Polypharmacy PatientsNCT05589870
Assessment of a Novel Algorithm System for Polypharmacy Patient Medication Safety and Consultation
An observational study of Polypharmacy Patients, run by MDI Health at 1 site in Israel.
Trial summary
The aim of this study is to determine if insights based on the analysis of historical data of multidrug patients' electronic health records, by a novel system and algorithm, is noninferior to a clinical pharmacist analysis and insights. Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Polypharmacy Patients
- What is being tested?
- Multi-drug analysis of polypharmacy treatment
- How many people
- 91 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Feb 2021to 7 Jul 2021
- 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 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥45 years, that were prescribed at least six (6) medications on hospital admission for one of the following medical conditions: type 2 diabetes mellitus, hypertension, hyperlipidemia, ischemic heart disease, s/p cerebrovascular accident (CVA), depression, dementia, neuropathy, and related symptoms and disease states [sleep disorder, pain, diabetic neuropathy, gastrointestinal (GI) discomfort]. Patients were excluded from the study if they had one of the following disease states: oncologic disease, dialysis / end-stage renal disease (ESRD), epilepsy, ventilated and sedated, hyperparathyroidism or were breastfeeding or pregnant.
Who may be able to join
- Men or women aged 45 and over (inclusive) at the time of admission to hospital. Hospitalized at Hadassah Hospital from 2010 to 2017 in one of the following departments: Internal Medicine, Cardiology, Orthopedics, Neurology, Rehabilitation.
- Patients who have available hospitalization summary information available that contains the content required to complete the indicated fields (according to the fields listed in Appendix 1 - Patient Sheet).
- The patient's chronic medications at admission to hospital are from the following pharmacological families / medications: angiotensin converting enzyme inhibitors (ACEI), angiotensin II receptor blockers (ARB), Beta Blockers, calcium channel blockers (CCB), Alpha blockers, Potassium-sparing diuretics, diuretics loop, diuretics thiazide, Anti platelets agents anticoagulants, Metformin Insulin, sulfonylurea (SU) / repaglinide glucagon like peptide 1 (GLP1) analogues, dipeptidyl peptidase IV (DPP-4) inhibitors, sodium-glucose transport protein 2 (SGLT2) inhibitor, statin Fibrates, benzodiazapines / Z-drugs, Mirtazapine, selective serotonin reuptake inhibitors (SSRIs) / norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCA), Antispasmodic / Anticholinergic, Antiepileplic agents) Gabapentin, Pregabalin, Primidone) , Opioids, proton-pump inhibitors (PPIs), histamine 2 (H2) blockers.
- Take at least six (6) chronic medications from the above list at the time of admission to the hospital (the list may also include medications that have been discontinued on admission to the hospital).
- -
Who cannot join
- Oncology patients
- Dialysis patients
- Epileptic patients
- Respiratory and anesthetized
- Breastfeeding patients
- Pregnant patients
- Patients with hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Comparative Study, for the Assessment of a Novel System, an Algorithm for Medication Safety and Consultation for Chronic Polypharmacy Patients
The aim of this study is to determine if insights based on the analysis of historical data of multidrug patients' electronic health records, by a novel system and algorithm, is noninferior to a clinical pharmacist analysis and insights.
Multidrug patients, also known as polypharmacy patients often suffer from adverse drug reactions (ADRs). In routine practice the clinical pharmacist helps prevent ADRs by comprehensive medication review, identifying drug related risks and problems and providing recommendations. The analysis of multidrug patients is highly complex and time consuming due to the large amount of multifactorial data of chronic multidrug patients' medications, symptoms, comorbidities and age-related issues. The MDI system is a tool for analyzing and providing insights on polypharmacy data [including electronic health records (EHRs) and claims data] to help clinicians evaluate complex medical records and ensure optimal and personal treatment recommendations.
Read more
After initial training of the MDI system on historical real-life patient EHRs, the MDI system and the clinical pharmacist reviewed patient EHR data from another patient cohort according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. The insights of this assessment were recorded on patient conclusion sheets and adjudicated by an external judging committee, comprised of two senior academic clinical pharmacists. The judging committee were blinded to the source of the conclusion sheets.
