Adverse Drug ReactionsSENATORNCT02097654
Clinical Trial of a New Software ENgine for the Assessment & Optimization of Drug and Non-drug Therapy in Older peRsons
A study testing SENATOR software generated pharmacotherapy advice report. in people with Adverse Drug Reactions, run by University College Cork at 1 site in Ireland.
Trial summary
Primary Objective: To quantify the benefits of the SENATOR decision support software on the reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the effect of SENATOR with regard to use of appropriate non-pharmacological therapies in subjects with one core geriatric syndrome. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Adverse Drug Reactions
- What is being tested?
- SENATOR software generated pharmacotherapy advice report.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,537 participants
- Where
- 1 siteIreland
- Study dates
- 9 Jul 2014to 30 Jun 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Provision of informed consent by the patient or legal guardian/next-of-kin
- Age ≥ 65 years
- Arrival to hospital within previous 72 hours
- Admitted as a general medical or surgical on call patient
- Anticipated in-hospital stay of > 48 hours,
- ≥ 3 active (requiring current medication) chronic medical disorders
Who cannot join
- Admitted under:
- Geriatric Medicine
- Clinical Pharmacology
- Palliative Medicine
- Clinical Oncology
- Hematology
Show all 19Show fewer
- Intention of primary team at the time of subject admission to seek a Geriatric Medicine, Clinical Pharmacology or Palliative Medicine in-patient consultation
- Life expectancy in the opinion of the admitting clinician of < 3 months
- Admission directly to an intensive care unit,
- Admission with primary acute psychiatric illness (excluding delirium)
- Admission with non-accidental overdose/self-harm
- Anticipated immediate transfer to alternative non-participating clinical service/hospital
- Clinical diagnosis of acute Liver failure
- estimated Glomerular Filtration Rate <10 ml/min per 1.73 m2
- Solid organ transplant recipients
- Patients with malignancy receiving systemic chemotherapy
- Hospitalized for elective procedure
- Patient was more than 24 hours in the Emergency Department under the care of a different team to that which finally is in charge of them
- Patients who are actively participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multinational, Randomized, Open Label Parallel Arm Trial With Blinded Outcome Adjudication Quantifying the Efficacy of SENATOR in Reducing Adverse Drug Reactions in Older Hospitalized Subjects
Primary Objective: To quantify the benefits of the SENATOR decision support software on the reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the effect of SENATOR with regard to use of appropriate non-pharmacological therapies in subjects with one core geriatric syndrome.
Tertiary Objectives: to examine the association of SENATOR use with subject survival, morbidity and health related quality of life.
Read more
Health Economic Objective: To examine the potential health economic consequences of using SENATOR.
There are two study phases:
Phase I: Prospective multinational, multicentre observational study to estimate the baseline adjudicated medical and surgical ADR rates by clinical subspeciality in 6 international sites.
Phase II: Prospective multinational, multicentre, block randomized, two parallel arm, open label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR software in reducing ADRs in older hospitalized subjects.
Read the detailed description
Phase I is designed to test the electronic case report form (eCRF) and the ADR ascertainment method in the six clinical sites in advance of Phase II (randomization phase).
In Phase I, we recruited 644 older multi-morbid patients from the 6 clinical sites. After obtaining written informed consent, patients' demographic, clinical and medication details were entered to the eCRF. In the event of one a 12 item Trigger List of adverse clinical events occurring, the eCRF automatically generated a Trigger List assessment proforma. The 12 items in the Trigger List included:
- New onset falls
- New onset unsteady gait
- Acute kidney injury
- Symptomatic orthostatic hypotension
- Serum electrolyte disturbance
- Symptomatic bradycardia
- New onset major constipation
- Acute bleeding
- Acute dyspepsia/nausea/vomiting
- Acute diarrhea
- Delirium
- Symptomatic hypoglycemia
In addition, we have included 'Unspecified adverse event' in order to capture the wide range of well recognized ADRs associated with various medications. For example, the rapid onset of a generalized maculopapular rash in a patient with penicillin hypersensitivity would be identified as an ADR under the 'Unspecified adverse event' category.
ADR adjudication in Phase I was blinded and no ADR adjudications were undertaken by the site principal investigator (PI). ADRs were defined as 'definite', probable', 'possible', 'unlikely' or 'indeterminate' according to WHO-UMC ADR causality critria. ADR severity was defined according to a modified Hartwig ADR severity scale ranging from Level 1 (trivial) to Level 7 (fatal).
Consensus on ADR causality was achieved through a potential endpoint adjudication committee (PEPAC), whose members were the 6 clinical site PI's. A matrix for achieving consensus was devised, such that there was a final decision on the causality of all potential ADRs.
- Conditions
- Adverse Drug Reactions
- Being tested
- SENATOR software generated pharmacotherapy advice report.
