysis, medicines will be classified into drug classes based on the first five characters of their WHO Anatomical Therapeutic Chemical (ATC) code. The prevalence (pre) and incidence (post) of polypharmacy (≥5 or more regular medicines) and hyper-polypharmacy (≥10 regular medicines) will be calculated. Potentially inappropriate prescribing will be assessed in individuals ≥65 years, applying Beers 2019, Start and Stopp 2014, explicit prescribing criteria. The analysis will be restricted to older individuals, as Beers criteria have not been validated in younger age groups. The anticholinergic burden will be assessed for all individuals ≥18 years will be assessed by applying the anticholinergic burden scale, and the PRIME tool will be applied to predict the likelihood of medication-related harm post-discharge. The PRIME tool consists of eight variables drawn from clinical, medication, and psychosocial domains. Applied at the point of discharge, it provides the absolute risk of an individual older adult experiencing medication-related harm during the eight weeks after discharge from acute hospital admission. This stratification is important in order to deliver targeted interventions in resource-limited healthcare settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is Internal medicine patients in hospital settings. The cohort will include 100% of tertiary care internal medicine admissions in Iceland and 70-80% of secondary care in Iceland. The study population includes 85942 number of participants.
Key inclusion criteria (1 listed)
- Population-based cohort study that included all patients ≥18 years hospitalized in internal medicine ward at Landspitali - The National University Hospital of Iceland during the study period 1st January 2010 and 31st December 2020
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of polypharmacy
Time frame: Two years, one year pre-admission and one year post-admisson, 2010-2020
Polypharmacy measured by by the number of different ATC classes of medications filled in the year preceding and year following surgery. Polypharmacy further quantified into categories of non-polypharmacy (<5), polypharmacy (5-9) and hyper-polypharmacy (≥10).
7 secondary outcomes
Incidence of polypharmacy
Time frame: Two years, one year pre-admission and one year post-admisson, 2010-2020
Potentially inappropriate prescribing by Beers criteria 2019
Time frame: 2010-2020
Anticholinergic burden by applying the Anticholinergic burden scale
Time frame: 2010-2020
Demographics
Time frame: 2010-2020
Comorbidity burden
Time frame: 2010-2020
Drug classes
Time frame: 2010-2020
Clinical outcomes
Time frame: 2010-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 38548367Jonsdottir F, Blondal AB, Gudmundsson A, Bates I, Stevenson JM, Sigurdsson MI. The association of degree of polypharmacy before and after among hospitalised internal medicine patients and clinical outcomes: a retrospective, population-based cohort study. BMJ Open. 2024 Mar 28;14(3):e078890. doi: 10.1136/bmjopen-2023-078890.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Internal Medicine, run by University of Iceland at 1 site in Iceland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. 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 Iceland. 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?
Results are not available in the source record.
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?
Prevalence of polypharmacy (time frame: Two years, one year pre-admission and one year post-admisson, 2010-2020). 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 NCT05756400, which also lists 1 linked publication.
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 Feb 2024.