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Evaluating the implementation and effectiveness of a multi-component intervention to reduce post-surgical opioid prescribing: study protocol of a mixed-methods design.

ABSTRACT: INTRODUCTION:Opioids prescribed after surgery accounted for 5% of the 191?million opioid prescriptions filled in 2017. Approximately 80% of the opioid pills prescribed by surgical care providers remain unused, leaving a substantial number of opioids available for non-medical use. We developed a multi-component intervention to address surgical providers' role in the overprescribing of opioids. Our study will determine effective strategies for reducing post-surgical prescribing while ensuring adequate post-surgery patient-reported pain-related outcomes, and will assess implementation of the strategies. METHODS AND ANALYSIS:The Minimising Opioid Prescribing in Surgery study will implement a multi-component intervention, in an Illinois network of six hospitals (one academical, two large community and three small community hospitals), to decrease opioid analgesics prescribed after surgery. The multi-component intervention involves four domains: (1) patient expectation setting, (2) baseline assessment of opioid use, (3) perioperative pain control optimisation and (4) post-surgical opioid minimisation. Four surgical specialities (general, orthopaedics, urology and gynaecology) at the six hospitals will implement the intervention. A mixed-methods approach will be used to assess the implementation and effectiveness of the intervention. Data from the network's enterprise data warehouse will be used to evaluate the intervention's effect on post-surgical prescriptions and a survey will collect pain-related patient-reported outcomes. Intervention effectiveness will be determined using a triangulation design, mixed-methods approach with staggered speciality-specific implementation for contemporaneous control of opioid prescribing changes over time. The Consolidated Framework for Implementation Research will be used to evaluate the site-specific contextual factors and adaptations to achieve implementation at each site. ETHICS AND DISSEMINATION:The study aims to identify the most effective hospital-type and speciality-specific intervention bundles for rapid dissemination into our 56-hospital learning collaborative and in hospitals throughout the USA. All study activities have been approved by the Northwestern University Institutional Review Board (ID STU00205053).

SUBMITTER: Stulberg JJ

PROVIDER: S-EPMC6561445 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Evaluating the implementation and effectiveness of a multi-component intervention to reduce post-surgical opioid prescribing: study protocol of a mixed-methods design.

Stulberg Jonah J JJ Schäfer Willemijn L A WLA Shallcross Meagan L ML Lambert Bruce L BL Huang Reiping R Holl Jane L JL Bilimoria Karl Y KY Johnson Julie K JK

BMJ open 20190603 6

<h4>Introduction</h4>Opioids prescribed after surgery accounted for 5% of the 191 million opioid prescriptions filled in 2017. Approximately 80% of the opioid pills prescribed by surgical care providers remain unused, leaving a substantial number of opioids available for non-medical use. We developed a multi-component intervention to address surgical providers' role in the overprescribing of opioids. Our study will determine effective strategies for reducing post-surgical prescribing while ensur ...[more]

PMID: 31164370

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Project description:ImportanceInsurers are increasingly limiting the duration of opioid prescriptions for acute pain. Among patients undergoing surgery, it is unclear whether implementation of these limits is associated with changes in opioid prescribing and patient-reported outcomes, such as pain.ObjectiveTo assess changes in surgical opioid prescribing and patient-reported outcomes after implementation of an opioid prescribing limit by a large commercial insurer in Michigan.Design, setting, and participantsThis was a cross-sectional study with an interrupted time series analysis. Data analyses were conducted from October 1, 2022, to February 28, 2023. The primary data source was the Michigan Surgical Quality Collaborative, a statewide registry containing data on opioid prescribing and patient-reported outcomes from adults undergoing common general surgical procedures. This registry is linked to Michigan's prescription drug monitoring program database, allowing observation of opioid dispensing. The study included 6045 adults who were covered by the commercial insurer and underwent surgery from January 1, 2017, to October 31, 2019.ExposurePolicy limiting opioid prescriptions to a 5-day supply in February 2018.Main outcomes and measuresAmong all patients, segmented regression models were used to assess for level or slope changes during February 2018 in 3 patient-reported outcomes: pain in the week after surgery (assessed on a scale of 1-4: 1 = none, 2 = minimal, 3 = moderate, and 4 = severe), satisfaction with surgical experience (scale of 0-10, with 10 being the highest satisfaction), and amount of regret regarding undergoing surgery (scale of 1-5, with 1 being the highest level of regret). Among patients with a discharge opioid prescription and a dispensed opioid prescription (prescription filled within 3 days of discharge), additional outcomes included total morphine milligram equivalents in these prescriptions, a standardized measure of opioid volume.ResultsAmong the 6045 patients included in the study, mean (SD) age was 48.7 (12.6) years and 3595 (59.5%) were female. Limit implementation was not associated with changes in patient-reported satisfaction or regret and was associated with only a slight level decrease in patient-reported pain score (-0.15 [95% CI, -0.26 to -0.03]). Among 4396 patients (72.7%) with a discharge and dispensed opioid prescription, limit implementation was associated with a -22.3 (95% CI, -32.8 to -11.9) and -26.1 (95% CI, -40.9 to -11.3) level decrease in monthly mean total morphine milligram equivalents of discharge and dispensed opioid prescriptions, respectively. These decreases corresponded approximately to 3 to 3.5 pills containing 5 mg of oxycodone.ConclusionsThis cross-sectional analysis of data from adults undergoing general surgical procedures found that implementation of an insurer's limit was associated with modest reductions in opioid prescribing but not with worsened patient-reported outcomes. Whether these findings generalize to other procedures warrants further study.

