PolypharmacySIMDANCT03901820
Evaluation of a Drug Interactions Software to Limit Polypharmacy
A study testing Medication Interaction System of Dr App (SIMDA) in people with Polypharmacy and Elderly, run by University of Buenos Aires at 1 site in Argentina.
Trial summary
Multiple morbidity is increasing, especially in elderly people, with a corresponding increase in polypharmacy and inappropriate prescriptions. According to different evaluations, between 25 and 75% of patients aged 75 or older are exposed to 5 or more drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypharmacy, Elderly, Inpatient
- What is being tested?
- Medication Interaction System of Dr App (SIMDA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,053 participants
- Where
- 1 siteArgentina
- Study dates
- 26 Mar 2019to 30 Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients interned in the medical clinic room of the Hospital de Clínicas José de San Martín
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital de Clínicas José de San Martín
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1121
About this study
Official title: Evaluation of a Drug Interactions Software to Limit Polypharmacy (Evaluación de un Programa de Interacciones Medicamentosas Para Limitar la Polifarmacia)
Multiple morbidity is increasing, especially in elderly people, with a corresponding increase in polypharmacy and inappropriate prescriptions. According to different evaluations, between 25 and 75% of patients aged 75 or older are exposed to 5 or more drugs. There is increasing evidence that polypharmacy can cause more harm than good, especially in elderly people, due to factors such as drug-drug and drug-disease interactions.
Many strategies were proposed to reduce polypharmacy and inappropriate prescribing, but there is little evidence to show benefit. There is an urgent need to implement effective strategies. The application methodology must be simple so that it does not fail in daily practice.
Read more
For the current plan, an electronic medical record, named "DrApp", will be used, which will include a drug interaction program, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient.
The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA program with the 4 months after the incorporation of the program. Between both stages a period of 2 weeks will be established in which the data will not be recorded. The minimum number of patients that will be included in each stage is 100.
The primary end point is to compare the total number of indications per inpatient, before the availability of the SIMDA program and after the application of this program.
The objective is to evaluate if the computer program of detection of drug interactions allows to limit the polypharmacy in hospitalized patients.
Read the detailed description
Multiple morbidity is increasing, especially in elderly people, with a corresponding increase in polypharmacy and inappropriate prescriptions. According to different evaluations, between 25 and 75% of patients aged 75 or older are exposed to 5 or more drugs. There is increasing evidence that polypharmacy can cause more harm than good, especially in elderly people, due to factors such as drug-drug and drug-disease interactions.
Many strategies were proposed to reduce polypharmacy and inappropriate prescribing, but there is little evidence to show benefit. There is an urgent need to implement effective strategies. The application methodology must be simple so that it does not fail in daily practice.
For the current plan, an electronic medical record, named "DrApp", will be used, which will include a drug interaction program, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient.
The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA program with the 4 months after the incorporation of the program. Between both stages a period of 2 weeks will be established in which the data will not be recorded. The minimum number of patients that will be included in each stage is 100.
The primary end point is to compare the total number of indications per inpatient, before the availability of the SIMDA program and after the application of this program.
The objective is to evaluate if the computer program of detection of drug interactions allows to limit the polypharmacy in hospitalized patients.
- Conditions
- Polypharmacy, Elderly, Inpatient, Drug Interaction
- Being tested
- Medication Interaction System of Dr App (SIMDA)
- Keywords
- Electronic Record, Drug interaction, Polypharmacy, Elderly, Adverse Drug reaction
- 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.
Medication Interaction System of Dr App (SIMDA)Device
Also called SIMDA
A module for the electronic clinical records allowing detection of the potential drug interactions
| Study group | Role | What they receive |
|---|---|---|
| DrApp Without SIMDA | No intervention | There are approximately 100 inpatients in whom the indications were registered through the use of DrApp, before the implementation of the drug interactions detection module. |
| DrApp With SIMDA | Experimental | There are approximately 100 inpatients in whom the indications were registered through the use of DrApp, AFTER the implementation of the drug interactions detection module (SIMDA). Receives: Device: Medication Interaction System of Dr App (SIMDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of polypharmacy cases detected in two internal medicine hospitalization units of a University Hospital
Through the electronic medical record called DrApp, the quantity of medicines prescribed to each patient is quantified and used for calculation of polypharmacy prevalence in tha basal period (pre-introduction of SIMDA) and late period (Post introduction of SIMDA).
