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

January 17, 2019 updated by: Denis O'Mahony, University College Cork

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1537

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Munster
      • Cork, Munster, Ireland, 2
        • University College Cork

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 14 of hospital stay or discharge, which ever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Collaborators

University of East Anglia
Hospital Universitario Ramon y Cajal
University Ghent
NHS Grampian
Landspitali University Hospital
Istituto Nazionale di Ricovero e Cura per Anziani
Clininfo S.A.
ARTTIC International Management Services
Clanwilliam Health

Investigators

  • 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 Ramon 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2014

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRF-C-12-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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