Browsing by Author "Chelminski, Paul R"

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    ItemOpen Access
    Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol.
    (Contemporary clinical trials, 2023-12) Edlund, Mark J; Thomas, Sonia M; Wagner, Laura K; Thompson, Jessica E; Wu, Li-Tzy; Dolor, Rowena J; Chelminski, Paul R; Ives, Timothy J; Archer, Kristin R; Dewey, Charlene M; Sullivan, Mark D; McCormack, Lauren A; INSPIRE Study Team

    Background

    This paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain.

    Methods

    Participants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months.

    Conclusion

    This trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain.

    Clinical trial registration number

    NCT03454555.

    Clinical trials registration

    ClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019.
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    Development and validation of an electronic health records-based opioid use disorder algorithm by expert clinical adjudication among patients with prescribed opioids.
    (Pharmacoepidemiology and drug safety, 2023-05) Ranapurwala, Shabbar I; Alam, Ishrat Z; Pence, Brian W; Carey, Timothy S; Christensen, Sean; Clark, Marshall; Chelminski, Paul R; Wu, Li-Tzy; Greenblatt, Lawrence H; Korte, Jeffrey E; Wolfson, Mark; Douglas, Heather E; Bowlby, Lynn A; Capata, Michael; Marshall, Stephen W

    Background

    In the US, over 200 lives are lost from opioid overdoses each day. Accurate and prompt diagnosis of opioid use disorders (OUD) may help prevent overdose deaths. However, international classification of disease (ICD) codes for OUD are known to underestimate prevalence, and their specificity and sensitivity are unknown. We developed and validated algorithms to identify OUD in electronic health records (EHR) and examined the validity of OUD ICD codes.

    Methods

    Through four iterations, we developed EHR-based OUD identification algorithms among patients who were prescribed opioids from 2014 to 2017. The algorithms and OUD ICD codes were validated against 169 independent "gold standard" EHR chart reviews conducted by an expert adjudication panel across four healthcare systems. After using 2014-2020 EHR for validating iteration 1, the experts were advised to use 2014-2017 EHR thereafter.

    Results

    Of the 169 EHR charts, 81 (48%) were reviewed by more than one expert and exhibited 85% expert agreement. The experts identified 54 OUD cases. The experts endorsed all 11 OUD criteria from the Diagnostic and Statistical Manual of Mental Disorders-5, including craving (72%), tolerance (65%), withdrawal (56%), and recurrent use in physically hazardous conditions (50%). The OUD ICD codes had 10% sensitivity and 99% specificity, underscoring large underestimation. In comparison our algorithm identified OUD with 23% sensitivity and 98% specificity.

    Conclusions and relevance

    This is the first study to estimate the validity of OUD ICD codes and develop validated EHR-based OUD identification algorithms. This work will inform future research on early intervention and prevention of OUD.
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    Implementation of mandatory opioid prescribing limits in North Carolina: healthcare administrator and prescriber perspectives.
    (BMC health services research, 2021-11-03) Blackburn, Natalie A; Joniak-Grant, Elizabeth; Nocera, Maryalice; Dorris, Samantha Wooten; Dasgupta, Nabarun; Chelminski, Paul R; Carey, Timothy S; Wu, Li-Tzy; Edwards, David A; Marshall, Stephen W; Ranapurwala, Shabbar I

    Background

    Recent increases in state laws to reduce opioid prescribing have demonstrated a need to understand how they are interpreted and implemented in healthcare systems. The purpose of this study was to explore the systems, strategies, and resources that hospital administrators and prescribers used to implement the 2017 North Carolina Strengthen Opioid Prevention (STOP) Act opioid prescribing limits, which limited initial prescriptions to a five (for acute) or seven (for post-surgical) days' supply.

    Methods

    We interviewed 14 hospital administrators and 38 prescribers with degrees in medicine, nursing, pharmacy, business administration and public health working across North Carolina. Interview guides, informed by the Consolidated Framework for Implementation Research, explored barriers and facilitators to implementation. Interview topics included communication, resources, and hospital system support. Interviews were recorded and transcribed, then analyzed using flexible coding, integrating inductive and deductive coding, to inform analytic code development and identify themes.

    Results

    We identified three main themes around implementation of STOP act mandated prescribing limits: organizational communication, prescriber education, and changes in the electronic medical record (EMR) systems. Administrators reflected on implementation in the context of raising awareness and providing reminders to facilitate changes in prescriber behavior, operationalized through email and in-person communications as well as dedicated resources to EMR changes. Prescribers noted administrative communications about prescribing limits often focused on legality, suggesting a directive of the organization's policy rather than a passive reminder. Prescribers expressed a desire for more spaces to have their questions answered and resources for patient communications. While hospital administrators viewed compliance with the law as a priority, prescribers reflected on concerns for adequately managing their patients' pain and limited time for clinical care.

    Conclusions

    Hospital administrators and prescribers approached implementation of the STOP act prescribing limits with different mindsets. While administrators were focused on policy compliance, prescribers were focused on their patients' needs. Strategies to implement the mandate then had to balance patient needs with policy compliance. As states continue to legislate to prevent opioid overdose deaths, understanding how laws are implemented by healthcare systems and prescribers will improve their effectiveness through tailoring and maximizing available resources.