Project description:IntroductionSurgical patients are commonly prescribed more opioids at discharge than needed to manage their postoperative pain. These excess opioids increase the risks of new persistent opioid use, opioid-induced ventilatory impairment and opioid diversion. This study tests the effectiveness of two behavioural nudges, one based on peer behaviour and one based on best practice guidelines, in reducing excessive postoperative opioid prescriptions.Methods and analysisThe study will be conducted at 19 hospitals within a large healthcare delivery system in northern California, USA. Three surgical specialties (general surgery, orthopaedic surgery and obstetric/gynaecological surgery) at each hospital will be randomised either to a control group or to one of two active intervention arms. One intervention is grounded in the theory of injunctive norms, and provides feedback to surgeons on their postoperative opioid prescribing relative to prescribing guidelines endorsed by their institution. The other intervention draws from the theory of descriptive norms, and provides feedback similar to the first intervention but using peers' behaviour rather than guidelines as the benchmark for the surgeon's prescribing behaviour. The interventions will be delivered by a monthly email. Both interventions will be active for twelve months. The effects of each intervention relative to the control group and to each other will be tested using a four-level hierarchical model adjusted for multiple hypothesis testing.Ethics and disseminationUsing behavioural nudges rather than rigid policy changes allows us to target excessive prescribing without preventing clinicians from using their clinical judgement to address patient pain. All study activities have been approved by the RAND Human Subjects Protection Committee (ID 2018-0988). Findings will be disseminated through conference presentations, peer-reviewed publications and social media accounts.Trial registration numberNCT05070338.

Project description:ImportanceOverprescribing of opioids has generated and sustains the opioid overdose epidemic. Health systems have a responsibility to lead the effort to reduce overprescribing.ObjectiveTo measure the effects of multilevel interventions on opioid prescribing within a health system.Design, setting, and participantsQuality improvement study comparing a 6-month preintervention baseline with a 16-month postintervention period ending in April 2018. Inpatient and outpatient clinical activity within a regional health system including an acute care hospital, same-day surgery, and outpatient clinics. Opioid prescribing activity by hundreds of clinicians involving over a million clinical encounters was measured using a health system's electronic medical record.InterventionsMultiple parallel interventions in different domains, including prescriber education and accountability, enhanced oversight via measurement of individual prescribers, tools to right-size postoperative discharge prescriptions, reduction of default amounts on standard opioid prescription orders, and professionally written patient and public education about opioid risks and alternatives.Main outcomes and measuresMorphine milligram equivalents (MME) per encounter per month, MME per opioid prescription, and rate of opioid prescriptions (opioid prescriptions per encounter per month).ResultsMore than 44?000 clinical encounters per month were recorded. All baseline trends were not significantly different from 0. Total health system MME per encounter decreased 1.0 MME per encounter per month. At the end of the postintervention observation period, the monthly MME per encounter was 58% lower than the average of the 6-month baseline, the MME per opioid prescription per month was 34% less than the average of the baseline, and the opioid prescription rate was 38% lower than the average of the baseline.Conclusions and relevanceOpioid overprescribing was reduced with multifocal interventions targeting patient and public demand, creating prescriber awareness and accountability, and creating tools for clinical leadership accountability. The interventions described are adoptable by most organized health systems. Reducing total opioid supply within communities should be given high priority by those with a mission to protect and improve public health.

Project description:BackgroundThe 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting.MethodsTOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination).ResultsPCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs).ConclusionsCDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939 . Registration date: 9/13/2018.

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Evaluating the implementation and effectiveness of a multi-component intervention to reduce post-surgical opioid prescribing: study protocol of a mixed-methods design.

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Evaluating the implementation and effectiveness of a multi-component intervention to reduce post-surgical opioid prescribing: study protocol of a mixed-methods design.

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