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2019 5
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Page 1
Randomized Controlled Trial
. 2021 Mar;29(3):304-315.
doi: 10.1016/j.jagp.2020.07.004. Epub 2020 Jul 11.

Less Is More: The Impact of Deprescribing Psychotropic Drugs on Behavioral and Psychological Symptoms and Daily Functioning in Nursing Home Patients. Results From the Cluster-Randomized Controlled COSMOS Trial

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Free article
Randomized Controlled Trial

Less Is More: The Impact of Deprescribing Psychotropic Drugs on Behavioral and Psychological Symptoms and Daily Functioning in Nursing Home Patients. Results From the Cluster-Randomized Controlled COSMOS Trial

Marie H Gedde et al. Am J Geriatr Psychiatry. 2021 Mar.
Free article

Abstract

Objective: To investigate the impact of medication reviews using collegial mentoring and systematic clinical evaluation on psychotropic prescriptions, behavioral and psychological symptoms of dementia (BPSD), and activities of daily living (ADL).

Design: Four-month multicenter, multicomponent, cluster-randomized, single-blinded controlled trial.

Setting: Thirty-three Norwegian nursing homes including 67 nursing home wards (clusters).

Participants: A total of 723 enrolled patients, of which 428 participated in the study; 217 were randomized to the intervention and 211 to care as usual (control).

Intervention: The COSMOS intervention consisted of Communication, Systematic pain management, Medication reviews, Organization of activities, and Safety. During medication review, the nursing home physician evaluated treatment with colleagues systematically using the results from validated clinical assessments.

Measurements: Mean changes from baseline to month 4 in the number of prescribed psychotropic drugs (antipsychotics, anxiolytics, hypnotics or sedatives, antidepressants, and antidementia drugs); Neuropsychiatric Inventory Nursing Home Version (NPI-NH) and Cornell Scale of Depression in Dementia (CSDD); Lawton and Brody's Physical Self Maintenance Scale (PSMS).

Results: Compared to control, the mean change in prescribed psychotropic drugs was reduced both in total and regular number, while mean changes in NPI-NH and CSDD scores did not differ between the groups. Mean change in PSMS showed improvement in the intervention group, and deterioration in the control group.

Conclusion: Medication reviews using collegial mentoring and systematic clinical evaluation led to safe deprescribing, as the reductions in psychotropic drug use did not negatively affect BPSD, while ADL improved.

Trial registration: ClinicalTrials.gov NCT02238652.

Keywords: Deprescribing; activities of daily living (ADL); behavioral and psychological symptoms of dementia (BPSD); dementia; medication review; neuropsychiatric symptoms (NPS); nursing homes; psychotropic drugs.

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Randomized Controlled Trial
. 2021 Feb;38(2):157-168.
doi: 10.1007/s40266-020-00821-7. Epub 2020 Dec 23.

Pharmacist Identification of Medication Therapy Problems Involving Cognition Among Older Adults Followed by a Home-Based Care Team

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Randomized Controlled Trial

Pharmacist Identification of Medication Therapy Problems Involving Cognition Among Older Adults Followed by a Home-Based Care Team

Allison M P Levine et al. Drugs Aging. 2021 Feb.

Abstract

Background: Dementia, depression, and delirium alone or in combination (3Ds) can threaten independence among older adults, and polypharmacy may further accelerate decline. Clinical pharmacists can play an important role on multidisciplinary home-based care teams by identifying medication therapy problems (MTPs) involving cognition. Within a larger ongoing clinical trial, this paper describes cognition-related MTPs and pharmacist recommendations among older adults with 3Ds followed by a home-based care team.