Diagnostic accuracy parameters: agreement, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the MDI system and the clinical pharmacist were assessed. The gold standard of the diagnostic accuracy analysis was the judging committee.
Assuming that the total agreement is 5% higher for the MDI System, with a non-inferiority margin of 5%, α level of 5%, statistical power of 90%, and an expected standard deviation of 15%, the minimum sample size is about 20 cases. The achieved recruitment level was more than twice as much in the actual clinical trial.
Read the detailed description
This is an observational, retrospective study performed on deidentified electronic health records (EHRs). The study includes two stages: A pilot study for training and verification of a novel system; and a clinical validation study for evaluating the MDI system performance in comparison to the clinical pharmacist.
The main aim of the study is to determine the noninferiority of a novel system performance in comparison to the clinical pharmacist, for the creation of insights based on the analysis of multidrug patients' EHRs. The quality and accuracy of the analysis and insights is adjudicated by an external judging committee (the gold standard), comprised of two (2) senior academic clinical pharmacists (Pharm.D, Ph.D).
The clinical site's Information systems division scanned for EHRs of multidrug patients according to extraction criteria. The raw data of the patients' records were reviewed by the principal investigator (PI). Medical coding definitions of the extraction criteria were modified according to discrepancies found by the PI. The patients' deidentified EHRs were randomized to a training cohort for the training phase and to the clinical validation cohort.
Stage 1 of the trial was for training the MDI system on real-life patient EHRs. Deidentified EHRs of the training cohort were uploaded to the MDI System platform, which calculates each patient's risk for drug induced problems according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. The MDI System output report is reviewed by the clinical team. The algorithms are modified based on the system-wide conclusions and the risk calculation model.
Stage 2 of the trial was for the clinical validation of the MDI system. The MDI system and clinical pharmacists independently evaluated the clinical cohort EHRs and reported insights on conclusion sheets according to the five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. An external judging committee comprised of two (2) senior clinical pharmacy doctors, who were blinded to the source of the conclusion sheets, adjudicated the MDI system and clinical pharmacist insights.
Agreement is defined as an identical conclusion between the MDI system/clinical pharmacist's conclusion on any of the categories / problems documented on the patient's conclusion sheet and the judging committee conclusion (the gold standard). The judges were also instructed to add any finding that was missing in their professional opinion from the documented patient conclusion sheets. Agreement of a conclusion with the judging committee's conclusion is marked as true positive. Nonagreement of a conclusion and the judging committee's conclusion is marked as false positive. A conclusion variable found missing by the judging committee is marked as false negative. True negatives are defined as agreement between a conclusion regarding a missing finding in one of the categories.
The sample size for the clinical validation of the MDI System was based on the primary endpoint of non-inferiority of the diagnostic total agreement of the MDI System compared to the diagnostic total agreement of the Clinical Pharmacists for the total of the Combined Categories. The gold standard was the Judging Committee. Assuming that the total agreement is 5% higher for the MDI System, with a non-inferiority margin of 5%, α level of 5%, statistical power of 90%, and an expected standard deviation of 15%, the minimum sample size is about 20 cases. The achieved recruitment level was more than twice as much in the actual clinical trial.
Confidence intervals of 95% (95%CI) were calculated according to the T distribution under the non-inferiority assumption that the total agreement of the MDI algorithm system will not be inferior than the agreement accuracy of the clinical pharmacist. If the 95% CI limit of the percentage differences did not exceed 5% in favor of the clinical pharmacist, the non-inferiority hypothesis was confirmed. The calculation was performed for the primary endpoint (total of the five categories) and the secondary endpoints for each individual category.
The discrete variables assessed in the categories: duplication of therapy, age-related issues and incorrect dose were medications. The discrete variables assessed in the categories: current side effects and future side effects were the individual side effects. Diagnostic accuracy of the MDI System and the Clinical Pharmacists were assessed by the Judging Committee (the "gold standard").
For each subject, total agreement, PPV, NPV, sensitivity and specificity were calculated for all the combined categories together and for each separate category. The diagnostic accuracy of the total subjects is presented as mean, 95%CI of the mean, standard deviation (Std), median, minimum and maximum.
