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Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial.

ABSTRACT: INTRODUCTION:As opioid analgesic consumption has grown, so have opioid use disorder and opioid-related overdoses. Reducing the quantity of opioid analgesics prescribed for acute non-cancer pain can potentially reduce risks to the individual receiving the prescription and to others who might unintentionally or intentionally consume any leftover tablets. Reducing the default dispense quantity for new opioid analgesic prescriptions in the electronic health record (EHR) is a promising intervention to reduce prescribing. METHODS AND ANALYSIS:This study is a prospective cluster randomised controlled trial with two parallel arms. Primary care sites (n=32) and emergency departments (n=4) will be randomised in matched pairs to either a modification of the EHR so that new opioid analgesic prescriptions default to a dispense quantity of 10 tablets (intervention) or to no EHR change (control). The dispense quantity will remain fully modifiable by providers in both arms. From 6 months preintervention to 18 months postintervention, patient-level data will be analysed (ie, the patient is the unit of inference). Patient eligibility criteria are: (A) received a new opioid analgesic prescription, defined as no other opioid analgesic prescription in the prior 6 months; (B) age ?18 years; and (C) no cancer diagnosis within 1?year prior to the new opioid analgesic prescription. The primary outcome will be the quantity of opioid analgesics prescribed in the initial prescription. Secondary outcomes will include opioid analgesic reorders and health service utilisation within 30 days after the initial prescription. Outcomes will be compared between study arms using a difference-in-differences analysis. ETHICS AND DISSEMINATION:This study has been approved by the Montefiore Medical Center/Albert Einstein College of Medicine Institutional Review Board with a waiver of informed consent (2016-6036) and is registered on ClinicalTrials.gov (NCT03003832, 6 December 2016). Findings will be disseminated through publication, conferences and meetings with health system leaders. TRIAL REGISTRATION NUMBER:NCT03003832; Pre-results.

SUBMITTER: Bachhuber MA

PROVIDER: S-EPMC5914704 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial.

Bachhuber Marcus A MA Nash Denis D Southern William N WN Heo Moonseong M Berger Matthew M Schepis Mark M Cunningham Chinazo O CO

BMJ open 20180420 4

<h4>Introduction</h4>As opioid analgesic consumption has grown, so have opioid use disorder and opioid-related overdoses. Reducing the quantity of opioid analgesics prescribed for acute non-cancer pain can potentially reduce risks to the individual receiving the prescription and to others who might unintentionally or intentionally consume any leftover tablets. Reducing the default dispense quantity for new opioid analgesic prescriptions in the electronic health record (EHR) is a promising interv ...[more]

PMID: 29678969

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Project description:ImportanceInterventions to improve judicious prescribing of opioid analgesics for acute pain are needed owing to the risks of diversion, misuse, and overdose.ObjectiveTo assess the effect of modifying opioid analgesic prescribing defaults in the electronic health record (EHR) on prescribing and health service use.Design, setting, and participantsA cluster randomized clinical trial with 2 parallel arms was conducted between June 13, 2016, and June 13, 2018, in a large urban health care system comprising 32 primary care and 4 emergency department (ED) sites in the Bronx, New York. Data were analyzed using a difference-in-differences method from 6 months before implementation through 18 months after implementation. Data were analyzed from January 2019 to February 2020.InterventionsA default dispense quantity for new opioid analgesic prescriptions of 10 tablets (intervention) vs no change (control) in the EHR.Main outcomes and measuresThe primary outcome was the quantity of opioid analgesics prescribed with the new default prescription. Secondary outcomes were opioid analgesic reorders and health service use within 30 days after the new prescription. Intention-to-treat analysis was conducted.ResultsOverall, 21 331 patients received a new opioid analgesic prescription from 490 prescribers. Comparing the intervention and control arms, site, prescriber, and patient characteristics were similar. For the new prescription, compared with the control arm, patients in the intervention arm had significantly more prescriptions for 10 tablets or fewer (7.6 percentage points; 95% CI, 6.1-9.2 percentage points), a lower number of tablets prescribed (-2.1 tablets; 95% CI, -3.3 to -0.9 tablets), and lower morphine milligram equivalents (MME) prescribed (-14.6 MME; 95% CI, -22.6 to -6.6 MME). Within 30 days after the new prescription, significant differences remained in the number of tablets prescribed (-2.7 tablets; 95% CI, -4.8 to -0.6 tablets), but not MME (-15.8 MME; 95% CI, -33.8 to 2.2 MME). Within this 30-day period, there were no significant differences between the arms in health service use.Conclusions and relevanceIn this study, implementation of a uniform reduced default dispense quantity of 10 tablets for opioid analgesic prescriptions led to a modest reduction in the quantity prescribed initially, without significantly increasing health service use. However, during 30 days after implementation, the influence on prescribing was mixed. Reducing EHR default dispense quantities for opioid analgesics is a feasible strategy that can be widely disseminated and may modestly reduce prescribing.Trial registrationClinicalTrials.gov Identifier: NCT03003832.

