Prescription Opioid Discontinuation: Honoring Patient Insights and Experience to Support Safe and Caring Transitions -- Decision Aid Pilot

NCT07202026 | Enrolling By Invitation

• 1 other identifier: R01HS027790
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Tapering

Keywords

Chronic pain; Decision Aids; Long-term opioid therapy; Opioid tapering

Outcome Measures

Primary Outcomes (1)

• Acceptability of DA

  We will use Matlock et al.'s acceptability ranking scale to assess the acceptability of the DA to patients

  1-2 weeks

Study Arms (1)

Decision Aid Pilot Test

EXPERIMENTAL

Behavioral: Patient-centered Decision Aid to support long-term opioid therapy tapering

Interventions

Patient-centered Decision Aid to support long-term opioid therapy tapering 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.

Decision Aid Pilot Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• Have been taking opioids for chronic pain for at least 6 months
• Able to speak and read English

You may not qualify 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• University of Arkansas: collaborator
• University of Washington: collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clarissa W Hsu, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Investigator

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: October 29, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)