- Keywords
- Hospital acquired, Elderly
- 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.
SENATOR software generated pharmacotherapy advice report.Other
| Study group | Role | What they receive |
|---|---|---|
| SENATOR | Experimental | Physicians attending multi-morbid older patients i.e. with 3 or more chronic medical conditions receive a SENATOR software-generated report with advice details on potentially inappropriate pharmacotherapy and/or potentially inappropriate prescribing omissions. Receives: Other: SENATOR software generated pharmacotherapy advice report. |
| Control | No intervention | Standard pharmaceutical care as per local practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR.
Subjects adjudicated by the Potential Endpoint Committee as having experienced one or more probable or certain adverse drug reactions (ADRs).
Measured: Day 14 of hospital stay or discharge, which ever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study start9 Jul 2014
- Primary completion28 Feb 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug ReactionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomized parallel arm trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Clanwilliam Health, University of East Anglia, ARTTIC International Management Services, Clininfo S.A., NHS Grampian, University Ghent, Hospital Universitario Ramon y Cajal, Istituto Nazionale di Ricovero e Cura per Anziani, Landspitali University Hospital
- Responsible party
- Principal investigator, Denis O'Mahony, University College Cork
- Investigators
- Joesph Eustace, MD FRCPI, Study director, University College Cork, IrelandAntonio Cherubini, MD PhD, Principal investigator, IRCCS-INRCA Ancona, ItalyAdalsteinn Gudmundsson, MD PhD, Principal investigator, Landspitali University Hospital, IcelandAlfonso Cruz-Jentoft, MD, Principal investigator, Hospital Universitario Ramōn y Cajal MadridRoy Soiza, MD FRCP, Principal investigator, NHS Grampian, Aberdeen, ScotlandMirko Petrovic, MD PhD, Principal investigator, Ghent University Hospital, Ghent, BelgiumDenis O'Mahony, MD FRCPI, Study chair, University College Cork, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097654
- Sponsor's protocol ID
- CRF-C-12-05
- Acronym
- SENATOR
- Status last verified
- Jan 2019
- First submitted
- 21 Mar 2014
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dalton K, Curtin D, O'Mahony D, Byrne S. Computer-generated STOPP/START recommendations for hospitalised older adults: evaluation of the relationship between clinical relevance and rate of implementation in the SENATOR trial. Age Ageing. 2020 Jul 1;49(4):615-621. doi: 10.1093/ageing/afaa062.
PubMed 32484853Lavan AH, O'Mahony D, Gallagher P, Fordham R, Flanagan E, Dahly D, Byrne S, Petrovic M, Gudmundsson A, Samuelsson O, Cherubini A, J Cruz-Jentoft A, Soiza RL, Eustace JA. The effect of SENATOR (Software ENgine for the Assessment and optimisation of drug and non-drug Therapy in Older peRsons) on incident adverse drug reactions (ADRs) in an older hospital cohort - Trial Protocol. BMC Geriatr. 2019 Feb 13;19(1):40. doi: 10.1186/s12877-019-1047-9.
PubMed 30760204
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multinational, Randomized, Open Label Parallel Arm Trial With Blinded Outcome Adjudication Quantifying the Efficacy of SENATOR in Reducing Adverse Drug Reactions in Older Hospitalized Subjects
- ClinicalTrials.gov ID
- NCT02097654
- Acronym / sponsor ID
- SENATOR / CRF-C-12-05
- Conditions
- Adverse Drug Reactions
- Keywords
- Hospital acquired, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,537 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Clanwilliam Health, University of East Anglia, ARTTIC International Management Services, Clininfo S.A., NHS Grampian, University Ghent, Hospital Universitario Ramon y Cajal, Istituto Nazionale di Ricovero e Cura per Anziani, Landspitali University Hospital
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 27 Mar 2014 (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.
Primary Objective: To quantify the benefits of the SENATOR decision support software on the reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the effect of SENATOR with regard to use of appropriate non-pharmacological therapies in subjects with one core geriatric syndrome.
Tertiary Objectives: to examine the association of SENATOR use with subject survival, morbidity and health related quality of life.
Health Economic Objective: To examine the potential health economic consequences of using SENATOR.
There are two study phases:
Phase I: Prospective multinational, multicentre observational study to estimate the baseline adjudicated medical and surgical ADR rates by clinical subspeciality in 6 international sites.
Phase II: Prospective multinational, multicentre, block randomized, two parallel arm, open label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR software in reducing ADRs in older hospitalized subjects.
Detailed description
Phase I is designed to test the electronic case report form (eCRF) and the ADR ascertainment method in the six clinical sites in advance of Phase II (randomization phase).