Project description:INTRODUCTION:A model of general practitioner (GP) and pharmacist collaboration in primary care may be an effective strategy to reduce medication-related problems and provide better support to patients after discharge. The aim of this study is to investigate whether a model of structured pharmacist and GP care reduces hospital readmissions in high-risk patients. METHODS AND ANALYSIS:This protocol details a stepped-wedge, cluster-randomised trial that will recruit participants over 9 months with a 12-month follow-up. There will be 14 clusters each representing a different general practice medical centre. A total of 2240 participants will be recruited from hospital who attend an enrolled medical centre, take five or more long-term medicines or whose reason for admission was related to heart failure or chronic obstructive pulmonary disease.The intervention is a multifaceted service, involving a pharmacist integrated into a medical centre to assist patients after hospitalisation. Participants will meet with the practice pharmacist and their GP after discharge to review and reconcile their medicines and discuss changes made in hospital. The pharmacist will follow-up with the participant and liaise with other health professionals involved in the participant's care. The control will be usual care, which usually involves a patient self-organising a visit to their GP after hospital discharge.The primary outcome is the rate of unplanned, all-cause hospital readmissions over 12 months, which will be analysed using a mixed effects Poisson regression model with a random effect for cluster and a fixed effect to account for any temporal trend. A cost analysis will be undertaken to compare the healthcare costs associated with the intervention to those of usual care. ETHICS AND DISSEMINATION:The study has received ethical approval (HREC/16/QRBW/410). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders. TRIAL REGISTRATION NUMBER:ACTRN12616001627448.

Project description:BACKGROUND:Urinary tract infection (UTI) is the most common reason for antibiotic prescription in nursing homes. Overprescription causes antibiotic-related harms in those who are treated and others residing within the nursing home. The diagnostic process in nursing homes is complicated with both challenging issues related to the elderly population and the nursing home setting. A physician rarely visits a nursing home for suspected UTI. Consequently, the knowledge of UTI and communication skills of staff influence the diagnosis. OBJECTIVE:The objective of this study is to describe a cluster randomized controlled trial with a tailored complex intervention for improving the knowledge of UTI and communication skills of nursing home staff in order to decrease the number of antibiotic prescriptions for UTI in nursing home residents, without changing hospitalization and mortality. METHODS:The study describes an open-label cluster randomized controlled trial with two parallel groups and a 1:1 allocation ratio. Twenty-two eligible nursing homes are sampled from the Capital Region of Denmark, corresponding to 1274 nursing home residents. The intervention group receives a dialogue tool, and all nursing home staff attend a workshop on UTI. The main outcomes of the study are the antibiotic prescription rate for UTI, all-cause hospitalization, all-cause mortality, and suspected UTI during the trial period. RESULTS:The trial ended in April 2019. Data have been collected and are being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in the fall of 2020. CONCLUSIONS:The greatest strengths of this study are the randomized design, tailored development of the intervention, and access to medical records. The potential limitations are the hierarchy in the prescription process, Hawthorne effect, and biased access to data on signs and symptoms through a UTI diary. The results of this trial could offer a strategy to overcome some of the challenges of increased antibiotic resistance and could have implications in terms of how to handle cases of suspected UTI. TRIAL REGISTRATION:ClinicalTrials.gov NCT03715062; https://clinicaltrials.gov/ct2/show/NCT03715062. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17710.

