Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain (AIM-CP)

University of Washington

Status: Active, not recruiting

Conditions: Chronic Pain

Treatments: Other: Standard Clinical Practice Regimen; Behavioral: Exercise Counseling and tele-EnhanceFitness; Other: Care Coordination; Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06407115

STUDY00019595

4UH3NR020930-02 (U.S. NIH Grant/Contract)

1UG3NR020930 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Chronic pain affects over 20% U.S. adults and has debilitating effects on quality of life and physical and mental health. Individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes due to pain. The 46 million Americans who live in rural areas frequently lack access to evidence-based, non-pharmacologic treatments for chronic pain. As such, a critical need exists to implement effective, comprehensive programs for pain management that include treatment options other than medications. Nurse care management (NCM) has been successfully used to enhance care for individuals with other long-term health issues. The study teams proposes to adapt, pilot, and implement a NCM model that includes care coordination, cognitive behavioral therapy (CBT), and referrals to a remotely delivered exercise program for rural patients with chronic pain.

Full description

Care managers will provide care coordination to help patients address their health holistically and help link them key resources in the community. In addition, the care managers will be trained to deliver cognitive behavioral therapy (CBT) to address unhelpful thought patterns and behaviors around chronic pain and also facilitate patients' participation in physical exercise. One exercise option offered is EnhanceFitness (tele-EF), an evidence-based exercise program that can be accessed from home. The rationale is that both tele-EF and CBT have been independently shown to improve pain, functioning, and quality of life and that care managers could support patients in accessing and engaging in these services.

Phase 1 allowed the study team to prepare for a randomized controlled trial to test the adapted NCM model with rural patients who have chronic pain. Investigators assessed feasibility of implementing this intervention in rural serving health care systems using two practice-based research networks with substantial rural presence, the WWAMI (Washington, Wyoming, Alaska, Montana, and Idaho) region Practice and Research Network and Mecklenburg Area Partnership for Primary Care Research in North Carolina. In combination, recruitment in these two networks will allow the study team to reach ethnically diverse participants across broad rural geographies.

Phase 2 is the randomized controlled trial across multiple sites of the integrated NCM model to test whether it is effective in reducing pain interference.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current primary care patient with one care visit in the last year
• Experience pain for at least 3 months
• Live in a rural area
• Proficient in English
• A total score ≥ 12 on the 3-item Pain, Enjoyment, and General Activities scale

Exclusion criteria

• Pain is cancer-related
• Current treatment with chemotherapy and/or radiation therapy regardless of underlying diagnosis
• Scheduled surgical procedures in the next 6 months
• Has received skills training or education for pain management in the past 6 months
• Moderate or severe cognitive impairment (documented Alzheimer's or dementia diagnosis in EHR or score 12 or lower on the telephone Montreal Cognitive Assessment)
• On palliative care or living in a nursing home or inpatient treatment facility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Nurse Care Manager Arm

Experimental group

Description:

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 counsel participants on physical exercise and refer patients to tele-EnhanceFitness, an online community program that allows users to access instructor-led group exercise classes from home.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Other: Care Coordination

Behavioral: Exercise Counseling and tele-EnhanceFitness

Other: Standard Clinical Practice Regimen

Treatment as Usual

Active Comparator group

Description:

In the Treatment as Usual arm, participants will continue receiving routine care from their primary care team. This may include referrals to specialists or allied health professionals, Given the heterogeneity among patients and between sites, it will be characterized in research assessments to allow for transparent reporting.

Treatment:

Other: Standard Clinical Practice Regimen