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This article discusses a cluster-randomized clinical trial that aims to determine if a multicomponent intervention, Transforming Opioid Prescribing in Primary Care (TOPCARE), improves guideline adherence and reduces opioid misuse risk in primary care settings. The study found that the intervention increased guideline-concordant care, opioid discontinuation, and dose reduction in patients receiving long-term opioid therapy.
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Journal Club Alcohol, Other Drugs, and Health: Current Evidence November-December, 2017
Featured Article Improving adherence to long-term opioid therapy guidelines to reduce opioid misuse in primary care: a cluster-randomized clinical trial Liebschutz JM, et al. JAMA Intern Med. 2017;177(9):1265–1272.
Study Objectives • “To determine whether a multicomponent intervention, Transforming Opioid Prescribing in Primary Care (TOPCARE; http://mytopcare.org/), improves guideline adherence while decreasing opioid misuse risk.” www.aodhealth.org
Study Design • Cluster-randomized clinical trial among 53 primary care clinicians (PCCs) and their 985 patients (across 4 safety-net primary care practices) receiving long-term opioid therapy for pain. • Intervention arm included for providers: electronic registry, academic detailing, nurse care management, electronic decision tools. • Control arm included electronic decision tools only. www.aodhealth.org
Assessing Validity of an Article about Therapy • Are the results valid? • What are the results? • How can I apply the results to patient care? www.aodhealth.org
Are the Results Valid? • Were participants randomized? • Was randomization concealed? • Were participants analyzed in the groups to which they were randomized? • Were participants in the intervention and control groups similar? www.aodhealth.org
Are the Results Valid?(cont‘d) • Were participants aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete? www.aodhealth.org
Were participants randomized? • Yes. • Cluster randomization was performed at the provider level. www.aodhealth.org
Was randomization concealed? • Yes. www.aodhealth.org
Were participants analyzed in the groups to which they were randomized? • Yes. www.aodhealth.org
Were the participants in the intervention and control groups similar? • Yes. • There were no differences between groups of providers in terms of demographics or practice characteristics. • Demographic characteristics of the intervention and control patients were similar at baseline. www.aodhealth.org
Were participants aware of group allocation? • Yes, providers were aware of group assignment, but not the study hypothesis. • Patients in the intervention group only knew that there was a new nurse care manager or change in medication refill process. Patients in the control group were not aware of group allocation. www.aodhealth.org
Were outcome assessors aware of group allocation? • No. www.aodhealth.org
Was follow-up complete? • Yes. www.aodhealth.org
What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www.aodhealth.org
How large and precise was the treatment effect? • Patients in the intervention group (n=586) were more likely than controls (n=399) to receive guideline-concordant care (adjusted odds ratio [aOR], 6.0), but no less likely than controls to have ≥2 early refills (aOR, 1.1). • Intervention group patients were more likely than controls to have opioid discontinuation (aOR, 1.5) or opioid dose reduction (aOR, 1.6). www.aodhealth.org 16
How Can I Apply the Results to Patient Care? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs? www.aodhealth.org
Were all clinically important outcomes considered? • Mostly, although the authors comment that “fearful prescribing” may have contributed to the increase in opioid discontinuation among patients in the intervention group. www.aodhealth.org
Are the likely treatment benefits worth the potential harm and costs? • Probably. This trial demonstrates that a primary care-based multicomponent intervention can increase guideline-concordant opioid therapy, opioid discontinuation, and dose reduction. • Further research will be required to determine whether similar interventions decrease opioid-related adverse outcomes while maintaining patient pain control and function. www.aodhealth.org