In addition, overall by-line (regardless of subject) validity parameters (overall agreement, PPV, NPV, Sensitivity and Specificity) were analyzed using frequency, percentages and 95% CI.
- Conditions
- Polypharmacy Patients
- Being tested
- Multi-drug analysis of polypharmacy treatment
- Keywords
- Polypharmacy, Adverse Drug Reaction, Drug related problems, Drug induced disease, Multi-morbidity, Multi-drug treatments, Drug safety, Comprehensive medication reviews, Drug interactions, Side effects, Clinical pharmacists, Drug effects, Drug related risks
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-drug analysis of polypharmacy treatmentOther
Multi-drug analysis to assess and provide insights for lowering the risk of ADRs and increasing the benefit of polypharmacy treatment
| Study group | Role | What they receive |
|---|---|---|
| Clinical pharmacists group | A group of patient files that were evaluated by the clinical pharmacists, Insights Insights were categorized according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. An external judging committee comprised of two (2) senior clinical pharmacy doctors, who were blinded to the source of the conclusion sheets, adjudicated the MDI system and clinical pharmacist insights. Receives: Other: Multi-drug analysis of polypharmacy treatment | |
| MDI system group | A group of patient files that were evaluated by the MDI system. Insights were categorized according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. An external judging committee comprised of two (2) senior clinical pharmacy doctors, who were blinded to the source of the conclusion sheets, adjudicated the MDI system and clinical pharmacist insights. Receives: Other: Multi-drug analysis of polypharmacy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure: Noninferiority of agreement for combined categories
The overall mean percentage of agreement between the MDI system/clinical pharmacists and the judging committee (gold standard) for the combined categories
Measured: 90 days
Secondary outcomes (3)
Secondary Outcome: Noninferiority of agreement for separate categories
The mean percentage of agreement between the MDI system/clinical pharmacists and the judging committee (gold standard) for the separate categories
Measured: 90 days
Secondary Outcome: Noninferiority of PPV, NPV, sensitivity and specificity for the combined categories
PPV, NPV, sensitivity and specificity for the MDI system/clinical pharmacists according to the judging committee (gold standard) for the combined categories
Measured: 90 days
Secondary Outcome: Noninferiority of PPV, NPV, sensitivity and specificity for the separate categories
PPV, NPV, sensitivity and specificity for the MDI system/clinical pharmacists according to the judging committee (gold standard) for the separate categories
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start13 Feb 2021
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
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 Polypharmacy PatientsStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDI Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Sigal Shafran, Dr., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589870
- Sponsor's protocol ID
- HMO-0353-19
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC Geriatr. 2017 Oct 10;17(1):230. doi: 10.1186/s12877-017-0621-2.
PubMed 29017448Parameswaran Nair N, Chalmers L, Peterson GM, Bereznicki BJ, Castelino RL, Bereznicki LR. Hospitalization in older patients due to adverse drug reactions -the need for a prediction tool. Clin Interv Aging. 2016 May 2;11:497-505. doi: 10.2147/CIA.S99097. eCollection 2016.
PubMed 27194906Fabbri E, Zoli M, Gonzalez-Freire M, Salive ME, Studenski SA, Ferrucci L. Aging and Multimorbidity: New Tasks, Priorities, and Frontiers for Integrated Gerontological and Clinical Research. J Am Med Dir Assoc. 2015 Aug 1;16(8):640-7. doi: 10.1016/j.jamda.2015.03.013. Epub 2015 May 7.
PubMed 25958334Johnell K, Klarin I. The relationship between number of drugs and potential drug-drug interactions in the elderly: a study of over 600,000 elderly patients from the Swedish Prescribed Drug Register. Drug Saf. 2007;30(10):911-8. doi: 10.2165/00002018-200730100-00009.
PubMed 17867728Syrowatka A, Song W, Amato MG, Foer D, Edrees H, Co Z, Kuznetsova M, Dulgarian S, Seger DL, Simona A, Bain PA, Purcell Jackson G, Rhee K, Bates DW. Key use cases for artificial intelligence to reduce the frequency of adverse drug events: a scoping review. Lancet Digit Health. 2022 Feb;4(2):e137-e148. doi: 10.1016/S2589-7500(21)00229-6. Epub 2021 Nov 23.