Methods: We conducted a retrospective analysis of medication data among Medicare Advantage members aged ≥ 65 years living at home in Connecticut with International Statistical Classification of Diseases and Related Health Problems, 10th Revision codes related to 3Ds; analyses include the first 105 subjects randomized to the home-based care team from March 2017 to January 2019. Advanced practice registered nurses conducted in-home medication reconciliations along with medical and cognitive assessments. Clinical pharmacists then conducted medication reviews centered on agents treating or exacerbating 3Ds. After review by the study advanced practice registered nurse, geriatrician, and psychiatrist, salient recommendations were forwarded to primary care providers for consideration. Medication therapy problems related to cognition were retrospectively abstracted and classified as: (1) indication: underuse or overuse; (2) effectiveness: ineffective agent or low dose (mainly for antidepressants); and (3) safety: undesirable effect (e.g., impaired cognition, dementia treatment side effects), unsafe medication (e.g., potentially inappropriate medications that can harm cognition), drug interaction, or high dose.

Results: Pharmacists identified 166 cognitive MTPs, with a mean (standard deviation) of 1.58 (1.35) [range 0-6] MTPs per subject. Indication MTPs represented 34% of total MTPs, of which 79% involved underuse and 21% overuse; effectiveness represented 13% of total MTPs; and safety represented over half (52%) of all MTPs, with benzodiazepines and anticholinergics frequently implicated. Recommendations commonly included medication reduction (discontinuation 23% and dose reduction 19%). We found MTPs involving cognition among most (79%) patients.

Conclusions: Our study findings support the role of pharmacists on multidisciplinary teams to identify cognitively harmful medications, dementia treatment side effects, and untreated cognitive conditions.

Clinical trial registration: ClinicalTrials.gov NCT02945085.

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Randomized Controlled Trial
. 2021 Jan;22(1):173-177.
doi: 10.1016/j.jamda.2020.07.040. Epub 2020 Sep 16.

Improvements in Antibiotic Appropriateness for Cystitis in Older Nursing Home Residents: A Quality Improvement Study With Randomized Assignment

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Randomized Controlled Trial

Improvements in Antibiotic Appropriateness for Cystitis in Older Nursing Home Residents: A Quality Improvement Study With Randomized Assignment

Joseph T Hanlon et al. J Am Med Dir Assoc. 2021 Jan.

Abstract

Objective: To determine the impact of an educational quality improvement initiative on the appropriateness of antibiotic prescribing restricted to uncomplicated cystitis in older noncatheterized nursing home residents.

Design: Quality improvement study with randomized assignment.

Settings and participants: Twenty-five nursing homes in United States were randomized to the intervention or usual care group by strata that included state, urban/rural status, bed size, and geographic separation.

Methods: A 12-month trial of a low-intensity multifaceted antimicrobial stewardship intervention focused on uncomplicated cystitis in nursing home residents vs usual care. The outcome was the modified Medication Appropriateness Index as assessed by a blinded geriatric clinical pharmacist and consisted of an assessment of antibiotic effectiveness, dosage, drug-drug interactions, and duration.

Results: There were 75 cases (0.15/1000 resident days) in intervention and 92 (0.22/1000 resident days) in control groups with a probable cystitis per consensus guidelines. Compared with controls, there was a statistically nonsignificant 21% reduction in the risk of inappropriate antibiotic prescribing (nonzero Medication Appropriateness Index score rate 0.13 vs 0.21/1000 person days; adjusted incident rate ratio 0.79; 95% confidence interval 0.45‒1.38). There was a favorable comparison in inappropriateness of duration (77% vs 89% for intervention vs control groups, respectively; P = .0394). However, the intervention group had more problems with drug-drug interactions than the control group (8% vs 1%, respectively; P = .0463). Similarly, the intervention group had a nonsignificant trend toward more problems with dosage (primarily because of the lack of adjustment for decreased renal function) than the control group (32% vs 25%, respectively; P = .3170). Both groups had similar rates of problems with choice/effectiveness (44% vs 45%; P = .9417). The most common class of antibiotics prescribed inappropriately was quinolones (25% vs 23% for intervention versus control groups, respectively; P = .7057).

