Opiate Replacement TherapyNCT03748862
The Effect of Primary Care Opioid Taper Plans on Sustained Opioid Taper
An observational study of Opiate Replacement Therapy, run by Kaiser Permanente at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Replacement Therapy
- What is being tested?
- Taper Plan
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: The Effect of Primary Care Opioid Taper Plans and Their Components on Sustained Opioid Taper and Opioid Discontinuation
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.
Read the 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
- Being tested
- Taper Plan
- Keywords
- Opioids, Chronic Pain, Opioid Therapy, Opioid Taper
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taper PlanOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Taper Plan | |
| 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. Receives: Other: Taper Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: This study takes place from 2010 to 2017.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Jan 2018
- Primary completion30 Oct 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opiate Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Mark Sullivan, MD, PhD, Principal investigator, University of WashingtonDavid S Carrell, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748862
- Sponsor's protocol ID
- RNG003104
- Status last verified
- Aug 2019
- First submitted
- 19 Nov 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers or institutions.
Publications
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.
PubMed 26476264Thielke 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.
PubMed 23535150Von 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.
PubMed 26814284Hylan 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.
PubMed 25640294
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Primary Care Opioid Taper Plans and Their Components on Sustained Opioid Taper and Opioid Discontinuation
- ClinicalTrials.gov ID
- NCT03748862
- Acronym / sponsor ID
- RNG003104
- Conditions
- Opiate Replacement Therapy
- Keywords
- Opioids, Chronic Pain, Opioid Therapy, Opioid Taper
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Taper PlanPatients 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. |
| Controls | – | Other: Taper PlanPatients who were receiving high-dose, long-term opioid therapy at study entry and didn't achieve a sustained taper during the follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taper PlanOccurrence 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). | Other | Cases, Controls |
Primary outcome
Description of patients with high-dose opioid therapy
Time frame: This study takes place from 2010 to 2017.
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
Taper Plan Assessment
Time frame: This study takes place from 2010 to 2017.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Results publication: PubMed 26476264Von 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.
- Results publication: PubMed 23535150Thielke 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.
- Results publication: PubMed 26814284Von 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.
- Results publication: PubMed 25640294Hylan 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.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers or institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Sullivan, MD, PhD principal investigator
University of Washington
David S Carrell, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiate Replacement Therapy, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of patients with high-dose opioid therapy (time frame: This study takes place from 2010 to 2017.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03748862, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.