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

NCT ID: NCT07202026

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-29
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Decision Aid Pilot Test

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Clarissa Hsu

Associate Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clarissa W Hsu, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States

Countries

United States

Other Identifiers

R01HS027790

Identifier Type: AHRQ

Identifier Source: secondary_id

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R01HS027790

Identifier Type: AHRQ

Identifier Source: org_study_id

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