Measured: 1 year
Secondary outcomes (3)
SIMDA associated change in the number of total prescribed drug per patient
Change in total prescribed drug per patient will be calculated as the differene between basal total prescribed drug per patient (Pre-SIMDA) minus resulting total prescribed drug per patient (Post-SIMDA)
Measured: 1 year
Number of total drug interactions per patient and subclassification by severity (in post-SIMDA period).
The addition of the application called SIMDA, will allow detecting the presence of drug interactions and their severity in the second phase. These will be reported as the total number of interactions reported per patient, and subclassificated into number of mild (no need to take action), moderate (require patient monitoring), and severe (possible contraindication) interactions detected per patient.
Measured: 1 year
difference between Number of total drug interactions per patient in the local environment with those reported in the literature at the international level
The difference will be calculated as the number of total drug interactions per patient minus the value (number of drug interaction per patient) reported in the bibliography at international level in similar populations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start26 Mar 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An electronic medical record, DrApp, will be used, which will include a drug interaction program, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient. The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA program with the 4 months after the incorporation of the program. Between both stages a period of 2 weeks will be established in which the data will not be recorded. The minimum number of patients that will be included in each stage is 100.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Alberto Keller, University of Buenos Aires
- Investigators
- Ricardo Barcia, MD, Principal investigator, Universidad de Buenos Aires, Hospital de Clínicas José de San MartínFrancisco Azzato, MD PhD, Study director, Universidad de Buenos Aires, Hospital de Clínicas José de San MartínRoberto A Diez, MD PhD, Study director, Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de MedicamentosGuillermo A Keller, MD PhD, Principal investigator, Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901820
- Sponsor's protocol ID
- RB-001
- Acronym
- SIMDA
- Status last verified
- May 2022
- First submitted
- 27 Mar 2019
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is an intention to publish all the results obtained and share them with other researchers.
Publications
Sonnichsen A, Trampisch US, Rieckert A, Piccoliori G, Vogele A, Flamm M, Johansson T, Esmail A, Reeves D, Loffler C, Hock J, Klaassen-Mielke R, Trampisch HJ, Kunnamo I. Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial. Trials. 2016 Jan 29;17:57. doi: 10.1186/s13063-016-1177-8.
PubMed 26822311Rieckert A, Sommerauer C, Krumeich A, Sonnichsen A. Reduction of inappropriate medication in older populations by electronic decision support (the PRIMA-eDS study): a qualitative study of practical implementation in primary care. BMC Fam Pract. 2018 Jul 9;19(1):110. doi: 10.1186/s12875-018-0789-3.
PubMed 29986668Clyne B, Bradley MC, Hughes CM, Clear D, McDonnell R, Williams D, Fahey T, Smith SM; OPTI-SCRIPT study team. Addressing potentially inappropriate prescribing in older patients: development and pilot study of an intervention in primary care (the OPTI-SCRIPT study). BMC Health Serv Res. 2013 Aug 14;13:307. doi: 10.1186/1472-6963-13-307.
PubMed 23941110Clyne B, Cooper JA, Hughes CM, Fahey T, Smith SM; OPTI-SCRIPT study team. A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study). Trials. 2016 Aug 3;17(1):386. doi: 10.1186/s13063-016-1513-z.
PubMed 27488272Bril F, Castro V, Centurion IG, Espinosa J, Keller GA, Gonzalez CD, Riera MC, Saubidet CL, Di Girolamo G, Pujol GS, Alvarez PA. A Systematic Approach to Assess the Burden of Drug Interactions in Adult Kidney Transplant Patients. Curr Drug Saf. 2016;11(2):156-63. doi: 10.2174/157488631102160429003742.
PubMed 27194037Alvarez PA, Bril F, Castro V, Meiville I, Gonzalez CD, Centurion IG, Parejas G, Riera CS, Saubidet CL, Di Girolamo G, Keller GA. Adverse drug reactions as a reason for admission to an internal medicine ward in Argentina. Int J Risk Saf Med. 2013;25(3):185-92. doi: 10.3233/JRS-130596.
