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

NCT07202026 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clarissa W Hsu, PhD · Kaiser Permanente

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-29
Primary Completion
2026-03-31
Completion
2026-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07202026 on ClinicalTrials.gov