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

Amanda H Lavan, Denis O'Mahony, Paul Gallagher, Richard Fordham, Evelyn Flanagan, Darren Dahly, Stephen Byrne, Mirko Petrovic, Adalsteinn Gudmundsson, Ólafur Samuelsson, Antonio Cherubini, Alfonso J. Cruz-Jentoft, Roy L. Soiza, Joseph A Eustace (Corresponding Author)

Research output: Contribution to journalArticle

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Abstract

Background
The aim of this trial is to evaluate the effect of SENATOR software on incident, adverse drug reactions (ADRs) in older, multimorbid, hospitalized patients. The SENATOR software produces a report designed to optimize older patients’ current prescriptions by applying the published STOPP and START criteria, highlighting drug-drug and drug-disease interactions and providing non-pharmacological recommendations aimed at reducing the risk of incident delirium.

Methods
We will conduct a multinational, pragmatic, parallel arm Prospective Randomized Open-label, Blinded Endpoint (PROBE) controlled trial. Patients with acute illnesses are screened for recruitment within 48 h of arrival to hospital and enrolled if they meet the relevant entry criteria. Participants’ medical history, current prescriptions, select laboratory tests, electrocardiogram, cognitive status and functional status are collected and entered into a dedicated trial database. Patients are individually randomized with equal allocation ratio. Randomization is stratified by site and medical versus surgical admission, and uses random block sizes. Patients randomized to either arm receive standard routine pharmaceutical clinical care as it exists in each site. Additionally, in the intervention arm an individualized SENATOR-generated medication advice report based on the participant’s clinical and medication data is placed in their medical record and a senior medical staff member is requested to review it and adopt any of its recommendations that they judge appropriate. The trial’s primary outcome is the proportion of patients experiencing at least one adjudicated probable or certain, non-trivial ADR, during the index hospitalization, assessed at 14 days post-randomization or at index hospital discharge if it occurs earlier. Potential ADRs are identified retrospectively by the site researchers who complete a Potential Endpoint Form (one per type of event) that is adjudicated by a blinded, expert committee. All occurrences of 12 pre-specified events, which represent the majority of ADRs, are reported to the committee along with other suspected ADRs. Participants are followed up 12 (+/− 4) weeks post-index hospital discharge to assess medication quality and healthcare utilization.

This is the first clinical trial to examine the effectiveness of a software intervention on incident ADRs and associated healthcare costs during hospitalization in older people with multi-morbidity and polypharmacy.
Original languageEnglish
Article number40
JournalBMC Geriatrics
Volume19
DOIs
Publication statusPublished - 13 Feb 2019

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Clinical Protocols
Drug-Related Side Effects and Adverse Reactions
Software
Pharmaceutical Preparations
Random Allocation
Prescriptions
Hospitalization
Therapeutics
Polypharmacy
Pharmaceutical Services
Delirium
Quality of Health Care
Medical Staff
Drug Interactions
Health Care Costs
Medical Records
Electrocardiography
Research Personnel
Clinical Trials
Databases

Keywords

  • adverse drug reactions
  • randomized controlled trial
  • older adults
  • hospitalization
  • computer software
  • intervention study
  • medication alert systems
  • polypharmacy
  • multimorbidity
  • Medication alert systems
  • Computer software
  • Hospitalization
  • Adverse drug reactions
  • Older adults
  • Randomized controlled trial
  • Multimorbidity
  • Intervention study
  • Polypharmacy
  • PREVENTION
  • INPATIENTS
  • RISK
  • ALERT
  • RIGHT TREATMENT CRITERIA
  • SCREENING TOOL

ASJC Scopus subject areas

  • Geriatrics and Gerontology

Cite this

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. / Lavan, Amanda H; O'Mahony, Denis; Gallagher, Paul; Fordham, Richard; Flanagan, Evelyn; Dahly, Darren; Byrne, Stephen; Petrovic, Mirko ; Gudmundsson, Adalsteinn ; Samuelsson, Ólafur; Cherubini, Antonio; Cruz-Jentoft, Alfonso J. ; Soiza, Roy L.; Eustace, Joseph A (Corresponding Author).

In: BMC Geriatrics, Vol. 19, 40, 13.02.2019.

