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Clinical Trial of a New Software ENgine for the Assessment & Optimization of Drug and Non-drug Therapy in Older peRsons (SENATOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02097654
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : January 22, 2019
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
Information provided by (Responsible Party):
Denis O'Mahony, University College Cork

Brief 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.

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

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:

  1. New onset falls
  2. New onset unsteady gait
  3. Acute kidney injury
  4. Symptomatic orthostatic hypotension
  5. Serum electrolyte disturbance
  6. Symptomatic bradycardia
  7. New onset major constipation
  8. Acute bleeding
  9. Acute dyspepsia/nausea/vomiting
  10. Acute diarrhea
  11. Delirium
  12. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1537 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: SENATOR
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.

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Provision of informed consent by the patient or legal guardian/next‐of‐kin
  2. Age ≥ 65 years
  3. Arrival to hospital within previous 72 hours
  4. Admitted as a general medical or surgical on call patient
  5. Anticipated in‐hospital stay of > 48 hours,
  6. ≥ 3 active (requiring current medication) chronic medical disorders

Exclusion Criteria:

  1. Admitted under:

    • Geriatric Medicine
    • Clinical Pharmacology
    • Palliative Medicine
    • Clinical Oncology
    • Hematology
  2. Intention of primary team at the time of subject admission to seek a Geriatric Medicine, Clinical Pharmacology or Palliative Medicine in‐patient consultation
  3. Life expectancy in the opinion of the admitting clinician of < 3 months
  4. Admission directly to an intensive care unit,
  5. Admission with primary acute psychiatric illness (excluding delirium)
  6. Admission with non‐accidental overdose/self‐harm
  7. Anticipated immediate transfer to alternative non‐participating clinical service/hospital
  8. Clinical diagnosis of acute Liver failure
  9. estimated Glomerular Filtration Rate <10 ml/min per 1.73 m2
  10. Solid organ transplant recipients
  11. Patients with malignancy receiving systemic chemotherapy
  12. Hospitalized for elective procedure
  13. 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
  14. Patients who are actively participating in another clinical trial

Information from the National Library of Medicine

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 identifier (NCT number): NCT02097654

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University College Cork
Cork, Munster, Ireland, 2
Sponsors and Collaborators
University College Cork
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
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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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Denis O'Mahony, Professor, Department of Medicine, University College Cork Identifier: NCT02097654    
Other Study ID Numbers: CRF-C-12-05
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Keywords provided by Denis O'Mahony, University College Cork:
Hospital acquired
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders