The Effect of Primary Care Opioid Taper Plans on Sustained Opioid Taper

Study Overview
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Brief Summary
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The objective of this study is to examine the effects of opioid taper plans as documented in the electronic medical record for Kaiser Permanente Washington (KPWA) patients. The study will compare different types of opioid tapering plans and will report on their effectiveness in producing sustained taper or discontinuation of long-term opioid therapy for chronic non-cancer pain while maintaining adequate pain control. The study population is KPWA patients receiving long-term opioid therapy from 2010 to 2017.

Detailed Description
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Opioid taper is now encouraged by many health care organizations, but it is unclear if explicit plans for opioid taper by primary care providers are effective at promoting tapering or discontinuation, and if they are effective, which components account for their effectiveness. Patients receiving long-term opioid therapy (LtOT), who are candidates for tapering, often perceive a low risk of overdose and a high risk of increased pain with opioid tapering. They fear opioid withdrawal and lack of effectiveness of non-opioid therapies. For patients with opioid tapering experience, support from family and a trusted health care provider eased opioid tapering. Many patients report improved quality of life following taper. Little data exists on the optimal opioid taper strategy, including: use of long or short-acting opioids, frequency of clinic visits, use of adjunctive medications and the role of psychological support. Recent initiatives to reduce high-dose opioid use at Kaiser Permanente Washington offer an opportunity to study the effect of opioid taper plans and their components in an integrated care system with an electronic health record including all health encounters and pharmacy dispensing. This study will report the proportion of LtOT patients who successfully taper compared to a similar group of LtOT patients who don't achieve tapering or discontinuation of tapering. We will also evaluate whether taper plans, defined by the patient's primary care provider, increase the likelihood of successfully tapering comparing the two groups cited above.

Official Title
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The Effect of Primary Care Opioid Taper Plans and Their Components on Sustained Opioid Taper and Opioid Discontinuation

Conditions
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Opiate Replacement Therapy

Intervention / Treatment
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* Other: Taper Plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A cohort of patients enrolled in Kaiser Permanente Washington who were receiving high dose, long-term opioid therapy (LtOT) for treatment of chronic non-cancer pain during 2010-2017. High dose LtOT defined above. Patients must be age >18 years as of cohort entry and enrolled for at least 18 months during the study period. Exclusion Criteria: Patients under 18 years old Patients with any cancer diagnosis, hospice, nursing home care, methadone maintenance, buprenorphine for opioid use disorder, cognitive impairment, spinal cord stimulator, or intrathecal opioids.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients who were receiving high-dose, long-term opioid therapy at study entry and achieved a sustained taper during the follow-up period. A Taper Plan is a plan to reduce or discontinue use of opioids discussed with the primary care provider. Evidence of a taper plan is found in the prescription notes or medical encounter notes in the electronic health record. | Other: Taper Plan<br>* Occurrence of a taper plan defined by a primary care provider during the follow-up period. Evidence of a taper plan will be obtained by searching prescriptions (SIGs) and medical encounter notes using natural language processing (NLP).<br>|
| Controls<br>Patients who were receiving high-dose, long-term opioid therapy at study entry and didn't achieve a sustained taper during the follow-up period. | Other: Taper Plan<br>* Occurrence of a taper plan defined by a primary care provider during the follow-up period. Evidence of a taper plan will be obtained by searching prescriptions (SIGs) and medical encounter notes using natural language processing (NLP).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of patients with high-dose opioid therapy | First, the study will describe the proportion and characteristics of patients on long-term, high-dose opioid therapy (LtOT) for chronic non-cancer pain who: a) initiate a taper attempt, b) successfully taper, or c) discontinue opioids. Demographic and clinical characteristics of patients who successfully taper will be compared to characteristics of patients who do not. We consider a successful taper to have occurred when a patient's average quarterly morphine milligram equivalents (MME) dose (calculated as the rolling average of the current and previous quarter's mean quarterly MME) falls below a specified threshold for two consecutive quarters after study entry. Each quarter of a sustained taper must meet one of the following two criteria and can be a combination of the two: Low dose of ≤30 MME (considered a safe dose) At least a 50% reduction in MME from the near peak dose | This study takes place from 2010 to 2017. | 
| Taper Plan Assessment | The study will assess whether the presence of EHR-documented opioid taper plans is associated with successful taper, and if so, determine which components of taper plans are associated with the greatest likelihood of success. | This study takes place from 2010 to 2017. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioids, Chronic Pain, Opioid Therapy, Opioid Taper