Menu
Enrolling by invitation NCT07202026

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

No phase Interventional Opioid Tapering

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient-centered Decision Aid to support long-term opioid therapy tapering.
Who it may be relevant to
Registry conditions: Opioid Tapering. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Patient Perspectives on Prescription Opioid Discontinuation: Understanding and Promoting Safe Transitions

Overview

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.

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 satisfacti

Primary outcome measures

  • Acceptability of DA [Time frame: 1-2 weeks]

Eligibility criteria

EHR-based 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)

Inclusion criteria confirmed by participant

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

EHR-based 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

Exclusion criteria determined by study

\- participated in an interview for Aim 1 of this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Kaiser Permanente Washington Health Research Institute — Seattle

Identifiers

NCT: NCT07202026 · R01HS027790 · R01HS027790

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