What this study is
Because of recent policies to decrease opioid use, some people using long-term opioid therapy (LTOT) are encouraged or required to stop (discontinue) taking opioids. That has led experts to be concerned that patients whose LTOT is discontinued could have untreated pain, turn to other substance use and possibly illicit opioids, or have worsened mental health symptoms leading to suicide. To guide safer policies, guidelines, and care, this study will interview patients and doctors about discontinuing LTOT and use the results to develop a patient-centered decision aid (DA) to improve patient-provider communication around discontinuation of LTOT. Once the DA is finalized, it will be pilot tested with a group of 30 patients who are currently on LTOT. The pilot will assess DA implementation feasibility; acceptability; knowledge transfer; and ability to successfully foster positive, patient-centered conversations about opioid discontinuation.
What's being tested
- Patient-centered Decision Aid to support long-term opioid therapy tapering
Intervention · BEHAVIORAL
Earlier aims of this study developed a patient-centered Decision Aid (DA) that uses stories of people who benefited from discontinuing and clear explanations of evidence for key choices to decrease stigma; empower patients; increase engagement and productive interaction with providers in decision making; and reduce fear, anger and anxiety about tapering. The DA will be designed to support conversations that providers often find challenging and help providers maintain patient trust and satisfaction. Participants in the pilot test will be asked to: 1) complete a pre-DA survey, 2) review the DA, 3) have a guided conversation with a trained study interventionist with a behavioral health background who is trained on how to use the DA, and 4) complete a post-DA survey.
Study details
- Official title
- Patient Perspectives on Prescription Opioid Discontinuation: Understanding and Promoting Safe Transitions
- Sponsor
- Kaiser Permanente
- Conditions
- Opioid Tapering
- Enrolling
- 30 people
- Starts
- 2025-10-29
- Est. completion
- 2026-09
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedEHR-based
You may qualify if
- Age 18 or older
- LTOT in the past 18 months (LTOT is ≥60 days of ≥50 MEDs day in each of 2 consecutive 90-day periods with medication treatment for OUD excluded)
You can't join if
- Cancer diagnosis in the last 5 years (excluding non-melanoma skin cancers)
- Current palliative or hospice care
- Cognitive disability
- Psychiatric hospitalization in the last year
- Surgery in the last 6 months
- Current residence in an inpatient rehabilitation or skilled nursing facility
- Participated in an interview for Aim 1 of this study
confirmed by participant
You may qualify if
- Have been taking opioids for chronic pain for at least 6 months
- Able to speak and read English
You can't join if
- Participated in an interview for Aim 1 of this study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openKaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
Study team
Sponsor
Kaiser Permanente
Study ID R01HS027790
Principal investigator
Clarissa W Hsu, PhD
Kaiser Permanente
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.