Conclusions and implications: A low-intensity intervention showed a trend toward improved appropriate antibiotic prescribing in nursing home residents with likely uncomplicated cystitis. Efforts to improve antibiotic prescribing in addition to the low-intensity intervention might include a consultant pharmacist in a nursing home to identify inappropriate prescribing practices.

Keywords: Aged; antibacterial-agents; cystitis; inappropriate prescribing; nursing homes; randomized controlled trial.

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Randomized Controlled Trial
. 2021 Jan;22(1):74-81.
doi: 10.1016/j.jamda.2020.07.007. Epub 2020 Sep 3.

Interprofessional Medication Assessment has Effects on the Quality of Medication Among Home Care Patients: Randomized Controlled Intervention Study

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Free article
Randomized Controlled Trial

Interprofessional Medication Assessment has Effects on the Quality of Medication Among Home Care Patients: Randomized Controlled Intervention Study

Kati J Auvinen et al. J Am Med Dir Assoc. 2021 Jan.
Free article

Abstract

Objective: Multimorbidity and complex medications increase the risk of medication-related problems, especially in vulnerable home care patients. The objective of this study was to examine whether interprofessional medication assessment has an effect on medication quality among home care patients.

Design: The FIMA (Finnish Interprofessional Medication Assessment) study was a randomized, controlled study comparing physician-led interprofessional medication assessment and usual care.

Setting and participants: The FIMA study was conducted in home care settings in Finland. The participants were ≥65-year-old home care patients with ≥6 drugs daily, dizziness, orthostatic hypotension, or a recent fall.

Methods: Primary outcome measures over the 6-month follow-up were number of drugs, drug-drug-interactions, medication-related risk loads, and use of potentially inappropriate medications (PIMs) examined by SFINX, RENBASE, PHARAO, and Meds75+ databases. The databases classified information as follows: A (no known pharmacologic or clinical basis for an increased risk), B (evidence not available/uncertain), C (moderately increased risk which may have clinical relevance), and D (high risk, best to avoid). Logistic regression adjusted for age, sex, and the baseline level of the outcome measure served as statistical methods.

Results: The mean number of all drugs for home care patients (n = 512) was 15. The odds of drug-induced impairment of renal function (RENBASE D, P = .020) and medication-related risk loads for bleeding (PHARAO D, P = .001), anticholinergic effects (PHARAO D, P = .009), and constipation (PHARAO D, P = .003) decreased significantly in the intervention group compared with usual care. The intervention also reduced the odds of using PIMs (Meds75+ D, P = .005). There were no significant changes in drug-drug-interactions or number of drugs.

Conclusions and implications: FIMA intervention improved the medication quality of home care patients. Risks for renal failure, anticholinergic effects, bleeding, constipation, and the use of PIMs were reduced significantly.

Keywords: Home care; medication therapy management; medicines; older people.

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Randomized Controlled Trial
. 2021 Jan;22(1):82-89.e3.
doi: 10.1016/j.jamda.2020.03.012. Epub 2020 May 15.

Association of Deprescribing With Reduction in Mortality and Hospitalization: A Pragmatic Stepped-Wedge Cluster-Randomized Controlled Trial

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Randomized Controlled Trial

Association of Deprescribing With Reduction in Mortality and Hospitalization: A Pragmatic Stepped-Wedge Cluster-Randomized Controlled Trial

Chong-Han Kua et al. J Am Med Dir Assoc. 2021 Jan.

Abstract

Objectives: Deprescribing has gained awareness recently, but the clinical benefits observed from randomized trials are limited. The aim of this study was to examine the effectiveness of a pharmacist-led 5-step team-care deprescribing intervention in nursing homes to reduce falls (fall risks and fall rates). Secondary aims include reducing mortality, number of hospitalized residents, pill burden, medication cost, and assessing the deprescribing acceptance rate.

Design: Pragmatic multicenter stepped-wedge cluster randomized controlled trial.

