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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

(2019) BMC Geriatrics. 19(1).
Author
Organization
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 postrandomization 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
Keywords
Adverse drug reactions, Randomized controlled trial, Older adults, Hospitalization, Computer software, Intervention study, Medication alert systems, Polypharmacy, Multimorbidity

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Chicago
Lavan, Amanda H., Denis O’Mahony, Paul Gallagher, Richard Fordham, Evelyn Flanagan, Darren Dahly, Stephen Byrne, et al. 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 19 (1).
APA
Lavan, A. H., O’Mahony, D., Gallagher, P., Fordham, R., Flanagan, E., Dahly, D., Byrne, S., et al. (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, 19(1).
Vancouver
1.
Lavan AH, O’Mahony D, Gallagher P, Fordham R, Flanagan E, Dahly D, et al. 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. Springer Nature; 2019;19(1).
MLA
Lavan, Amanda H. et al. “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 19.1 (2019): n. pag. Print.
@article{8601361,
  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{\textquoteright} 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{\textquoteright} 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{\textquoteright}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{\textquoteright}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 postrandomization
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 (+/\ensuremath{-} 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},
  author       = {Lavan, Amanda H. and O{\textquoteright}Mahony, Denis and Gallagher, Paul and Fordham, Richard and Flanagan, Evelyn and Dahly, Darren and Byrne, Stephen and Petrovic, Mirko and Gudmundsson, Adalsteinn and Samuelsson, Olafur and Cherubini, Antonio and J. Cruz-Jentoft, Alfonso and Soiza, Roy L. and Eustace, Joseph A.},
  issn         = {1471-2318},
  journal      = {BMC Geriatrics},
  number       = {1},
  publisher    = {Springer Nature},
  title        = {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},
  url          = {http://dx.doi.org/10.1186/s12877-019-1047-9},
  volume       = {19},
  year         = {2019},
}

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