Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
University of Washington
Study ID
NCT06407115
Status
Enrolling By Invitation

Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy (CBT) — BEHAVIORAL
    CBT in this study will consist of a series of 6-10, 30-45-minute sessions with the care manager. These 1-on-1 sessions will occur every week or every other week virtually. Content will be focus on addressing unhelpful thinking and small behavioral changes that may help participants better manage their pain.
  • Exercise Counseling and tele-EnhanceFitness — BEHAVIORAL
    Participants will be counseling on physical exercise and encouraged enroll in instructor-led exercises classes for up to an hour, 3 days per week. These classes can be accessed from home. Data plans and tablets are available to aid participants that need them to gain access to the classes.
  • Care Coordination — OTHER
    Care manager will meet with patient in virtual sessions once a month to create a care plan and monitor progress. Care manager will assess social determinants of health and link participants to resources in the community as appropriate. In addition, participants will take monthly assessments about pain and mood to help guide clinical decision making.
  • Standard Clinical Practice Regimen — OTHER
    Routine clinical care provided by the primary care team. This may include, consultations, medications, and referrals.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nurse Care Manager Arm
    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.
  • Active Comparator: Treatment as Usual
    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.

Primary Outcome Measure

Pain Interference [ Time Frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health/Wake Forest BaptistWinston-SalemNorth Carolina27157-

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By research site
Atrium Health/Wake Forest Baptist· Winston-Salem, NC

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