Setting and participants: Residents across 4 nursing homes in Singapore were included if they were aged 65 years and above, and taking 5 or more medications.

Methods: The intervention involved a 5-step deprescribing intervention, which involved a multidisciplinary team-care medication review with pharmacists, physicians, and nurses (in which pharmacists discussed with other team members the feasibility of deprescribing and implementation using the Beers and STOPP criteria) or to an active waitlist control for the first 3 months.

Results: Two hundred ninety-five residents from 4 nursing homes participated in the study from February 2017 to March 2018. At 6 months, the deprescribing intervention did not reduce falls. Subgroup analysis showed that intervention reduced fall risk scores within the deprescribing-naïve group by 0.18 (P = .04). Intervention was associated with a reduction in mortality [hazard ratio (HR) 0.16, 95% confidence interval 0.07, 0.41; P < .001] and number of hospitalized residents (HR 0.16, 95% CI 0.10, 0.26; P < .001). Pre-post analysis witnessed a reduction in pill burden at the end of the study, and a conservative daily cost saving estimate of US$11.42 (SG$15.65) for the study population. Approximately three-quarters of deprescribing interventions initiated by the pharmacists were accepted by the physicians.

Conclusions and implications: Multidisciplinary medication review-directed deprescribing was associated with reductions in mortality and number of hospitalized residents in nursing homes and should be considered for all nursing home residents.

Keywords: Deprescribing; falls; hospitalization; mortality; older adults; polypharmacy.

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Randomized Controlled Trial
. 2020 Dec:192:111354.
doi: 10.1016/j.mad.2020.111354. Epub 2020 Sep 15.

Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course

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Randomized Controlled Trial

Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course

Francisca Leiva-Fernández et al. Mech Ageing Dev. 2020 Dec.

Abstract

Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.

Trial registration: ClinicalTrials.gov NCT02866799.

Keywords: Educational measurement; Inappropriate prescribing; Medical education; Multimorbidity; Polypharmacy; Primary health care; Problem-based learning.

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Randomized Controlled Trial
. 2020 Dec;68(12):2768-2777.
doi: 10.1111/jgs.16751. Epub 2020 Aug 12.

Benzodiazepine Use and Deprescribing in Belgian Nursing Homes: Results from the COME-ON Study

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Randomized Controlled Trial

Benzodiazepine Use and Deprescribing in Belgian Nursing Homes: Results from the COME-ON Study

Perrine Evrard et al. J Am Geriatr Soc. 2020 Dec.

Abstract

Background/objectives: To describe the use and deprescribing of benzodiazepine receptor agonists (BZRAs) among nursing home residents (NHRs), to evaluate appropriateness of use and to identify factors associated with BZRA use and deprescribing.

Design: Posthoc analysis of the Collaborative Approach to Optimize Medication Use for Older People in Nursing Homes (COME-ON) study, a cluster controlled trial that evaluated the impact of a complex intervention on potentially inappropriate prescriptions (PIPs) in nursing homes (NHs).

Setting: A total of 54 NHs in Belgium.

Participants: A total of 797 NHRs included in the study who had complete medical, clinical, and medication information at baseline and at the end of the study (month 15).

Measurements: Data were recorded by participating healthcare professionals. Reasons why BZRA use was considered as PIPs were assessed using the 2019 American Geriatrics Society Beers Criteria® and the Screening Tool of Older Persons' Prescriptions (STOPP) criteria, version 2. Deprescribing included complete cessation or decreased daily dose. We identified factors at the NHR, prescriber, and NH levels associated with BZRA use and BZRA deprescribing using multivariable binary and multinomial logistic regression, respectively.

