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

NCT02097654 | Completed DMC

• 1 other identifier: CRF-C-12-05
• Study Type: interventional
• Target: 1,537
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Drug Reactions

Keywords

Hospital acquired; Elderly

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 14 of hospital stay or discharge, which ever comes first

Study Arms (2)

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.

Other: SENATOR software generated pharmacotherapy advice report.

Control

NO INTERVENTION

Standard pharmaceutical care as per local practice.

Interventions

SENATOR software generated pharmacotherapy advice report. OTHER

SENATOR

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Admitted under:
• Geriatric Medicine
• Clinical Pharmacology
• Palliative Medicine
• Clinical Oncology
• Hematology
• 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

Sponsors & Collaborators

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

Study Sites (1)

University College Cork

Cork, Munster, 2, Ireland

Location

Related Publications (2)

• 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.

  PMID: 32484853 DERIVED

• Lavan 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.

  PMID: 30760204 DERIVED

Related Links

• Development and clinical trial of a new Software ENgine for the Assessment \& Optimization of drug and non-drug Therapy in Older peRsons (SENATOR).

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Joesph Eustace, MD FRCPI

  University College Cork, Ireland

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• Denis O'Mahony, MD FRCPI

  University College Cork, Ireland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine

Model Details: Block randomized parallel arm trial.

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 27, 2014
• Study Start: July 9, 2014
• Primary Completion: February 28, 2018
• Study Completion: June 30, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

IE (1)