In Phase I, we recruited 644 older multi-morbid patients from the 6 clinical sites. After obtaining written informed consent, patients' demographic, clinical and medication details were entered to the eCRF. In the event of one a 12 item Trigger List of adverse clinical events occurring, the eCRF automatically generated a Trigger List assessment proforma. The 12 items in the Trigger List included:
- New onset falls
- New onset unsteady gait
- Acute kidney injury
- Symptomatic orthostatic hypotension
- Serum electrolyte disturbance
- Symptomatic bradycardia
- New onset major constipation
- Acute bleeding
- Acute dyspepsia/nausea/vomiting
- Acute diarrhea
- Delirium
- Symptomatic hypoglycemia
In addition, we have included 'Unspecified adverse event' in order to capture the wide range of well recognized ADRs associated with various medications. For example, the rapid onset of a generalized maculopapular rash in a patient with penicillin hypersensitivity would be identified as an ADR under the 'Unspecified adverse event' category.
ADR adjudication in Phase I was blinded and no ADR adjudications were undertaken by the site principal investigator (PI). ADRs were defined as 'definite', probable', 'possible', 'unlikely' or 'indeterminate' according to WHO-UMC ADR causality critria. ADR severity was defined according to a modified Hartwig ADR severity scale ranging from Level 1 (trivial) to Level 7 (fatal).
Consensus on ADR causality was achieved through a potential endpoint adjudication committee (PEPAC), whose members were the 6 clinical site PI's. A matrix for achieving consensus was devised, such that there was a final decision on the causality of all potential ADRs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Block randomized parallel arm trial.
| Arm | Type | Receives |
|---|---|---|
| SENATOR | Experimental | Other: SENATOR software generated pharmacotherapy advice report.Physicians attending multi-morbid older patients i.e. with 3 or more chronic medical conditions receive a SENATOR software-generated report with advice details on potentially inappropriate pharmacotherapy and/or potentially inappropriate prescribing omissions. |
| Control | No intervention | –Standard pharmaceutical care as per local practice. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Provision of informed consent by the patient or legal guardian/next-of-kin
- Age ≥ 65 years
- Arrival to hospital within previous 72 hours
- Admitted as a general medical or surgical on call patient
- Anticipated in-hospital stay of > 48 hours,
Key exclusion criteria (19 listed)
- Admitted under:
- Intention of primary team at the time of subject admission to seek a Geriatric Medicine, Clinical Pharmacology or Palliative Medicine in-patient consultation
- Life expectancy in the opinion of the admitting clinician of < 3 months
- Admission directly to an intensive care unit,
- Admission with primary acute psychiatric illness (excluding delirium)
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 |
|---|---|---|
| SENATOR software generated pharmacotherapy advice report. | Other | SENATOR |
Primary outcome
Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR.
Time frame: Day 14 of hospital stay or discharge, which ever comes first
Subjects adjudicated by the Potential Endpoint Committee as having experienced one or more probable or certain adverse drug reactions (ADRs).
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 22 Jan 2019.
- Derived from this study: PubMed 32484853Dalton K, Curtin D, O'Mahony D, Byrne S. Computer-generated STOPP/START recommendations for hospitalised older adults: evaluation of the relationship between clinical relevance and rate of implementation in the SENATOR trial. Age Ageing. 2020 Jul 1;49(4):615-621. doi: 10.1093/ageing/afaa062.
- Derived from this study: PubMed 30760204Lavan AH, O'Mahony D, Gallagher P, Fordham R, Flanagan E, Dahly D, Byrne S, Petrovic M, Gudmundsson A, Samuelsson O, Cherubini A, J Cruz-Jentoft A, Soiza RL, Eustace JA. The effect of SENATOR (Software ENgine for the Assessment and optimisation of drug and non-drug Therapy in Older peRsons) on incident adverse drug reactions (ADRs) in an older hospital cohort - Trial Protocol. BMC Geriatr. 2019 Feb 13;19(1):40. doi: 10.1186/s12877-019-1047-9.
- Development and clinical trial of a new Software ENgine for the Assessment \& Optimization of drug and non-drug Therapy in Older peRsons (SENATOR).Link provided by the sponsor.
Related trials for Adverse Drug Reactions
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
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.
Joesph Eustace, MD FRCPI study director
University College Cork, Ireland
Antonio Cherubini, MD PhD principal investigator
IRCCS-INRCA Ancona, Italy
Adalsteinn Gudmundsson, MD PhD principal investigator
Landspitali University Hospital, Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENATOR software generated pharmacotherapy advice report. in people with Adverse Drug Reactions, run by University College Cork at 1 site in Ireland.
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 6 inclusion and 19 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 22 Jan 2019. 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 Ireland. 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?
Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR. (time frame: Day 14 of hospital stay or discharge, which ever comes first). 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 NCT02097654, which also lists 2 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 22 Jan 2019.