Decision Aid for Chronic Pain

(PHOENIX Trial)

Overseen By Sarah J McDonald, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must be taking: Opioids

Disqualifiers: Cancer, Palliative care, Cognitive disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create a tool to help patients and doctors discuss stopping long-term opioid treatment. This is important because suddenly stopping opioids can lead to increased pain or the use of unsafe alternatives. The trial will test whether this patient-centered decision aid improves conversations and understanding about stopping opioid use. Participants should have taken opioids for chronic pain for at least six months and be able to read and speak English. As an unphased trial, this study offers a unique opportunity to contribute to developing a tool that could significantly enhance patient-doctor communication.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it focuses on people who are currently taking long-term opioid therapy. It seems likely that you will continue your current opioid medication during the study.

What prior data suggests that this decision aid is safe for patients on long-term opioid therapy?

Research has shown that tools like the one tested in this study, which facilitate discussions between patients and doctors about treatment options, are generally well-received. These tools simplify the decision-making process for both parties. Studies have found that they can enhance communication and understanding without causing harm.

No evidence suggests that using these tools leads to negative effects. They provide information and support rather than direct medical treatment, so they don't carry the same risks as medications or surgeries. The tool's main goal is to help people make better choices about their care, especially in challenging situations like changing long-term opioid use. So far, this approach appears safe and helpful for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for chronic pain because it empowers patients to take an active role in their treatment choices. Unlike typical treatments that focus on medication or physical therapy, this approach provides a personalized tool to help patients understand their options and decide what works best for them. This patient-centered strategy aims to improve satisfaction and outcomes by aligning treatment decisions with individual values and preferences.

What evidence suggests that this decision aid is effective for improving patient-provider communication around opioid discontinuation?

Research has shown that decision aids, such as the Patient-centered Decision Aid tested in this trial, help patients better understand their treatment options for chronic pain. While these tools increase knowledge, they might not significantly change other outcomes like pain levels or quality of life. Some studies suggest that using these aids to encourage shared decision-making can lead to better pain management. Specifically, combining patient education with decision aids can improve satisfaction in patient-doctor interactions. Overall, these tools aim to enhance communication and assist patients in making informed choices about stopping opioid use. ^{6 7 8 9 10}

Who Is on the Research Team?

Clarissa W Hsu, PhD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for individuals on long-term opioid therapy (LTOT) who are being encouraged or required to stop taking opioids. Participants should be willing to discuss their experiences and use a decision aid designed to improve communication with providers about discontinuing LTOT.

Inclusion Criteria

Able to speak and read English

I am 18 years old or older.

I've been on long-term opioid therapy for pain, not for opioid use disorder, in the past 18 months.

Exclusion Criteria

Cognitive disability

Psychiatric hospitalization in the last year

Current residence in an inpatient rehabilitation or skilled nursing facility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interviews and Decision Aid Development

Interviews with patients and doctors about discontinuing LTOT to develop a patient-centered decision aid

Not specified

Decision Aid Pilot Test

Pilot testing of the decision aid with 30 patients currently on LTOT to assess implementation feasibility, acceptability, and knowledge transfer

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the pilot test

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient-centered Decision Aid

Trial Overview The study is developing and testing a patient-centered decision aid aimed at facilitating better conversations between patients and doctors regarding the safe discontinuation of LTOT. The pilot will involve interviews, development of the tool, and then testing it with 30 patients.

How Is the Trial Designed?

Group I: Decision Aid Pilot Test Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7209464/

Do Decision Aids Benefit Patients with Chronic ... Decision aids may improve patients' knowledge about treatment options for chronic musculoskeletal pain but largely did not impact other outcomes.

2. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/scaling-interoperable-clinical-decision-support-patient-centered-chronic-pain-care

Scaling Interoperable Clinical Decision Support for Patient ... This research will implement and scale a tailored interoperable clinical decision support tool and evaluate its impact on improving patient-centered chronic ...

3. pcori.org pcori.org/research-results/2017/does-motivational-interviewing-plus-cognitive-behavioral-therapy-reduce-opioid-use-among-adults-chronic-pain-better-shared-decision-making-inspire-study

The INSPIRE Study Does Motivational Interviewing Plus Cognitive Behavioral Therapy Reduce Opioid Use Among Adults with Chronic Pain Better Than Shared Decision ...

4. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-022-01217-4

Study protocol for a type III hybrid effectiveness ... We further hypothesize that increases in shared decision making will lead to improved patient outcomes for managing pain and improving physical ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023004364

Cluster-Randomized Comparative Effectiveness Trial of ... We compared patient education versus clinical decision support for managing opioids. Patient education improved overall satisfaction with patient-physician ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12439314/

Primary Care Clinician Perspectives on Older Adult ... Clinical decision support systems (CDSSs) may improve care by integrating guideline-based recommendations, synthesizing relevant patient data, ...

7. digital.ahrq.gov digital.ahrq.gov/sites/default/files/docs/citation/r01hs023306-harle-final-report-2020.pdf

Designing User-Centered Decision Support Tools for Chronic ... The overall objective of this study was to characterize common patterns in information availability, information use, and care planning by primary care ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836549

One-Page Patient Fact Sheets for Low Back Pain in ... This study suggests that fact sheets listing treatment options may better support decision-making than a traditional advice sheet.

9. bmcmedethics.biomedcentral.com bmcmedethics.biomedcentral.com/articles/10.1186/s12910-024-01096-y

Assessment of decision-making autonomy in chronic pain ... Results from the present pilot study suggest that patients suffering from chronic pain do not appear to be entirely autonomous in their decision to consent.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6760988/

Decision-Centered Design of Patient Information ... Conclusion This study designed the Chronic Pain Treatment Tracker, a novel approach to decision support that presents clinicians with the information they need ...