Research output: Contribution to journalArticle

Lavan, AH, O'Mahony, D, Gallagher, P, Fordham, R, Flanagan, E, Dahly, D, Byrne, S, Petrovic, M, Gudmundsson, A, Samuelsson, Ó, Cherubini, A, Cruz-Jentoft, AJ, Soiza, RL & Eustace, JA 2019, '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 Geriatrics, vol. 19, 40. https://doi.org/10.1186/s12877-019-1047-9
Lavan, Amanda H ; O'Mahony, Denis ; Gallagher, Paul ; Fordham, Richard ; Flanagan, Evelyn ; Dahly, Darren ; Byrne, Stephen ; Petrovic, Mirko ; Gudmundsson, Adalsteinn ; Samuelsson, Ólafur ; Cherubini, Antonio ; Cruz-Jentoft, Alfonso J. ; Soiza, Roy L. ; Eustace, Joseph A. / 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. In: BMC Geriatrics. 2019 ; Vol. 19.
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abstract = "BackgroundThe aim of this trial is to evaluate the effect of SENATOR software on incident, adverse drug reactions (ADRs) in older, multimorbid, hospitalized patients. The SENATOR software produces a report designed to optimize older patients’ current prescriptions by applying the published STOPP and START criteria, highlighting drug-drug and drug-disease interactions and providing non-pharmacological recommendations aimed at reducing the risk of incident delirium.MethodsWe will conduct a multinational, pragmatic, parallel arm Prospective Randomized Open-label, Blinded Endpoint (PROBE) controlled trial. Patients with acute illnesses are screened for recruitment within 48 h of arrival to hospital and enrolled if they meet the relevant entry criteria. Participants’ medical history, current prescriptions, select laboratory tests, electrocardiogram, cognitive status and functional status are collected and entered into a dedicated trial database. Patients are individually randomized with equal allocation ratio. Randomization is stratified by site and medical versus surgical admission, and uses random block sizes. Patients randomized to either arm receive standard routine pharmaceutical clinical care as it exists in each site. Additionally, in the intervention arm an individualized SENATOR-generated medication advice report based on the participant’s clinical and medication data is placed in their medical record and a senior medical staff member is requested to review it and adopt any of its recommendations that they judge appropriate. The trial’s primary outcome is the proportion of patients experiencing at least one adjudicated probable or certain, non-trivial ADR, during the index hospitalization, assessed at 14 days post-randomization or at index hospital discharge if it occurs earlier. Potential ADRs are identified retrospectively by the site researchers who complete a Potential Endpoint Form (one per type of event) that is adjudicated by a blinded, expert committee. All occurrences of 12 pre-specified events, which represent the majority of ADRs, are reported to the committee along with other suspected ADRs. Participants are followed up 12 (+/− 4) weeks post-index hospital discharge to assess medication quality and healthcare utilization.This is the first clinical trial to examine the effectiveness of a software intervention on incident ADRs and associated healthcare costs during hospitalization in older people with multi-morbidity and polypharmacy.",
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note = "This work is sponsored by University College Cork, Cork Ireland and funded by the European Commission’s Seventh Framework Programme Grant Agreement no. Health-F2–2012-305930. Neither the funder nor the sponsor had no direct role in the design, conduct or reporting of this trial. The datasets used and/or analyses during the current study are available from the corresponding author on reasonable request as circumstances allow.",
year = "2019",
month = "2",
day = "13",
doi = "10.1186/s12877-019-1047-9",
language = "English",
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journal = "BMC Geriatrics",
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TY - JOUR

T1 - 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

T2 - Trial Protocol

AU - Lavan, Amanda H

AU - O'Mahony, Denis

AU - Gallagher, Paul

AU - Fordham, Richard

AU - Flanagan, Evelyn

AU - Dahly, Darren

AU - Byrne, Stephen

AU - Petrovic, Mirko

AU - Gudmundsson, Adalsteinn

AU - Samuelsson, Ólafur

AU - Cherubini, Antonio

AU - Cruz-Jentoft, Alfonso J.

AU - Soiza, Roy L.

AU - Eustace, Joseph A

N1 - This work is sponsored by University College Cork, Cork Ireland and funded by the European Commission’s Seventh Framework Programme Grant Agreement no. Health-F2–2012-305930. Neither the funder nor the sponsor had no direct role in the design, conduct or reporting of this trial. The datasets used and/or analyses during the current study are available from the corresponding author on reasonable request as circumstances allow.

