NCT03748862|Completed
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Sponsor study identifier
observational
2,500
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
October 30, 2018
Actual (reported)Study Completion
March 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)October 30, 2018
Actual (reported)November 19, 2018
Actual (reported)November 21, 2018
Actual (reported)March 31, 2019
Actual (reported)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: 1. Low dose of ≤30 MME (considered a "safe" dose) 2. 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.
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.
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.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
To be eligible for this study a patient must be receiving long-term opioid therapy (LtOT) as follows: 1) must be Kaiser Permanente Washington (KPWA) patient, 2) must receive opioid therapy consisting of at least a 60-day supply and a mean daily dose of at least 50 milligrams morphine equivalent (MME) per calendar quarter for two consecutive calendar quarters between Jan 2011 and Dec 2015, 3) must not die, have a gap in health plan enrollment or pharmacy benefits during the two calendar quarters in which they qualified for study entry, 4) must have no cancer diagnoses during the study period (2010-2017), and 5) must have at least two quarters of follow-up after study entry. A sub-analysis will focus on LtOT patients with a mean daily dose of at least 90 MME instead of 50 MME.
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101, United States
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.
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.
Mark Sullivan, MD, PhD
University of Washington
David S Carrell, PhD
Kaiser Permanente
2,500 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2018
First Posted
November 21, 2018
Study Start
January 1, 2018
Actual (reported)Automated Prize-based Contingency Management to Increase Counseling Attendance in Opiate-Replacement-Therapy Patients
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
October 30, 2018
Actual (reported)Study Completion
March 31, 2019
Actual (reported)Last Updated
August 21, 2019
Record last verified: 2019-08
No IPD will be shared with other researchers or institutions.
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Source: ClinicalTrials.gov.
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