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

NCT ID: NCT03748862

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-03-31

Brief Summary

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

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.

Conditions

Opiate Replacement Therapy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cases

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.

Taper Plan

Intervention Type: OTHER

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).

Controls

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.

Taper Plan

Intervention Type: OTHER

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).

Interventions

Taper Plan

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Sullivan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

David S Carrell, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States

Countries

United States

References

Von Korff M, Dublin S, Walker RL, Parchman M, Shortreed SM, Hansen RN, Saunders K. The Impact of Opioid Risk Reduction Initiatives on High-Dose Opioid Prescribing for Patients on Chronic Opioid Therapy. J Pain. 2016 Jan;17(1):101-10. doi: 10.1016/j.jpain.2015.10.002. Epub 2015 Oct 22.

Reference Type: RESULT

PMID: 26476264 (View on PubMed)

Thielke SM, Turner JA, Shortreed SM, Saunders K, Leresche L, Campbell CI, Weisner CC, Korff MV. Do patient-perceived pros and cons of opioids predict sustained higher-dose use? Clin J Pain. 2014 Feb;30(2):93-101. doi: 10.1097/AJP.0b013e31828e361b.

Reference Type: RESULT

PMID: 23535150 (View on PubMed)

Von Korff M, Turner JA, Shortreed SM, Saunders K, Rosenberg D, Thielke S, LeResche L. Timeliness of Care Planning upon Initiation of Chronic Opioid Therapy for Chronic Pain. Pain Med. 2016 Mar;17(3):511-520. doi: 10.1093/pm/pnv054. Epub 2015 Dec 14.

Reference Type: RESULT

PMID: 26814284 (View on PubMed)

Hylan TR, Von Korff M, Saunders K, Masters E, Palmer RE, Carrell D, Cronkite D, Mardekian J, Gross D. Automated prediction of risk for problem opioid use in a primary care setting. J Pain. 2015 Apr;16(4):380-7. doi: 10.1016/j.jpain.2015.01.011. Epub 2015 Jan 29.

Reference Type: RESULT

PMID: 25640294 (View on PubMed)

Other Identifiers

RNG003104

Identifier Type: -

Identifier Source: org_study_id