PubMed 34836823
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Comparative Study, for the Assessment of a Novel System, an Algorithm for Medication Safety and Consultation for Chronic Polypharmacy Patients
- ClinicalTrials.gov ID
- NCT05589870
- Acronym / sponsor ID
- HMO-0353-19
- Conditions
- Polypharmacy Patients
- Keywords
- Polypharmacy, Adverse Drug Reaction, Drug related problems, Drug induced disease, Multi-morbidity, Multi-drug treatments, Drug safety, Comprehensive medication reviews
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- MDI HealthIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- 13 Feb 2021 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 21 Oct 2022 (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 aim of this study is to determine if insights based on the analysis of historical data of multidrug patients' electronic health records, by a novel system and algorithm, is noninferior to a clinical pharmacist analysis and insights.
Multidrug patients, also known as polypharmacy patients often suffer from adverse drug reactions (ADRs). In routine practice the clinical pharmacist helps prevent ADRs by comprehensive medication review, identifying drug related risks and problems and providing recommendations. The analysis of multidrug patients is highly complex and time consuming due to the large amount of multifactorial data of chronic multidrug patients' medications, symptoms, comorbidities and age-related issues. The MDI system is a tool for analyzing and providing insights on polypharmacy data [including electronic health records (EHRs) and claims data] to help clinicians evaluate complex medical records and ensure optimal and personal treatment recommendations.
After initial training of the MDI system on historical real-life patient EHRs, the MDI system and the clinical pharmacist reviewed patient EHR data from another patient cohort according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. The insights of this assessment were recorded on patient conclusion sheets and adjudicated by an external judging committee, comprised of two senior academic clinical pharmacists. The judging committee were blinded to the source of the conclusion sheets.
Diagnostic accuracy parameters: agreement, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the MDI system and the clinical pharmacist were assessed. The gold standard of the diagnostic accuracy analysis was the judging committee.
Assuming that the total agreement is 5% higher for the MDI System, with a non-inferiority margin of 5%, α level of 5%, statistical power of 90%, and an expected standard deviation of 15%, the minimum sample size is about 20 cases. The achieved recruitment level was more than twice as much in the actual clinical trial.
Detailed description
This is an observational, retrospective study performed on deidentified electronic health records (EHRs). The study includes two stages: A pilot study for training and verification of a novel system; and a clinical validation study for evaluating the MDI system performance in comparison to the clinical pharmacist.
The main aim of the study is to determine the noninferiority of a novel system performance in comparison to the clinical pharmacist, for the creation of insights based on the analysis of multidrug patients' EHRs. The quality and accuracy of the analysis and insights is adjudicated by an external judging committee (the gold standard), comprised of two (2) senior academic clinical pharmacists (Pharm.D, Ph.D).
The clinical site's Information systems division scanned for EHRs of multidrug patients according to extraction criteria. The raw data of the patients' records were reviewed by the principal investigator (PI). Medical coding definitions of the extraction criteria were modified according to discrepancies found by the PI. The patients' deidentified EHRs were randomized to a training cohort for the training phase and to the clinical validation cohort.
Stage 1 of the trial was for training the MDI system on real-life patient EHRs. Deidentified EHRs of the training cohort were uploaded to the MDI System platform, which calculates each patient's risk for drug induced problems according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. The MDI System output report is reviewed by the clinical team. The algorithms are modified based on the system-wide conclusions and the risk calculation model.
Stage 2 of the trial was for the clinical validation of the MDI system. The MDI system and clinical pharmacists independently evaluated the clinical cohort EHRs and reported insights on conclusion sheets according to the five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. An external judging committee comprised of two (2) senior clinical pharmacy doctors, who were blinded to the source of the conclusion sheets, adjudicated the MDI system and clinical pharmacist insights.