Results: At baseline, 418 (52.4%) NHRs were taking a BZRA. The use of BZRA for longer than 4 weeks, with two or more other central nervous system active drugs, and in patients with delirium, cognitive impairment, falls, or fractures was found in more than 67% of BZRA users. Eight NHR-related variables and two prescriber-related variables were associated with regular BZRA use. Deprescribing occurred in 28.1% of BZRA users (32.9% in the intervention group and 22.1% in the control group). In addition to four other factors, dementia (odds ratio [OR] = 2.35; 95% confidence interval [CI] = [1.45-3.83]) and intervention group (OR = 1.74; 95% CI = 1.07-2.87) were associated with deprescribing.

Conclusion: Use of BZRAs was highly prevalent, and reasons to consider it as PIP were frequent. Deprescribing occurred in one-fourth of NHRs, which is encouraging. Future interventions should focus on specific aspects of PIPs (ie, indication, duration, drug-drug and drug-disease interactions) as well as on nondementia patients.

Keywords: benzodiazepine; deprescribing; inappropriate prescribing; nursing homes; older adults.

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Randomized Controlled Trial
. 2020 Dec;28(6):626-634.
doi: 10.1111/ijpp.12656. Epub 2020 Jul 14.

Clinical and cost effectiveness of a multi-professional medication reviews in care homes (CAREMED)

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Randomized Controlled Trial

Clinical and cost effectiveness of a multi-professional medication reviews in care homes (CAREMED)

James A Desborough et al. Int J Pharm Pract. 2020 Dec.

Abstract

Objectives: With 70% of care home residents experiencing a medication error every day in the UK, better multi-professional working between medical practitioners, pharmacists and care homes was recommended. The aim of this study was to determine the effectiveness (falls reduction) and cost-effectiveness, of a multi-professional medication review (MPMR) service in care homes for older people.

Method: A total of care homes in the East of England were cluster randomised to 'usual care' or two multi-professional (General practitioner, clinical pharmacist and care homes staff) medication reviews during the 12-month trial period. Target recruitment was 900 residents with 10% assumed loss to follow-up. Co-primary outcome measures were number of falls and potentially inappropriate prescribing assessed by the Screening Tool of Older Persons Prescriptions.

Key findings: A total of 826 care home residents were recruited with 324 lost to follow-up for at least one primary outcome measure. The mean number of falls per resident per annum was 3.3 for intervention and 3.0 for control (P = 0.947). Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046). No significant difference identified in emergency hospital admissions or deaths. Estimated unadjusted incremental mean cost per resident was £374.26 higher in the intervention group.

Conclusions: In line with other medication review based interventions in care homes, two MPMRs improved medication appropriateness but failed to demonstrate improvements in clinical outcomes. From a health system perspective costs where estimated to increase overall and therefore a different model of medicines management is required.

Keywords: health services research; medication safety; nursing homes; pharmacists.

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Randomized Controlled Trial
. 2020 Oct;40(10):1042-1053.
doi: 10.1002/phar.2461.

Prescription Medication Use in Older Adults Without Major Cardiovascular Disease Enrolled in the Aspirin in Reducing Events in the Elderly (ASPREE) Clinical Trial

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Randomized Controlled Trial

Prescription Medication Use in Older Adults Without Major Cardiovascular Disease Enrolled in the Aspirin in Reducing Events in the Elderly (ASPREE) Clinical Trial

Jessica E Lockery et al. Pharmacotherapy. 2020 Oct.

Abstract

Background: Efforts to minimize medication risks among older adults include avoidance of potentially inappropriate medications. Contemporary analysis of medication use in community-dwelling older people compared with the general population is lacking.

Participants: A total of 19,114 community-dwelling adults in Australia and the United States aged 70 years or older (65 years or older for U.S. minorities) without histories of major cardiovascular disease, cognitive impairment, or disability participated in a randomized, placebo-controlled trial of aspirin: ASPirin in Reducing Events in the Elderly study. Measurements Prescribed baseline medications obtained by self-report and medical record review were grouped by World Health Organization Anatomic and Therapeutic Chemical category. Potentially inappropriate medications were defined using a modified American Geriatrics Society Beers Criteria. Polypharmacy was defined as 5 or more medications, and hyperpolypharmacy defined as 10 or more medications. Cross-sectional descriptive statistics and adjusted odds ratios were computed.