PubMed 24047689Barcia RE, Keller GA, Azzato F, Diez RA, Sielecki M, Kleine RS, Lescano JA, Giunti G. Development and Implementation of the Hdc.DrApp.la and SIMDA Programs to Reduce Polypharmacy and Drug-drug Interactions in Patients Hospitalized in Internal Medicine. Rev Recent Clin Trials. 2023;18(2):156-166. doi: 10.2174/1574887118666230208124744.
PubMed 36752290
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Drug Interactions Software to Limit Polypharmacy (Evaluación de un Programa de Interacciones Medicamentosas Para Limitar la Polifarmacia)
- ClinicalTrials.gov ID
- NCT03901820
- Acronym / sponsor ID
- SIMDA / RB-001
- Conditions
- Polypharmacy, Elderly, Inpatient, Drug Interaction
- Keywords
- Electronic Record, Drug interaction, Polypharmacy, Elderly, Adverse Drug reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- University of Buenos AiresUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 3 Apr 2019 (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.
Multiple morbidity is increasing, especially in elderly people, with a corresponding increase in polypharmacy and inappropriate prescriptions. According to different evaluations, between 25 and 75% of patients aged 75 or older are exposed to 5 or more drugs. There is increasing evidence that polypharmacy can cause more harm than good, especially in elderly people, due to factors such as drug-drug and drug-disease interactions.
Many strategies were proposed to reduce polypharmacy and inappropriate prescribing, but there is little evidence to show benefit. There is an urgent need to implement effective strategies. The application methodology must be simple so that it does not fail in daily practice.
For the current plan, an electronic medical record, named "DrApp", will be used, which will include a drug interaction program, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient.
The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA program with the 4 months after the incorporation of the program. Between both stages a period of 2 weeks will be established in which the data will not be recorded. The minimum number of patients that will be included in each stage is 100.
The primary end point is to compare the total number of indications per inpatient, before the availability of the SIMDA program and after the application of this program.
The objective is to evaluate if the computer program of detection of drug interactions allows to limit the polypharmacy in hospitalized patients.
Detailed description
Multiple morbidity is increasing, especially in elderly people, with a corresponding increase in polypharmacy and inappropriate prescriptions. According to different evaluations, between 25 and 75% of patients aged 75 or older are exposed to 5 or more drugs. There is increasing evidence that polypharmacy can cause more harm than good, especially in elderly people, due to factors such as drug-drug and drug-disease interactions.
Many strategies were proposed to reduce polypharmacy and inappropriate prescribing, but there is little evidence to show benefit. There is an urgent need to implement effective strategies. The application methodology must be simple so that it does not fail in daily practice.
For the current plan, an electronic medical record, named "DrApp", will be used, which will include a drug interaction program, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient.
The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA program with the 4 months after the incorporation of the program. Between both stages a period of 2 weeks will be established in which the data will not be recorded. The minimum number of patients that will be included in each stage is 100.
The primary end point is to compare the total number of indications per inpatient, before the availability of the SIMDA program and after the application of this program.
The objective is to evaluate if the computer program of detection of drug interactions allows to limit the polypharmacy in hospitalized patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- An electronic medical record, DrApp, will be used, which will include a drug interaction program, SIMDA, which will automatically indicate the medication prescriptions that involve a risk for the patient. The first indication of each patient admitted to two rooms of the Internal Medicine Department of the Hospital de Clínicas José de San Martín will be registered. The indications will be compared in the 4 months prior to the incorporation of the SIMDA program with the 4 months after the incorporation of the program. Between both stages a period of 2 weeks will be established in which the data will not be recorded. The minimum number of patients that will be included in each stage is 100.
| Arm | Type | Receives |
|---|---|---|
| DrApp Without SIMDA | No intervention | –There are approximately 100 inpatients in whom the indications were registered through the use of DrApp, before the implementation of the drug interactions detection module. |
| DrApp With SIMDA | Experimental | Device: Medication Interaction System of Dr App (SIMDA)There are approximately 100 inpatients in whom the indications were registered through the use of DrApp, AFTER the implementation of the drug interactions detection module (SIMDA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients interned in the medical clinic room of the Hospital de Clínicas José de San Martín
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Medication Interaction System of Dr App (SIMDA)Also: SIMDAA module for the electronic clinical records allowing detection of the potential drug interactions | Device | DrApp With SIMDA |
Primary outcome
Prevalence of polypharmacy cases detected in two internal medicine hospitalization units of a University Hospital
Time frame: 1 year
Through the electronic medical record called DrApp, the quantity of medicines prescribed to each patient is quantified and used for calculation of polypharmacy prevalence in tha basal period (pre-introduction of SIMDA) and late period (Post introduction of SIMDA).