Project description:ImportancePrescription opioid misuse is a public health problem that leads to overdose. Although existing interventions focus on limiting prescribing to patients at high risk, individuals may still access prescription opioids dispensed to family members.ObjectiveTo determine whether opioid prescriptions to family members were associated with overdose for individuals who themselves did not have an opioid prescription.Design, setting, and participantsWe conducted a 1:4 matched case-control study using health care utilization data from 2004 through 2015 from a large US commercial insurance company. Eligible individuals were required to have at least 12 months of continuous enrollment and 1 or more family members in the database. Individuals who experienced overdose were identified by their first opioid overdose after the baseline period and matched to control participants by time in the database, calendar time, age, sex, and number of individuals in the family unit. Both groups were restricted to individuals with no prior opioid dispensing of their own. Data analysis was conducted from January 2018 to August 2018.ExposuresAny prior opioid dispensing to a family member, total morphine milligram equivalents dispensed to family members, and the type of opioid product dispensed.Main outcomes and measuresIndividual odds of opioid overdose resulting in an emergency department visit or hospitalization were the primary end point. The primary analysis evaluated the odds of overdose among individuals whose family members had been dispensed an opioid. Sensitivity analyses examined the odds stratified by age and timing relative to the dispensing of opioids to family members.ResultsA total of 2303 individuals who experienced opioid overdose and 9212 matched control individuals were identified. The mean (SD) age was 23.2 (18.1) years; 1158 affected individuals and 4632 control individuals (50.3%) were female. The mean (SD) time in the database before an overdose case was 3.2 (3.3) years. Prior opioid dispensing to family members was associated with individual overdose (odds ratio [OR], 2.89 [95% CI, 2.59-3.23]). There was a significant dose-response association between increasing amounts of opioids dispensed to family members and odds of overdose (>0-<50 morphine milligram equivalents per day: OR, 2.71 [95% CI, 2.42-3.03]; 50-<90 morphine milligram equivalents per day: OR, 7.80 [95% CI, 3.63-16.78]; ≥90 morphine milligram equivalents per day: OR, 15.08 [95% CI, 8.66-26.27]).Conclusions and relevanceIn this analysis, opioid prescriptions to family members were associated with overdose among individuals who do not receive opioid prescriptions. Interventions may focus on expanding access to opioid antagonists, locking prescription opioids in the home, and providing greater patient education to limit fatal overdose among family members.

Project description:BackgroundNew Zealand has relatively high rates of morbidity and mortality from infectious disease compared with other OECD countries, with infectious disease being more prevalent in children compared with others in the population. Consequences of infectious disease in children may have significant economic and social impact beyond the direct effects of the disease on the health of the child; including absence from school, transmission of infectious disease to other pupils, staff, and family members, and time off work for parents/guardians. Reduction of the transmission of infectious disease between children at schools could be an effective way of reducing the community incidence of infectious disease. Alcohol based no-rinse hand sanitisers provide an alternative hand cleaning technology, for which there is some evidence that they may be effective in achieving this. However, very few studies have investigated the effectiveness of hand sanitisers, and importantly, the potential wider economic implications of this intervention have not been established.AimsThe primary objective of this trial is to establish if the provision of hand sanitisers in primary schools in the South Island of New Zealand, in addition to an education session on hand hygiene, reduces the incidence rate of absence episodes due to illness in children. In addition, the trial will establish the cost-effectiveness and conduct a cost-benefit analysis of the intervention in this setting.Methods/designA cluster randomised controlled trial will be undertaken to establish the effectiveness and cost-effectiveness of hand sanitisers. Sixty-eight primary schools will be recruited from three regions in the South Island of New Zealand. The schools will be randomised, within region, to receive hand sanitisers and an education session on hand hygiene, or an education session on hand hygiene alone. Fifty pupils from each school in years 1 to 6 (generally aged from 5 to 11 years) will be randomly selected for detailed follow-up about their illness absences, providing a total of 3400 pupils. In addition, absence information will be collected on all children from the school rolls. Investigators not involved in the running of the trial, outcome assessors, and the statistician will be blinded to the group allocation until the analysis is completed.Trial registrationACTRN12609000478213.

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Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial.

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Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial.

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