Results: The median number of prescription medications per participant was three, regardless of age. Women had a higher medication prevalence. Cardiovascular drugs (primarily antihypertensives) were the most commonly reported (64%). Overall, 39% of the cohort reported taking at least one potentially inappropriate medication, with proton-pump inhibitors being the most commonly reported (21.2% of cohort). Of the cohort, 27% had polypharmacy, and 2% hyperpolypharmacy. Age 75 years or older, less than 12 years of education, hypertension, diabetes mellitus, chronic kidney disease, frailty, gastrointestinal complaint, and depressive symptoms were associated with an increased likelihood of potentially inappropriate medications and polypharmacy. For almost all medication classes, prevalence was equivalent or lower than the general older population.

Conclusion: Overall medication burden and polypharmacy are low in older adults free of major cardiovascular disease, disability, and cognitive impairment. The prevalence of potentially inappropriate medications is higher than previously reported and similar to more vulnerable populations as a result of the introduction of proton-pump inhibitors to the American Geriatrics Society Beers Criteria. Longitudinal follow-up is required to further understand the balance of benefits and risks for potentially inappropriate medications and polypharmacy in community-dwelling older people.

Trial registration: ClinicalTrials.gov NCT01038583.

Keywords: healthy aging; pharmacoepidemiology; polypharmacy; potentially inappropriate medications.

Conflict of interest statement

Conflict of interest: The authors have declared no conflicts of interest for this article.

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Randomized Controlled Trial
. 2020 Sep;37(9):703-713.
doi: 10.1007/s40266-020-00787-6.

Factors Affecting Prescriber Implementation of Computer-Generated Medication Recommendations in the SENATOR Trial: A Qualitative Study

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Randomized Controlled Trial

Factors Affecting Prescriber Implementation of Computer-Generated Medication Recommendations in the SENATOR Trial: A Qualitative Study

Kieran Dalton et al. Drugs Aging. 2020 Sep.

Abstract

Background: The SENATOR trial intervention included the provision of computer-generated medication recommendations to physician prescribers caring for hospitalised older adults (≥ 65 years), with the aim of reducing in-hospital adverse drug reactions. Interim data analysis during the trial revealed that the prescriber implementation rates of the computer-generated STOPP/START recommendations were lower than expected across all six trial sites.

Aim: The aim of this qualitative study was to identify the factors affecting prescriber implementation of the medication recommendations in the SENATOR trial.

Methods: Semi-structured interviews were conducted with trial researchers and physician prescribers who were provided with SENATOR recommendations. Content analysis was used to identify the most relevant domains from the Theoretical Domains Framework (TDF) that affected recommendation uptake.

Results: Ten trial researchers and fourteen prescribers were interviewed across the six trial sites. Eight TDF domains were found to be most relevant in affecting prescriber implementation: 'environmental context and resources', 'goals', 'intentions', 'knowledge', 'beliefs about consequences', 'memory, attention and decision processes', 'social/professional role and identity', and 'social influences'. Interviewees felt that there was often a disconnect between the time prescribers were reviewing the patient and the point at which the recommendations were provided. However, when recommendations were reviewed, prescriber inertia was highly pervasive, with a particular reluctance to make pharmacotherapy changes outside their own specialty. Implementation was facilitated by recommendations reaching a 'decision-maker', but this was often not possible as the software could not evaluate the entire clinical context of patients, and thus frequently produced recommendations of low clinical relevance.

Conclusion: This study has demonstrated that the clinical relevance of the SENATOR prescribing recommendations was a significant factor affecting their implementation. Whilst software refinement will be necessary to improve the quality of recommendations, future interventions will need to be multifaceted to overcome the complex prescriber specialty culture within the acute hospital environment.

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26 results