Clinical Trial of a New Software ENgine for the Assessment & Optimization of Drug and Non-drug Therapy in Older peRsons (SENATOR)
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|ClinicalTrials.gov Identifier: NCT02097654|
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : January 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Reactions||Other: SENATOR software generated pharmacotherapy advice report.||Not Applicable|
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
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1537 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Block randomized parallel arm trial.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||For outcome data, details were extracted from patients' case records to determine if trigger list adverse clinical events had occurred following randomization. These trigger list events represented the great majority of adverse drug reactions (ADRs) and were independently adjudicated by a blinded end-point committee comprised of the co-PI's, such that no co-PI adjudicated potential ADRs at his own site.|
|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|
|Actual Study Start Date :||July 9, 2014|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||June 30, 2018|
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.
Other: SENATOR software generated pharmacotherapy advice report.
No Intervention: Control
Standard pharmaceutical care as per local practice.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097654
|University College Cork|
|Cork, Munster, Ireland, 2|
|Study Director:||Joesph Eustace, MD FRCPI||University College Cork, Ireland|
|Principal Investigator:||Antonio Cherubini, MD PhD||IRCCS‐INRCA Ancona, Italy|
|Principal Investigator:||Adalsteinn Gudmundsson, MD PhD||Landspitali University Hospital, Iceland|
|Principal Investigator:||Alfonso Cruz-Jentoft, MD||Hospital Universitario Ramōn y Cajal Madrid|
|Principal Investigator:||Roy Soiza, MD FRCP||NHS Grampian, Aberdeen, Scotland|
|Principal Investigator:||Mirko Petrovic, MD PhD||Ghent University Hospital, Ghent, Belgium|
|Study Chair:||Denis O'Mahony, MD FRCPI||University College Cork, Ireland|