Agreement is defined as an identical conclusion between the MDI system/clinical pharmacist's conclusion on any of the categories / problems documented on the patient's conclusion sheet and the judging committee conclusion (the gold standard). The judges were also instructed to add any finding that was missing in their professional opinion from the documented patient conclusion sheets. Agreement of a conclusion with the judging committee's conclusion is marked as true positive. Nonagreement of a conclusion and the judging committee's conclusion is marked as false positive. A conclusion variable found missing by the judging committee is marked as false negative. True negatives are defined as agreement between a conclusion regarding a missing finding in one of the categories.
The sample size for the clinical validation of the MDI System was based on the primary endpoint of non-inferiority of the diagnostic total agreement of the MDI System compared to the diagnostic total agreement of the Clinical Pharmacists for the total of the Combined Categories. The gold standard was the Judging Committee. Assuming that the total agreement is 5% higher for the MDI System, with a non-inferiority margin of 5%, α level of 5%, statistical power of 90%, and an expected standard deviation of 15%, the minimum sample size is about 20 cases. The achieved recruitment level was more than twice as much in the actual clinical trial.
Confidence intervals of 95% (95%CI) were calculated according to the T distribution under the non-inferiority assumption that the total agreement of the MDI algorithm system will not be inferior than the agreement accuracy of the clinical pharmacist. If the 95% CI limit of the percentage differences did not exceed 5% in favor of the clinical pharmacist, the non-inferiority hypothesis was confirmed. The calculation was performed for the primary endpoint (total of the five categories) and the secondary endpoints for each individual category.
The discrete variables assessed in the categories: duplication of therapy, age-related issues and incorrect dose were medications. The discrete variables assessed in the categories: current side effects and future side effects were the individual side effects. Diagnostic accuracy of the MDI System and the Clinical Pharmacists were assessed by the Judging Committee (the "gold standard").
For each subject, total agreement, PPV, NPV, sensitivity and specificity were calculated for all the combined categories together and for each separate category. The diagnostic accuracy of the total subjects is presented as mean, 95%CI of the mean, standard deviation (Std), median, minimum and maximum.
In addition, overall by-line (regardless of subject) validity parameters (overall agreement, PPV, NPV, Sensitivity and Specificity) were analyzed using frequency, percentages and 95% CI.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical pharmacists group | – | Other: Multi-drug analysis of polypharmacy treatmentA group of patient files that were evaluated by the clinical pharmacists, Insights Insights were categorized according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. An external judging committee comprised of two (2) senior clinical pharmacy doctors, who were blinded to the source of the conclusion sheets, adjudicated the MDI system and clinical pharmacist insights. |
| MDI system group | – | Other: Multi-drug analysis of polypharmacy treatmentA group of patient files that were evaluated by the MDI system. Insights were categorized according to five categories: 1) duplication of therapy, 2) age-related issues, 3) incorrect dose, 4) current side effects and 5) future side effects risks. An external judging committee comprised of two (2) senior clinical pharmacy doctors, who were blinded to the source of the conclusion sheets, adjudicated the MDI system and clinical pharmacist insights. |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥45 years, that were prescribed at least six (6) medications on hospital admission for one of the following medical conditions: type 2 diabetes mellitus, hypertension, hyperlipidemia, ischemic heart disease, s/p cerebrovascular accident (CVA), depression, dementia, neuropathy, and related symptoms and disease states [sleep disorder, pain, diabetic neuropathy, gastrointestinal (GI) discomfort]. Patients were excluded from the study if they had one of the following disease states: oncologic disease, dialysis / end-stage renal disease (ESRD), epilepsy, ventilated and sedated, hyperparathyroidism or were breastfeeding or pregnant.
Key inclusion criteria (5 listed)
- Men or women aged 45 and over (inclusive) at the time of admission to hospital. Hospitalized at Hadassah Hospital from 2010 to 2017 in one of the following departments: Internal Medicine, Cardiology, Orthopedics, Neurology, Rehabilitation.
- Patients who have available hospitalization summary information available that contains the content required to complete the indicated fields (according to the fields listed in Appendix 1 - Patient Sheet).
