Nurse Care Management for Chronic Pain

(AIM-CP Trial)

Overseen By Dennis Ang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Cancer pain, Major surgery, Cognitive impairment, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people in rural areas manage chronic pain without medication. Participants will work with a nurse care manager for six months, receiving support such as cognitive behavioral therapy (CBT), which teaches pain management strategies, and guidance to join online exercise classes. The trial seeks individuals who have experienced ongoing pain for at least three months and are current primary care patients living in rural areas. As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies without medication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-medication treatments for chronic pain, so it's best to discuss your current medications with the trial team.

What prior data suggests that this nurse care management model is safe for chronic pain management?

Research has shown that cognitive behavioral therapy (CBT) is a safe and effective method for helping individuals with chronic pain. Studies have found that CBT can reduce pain and improve pain management without causing harm. It has been used safely to enhance both mental and physical health.

Care coordination, another aspect of this study, is well-received. It involves organizing patient care and has been safely implemented in many healthcare settings to improve outcomes without major issues.

The exercise component, Enhance Fitness, is an online program that helps individuals stay active. Research has demonstrated its safety and effectiveness in easing symptoms of conditions like arthritis. It is easy to follow from home and has not raised any major safety concerns.

Overall, these treatments have proven safe in other settings and conditions, making them a promising option for managing chronic pain in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment for chronic pain because it combines Cognitive Behavioral Therapy (CBT) with personalized care management. Unlike standard treatments that often rely solely on medication, this approach empowers patients to actively manage their pain through skills and strategies learned in CBT. Additionally, the integration of a care manager who provides monthly virtual appointments and referrals to online fitness classes offers a holistic and accessible way to address pain. This comprehensive strategy not only targets the physical aspects of pain but also supports mental and emotional well-being, making it a promising alternative to traditional pain management methods.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that cognitive behavioral therapy (CBT), which participants in this trial will receive, effectively manages chronic pain. Studies indicate that CBT reduces pain and disability more effectively than waiting or receiving standard care. In this trial, all participants will also work with a care manager, a method known as care coordination, which has successfully managed chronic pain over the long term. Additionally, participants will be referred to the Enhance Fitness program, an online exercise class linked to less pain and improved function. Combining these methods in a nurse care management model may provide strong support for people with chronic pain, especially in rural areas. ^{4 5 6 7 8}

Who Is on the Research Team?

Sebastian Tong, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults living in rural areas who suffer from chronic pain. Participants should not have access to non-medication-based treatments and must be willing to engage with a nurse-led care program that includes cognitive therapy and exercise.

Inclusion Criteria

I have been experiencing pain for at least 3 months.

Current primary care patient with one care visit in the last year

Live in a rural area

Exclusion Criteria

I have received training or education for managing pain in the last 6 months.

Living in a nursing home or inpatient treatment facility

Moderate or severe cognitive impairment (documented diagnosis or score 12 or lower on the telephone Montreal Cognitive Assessment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants work with a care manager for 6 months, including monthly virtual appointments, 6-10 sessions of Cognitive Behavioral Therapy (CBT), and referrals to the Enhance Fitness program

6 months

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Care Coordination
• Cognitive Behavioral Therapy (CBT)
• Enhance Fitness

Trial Overview The study tests a Nurse Care Management model which involves coordinating care, providing Cognitive Behavioral Therapy (CBT), and referring patients to an exercise program designed for those with chronic pain, all delivered remotely.

How Is the Trial Designed?

Group I: Care Manager Arm Experimental Treatment 3 Interventions

In this feasibility pilot, all participants will be assigned to work with a care manager for 6 months and receive all components of the intervention. The care manager will meet with participants in virtual appointments every month to create a care plan and monitor progress. The program will also include: 6-10 sessions of Cognitive Behavioral Therapy (CBT) for chronic pain, which focuses on skills and strategies to empower participants to better manage their pain. Finally, the Care Manager will help refer patients to Enhance Fitness, an online community program that allows users to access instructor-led group exercise classes from home.

