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

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.

Conditions

• Adverse Drug Reactions

Interventions

OTHER

SENATOR software generated pharmacotherapy advice report.

Sponsors & Collaborators

• Clanwilliam Health

  collaborator UNKNOWN

• University of East Anglia

  collaborator OTHER

• ARTTIC International Management Services

  collaborator UNKNOWN

• Clininfo S.A.

  collaborator INDUSTRY

• NHS Grampian

  collaborator OTHER_GOV

• University Ghent

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Istituto Nazionale di Ricovero e Cura per Anziani

  collaborator OTHER

• Landspitali University Hospital

  collaborator OTHER

• University College Cork

  lead OTHER

Principal Investigators

• Joesph Eustace, MD FRCPI · University College Cork, Ireland

• Antonio Cherubini, MD PhD · IRCCS-INRCA Ancona, Italy

• Adalsteinn Gudmundsson, MD PhD · Landspitali University Hospital, Iceland

• Alfonso Cruz-Jentoft, MD · Hospital Universitario Ramōn y Cajal Madrid

• Roy Soiza, MD FRCP · NHS Grampian, Aberdeen, Scotland

• Mirko Petrovic, MD PhD · Ghent University Hospital, Ghent, Belgium

• Denis O'Mahony, MD FRCPI · University College Cork, Ireland

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-09

Primary Completion

2018-02-28

Completion

2018-06-30

Countries

• Ireland

Study Locations