PY - 2019/2/13

Y1 - 2019/2/13

N2 - BackgroundThe aim of this trial is to evaluate the effect of SENATOR software on incident, adverse drug reactions (ADRs) in older, multimorbid, hospitalized patients. The SENATOR software produces a report designed to optimize older patients’ current prescriptions by applying the published STOPP and START criteria, highlighting drug-drug and drug-disease interactions and providing non-pharmacological recommendations aimed at reducing the risk of incident delirium.MethodsWe will conduct a multinational, pragmatic, parallel arm Prospective Randomized Open-label, Blinded Endpoint (PROBE) controlled trial. Patients with acute illnesses are screened for recruitment within 48 h of arrival to hospital and enrolled if they meet the relevant entry criteria. Participants’ medical history, current prescriptions, select laboratory tests, electrocardiogram, cognitive status and functional status are collected and entered into a dedicated trial database. Patients are individually randomized with equal allocation ratio. Randomization is stratified by site and medical versus surgical admission, and uses random block sizes. Patients randomized to either arm receive standard routine pharmaceutical clinical care as it exists in each site. Additionally, in the intervention arm an individualized SENATOR-generated medication advice report based on the participant’s clinical and medication data is placed in their medical record and a senior medical staff member is requested to review it and adopt any of its recommendations that they judge appropriate. The trial’s primary outcome is the proportion of patients experiencing at least one adjudicated probable or certain, non-trivial ADR, during the index hospitalization, assessed at 14 days post-randomization or at index hospital discharge if it occurs earlier. Potential ADRs are identified retrospectively by the site researchers who complete a Potential Endpoint Form (one per type of event) that is adjudicated by a blinded, expert committee. All occurrences of 12 pre-specified events, which represent the majority of ADRs, are reported to the committee along with other suspected ADRs. Participants are followed up 12 (+/− 4) weeks post-index hospital discharge to assess medication quality and healthcare utilization.This is the first clinical trial to examine the effectiveness of a software intervention on incident ADRs and associated healthcare costs during hospitalization in older people with multi-morbidity and polypharmacy.

AB - BackgroundThe aim of this trial is to evaluate the effect of SENATOR software on incident, adverse drug reactions (ADRs) in older, multimorbid, hospitalized patients. The SENATOR software produces a report designed to optimize older patients’ current prescriptions by applying the published STOPP and START criteria, highlighting drug-drug and drug-disease interactions and providing non-pharmacological recommendations aimed at reducing the risk of incident delirium.MethodsWe will conduct a multinational, pragmatic, parallel arm Prospective Randomized Open-label, Blinded Endpoint (PROBE) controlled trial. Patients with acute illnesses are screened for recruitment within 48 h of arrival to hospital and enrolled if they meet the relevant entry criteria. Participants’ medical history, current prescriptions, select laboratory tests, electrocardiogram, cognitive status and functional status are collected and entered into a dedicated trial database. Patients are individually randomized with equal allocation ratio. Randomization is stratified by site and medical versus surgical admission, and uses random block sizes. Patients randomized to either arm receive standard routine pharmaceutical clinical care as it exists in each site. Additionally, in the intervention arm an individualized SENATOR-generated medication advice report based on the participant’s clinical and medication data is placed in their medical record and a senior medical staff member is requested to review it and adopt any of its recommendations that they judge appropriate. The trial’s primary outcome is the proportion of patients experiencing at least one adjudicated probable or certain, non-trivial ADR, during the index hospitalization, assessed at 14 days post-randomization or at index hospital discharge if it occurs earlier. Potential ADRs are identified retrospectively by the site researchers who complete a Potential Endpoint Form (one per type of event) that is adjudicated by a blinded, expert committee. All occurrences of 12 pre-specified events, which represent the majority of ADRs, are reported to the committee along with other suspected ADRs. Participants are followed up 12 (+/− 4) weeks post-index hospital discharge to assess medication quality and healthcare utilization.This is the first clinical trial to examine the effectiveness of a software intervention on incident ADRs and associated healthcare costs during hospitalization in older people with multi-morbidity and polypharmacy.

KW - adverse drug reactions

KW - randomized controlled trial

KW - older adults

KW - hospitalization

KW - computer software

KW - intervention study

KW - medication alert systems

KW - polypharmacy

KW - multimorbidity

KW - Medication alert systems

KW - Computer software

KW - Hospitalization

KW - Adverse drug reactions

KW - Older adults

KW - Randomized controlled trial

KW - Multimorbidity

KW - Intervention study

KW - Polypharmacy

KW - PREVENTION

KW - INPATIENTS

KW - RISK

KW - ALERT

KW - RIGHT TREATMENT CRITERIA

KW - SCREENING TOOL

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UR - http://www.mendeley.com/research/effect-senator-software-engine-assessment-optimisation-drug-nondrug-therapy-older-persons-incident-a-1

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