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A single-session videoconference intervention called empowered relief (ER) significantly reduced pain catastrophizing and improved pain-related outcomes in adults with chronic pain, showing substantial clinical importance at 3 months post-treatment.

Participants reported high satisfaction and engagement with the ER program, suggesting that web-based delivery can enhance accessibility and address barriers to in-person pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Single-Session "Empowered Relief" Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic. Ziadni, MS., Gonzalez-Castro, L., Anderson, S., et al.[2022]

A study involving 14 patients with chronic pain explored their experiences with a high-intensity cognitive-behavioral therapy (CBT) protocol, which included various innovative techniques like tactile attention-shift training and video feedback.

Patients reported varying levels of helpfulness from different CBT components, with memory work being beneficial for nine patients and visual feedback being very helpful for six, indicating that personalized approaches in CBT may enhance treatment outcomes for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. Kutsuzawa, K., Taguchi, K., Shimizu, E.[2022]

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) shows promising effectiveness in primary care settings, with significant improvements in pain intensity and functional limitations observed by the third appointment among 118 patients.

The most effective components of Brief CBT-CP included psychoeducation, goal setting, pacing, and relaxation training, suggesting that these strategies are beneficial for managing chronic pain without relying on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. Beehler, GP., Murphy, JL., King, PR., et al.[2020]

A survey of 152 physical therapists revealed that while only a minority currently use cognitive-behavioral therapy (CBT) techniques like activity pacing (81%) and pleasurable activity scheduling (30%) for treating older patients with chronic pain, there is a significant interest in incorporating these methods into practice.

Barriers to using CBT include a lack of knowledge and skills, concerns about reimbursement, and time constraints, indicating that addressing these issues could enhance the integration of CBT into physical therapy for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Beissner, K., Henderson, CR., Papaleontiou, M., et al.[2021]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

A systematic review of 19 studies on cognitive behavioral therapy (CBT) for chronic pain found that psychological factors like anxiety, depression, and negative thoughts about pain significantly influence treatment outcomes, with medium to large effect sizes.

Sociodemographic factors had only small effects on CBT outcomes and were not consistently replicable, highlighting the need for more research to identify reliable predictors and improve the consistency of study designs in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. Forden, G., Ronaghan, S., Williams, P., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2709080/

Long-term effectiveness of a comprehensive pain ... Overall, this study strengthens the case for interdisciplinary care for chronic pain management and provides evidence for the long-term effectiveness of this ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1524904225001912

Unleashing the Potential of Primary Care Nurses in ... This study aimed to identify and prioritize nursing activities for CP management. A three-round Delphi study was conducted among primary care ...

3. healthviewx.com healthviewx.com/setting-up-team-based-care-coordination-for-chronic-pain-management-cpm-patients/

Setting up Team-Based Care Coordination for Chronic ... Setting up effective team-based care coordination for chronic pain management represents both a significant opportunity and a complex ...

4. qualityhealth.org qualityhealth.org/bree/wp-content/uploads/sites/8/2019/01/Recommendations-Chronic-Pain-Final-2018.pdf

Collaborative Care for Chronic Pain Report and ... Ideally, both acute and chronic pain will be managed and treated over time using a systems approach to allow patients to stay within primary ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06407115

NCT06407115 | Adapting and Implementing a Nurse Care ... This phase allows the study team to prepare for a randomized controlled trial to test the adapted NCM model with rural patients who have chronic pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6784624/

Implementation of a care coordination system for chronic ... Case management primarily provides some care coordination functions for high-risk patients, while the care coordinator strives to complete ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672376/

The Management of Chronic Pain: Re-Centring Person- ... It explores innovative approaches to chronic pain management that have the potential to optimise effectiveness and offer person-centred care.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1555415522002422

Improving Care Coordination of Patients With Chronic ... The Care Coordination Model is a method of examining care transitions that enables the multidisciplinary team to integrate collaboration between clinical care ...