- The patient's chronic medications at admission to hospital are from the following pharmacological families / medications: angiotensin converting enzyme inhibitors (ACEI), angiotensin II receptor blockers (ARB), Beta Blockers, calcium channel blockers (CCB), Alpha blockers, Potassium-sparing diuretics, diuretics loop, diuretics thiazide, Anti platelets agents anticoagulants, Metformin Insulin, sulfonylurea (SU) / repaglinide glucagon like peptide 1 (GLP1) analogues, dipeptidyl peptidase IV (DPP-4) inhibitors, sodium-glucose transport protein 2 (SGLT2) inhibitor, statin Fibrates, benzodiazapines / Z-drugs, Mirtazapine, selective serotonin reuptake inhibitors (SSRIs) / norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCA), Antispasmodic / Anticholinergic, Antiepileplic agents) Gabapentin, Pregabalin, Primidone) , Opioids, proton-pump inhibitors (PPIs), histamine 2 (H2) blockers.
- Take at least six (6) chronic medications from the above list at the time of admission to the hospital (the list may also include medications that have been discontinued on admission to the hospital).
- -
Key exclusion criteria (7 listed)
- Oncology patients
- Dialysis patients
- Epileptic patients
- Respiratory and anesthetized
- Breastfeeding patients
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 |
|---|---|---|
| Multi-drug analysis of polypharmacy treatmentMulti-drug analysis to assess and provide insights for lowering the risk of ADRs and increasing the benefit of polypharmacy treatment | Other | Clinical pharmacists group, MDI system group |
Primary outcome
Primary Outcome Measure: Noninferiority of agreement for combined categories
Time frame: 90 days
The overall mean percentage of agreement between the MDI system/clinical pharmacists and the judging committee (gold standard) for the combined categories
3 secondary outcomes
Secondary Outcome: Noninferiority of agreement for separate categories
Time frame: 90 days
Secondary Outcome: Noninferiority of PPV, NPV, sensitivity and specificity for the combined categories
Time frame: 90 days
Secondary Outcome: Noninferiority of PPV, NPV, sensitivity and specificity for the separate categories
Time frame: 90 days
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 23 Oct 2023.
- Background: PubMed 29017448Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC Geriatr. 2017 Oct 10;17(1):230. doi: 10.1186/s12877-017-0621-2.
- Background: PubMed 27194906Parameswaran Nair N, Chalmers L, Peterson GM, Bereznicki BJ, Castelino RL, Bereznicki LR. Hospitalization in older patients due to adverse drug reactions -the need for a prediction tool. Clin Interv Aging. 2016 May 2;11:497-505. doi: 10.2147/CIA.S99097. eCollection 2016.
- Background: PubMed 25958334Fabbri E, Zoli M, Gonzalez-Freire M, Salive ME, Studenski SA, Ferrucci L. Aging and Multimorbidity: New Tasks, Priorities, and Frontiers for Integrated Gerontological and Clinical Research. J Am Med Dir Assoc. 2015 Aug 1;16(8):640-7. doi: 10.1016/j.jamda.2015.03.013. Epub 2015 May 7.
- Background: PubMed 17867728Johnell K, Klarin I. The relationship between number of drugs and potential drug-drug interactions in the elderly: a study of over 600,000 elderly patients from the Swedish Prescribed Drug Register. Drug Saf. 2007;30(10):911-8. doi: 10.2165/00002018-200730100-00009.
- Background: PubMed 34836823Syrowatka A, Song W, Amato MG, Foer D, Edrees H, Co Z, Kuznetsova M, Dulgarian S, Seger DL, Simona A, Bain PA, Purcell Jackson G, Rhee K, Bates DW. Key use cases for artificial intelligence to reduce the frequency of adverse drug events: a scoping review. Lancet Digit Health. 2022 Feb;4(2):e137-e148. doi: 10.1016/S2589-7500(21)00229-6. Epub 2021 Nov 23.
- Individual participant dataSharing planned: No
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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.
Sigal Shafran, Dr. principal investigator
Hadassah Medical Organization
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 Polypharmacy Patients, run by MDI Health at 1 site in Israel.
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 5 inclusion and 7 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 23 Oct 2023. 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 Israel. 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?
Primary Outcome Measure: Noninferiority of agreement for combined categories (time frame: 90 days). 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 NCT05589870, 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 23 Oct 2023.