3 secondary outcomes
SIMDA associated change in the number of total prescribed drug per patient
Time frame: 1 year
Number of total drug interactions per patient and subclassification by severity (in post-SIMDA period).
Time frame: 1 year
difference between Number of total drug interactions per patient in the local environment with those reported in the literature at the international level
Time frame: 1 year
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 20 May 2022.
- Background: PubMed 26822311Sonnichsen A, Trampisch US, Rieckert A, Piccoliori G, Vogele A, Flamm M, Johansson T, Esmail A, Reeves D, Loffler C, Hock J, Klaassen-Mielke R, Trampisch HJ, Kunnamo I. Polypharmacy in chronic diseases-Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial. Trials. 2016 Jan 29;17:57. doi: 10.1186/s13063-016-1177-8.
- Background: PubMed 29986668Rieckert A, Sommerauer C, Krumeich A, Sonnichsen A. Reduction of inappropriate medication in older populations by electronic decision support (the PRIMA-eDS study): a qualitative study of practical implementation in primary care. BMC Fam Pract. 2018 Jul 9;19(1):110. doi: 10.1186/s12875-018-0789-3.
- Background: PubMed 23941110Clyne B, Bradley MC, Hughes CM, Clear D, McDonnell R, Williams D, Fahey T, Smith SM; OPTI-SCRIPT study team. Addressing potentially inappropriate prescribing in older patients: development and pilot study of an intervention in primary care (the OPTI-SCRIPT study). BMC Health Serv Res. 2013 Aug 14;13:307. doi: 10.1186/1472-6963-13-307.
- Background: PubMed 27488272Clyne B, Cooper JA, Hughes CM, Fahey T, Smith SM; OPTI-SCRIPT study team. A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study). Trials. 2016 Aug 3;17(1):386. doi: 10.1186/s13063-016-1513-z.
- Background: PubMed 27194037Bril F, Castro V, Centurion IG, Espinosa J, Keller GA, Gonzalez CD, Riera MC, Saubidet CL, Di Girolamo G, Pujol GS, Alvarez PA. A Systematic Approach to Assess the Burden of Drug Interactions in Adult Kidney Transplant Patients. Curr Drug Saf. 2016;11(2):156-63. doi: 10.2174/157488631102160429003742.
- Background: PubMed 24047689Alvarez PA, Bril F, Castro V, Meiville I, Gonzalez CD, Centurion IG, Parejas G, Riera CS, Saubidet CL, Di Girolamo G, Keller GA. Adverse drug reactions as a reason for admission to an internal medicine ward in Argentina. Int J Risk Saf Med. 2013;25(3):185-92. doi: 10.3233/JRS-130596.
- Derived from this study: PubMed 36752290Barcia RE, Keller GA, Azzato F, Diez RA, Sielecki M, Kleine RS, Lescano JA, Giunti G. Development and Implementation of the Hdc.DrApp.la and SIMDA Programs to Reduce Polypharmacy and Drug-drug Interactions in Patients Hospitalized in Internal Medicine. Rev Recent Clin Trials. 2023;18(2):156-166. doi: 10.2174/1574887118666230208124744.
- Individual participant dataSharing planned: Yes. There is an intention to publish all the results obtained and share them with other researchers.
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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.
Ricardo Barcia, MD principal investigator
Universidad de Buenos Aires, Hospital de Clínicas José de San Martín
Francisco Azzato, MD PhD study director
Universidad de Buenos Aires, Hospital de Clínicas José de San Martín
Roberto A Diez, MD PhD study director
Universidad de Buenos Aires, Facultad de Medicina, Centro de Vigilancia y Seguridad de Medicamentos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Interaction System of Dr App (SIMDA) in people with Polypharmacy and Elderly, run by University of Buenos Aires at 1 site in Argentina.
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 0 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 20 May 2022. 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 Argentina. 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?
Prevalence of polypharmacy cases detected in two internal medicine hospitalization units of a University Hospital (time frame: 1 year). 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 NCT03901820, which also lists 7 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 20 May 2022.